Tuesday, August 14, 2012

Import Alert 66-40 from FDA--Red List of Foreign Processors: "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs";


Import Alert 66-40

Alert is found here.
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 66-40
Published Date: 07/26/2012
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"

Reason for Alert:
*** Foreign inspections of pharmaceutical manufacturers are being performed. Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).

Detention without physical examination may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveals conditions or practices warranting detention of either particular products or all products manufactured by a firm.

DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA Center. ***

Guidance:
*** Districts may detain, without physical sampling and analysis, the indicated drug products from the foreign processors noted in the Red List of this import alert.

Foreign processors listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation. For guidance on removal from detention without physical examination, refer to FDA�s Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)." Information supporting removal should be sent to CDER's Office of Compliance, (HFD-300). ***

Product Description:
Various drugs (See attachment)

Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control of pharmaceutical products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B)."

OASIS Charge Code: DRUG GMPS


AUSTRALIA

Radpharm Scientific
Date Published : 09/10/2009

57 Oatley Court , Belconnen, AUSTRALIA
66 V I P 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009

Notes:Nexavir


BELGIUM

Qualiphar Nv
Date Published : 01/18/2011

Rijksweg 9 , Bornem, BELGIUM
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/18/2011

Notes:All drug products
60 - - - -- Human and Animal Drugs
Date Published: 01/18/2011

Notes:All drug products
61 - - - -- Human and Animal Drugs
Date Published: 01/18/2011

Notes:All drug products
62 - - - -- Human and Animal Drugs
Date Published: 01/18/2011

Notes:All drug products
63 - - - -- Human and Animal Drugs
Date Published: 01/18/2011

Notes:All drug products
64 - - - -- Human and Animal Drugs
Date Published: 01/18/2011

Notes:All drug products
65 - - - -- Human and Animal Drugs
Date Published: 01/18/2011

Notes:All drug products
66 - - - -- Human and Animal Drugs
Date Published: 01/18/2011

Notes:All drug products


CANADA

Aleeda Inc
Date Published : 05/29/2012

7115 Tomken Rd , , Mississauga, ON CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/29/2012

60 - - - -- Human and Animal Drugs
Date Published: 05/29/2012

61 - - - -- Human and Animal Drugs
Date Published: 05/29/2012

62 - - - -- Human and Animal Drugs
Date Published: 05/29/2012

63 - - - -- Human and Animal Drugs
Date Published: 05/29/2012

64 - - - -- Human and Animal Drugs
Date Published: 05/29/2012

65 - - - -- Human and Animal Drugs
Date Published: 05/29/2012

66 - - - -- Human and Animal Drugs
Date Published: 05/29/2012


Macco Organiques
Date Published : 01/13/2011

100, Rue Mcarthur , Salaberry-de-valleyfield, Quebec CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/13/2011

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products

Pax-All Manufacturing Inc
Date Published : 02/23/2012

7115 Tomken Road , Mississauga, ON CANADA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 02/23/2012

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products


CHINA

BOAI NEW KAIYUAN PHARMACY CO.,LTD.
Date Published : 09/17/2010

No.9 ZhongShan Road , Boai City , Jiaosuo, CN-41 CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2010

Notes:All drug products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/17/2010

Notes:All drug products
60 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
61 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
62 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
63 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
64 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
65 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
66 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products

BOAI NKY PHARMACEUTICALS LTD.
Date Published : 09/17/2010

Suites 1808-9 Guohua Building, 857 Dagu- , Nan Road, Hexi , Tianjin,China , tianjin, CN-12 CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2010

Notes:All drug products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/17/2010

Notes:All drug products
60 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
61 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
62 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
63 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
64 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
65 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
66 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products

Bluetech Chemicals Limited
Date Published : 09/17/2010

Rm 703, No. 25, Lane 175 , Shanghai, CN-31 CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2010

Notes:All drug products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/17/2010

Notes:All drug products
60 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
61 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
62 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
63 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
64 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
65 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
66 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products

Boai Xinda Food Co., Ltd.
Date Published : 09/17/2010

The North Of Dong Wang He, Xiaojing , Boai, CN-41 CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2010

Notes:All drug products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/17/2010

Notes:All drug products
60 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
61 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
62 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
63 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
64 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
65 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
66 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products

Changzhou SPL Company, Ltd.
Date Published : 09/10/2009

3 Changhong West Rd., , Hutang Township, Wujin City , Changzhou, Jiangsu Province CHINA
55 R - - 75 Crude Heparin (Pharmaceutic Necessity)
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
57 D - - 38 Whole Blood (Human) Heparin (Blood and Blood Derivatives)
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
61 L - - 08 Heparin Sodium (Anti-Coagulant)
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
61 L - - 22 Anti-Coagulant Heparin Sol
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
61 L - - 30 Heparin Calcium (Anti-Coagulant)
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
74 L - - IS Heparin Coating Chemicals
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
80 N - - ZW Heparin Vascular access flush
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
81 J - - BR Test, Heparin Neutralization
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
81 J - - OX Analyzer, Heparin, Automated
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
81 K - - FF Assay, Heparin
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008
88 I - - AZ Heparin
Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

Chongqing Imperial Bio Chem Co
Date Published : 09/10/2009

5 Yanghe Sancun , 19-7 Citic Bank Building, Jiangbei Dist. , Chongqing, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009

Chongqing Paiquiang Agribyproduct Co., Ltd
Date Published : 09/10/2009

158 Gonglongpo , Yudong , Chongqing, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All APIs 3/16/2009

Fercy Personal Care Products Co., Ltd
Date Published : 05/10/2012

An'Wen Industrial Zone Pan County , Jinhua, Zhejiang CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/10/2012

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 05/10/2012

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 05/10/2012

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 05/10/2012

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 05/10/2012

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 05/10/2012

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 05/10/2012

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 05/10/2012

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 05/10/2012

Notes:All Drug Products

FriendsUnion(Tianjin) enterprises ltd.
Date Published : 09/17/2010

Suites 1808-9 Guohua Building, 857 Dagu- , Nan Road, Hexi , Tianjin,China , tianjin, CN-12 CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2010

Notes:All drug products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/17/2010

Notes:All drug products
60 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
61 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
62 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
63 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
64 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
65 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
66 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products

Guangdong Pharmaceutical Factory #1
Date Published : 09/10/2009

91 Fangcun Dadao , Guangzhou, CHINA
61 G - - -- A-Bacterial Pt. II (Not Antibiotic)
Date Published: 09/10/2009

Notes:Active Pharmaceutical Ingredients 12/12/1997
61 H - - -- A-Bacterial Pt. III (Not Antibiotic)
Date Published: 09/10/2009

Notes:Active Pharmaceutical Ingredients 12/12/1997

Jiangsu Province Jianerkang Medical Dressing Co.
Date Published : 04/27/2012

Zhizi Town , Jintan City, Jiangsu, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/27/2012

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 04/27/2012

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 04/27/2012

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 04/27/2012

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 04/27/2012

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 04/27/2012

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 04/27/2012

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 04/27/2012

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 04/27/2012

Notes:All Drug Products

Kunshan Chemicals & Pharmaceutical Factory
Date Published : 09/10/2009

No 242 Kun Tai Road , Kunshan City , Jiangsu, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:8/30/2007
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:8/30/2007
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:8/30/2007
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:8/30/2007
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:8/30/2007
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:8/30/2007
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:8/30/2007
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:8/30/2007
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:8/30/2007

Nanjing Maohai Biotech Co.
Date Published : 10/18/2011

8 Developing Zone , Yaxi Town, Gaochun County , Nanjing, Jiangsu Province, CHINA
55 R - - 75 Crude Heparin (Pharmaceutic Necessity)
Date Published: 10/18/2011

Desc:Crude Heparin (Pharmaceutical Necessity)
61 L - - 08 Heparin Sodium (Anti-Coagulant)
Date Published: 10/18/2011

Desc:Heparin Sodium (Anti-Coagulant)

Nanjing Pharmaceutical Factory Co., Ltd.
Date Published : 05/20/2010

No. 9, Fangshui East Road, , Nanjing Chemical Industry Park , Nanjing, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/20/2010

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 05/20/2010

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 05/20/2010

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 05/20/2010

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 05/20/2010

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 05/20/2010

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 05/20/2010

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 05/20/2010

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 05/20/2010

Notes:All Drug Products

Ningbo Smart Pharmaceutical Co., Ltd.
Date Published : 04/08/2011

Sec. C1, Ningbo Eco. & , Tech. Dev. Zone, Beilun District , Ningbo, Zhejiang CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/08/2011

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 04/08/2011

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

Notes:All Drug Products

Northeast Pharmaceutical Group Co., Ltd.
Date Published : 09/10/2009

37 Zhonggong Bei Street , Tiexi District , Shenyang, Liaoning CHINA
45 - - - -- Food Additives (Human Use)
Date Published: 08/28/2010

Notes:All Pharmaceutical Products; *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products.; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
46 - - - -- Food Additives (Human Use)
Date Published: 08/28/2010

Notes:All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 08/28/2010

Notes:*Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:10/30/2007;All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products;NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:10/30/2007 All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:10/30/2007 All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products;NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products;NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

Shanghai Biochemial And Pharmaceutical Co Ltd
Date Published : 09/10/2009

Room A403, No. 494 Zhongxing Road , Shanghai, CHINA
55 R - - 75 Crude Heparin (Pharmaceutic Necessity)
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
57 D - - 38 Whole Blood (Human) Heparin (Blood and Blood Derivatives)
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
61 L - - 08 Heparin Sodium (Anti-Coagulant)
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
61 L - - 22 Anti-Coagulant Heparin Sol
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
61 L - - 30 Heparin Calcium (Anti-Coagulant)
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
74 L - - IS Heparin Coating Chemicals
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
80 N - - ZW Heparin Vascular access flush
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
81 J - - BR Test, Heparin Neutralization
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
81 J - - OX Analyzer, Heparin, Automated
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
81 K - - FF Assay, Heparin
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009
88 I - - AZ Heparin
Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd.
Date Published : 09/10/2009

387 Shangqui Road , Shanghai, CHINA
55 R - - 75 Crude Heparin (Pharmaceutic Necessity)
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
55 R - - 99 Pharmaceutic Necessities, N.E.C.
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
57 D - - 38 Whole Blood (Human) Heparin (Blood and Blood Derivatives)
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
61 L - - 08 Heparin Sodium (Anti-Coagulant)
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
61 L - - 22 Anti-Coagulant Heparin Sol
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
61 L - - 30 Heparin Calcium (Anti-Coagulant)
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
74 L - - IS Heparin Coating Chemicals
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
80 N - - ZW Heparin Vascular access flush
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
81 J - - BR Test, Heparin Neutralization
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
81 J - - OX Analyzer, Heparin, Automated
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
81 K - - FF Assay, Heparin
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009
88 I - - AZ Heparin
Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd.
Date Published : 09/10/2009

1317 Jianchuan Road, , Minhang District , Shanghai, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.

Sichuan Pharmaceutical Co., Ltd.
Date Published : 05/08/2012

189 Hua Long Road , Pengzhou, Sichuan Province CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/08/2012

Notes:All drug products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 05/08/2012

Notes:All drug products
60 - - - -- Human and Animal Drugs
Date Published: 05/08/2012

Notes:All drug products
61 - - - -- Human and Animal Drugs
Date Published: 05/08/2012

Notes:All drug products
62 - - - -- Human and Animal Drugs
Date Published: 05/08/2012

Notes:All drug products
63 - - - -- Human and Animal Drugs
Date Published: 05/08/2012

Notes:All drug products
64 - - - -- Human and Animal Drugs
Date Published: 05/08/2012

Notes:All drug products
65 - - - -- Human and Animal Drugs
Date Published: 05/08/2012

Notes:All drug products
66 - - - -- Human and Animal Drugs
Date Published: 05/08/2012

Notes:All drug products

Tianjin Boai NKY International Ltd.
Date Published : 09/17/2010

Suites 1808-9 Guohua Building , Dagu-Nan Road, Hexi District , Tianjin, CN-12 CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2010

Notes:All drug products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/17/2010

Notes:All drug products
60 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
61 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
62 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
63 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
64 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
65 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
66 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products

Tianjin Boai Pharmaceutical Co. Ltd
Date Published : 09/17/2010

No.4, Ronghua Road, Xiqing District , Yong Hong Industry Zone, Nan He Town , Tianjin, CN-12 CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2010

Notes:All drug products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/17/2010

Notes:All drug products
60 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
61 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
62 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
63 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
64 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
65 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
66 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products

Tianjin Boai Pharmaceutical Ltd. co.
Date Published : 09/17/2010

6, Rd Ronghua , Town Nanhe, Dist. Xiqing , Tianjin , Tianjin, CN-12 CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2010

Notes:All drug products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/17/2010

Notes:All drug products
60 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
61 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
62 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
63 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
64 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
65 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products
66 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All drug products

Zhejiang Casing Animal By-Products Co.,Ltd.
Date Published : 10/18/2011

369 Dong Xing Road , Tonglu Economic Developing District , Hangzhou, Zhejiang Province CN-33 CHINA
61 L - - 08 Heparin Sodium (Anti-Coagulant)
Date Published: 10/18/2011

Desc:Heparin Sodium (Anti-coagulant)


DENMARK

Leo Pharma A/S
Date Published : 03/01/2011

Industriparken 55 , Ballerup, DENMARK
61 L - - 35 Tinzaparin Sodium (Anti-Coagulant)
Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.
61 L - - 99 Anti-Coagulant, N.E.C.
Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.

Leo Pharmaceutical Products
Date Published : 03/01/2011

Park Alle 26 , Vejen, DENMARK
61 L - - 35 Tinzaparin Sodium (Anti-Coagulant)
Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.
61 L - - 99 Anti-Coagulant, N.E.C.
Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.

Leo Pharmaceutical Products
Date Published : 03/01/2011

A 8 , Copenhagen, DENMARK
61 L - - 35 Tinzaparin Sodium (Anti-Coagulant)
Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.
61 L - - 99 Anti-Coagulant, N.E.C.
Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.


FRANCE

Compagnie Oris Industrie Lpib
Date Published : 09/10/2009

B.P. #2 91 Gif-Sur-Yvette , Saclay, FRANCE
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 Injection
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

Compagnie Oris Industrie, S.A.
Date Published : 09/10/2009

Centre D'Etudes Nucleaires De Marcoule , BP 171f , Bagnols, FRANCE
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

Societe Chimique Grevis
Date Published : 09/10/2009

Avenue De La Paix , Limay, FRANCE
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989



GERMANY

Bavarian Red Cross - Augsburg
Date Published : 09/10/2009

Westheimer Strasse 80 , Augsburg, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998
66 U - - -- Nat Body Part (Invivo Only)
Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998

Bavarian Red Cross - Bayreuth
Date Published : 09/10/2009

Dr. Franz-Strasse 3 , Bayreuth, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009

Desc:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998
Notes:Notes
66 U - - -- Nat Body Part (Invivo Only)
Date Published: 09/10/2009

Desc:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998
Notes:Notes

Bavarian Red Cross - Munich
Date Published : 09/10/2009

Herzog-Heinrich Strasse 4 , Munich, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998
66 U - - -- Nat Body Part (Invivo Only)
Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998

Bavarian Red Cross - Nurnberg
Date Published : 09/10/2009

Prof. Ernst Nathan Str. 1 , Nurnberg, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998
66 U - - -- Nat Body Part (Invivo Only)
Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998

Bavarian Red Cross - Regensburg
Date Published : 09/10/2009

Hoher Kreuz Weg 7 , Regensburg, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998
66 U - - -- Nat Body Part (Invivo Only)
Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998

Bavarian Red Cross - Wurzburg
Date Published : 09/10/2009

Klinikstrasse 5 , Wurzburg, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998
66 U - - -- Nat Body Part (Invivo Only)
Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998

Heel Gmbh , Biologische Heilmittel
Date Published : 09/10/2009

Ruhrstr, 14 , Baden, GERMANY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.

Transo-Pharm Handels-GmbH
Date Published : 04/11/2011

Bueltbek 5 , Siek, GERMANY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/11/2011

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 04/11/2011

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 04/11/2011

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 04/11/2011

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 04/11/2011

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 04/11/2011

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 04/11/2011

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 04/11/2011

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 04/11/2011

Notes:All Drug Products


INDIA

Aurobindo Pharma Limited
Date Published : 03/01/2011

Unit VI, Cephalosporin S.B.P., Survey , No. 329/39 & 329/47, Chitkul Village , Hyderabad, Andhra Pradesh, INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/01/2011

56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/01/2011

60 - - - -- Human and Animal Drugs
Date Published: 03/01/2011

61 - - - -- Human and Animal Drugs
Date Published: 03/01/2011

62 - - - -- Human and Animal Drugs
Date Published: 03/01/2011

63 - - - -- Human and Animal Drugs
Date Published: 03/01/2011

64 - - - -- Human and Animal Drugs
Date Published: 03/01/2011

65 - - - -- Human and Animal Drugs
Date Published: 03/01/2011

66 - - - -- Human and Animal Drugs
Date Published: 03/01/2011


Aurobindo Pharma Limited
Date Published : 02/07/2011

Unit VI, Cephalosporin S.B.P., Survey , No. 329/39 & 329/47, Chitkul Village , Hyderabad, Andhra Pradesh, INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 02/07/2011

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 02/28/2011

60 - - - -- Human and Animal Drugs
Date Published: 02/07/2011

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 02/07/2011

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 02/07/2011

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 02/07/2011

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 02/07/2011

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 02/07/2011

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 02/07/2011

Notes:All Drug Products

Claris Lifesciences Limited
Date Published : 06/03/2010

Chacharwadi-vasana , Ahmedabad, Gujarat INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 06/03/2010

Notes:All Sterile Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 06/03/2010

Notes:All Sterile Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 06/03/2010

Notes:All Sterile Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 06/03/2010

Notes:All Sterile Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 06/03/2010

Notes:All Sterile Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 06/03/2010

Notes:All Sterile Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 06/03/2010

Notes:All Sterile Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 06/03/2010

Notes:All Sterile Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 06/03/2010

Notes:All Sterile Drug Products

Fleming Laboratories
Date Published : 04/08/2011

Survey No. 270, Navabpet Village , Sivampet Mandal, INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/08/2011

56 - - - -- Antibiotics (Human/Animal)
Date Published: 04/08/2011

60 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

61 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

62 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

63 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

64 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

65 - - - -- Human and Animal Drugs
Date Published: 04/08/2011

66 - - - -- Human and Animal Drugs
Date Published: 04/08/2011


Fleming Laboratories Limited
Date Published : 04/11/2011

Plot No. 48, Temple Rock Enclave , Tarbund X Road , Secunderabad, INDIA
56 - - - -- Antibiotics (Human/Animal)
Date Published: 04/11/2011

Notes:All Drug Products
73 - - - -- Anesthesiology
Date Published: 04/11/2011

Notes:All Drug Products
74 - - - -- Cardiovascular
Date Published: 04/11/2011

Notes:All Drug Products
76 - - - -- Dental
Date Published: 04/11/2011

Notes:All Drug Products
77 - - - -- Ear,Nose And Throat
Date Published: 04/11/2011

Notes:All Drug Products
78 - - - -- Gastroenterological & Urological
Date Published: 04/11/2011

Notes:All Drug Products
79 - - - -- General & Plastic Surgery
Date Published: 04/11/2011

Notes:All Drug Products
80 - - - -- General Hospital/Personal Use
Date Published: 04/11/2011

Notes:All Drug Products
84 - - - -- Neurological
Date Published: 04/11/2011

Notes:All Drug Products
85 - - - -- Obstetrical & Gynecological
Date Published: 04/11/2011

Notes:All Drug Products
86 - - - -- Ophthalmic
Date Published: 04/11/2011

Notes:All Drug Products
87 - - - -- Orthopedic
Date Published: 04/11/2011

Notes:All Drug Products
89 - - - -- Physical Medicine
Date Published: 04/11/2011

Notes:All Drug Products
90 - - - -- Radiological
Date Published: 04/11/2011

Notes:All Drug Products

Nivedita Chemicals P lTd
Date Published : 11/23/2011

A14 MIDC Andheri East , Mumbai, IN-MH INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
60 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic)
Date Published: 11/23/2011

Desc:Chlorpheniramine maleate
61 X - - 29 Pyrilamine Maleate (Anti-Histaminic)
Date Published: 11/23/2011

Desc:Pyrilamine maleate Pyrilamine maleate USP
61 X - - 29 Pyrilamine Maleate (Anti-Histaminic)
Date Published: 11/23/2011

Desc:Chlorpheniramine maleate
61 X - - 99 Anti-Histaminic N.E.C.
Date Published: 11/23/2011

Desc:Pyrilamine maleate Pyrilamine maleate USP
61 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
62 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
63 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
64 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
65 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
66 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

Nivedita Chemicals Pvt. Ltd.
Date Published : 11/23/2011

A-14 M.I.D.C. Andheri (East) , Maharashtra, MS INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
60 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic)
Date Published: 11/23/2011

Desc:Chlorpheniramine maleate
61 X - - 29 Pyrilamine Maleate (Anti-Histaminic)
Date Published: 11/23/2011

Desc:Chlorpheniramine maleate
61 X - - 29 Pyrilamine Maleate (Anti-Histaminic)
Date Published: 11/23/2011

Desc:Pyrilamine maleate Pyrilamine maleate USP
61 X - - 99 Anti-Histaminic N.E.C.
Date Published: 11/23/2011

Desc:Pyrilamine maleate Pyrilamine maleate USP
61 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
62 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
63 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
64 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
65 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate
66 - - - -- Human and Animal Drugs
Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

Ranbaxy Laboratories, Limited
Date Published : 09/10/2009

Paonta Sahib , Himachal Pradesh , Simour District, INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

Ranbaxy Laboratories, Ltd.
Date Published : 09/10/2009

Industrial Area No. 3 , Madhya Pradesh , Dewas, Mp INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

Stericon Pharma Pvt. Ltd.
Date Published : 01/13/2011

No. 9, Sub Layout Of Plot 9 , 1st Phase Bommasandra Ind. Area , Bangalore, Karnataka, INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/13/2011

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 01/13/2011

Notes:All Drug Products

Wintac Limited
Date Published : 03/27/2012

163 Reservior Str , Bangalore, INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/27/2012

60 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

61 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

62 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

63 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

64 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

65 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

66 - - - -- Human and Animal Drugs
Date Published: 03/27/2012


Wintac Limited
Date Published : 03/27/2012

54/1, Boodihal Village, Nelamangala , Taluk , Bangalore, INDIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/27/2012

60 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

61 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

62 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

63 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

64 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

65 - - - -- Human and Animal Drugs
Date Published: 03/27/2012

66 - - - -- Human and Animal Drugs
Date Published: 03/27/2012


Yag Mag Labs Private Limited
Date Published : 09/13/2011

Survey No. 10, Gaddapotharam Village, , Jinnatam Mandel , Medak District, AP, INDIA
60 L - - 69 Tramadol HCl (Analgesic)
Date Published: 09/13/2011

Desc:Tramadol HCl (Analgesic)
60 L - - 99 Analgesic, N.E.C.
Date Published: 09/13/2011

Desc:Tramadol HCl (Analgesic)
64 H - - 02 Guaifenesin (Expectorant)
Date Published: 09/13/2011

Desc:Guaifensein (Expectorant)


ITALY

Topchem SRL
Date Published : 09/10/2009

Viale Andrea Doria 17 , Milano, MI ITALY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992


MEXICO

Compania Internacional de Comercio, S.A. de C.V.
Date Published : 05/17/2012

Calle Monzon No. 184 , Col.Cerro de la Estrella , Mexico, D.F., MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/17/2012

56 - - - -- Antibiotics (Human/Animal)
Date Published: 05/17/2012

60 - - - -- Human and Animal Drugs
Date Published: 05/17/2012

61 - - - -- Human and Animal Drugs
Date Published: 05/17/2012

62 - - - -- Human and Animal Drugs
Date Published: 05/17/2012

63 - - - -- Human and Animal Drugs
Date Published: 05/17/2012

64 - - - -- Human and Animal Drugs
Date Published: 05/17/2012

65 - - - -- Human and Animal Drugs
Date Published: 05/17/2012

66 - - - -- Human and Animal Drugs
Date Published: 05/17/2012


Farma Quimia S.A. de C.V.
Date Published : 02/23/2012

Av Andre Marie Ampere No 11 , Parque Industrial Cuamatla , Cuautitlan Izcalli, Mex MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 02/23/2012

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 02/23/2012

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 02/23/2012

Notes:All Drug Products

Laboratorios Jaloma S.A. de C.V.
Date Published : 03/09/2012

Aquiles Serdan No. 438 , Guadalajara, JAL MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/09/2012

60 - - - -- Human and Animal Drugs
Date Published: 03/09/2012

61 - - - -- Human and Animal Drugs
Date Published: 03/09/2012

62 - - - -- Human and Animal Drugs
Date Published: 03/09/2012

63 - - - -- Human and Animal Drugs
Date Published: 03/09/2012

64 - - - -- Human and Animal Drugs
Date Published: 03/09/2012

65 - - - -- Human and Animal Drugs
Date Published: 03/09/2012

66 - - - -- Human and Animal Drugs
Date Published: 03/09/2012


Selder S.A. de C.V.
Date Published : 04/10/2012

Fernando Villapando #48 , Colonia Guadalupe Inn , Mexico, D.F., MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/10/2012

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 04/10/2012

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 04/10/2012

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 04/10/2012

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 04/10/2012

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 04/10/2012

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 04/10/2012

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 04/10/2012

Notes:All Drug Products


POLAND

Nobilus Ent
Date Published : 03/05/2012

Ul Metalowa 6a , Kutno, POLAND
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/05/2012

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/05/2012

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products

Nobilus Ent
Date Published : 03/05/2012

Swarzewska 45 , Warszawa, POLAND
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/05/2012

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/05/2012

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 03/05/2012

Notes:All Drug Products


SERBIA

Hemofarm a.d.
Date Published : 04/26/2012

Beogradski put bb , Vrsac, SERBIA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/26/2012

60 - - - -- Human and Animal Drugs
Date Published: 04/26/2012

61 - - - -- Human and Animal Drugs
Date Published: 04/26/2012

62 - - - -- Human and Animal Drugs
Date Published: 04/26/2012

63 - - - -- Human and Animal Drugs
Date Published: 04/26/2012

64 - - - -- Human and Animal Drugs
Date Published: 04/26/2012

65 - - - -- Human and Animal Drugs
Date Published: 04/26/2012

66 - - - -- Human and Animal Drugs
Date Published: 04/26/2012



SOUTH AFRICA

Clover Production
Date Published : 09/17/2010

200 Constantia Drive , Weltevreden Park , johannesburg, ZA-GT SOUTH AFRICA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/17/2010

Notes:All sterile drug products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/17/2010

Notes:All sterile drug products
60 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All sterile drug products
61 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All sterile drug products
62 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All sterile drug products
63 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All sterile drug products
64 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All sterile drug products
65 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All sterile drug products
66 - - - -- Human and Animal Drugs
Date Published: 09/17/2010

Notes:All sterile drug products


SPAIN

Dysers S.A.L.
Date Published : 09/10/2009

Depositos 12 , Segovia, SPAIN
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992


TURKEY

Ansa
Date Published : 09/10/2009

UNKNOWN , Izmit, TURKEY
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009



UNITED ARAB EMIRATES

Gulf Pharmaceutical Industries
Date Published : 01/31/2012

Airport Road, Digdaga , Ras Al-Khaimah, UNITED ARAB EMIRATES
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/31/2012

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 01/31/2012

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 01/31/2012

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 01/31/2012

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 01/31/2012

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 01/31/2012

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 01/31/2012

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 01/31/2012

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 01/31/2012

Notes:All Drug Products


UNITED KINGDOM

A Nelson & Co., Ltd.
Date Published : 06/26/2012

5-9 Endeavour Way , Wimbledon, London UNITED KINGDOM
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 06/26/2012

60 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

61 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

62 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

63 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

64 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

65 - - - -- Human and Animal Drugs
Date Published: 06/26/2012

66 - - - -- Human and Animal Drugs
Date Published: 06/26/2012


Fresenius Kabi Oncology Plc
Date Published : 09/10/2009

Lion Court Farnham Road , Bordon, Hampshire UNITED KINGDOM
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/10/2009

Notes:All finished pharmaceutical products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:All finished pharmaceutical products
60 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products
61 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products
62 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products
63 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products
64 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products
65 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All finished pharmaceutical products

Hampshire Chemicals, Ltd.
Date Published : 09/10/2009

Seal Sands Road , Middlesborough, Cleveland UNITED KINGDOM
56 - - S -- Antibiotics (Human/Animal)
Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996
60 - - S -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996
61 - - S -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996
62 - - S -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996
63 - - S -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996
64 - - S -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996
65 - - S -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996
66 - - S -- Human and Animal Drugs
Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996


VENEZUELA

LABORATORIOS LO OFTALMI CA
Date Published : 05/14/2010

CTO. EMPRESARIAL "RS", CALLE 6 , ZONA INDUSTRIAL LA URBINA , Caracas, VE-NOTA VENEZUELA
56 - - - -- Antibiotics (Human/Animal)
Date Published: 05/14/2010

Notes:All Drug Products
73 - - - -- Anesthesiology
Date Published: 05/14/2010

Notes:All Drug Products
74 - - - -- Cardiovascular
Date Published: 05/14/2010

Notes:All Drug Products
76 - - - -- Dental
Date Published: 05/14/2010

Notes:All Drug Products
77 - - - -- Ear,Nose And Throat
Date Published: 05/14/2010

Notes:All Drug Products
78 - - - -- Gastroenterological & Urological
Date Published: 05/14/2010

Notes:All Drug Products
79 - - - -- General & Plastic Surgery
Date Published: 05/14/2010

Notes:All Drug Products
80 - - - -- General Hospital/Personal Use
Date Published: 05/14/2010

Notes:All Drug Products
84 - - - -- Neurological
Date Published: 05/14/2010

Notes:All Drug Products
85 - - - -- Obstetrical & Gynecological
Date Published: 05/14/2010

Notes:All Drug Products
86 - - - -- Ophthalmic
Date Published: 05/14/2010

Notes:All Drug Products
87 - - - -- Orthopedic
Date Published: 05/14/2010

Notes:All Drug Products
89 - - - -- Physical Medicine
Date Published: 05/14/2010

Notes:All Drug Products
90 - - - -- Radiological
Date Published: 05/14/2010

Notes:All Drug Products

Laboratorios L.O. Oftalmi, C.A.
Date Published : 05/14/2010

Calle 6, Centro Empresarial R.S. , Zona Industrial de La Urbina , Caracas, VENEZUELA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/14/2010

Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 05/14/2010

Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 05/14/2010

Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 05/14/2010

Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 05/14/2010

Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 05/14/2010

Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 05/14/2010

Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 05/14/2010

Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 05/14/2010

Notes:All Drug Products

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