FDA Has Lots of New Guidance Planned for 2013, including Track and Trace and Compounding

Draft Guidances For 2013 Will Grapple With Biosimilars, Track and Trace, Compounding

By Brenda Sandburg / Email the Author / Feb. 11, 2013 
Regulatory Update / Word Count: 928 / Article # 00130211012 / Posted: February 11 2013 12:00 AM

---

Executive Summary

FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.

To buy this report, click here

FDA Guidelines Regarding Drug Inspections

The FDA website contains the following guidance regarding drug inspections:

5.5 - DRUGS

 5.5.1 - DRUG INSPECTIONS

Authority for inspection is discussed in IOM 2.2. FD&C Act Sections 501(a)-(d) [21 U.S.C. 351(a)-(d)] describe the ways in which a drug may be or may become adulterated. Section 502 of the FD&C Act [21 U.S.C. 352] does the same, with respect to misbranding. Section 505 of the FD&C Act [21 U.S.C. 355] requires that new drugs be approved by FDA. Therefore, the purposes of a drug inspection are:

1. To evaluate a firm's adherence to the concepts of sanitation and good manufacturing practice; i.e.,production and control procedures include all reasonable precautions to ensure the identity, strength, quality, and purity of the finished products;
2. To identify deficiencies that could lead to the manufacturing and distribution of products in violation of the Act, e.g., non-conformance with Official Compendia, super/sub potency, substitution;
3. To determine whether a firm is distributing drugs that lack required FDA approval including counterfeit or diverted drugs;
4. To obtain correction of those deficiencies;
5. To determine if new drugs are manufactured by the same procedures and formulations as specified in the New Drug Application documents;
6. To determine the drug labeling and promotional practices of the firm;
7. To assure the firm is reporting NDA field alerts as required by 21 CFR 314.81 and Biological Product Deviation Reports (BPDRs) for therapeutic biological products as required by 21 CFR 600.14;
8. To determine if the firm is complying with the requirements of the Prescription Drug Marketing Act (PDMA) and regulations; and
9. To determine the disposition of Drug Quality Reports (DQRS) received from the Division of Compliance Risk Management and Surveillance/CDER; and
10. To determine if the firm is complying with postmarket Adverse Drug Experience reporting requirements as required by 21 CFR sections 310.305 (prescription drugs without approved NDA/ANDA), 314.80, 314.98, and 314.540 (application drug products), and 600.80 (therapeutic biological products), and Section 760 of the FD&C Act (non-application nonprescription products) [21 U.S.C. 379aa].

 5.5.1.1 - Preparation and References

Become familiar with current programs related to drugs. Determine the nature of the assignment, i.e., a specific drug problem or a routine inspection, and if necessary, consult other district personnel, such as chemists, microbiologists, etc., or center personnel, such as office of compliance staff. Review the district files of the firm to be inspected including:

1. Establishment Inspection Reports,
2. District Profiles,
3. OTC monographs and other pertinent references for non-application products,
4. Drug Applications (New, Abbreviated and Investigational) and the Knowledge Transfer Memo, if the Center has provided it for a specific pre-approval inspection,
5. Therapeutic Biologics License Applications,
6. Sample results,
7. Complaints and Recalls,
8. Regulatory files,
9. Drug Quality Reports (DQRs), NDA Field Alert Reports (FARs), and Biological Product Deviation Reports (BPDRs), 
10. Drug Registration and Listing 

During this review identify products which:

1. Are difficult to manufacture,
2. Require special tests or assays, or can not be assayed,
3. Require special processes or equipment, and
4. Are new drugs and/or potent low dosage drugs.
5. Are misbranded, unapproved, fraudulent, or compounded drugs containing ingredients that have been withdrawn or removed from the market for safety reasons.

Review the factory jacket, FACTS OEI and registration/listing data, and all complaint reports which are marked follow-up next inspection. These complaints are to be investigated during the inspection and discussed with management. See IOM 5.2.7.

Become familiar with current regulations and programs relating to drugs, CP 7356.002, et al. When making GMP inspections, discuss with your supervisor the advisability of using a microbiologist, analyst, engineer, or other technical personnel to aid in evaluating those areas of the firm germane to their expertise. Review the FD&C Act, Chapter V, Drugs and Devices. Review parts of 21 CFR 210/211 applicable to the inspection involved and Bioavailability (21 CFR 320). In the case of APIs, review FD&C Act section 501(a)(2)(B) [21 U.S.C 351(a)(2)(b)] and the ICH industry guideline entitled "Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients."

Review the current editions of the United States Pharmacopeia (USP), and Remington's Pharmaceutical Sciences for information on specific products or dosage forms. For compounding pharmacies, review USP Chapters 795 and 797. IOM 1.10.3 also provides a link to a consolidated list of pertinent guides and guidelines which may be applicable during drug inspections.

Review 21 CFR 203 "Prescription Drug Marketing", 21 CFR 205 "Guidelines for State Licensing of Rx Drug Distributors", and CP 7356.022, Enforcement of the Prescription Drug Marketing Act (PDMA).

Before conducting drug preapproval inspections (CP 7346.832) it is important to be familiar with the application and coordinate accomplishment of Center goals communicated by (1) inspectional memos, (2) pre-inspection briefings, and/or (3) Center participation on the inspection team.

Before conducting an inspection that may involve postmarketing adverse drug experience reporting, you should review 21 CFR Sections 310.305, 314.80, 314.98, 314.540, and 600.80, Section 760 of the FD&C Act[21 U.S.C. 379aa], CP 7353.001, and the training video, 'Field Investigators: Adverse Drug Effects (ADE) Detectives,' available online at http://www.fda.gov/Training/ForHealthProfessionals/ucm091001.htm.

The Office of Manufacturing and Product Quality (OMPQ) in CDER has established two mechanisms for you to obtain technical assistance before, during, or after an inspection: 

1. Office of Manufacturing and Product Quality (OMPQ) Subject Contacts.  This list contains the names and phone numbers of OMPQ individuals identified as technical specialists in various areas.
2. Questions and Answers on Current Good Manufacturing Practices for Drugs (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124740.htm).  This forum is intended to provide timely answers to questions about the meaning and application ofCGMPs for human, animal, and biological drugs, and to share these widely.  These questions and answers generally clarify statements of existing requirements or policy.

 5.5.1.2 - Inspectional Approach

Follow Compliance Program Guidance Manual (CP) 7356.002 and others as appropriate when conducting CGMP inspections.  In-depth inspection of all manufacturing and control operations is usually not feasible or practical. A risk-based systems audit approach is recommended in which higher risk, therapeutically significant, medically necessary, and difficult to manufacture drugs are covered in greater detail during an inspection. (Note: The status of a drug as medically necessary is determined by CDER, Office of New Drugs, Drug Shortages; They can be reached at 301-796-1300 and via email - drugshortages@fda.hhs.gov) The latter group includes, but is not limited to, time release and low dose products, metered dose aerosols, aseptically processed drugs, and formulations with components that are not freely soluble.

CP 7356.002 incorporates the systems-based approach to conducting an inspection and identifies six (6) systems in a drug establishment for inspection: Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling and Laboratory Control Systems.  The full inspection option includes coverage of at least four (4) of the systems; the abbreviated inspection option covers of at least two (2) systems. In both cases,  CP 7356.002, indicates the Quality System be selected as one of the systems being covered.  During the evaluation of the Quality System it is important to determine if top management makes science-based decisions and acts promptly to identify, investigate, correct, and prevent manufacturing problems likely to, or have led to, product quality problems.

When inspecting drug manufacturers marketing a number of drugs meeting the risk criteria, the following may help you identify suspect products:

1. Reviewing the firm's complaint files early in the inspection to determine relative numbers of complaints per product.
2. Inspecting the quarantine, returned, reprocessed, and/or rejected product storage areas to identify rejected product.
3. Identifying those products which have process control problems and batch rejections via review of processing trends and examining reviews performed under 21 CFR 211.180(e).
4. Reviewing summaries of laboratory data (e.g., laboratory workbooks), OOS investigations, and laboratory deviation reports.

 5.5.1.3 - CDER Bio-research Monitoring

Bio-research monitoring (BIMO) assignments for drugs will generally be issued by the Center for Drug Evaluation and Research (CDER) (see IOM 5.5.6).

 5.5.2 - DRUG REGISTRATION & LISTING

Registration and listing is required whether or not interstate commerce is involved. See Exhibit 5-12 and IOM 2.9.1.1 for additional information.

Two or more companies occupying the same premises and having interlocking management are considered one establishment and usually will be assigned a single registration number. See IOM 5.1.1.11 - Multiple Occupancy Inspections for additional information.

Independent laboratories providing analytical or other laboratory control services on commercially marketed drugs must register.

FACTS will indicate if the establishment is registered for the current year. If you determine registration and listing is required, advise your supervisor. After checking for past registration, cancellation, etc., the district will provide the firm with the proper forms and instructions.

Each establishment is required to list with FDA every drug in commercial distribution, whether or not the output of such establishment or any particular drug so listed enters interstate commerce.  During the establishment inspection, you should remind the firm of its responsibilities for ensuring its drug listing accurately reflects the current product line and updating its listing as necessary to include all product changes, NDC changes, and discontinuations in accordance with 21 CFR 207. If registration and listing deficiencies are found, document it in your EIR, collect a documentary sample and/or contact your supervisor.

 5.5.3 - PROMOTION AND ADVERTISING

21 CFR 202.1 which pertains only to prescription drugs, covers advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems. Determine what department or individual is responsible for promotion and advertising and how this responsibility is demonstrated. Ascertain what media (radio, television, newspapers, trade journals, etc.) are utilized to promote products.

Do not routinely collect examples of current advertising. Advertising should be collected only on assignment, or if, in your opinion, it is clearly in violation of Section 502(n) of the FD&C Act [21 U.S.C. 352 (n)] or 21 CFR 202.1.

FDA Field Guidance: Detention Without Physical Examination of Heparin and Related Products for Current Good Manufacturing Practices

In April 2012, the FDA issued the following field guidance:

 

Import Alert Name:

Detention Without Physical Examination of Different Forms of Heparin and Heparin- 
Related Products for CGMP Issues

Reason for Alert:

Heparin is a widely used anti-coagulant and is commonly used during surgical procedures and for those undergoing dialysis. There are an estimated 12 million Americans that use heparin each year. In 2008, a number of deaths in the United States were associated with either contaminated or adulterated heparin. The adverse events have included allergic or hypersensitivity-type reactions, with symptoms such as low blood pressure, angioedema, shortness of breath, nausea, diarrhea, and abdominal pain. 

The vast majority of crude heparin, heparin intermediates, and heparin API used in finished drug product in the United States is imported from other countries. The phrase "different forms of heparin and heparin-related products" is used for brevity to refer to articles such as crude heparin, heparin intermediates, heparin active pharmaceutical ingredient (API), heparin products, and heparin-containing products. 

As part of FDA's activities intended to protect the health and safety of U.S. consumers, FDA often conducts inspections of foreign establishments that produce FDA-regulated articles intended for use in the United States. One basis for detention without physical examination is that the firm's quality system is inadequate for the prevention of contamination or otherwise does not conform to CGMP. Heparin contaminated with oversulfated chondroitin sulfate (OSCS) clearly indicates that the "methods used in" or the "controls used for" the "manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity" with CGMP. OSCS is not part of the manufacturing process for heparin and its presence suggests that somewhere in the supply chain OSCS has been added intentionally to heparin for financial reasons because it is a very cheap material prepared by a simple synthetic process. In addition, it mimics certain heparin properties so that it would pass then current United States Pharmacopeia (USP) specifications for Heparin Sodium USP. (The USP has since revised in 2009 its monograph for Heparin Sodium USP to incorporate tests that can detect the presence of OSCS). 

Manufacturers must have adequate traceability, qualification, and testing systems in place in order to satisfy applicable CGMP requirements. Where there is an inspection that identifies an inadequate system in this regard, the firm's drug(s) or other products appear to be adulterated and are subject to imports refusal per 801(a)(3). 

Furthermore, if the firm appears to have been responsible for introducing contaminated forms of heparin or heparin-related products into the supply chain, then there is an appearance that the firm's quality system is inadequate or otherwise does not conform to CGMP. If the firm demonstrates that they have appropriate controls in place, the firm's drugs or other products may no longer appear to be adulterated. 

The attachment to this alert identifies firms for which we have information indicating that the different forms of heparin or heparin-related products appear to be adulterated for one of the reasons described above. It appears per 801(a) that the methods used in and controls used for the manufacture, processing, packing, or holding of the drugs or other products from the firms listed in the attachment do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B); therefore such articles are subject to refusal of admission into the United States.

Guidance:

Districts may detain without physical examination all forms of heparin and heparin-related products from the firm(s) identified on the attachment to this import alert. 

Since the article appears to be adulterated due to inadequate GMPs and is subject to Refusal of Admission per Section 801(a)(3) of the Act, FDA considers reconditioning or submission of analytical results to be insufficient to overcome the appearance of the violation. Drugs and other products offered for importation from the firm(s) listed on the attachment to this import alert are subject to detention without physical examination until FDA is satisfied that the appearance of a violation has been removed, either by inspection, reinspection, submission of documentation, and/or other actions requested by the FDA. 

Firms may provide copies of inspection reports for inspections performed by third parties to assist FDA in prioritizing inspection requests. An establishment wishing to schedule an FDA inspection or to provide a copy of an inspection report conducted by a third party, should do so by submitting a request or documentation to the following address: 

Food and Drug Administration 
Division of Import Operations and Policy (HFC-170) 
12420 Parklawn Drive, ELEM-3109 
Rockville, MD 20857 

Or via email: Importalerts2@fda.hhs.gov

Product Description:

Different Forms of Heparin and Heparin-Related Products (e.g., Crude Heparin, Heparin Intermediates, Heparin Active Pharmaceutical Ingredient (API), Heparin Products, and Heparin-Containing Products) from the firms listed below. 

PROBLEM: Good Manufacturing Practices

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other 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

---

 

 

 

 

The Following companies are subject to this guidance:

---

CHINA

---

Casing Factory Jintan City

Date Published : 02/22/2012

7 Bei Huan West Road , Jin Chen , Jintan City, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products 
Notes:Aliases;Jintan Yongmao Casing Co. LtdJintan Caliber Casing Co. Ltd

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products 
Notes:Aliases; Jintan Yongmao Casing Co. Ltd Jintan Caliber Casing Co. Ltd

Changsha Wulipai Food Stuff Factory

Date Published : 02/22/2012

"No 8 Bayi Road , Changsha, , Hunan, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Changzhou SPL Company, Ltd.

Date Published : 02/22/2012

3 Changhong West Rd., , Hutang Township, Wujin City , Changzhou, Jiangsu Province CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Chongqing Baijie Changhong Casing Co., Ltd

Date Published : 04/04/2012

Baijie, , Chongqing, CHINA

55 R - - 75 Crude Heparin (Pharmaceutic Necessity)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

55 R - - 99 Pharmaceutic Necessities, N.E.C.

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 08 Heparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 22 Anti-Coagulant Heparin Sol

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 26 Ardeparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 27 Dalteparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 29 Enoxaparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 30 Heparin Calcium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 35 Tinzaparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 99 Anti-Coagulant, N.E.C.

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

74 L - - IS Heparin Coating Chemicals

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

Chongqing Imperial Bio Chem Co

Date Published : 02/22/2012

5 Yanghe Sancun , 19-7 Citic Bank Building, Jiangbei Dist. , Chongqing, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Chongqing Paiquiang Agribyproduct Co., Ltd

Date Published : 02/22/2012

158 Gonglongpo , Yudong , Chongqing, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

HEILONGJIANG YUANGUANG CASING CO., LTD.

Date Published : 02/22/2012

7 Bohai Rd., Jizhong District , Haping Rd. Develop. District , Harbin, CN-23 CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products 
Notes:Alias;Heilongjiang Yuanguang Caliber Casing Co.; LtdAlternate Address;No.7 Bohai East Road;Jizhong District HeilongjiangChina

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products 
Notes:Alias; Heilongjiang Yuanguang Caliber Casing Co.; Ltd Alternate Address; No.7 Bohai East Road; Jizhong District Heilongjiang China

Henan Zhengping Huixin

Date Published : 02/22/2012

Fuzhuang Yangying Town , "Zhengping, , Henan, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products 
Notes:Aliases;Henan Zhengping Huixin

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products 
Notes:Aliases; Henan Zhengping Huixin

Hubei Anlu Food Stuff Factory

Date Published : 02/22/2012

Xinli Village, Zhuzhan Town , Xiaogan City, , Hubei, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 K - - -- A-Cholinergic

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Jiangsu Long Life Group

Date Published : 02/22/2012

No. 216 Renshou Rd. , Rucheng Town, Rugao, , Jiangsu, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Junan Hengxing Foodstuff Co., Ltd

Date Published : 02/22/2012

No. 126 Meishan Rd , Ju'nan County, , Shandong, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Nanjing Maohai Biotech Co.

Date Published : 02/22/2012

8 Developing Zone , Yaxi Town, Gaochun County , Nanjing, Jiangsu Province, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Nantong Jianhua Casing Co. Ltd

Date Published : 02/22/2012

Linjiang Village/Langshan Town, , Nantong, , Jiangsu , CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Qingdao Hualu Foods Co., Ltd

Date Published : 02/22/2012

Industrial Park of Jiaodong Town , Jiaozhou, , Qingdao, CHINA

55 Q - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Shandong Union Food Stuff Qingzhou Branch*

Date Published : 02/22/2012

Mojiacun Subu Town , Qingzhou, , Shandong, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products 
Notes:Aliases;Qingzhou United

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products 
Notes:Aliases; Qingzhou United

Shanghai Biochemial And Pharmaceutical Co Ltd

Date Published : 02/22/2012

Room A403, No. 494 Zhongxing Road , Shanghai, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd.

Date Published : 02/22/2012

387 Shangqui Road , Shanghai, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd.

Date Published : 02/22/2012

1317 Jianchuan Road, , Minhang District , Shanghai, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Sichuan Shuangliu Food Stuff Factory

Date Published : 02/22/2012

61 Wujiaba Nort Street , Shuangliu, , Sichuan, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Sichuan Zhongjiang Xiongjian Casing Co.

Date Published : 04/04/2012

"Kanjiang, , Zhongjiang, , Sichuan, CHINA

55 R - - 75 Crude Heparin (Pharmaceutic Necessity)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

55 R - - 99 Pharmaceutic Necessities, N.E.C.

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 08 Heparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 22 Anti-Coagulant Heparin Sol

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 26 Ardeparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 27 Dalteparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 29 Enoxaparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 30 Heparin Calcium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 35 Tinzaparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 99 Anti-Coagulant, N.E.C.

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

74 L - - IS Heparin Coating Chemicals

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

Weifang Legang Food Ltd.

Date Published : 02/22/2012

No. 1 Honghe Street , Honghe Town, Changle County , Weifang , Shandong, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Xinjiang Lanshanbinggong Food Factory

Date Published : 02/22/2012

No31 QinjianRoad , Gumudi Town, Miquan City, , Xinjiang, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Xuzhou City Mianshang Fengxian Shengda Casing Factory

Date Published : 02/22/2012

Zhangshicheng Village , Zhaozhuang Town , Xuzhou, Jiangsu, CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Zhejiang Casing Animal By-Products Co.,Ltd.

Date Published : 02/22/2012

369 Dong Xing Road , Tonglu Economic Developing District , Hangzhou, Zhejiang Province CN-33 CHINA

55 R - - -- Pharm Nec (Mfr)

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

61 L - - -- A-Coagulant

Date Published: 02/22/2012

Desc:Heparin and Heparin-related products

Zhengzhou Yuanlong Casing Co., Ltd

Date Published : 04/04/2012

"Renmin Road, , Zhengzhou, , Henan, CHINA

55 R - - 75 Crude Heparin (Pharmaceutic Necessity)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

55 R - - 99 Pharmaceutic Necessities, N.E.C.

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 08 Heparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 22 Anti-Coagulant Heparin Sol

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 26 Ardeparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 27 Dalteparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 29 Enoxaparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 30 Heparin Calcium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 35 Tinzaparin Sodium (Anti-Coagulant)

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

61 L - - 99 Anti-Coagulant, N.E.C.

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

74 L - - IS Heparin Coating Chemicals

Date Published: 04/04/2012

Desc:Heparin and Heparin-Related Products

To view entire guidance, click here.

 

-