| Joseph Alexander, New Delhi Monday, August 06, 2012, 08:00 Hrs [IST] |
India and China may together move the World Trade Organisation (WTO) against the European Union (EU) regulation on bulk drugs which may affect the current exports of Active Pharmaceutical Ingredients (APIs) from both the countries to Europe.
EU has changed the rules for importing active substances into EU for medicinal products for human use and the amended regulation would come into effect fully by July 2013. It would make mandatory the current good manufacturing practices (cGMP) certificate from the local authority for all bulk drugs exports.
To read the remainder of the article, click here.
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Showing posts with label China. Show all posts
Showing posts with label China. Show all posts
Sunday, August 5, 2012
India, China plan to jointly oppose EU regulation on API at WTO forum
China detains almost 2,000 in fake drug sweep
BEIJING |
BEIJING (Reuters) - Chinese police have
detained almost 2,000 people in a nationwide sweep on fake drugs, seizing more
than $180 million worth of counterfeit products and destroying some 1,100
production facilities, the public security ministry said on
Sunday.
The operation, involving around 18,000 police officers, discovered fake or
adulterated drugs purporting to deal with illnesses ranging from diabetes to
high blood pressure and rabies, the ministry said in a statement on its website
(www.mps.gov.cn).To read the remainder of the article click here.
Doing Business in China - Considerations for Effectively Leveraging Emerging Markets
The U.S. economic slowdown and the Eurozone debt crisis have created pressure in the pharma industry that shows no signs of relenting. Yet, with the global pharma market forecasted to languish in single digit growth, emerging markets such as Brazil, China, India, Mexico, Russia and Turkey anticipate double digit growth nearing 14 percent through to 2014. 1
It is clear that China and other emerging markets are set to occupy an expanding share of pharma’s geographical portfolio. Of these, China has emerged as central to many U.S. pharma strategies. According to a recent market analysis by IMS, the compound annual growth rate of the Chinese pharmaceutical market over the next five years will be 23.2 percent. Growth has been rapid: China is on course to become the world’s third-largest prescription medicines market, after the U.S. and Japan. 2
To continue reading this article published August 1, 2012, click here.
Thursday, July 5, 2012
Exit the dragon Indian drug makers are trying to shake off their dependence on China
Geetanjali Shukla Edition: May 27, 2012
It's a no-brainer that buying from a Chinese supplier is cheaper than from a Japanese one, right? Pravin Herlekar, Chairman of Omkar Speciality Chemicals, a Rs 100-crore bulk drug maker based in Badlapur, near Mumbai, learned the hard way that it is not always true. His company dumped its Japanese supplier of selenium when it found a cheaper source in China. But, Herlekar says, the Chinese suppliers resisted inspection of shipments before delivery. Within a few months, the intermediates that Omkar made using Chinese selenium began to suffer from quality issues. The company went back to sourcing selenium from Japan.
"Chinese suppliers often don't agree to third party inspections which help keep a check on quality," says Herlekar. Selenium derivatives are used to make an active pharmaceutical ingredient (API) or bulk drug. Bulk drugs are used to make medicines. For instance, intermediate compounds such as isobutyl benzene, aluminium chloride and sodium dichromate are used to make ibuprofen, the principal ingredient in formulation brands such as Combiflam.
With strong advantages such as economies of scale and government funding, Chinese companies have been flexing their muscles by resisting inspections, neglecting quality issues and raising prices. Many Indian companies are finding or creating alternatives to Chinese suppliers"
Lower prices offered by Chinese companies have caught the attention of many Indian drug makers. "In the last five years, API imports by Indian companies have doubled. In 2010/11, imports crossed $7 billion, of which China has a 60 per cent share," says O.R.S. Rao, Director, Cygnus Business Consulting and Research. "In the same period, India's bulk drug production has fallen to 35 per cent of its consumption, from about 70 per cent." The Hyderabad-based research firm releases a study on the Indian bulk drug industry every two years; the last edition was published in 2011. The Indian bulk drug market is valued at $13.5 billion, and its Chinese counterpart at $30 billion.
China and India are the leading players in bulk drugs, accounting for more than 40 percent of global bulk drug production. China is the largest bulk drug supplier, and India is second. Part of China's competitive advantage comes from the operating environment (lower interest rates, access to power and other infrastructure) and government aid (cheaper land, government funding). This has enabled Chinese manufacturers to benefit from economies of scale. China is also better endowed with raw materials such as phosphorous, potassium and sulphur. So it can produce bulk drugs at 10 percent of the cost in developed countries.
In 2010/11, bulk drug imports by Indian companies crossed dollar 7 billion, of which China has a 60 per cent share: O.R.S. RaoGiven their strong advantages, Chinese companies have been flexing their muscles by not allowing inspections, neglecting quality issues and raising prices. And Indian pharma seems to have finally decided that it needs to stop depending on China. Some Indian companies are integrating their operations backward to increase control over bulk drugs and intermediates. And, as price increases by Chinese manufacturers squeeze margins, Indian companies are trying to move up the value chain into the high-margin formulations business. Dependence on China has generated enough concerns for the Indian Drug Manufacturers' Association (IDMA) to call for anti-dumping duties on some bulk drugs and intermediates from China. IDMA also wants the government to set up a $700-million fund for bulk drug manufacturers. "Low-priced Chinese APIs are attractive, but this phenomenon can only be temporary," says Manish Doshi, President, IDMA.
"Nothing can stop them from raising prices once they know that Indian API manufacturers have closed down due to cut-throat competition. It is the government's duty to protect the industry from such dumping tactics by China." Doshi is also Managing Director at Amoli Organics and Umedica Laboratories, companies which were set up by his father and which make intermediates, bulk drugs and finished drugs. Naresh Gupta, who heads Lupin Laboratories's bulk drug unit, also argues that the government should try to level the playing field for Indian manufacturers. Incidentally, Lupin is the only Indian pharma major that exports bulk drugs to China.
Omkar Speciality Chemicals isn't waiting for the government act, however. Its strategy is to meet international standards. Its Badlapur factory has good manufacturing practices (GMP) status from the US Food and Drugs Administration. Regulatory authorities in many countries grant GMP status, but the most important for Indian companies are the US and British authorities, besides Indian regulators. Omkar will also seek GMP status for its factory coming up in Chiplun, Maharashtra. Herlekar says his advantage will be quality. "Indian formulations majors are increasingly sourcing from India, as they don't have to maintain large stocks and quality can be controlled," he says. "Most Indian API and intermediates manufacturers get their facilities audited by their customers, so quality isn't much of an issue."
Another strategy is backward integration. Shasun Chemicals and drugs, a Chennai-based Rs 1,000-crore company, has decided to manufacture some intermediates at its Andhra Pradesh plant, rather than importing them from China. Managing Director S. Abhaya Kumar says: "We have earmarked Rs 70 crore to move production of some of our key intermediates to India. The shift should be complete by December." He adds that intermediate prices in China have increased by 10 per cent in the last three months, because of rising petroleum prices and pressure on China to adhere to environmental norms. Shasun is the largest producer of ibuprofen in the world. It is developing 13 APIs for a few billion-dollar drugs whose patents expire in the next five years.
Another way to integrate backward is to acquire a bulk drug maker. For example, Mumbai-based Aanjaneya Lifecare bought intermediates manufacturer Apex Drugs in February for Rs 250 crore. The aim is to reduce dependence on third parties and reduce its vulnerability to fluctuations in price and supply. Similarly, Indoco Remedies, also based in Mumbai, acquired bulk drug maker La Nova Chem in 2006. The contribution of bulk drugs to overall revenues is negligible, but Indoco plans capital expenditure of Rs 55 crore over the next couple of years in its bulk drug factory at Patalganga, near Mumbai.
To counter the Chinese, big Indian drug makers such as Dr. Reddy's, Ranbaxy and Lupin have been moving up the value chain, from intermediates and bulk drugs to generics. But not everyone finds it easy to walk away from China.
"Only intermediates that have an impact on the quality of the finished product are manufactured in India or inhouse," says Sanjay Bhanushali, Head of International Business at Cipla. Procurement from China has increased five to eight per cent every year for the last three years." Cipla is looking at stronger alliances with other Indian or overseas companies to avoid sudden shocks. It is also open to dealing with companies in other markets, such as Brazil, Argentina, and Vietnam.
Lupin's Gupta says his company's Japanese operations are looking to shift all bulk drug manufacturing to India. "Despite price volatility in some inputs, the company was able to insulate itself due to hedging," he adds. Quality and research differentiate India from China. India has more than 175 plants approved by the US FDA - the highest number outside the US. Focus on quality has helped Indian companies increase their presence in developed markets. According to a report published in April by HSBC Global Research, half the Drug Master Files (DMF) in the first three months of this year are from Indian companies, compared to China's share of 14 per cent. DMF documents contain complete information about a drug's chemistry and manufacturing process, among other things, and enable a company to protect its intellectual property.
Many medium-sized bulk drug manufacturers have, with investments in research and development, shifted focus to late-stage intermediates and complex synthetic APIs. Chandigarh-based Parabolic Drugs , a Rs 900-crore company, recently commissioned a facility to manufacture bulk drugs in new therapy areas such as oncology and lifestyle ailments such as diabetes. The facility is likely to generate revenues of Rs 50 crore to Rs 75 crore in the current financial year and when fully operational, can generate up to Rs 300 crore.
But in the near future, it looks as if Chinese companies will continue to bleed Indian bulk drug makers. The capital-intensive nature of operations and extended working capital cycles have suppressed their return on capital. "Many bulk drug manufacturers are struggling financially," says Ajit Mahadevan, Partner - Life Sciences, Ernst & Young. "A lot of them are looking for funds and finding it difficult to manage them in these times." It may be a while before they are strong enough to fend off the dragon.
Article is located here.
It's a no-brainer that buying from a Chinese supplier is cheaper than from a Japanese one, right? Pravin Herlekar, Chairman of Omkar Speciality Chemicals, a Rs 100-crore bulk drug maker based in Badlapur, near Mumbai, learned the hard way that it is not always true. His company dumped its Japanese supplier of selenium when it found a cheaper source in China. But, Herlekar says, the Chinese suppliers resisted inspection of shipments before delivery. Within a few months, the intermediates that Omkar made using Chinese selenium began to suffer from quality issues. The company went back to sourcing selenium from Japan.
"Chinese suppliers often don't agree to third party inspections which help keep a check on quality," says Herlekar. Selenium derivatives are used to make an active pharmaceutical ingredient (API) or bulk drug. Bulk drugs are used to make medicines. For instance, intermediate compounds such as isobutyl benzene, aluminium chloride and sodium dichromate are used to make ibuprofen, the principal ingredient in formulation brands such as Combiflam.
With strong advantages such as economies of scale and government funding, Chinese companies have been flexing their muscles by resisting inspections, neglecting quality issues and raising prices. Many Indian companies are finding or creating alternatives to Chinese suppliers"
Lower prices offered by Chinese companies have caught the attention of many Indian drug makers. "In the last five years, API imports by Indian companies have doubled. In 2010/11, imports crossed $7 billion, of which China has a 60 per cent share," says O.R.S. Rao, Director, Cygnus Business Consulting and Research. "In the same period, India's bulk drug production has fallen to 35 per cent of its consumption, from about 70 per cent." The Hyderabad-based research firm releases a study on the Indian bulk drug industry every two years; the last edition was published in 2011. The Indian bulk drug market is valued at $13.5 billion, and its Chinese counterpart at $30 billion.
China and India are the leading players in bulk drugs, accounting for more than 40 percent of global bulk drug production. China is the largest bulk drug supplier, and India is second. Part of China's competitive advantage comes from the operating environment (lower interest rates, access to power and other infrastructure) and government aid (cheaper land, government funding). This has enabled Chinese manufacturers to benefit from economies of scale. China is also better endowed with raw materials such as phosphorous, potassium and sulphur. So it can produce bulk drugs at 10 percent of the cost in developed countries.
In 2010/11, bulk drug imports by Indian companies crossed dollar 7 billion, of which China has a 60 per cent share: O.R.S. RaoGiven their strong advantages, Chinese companies have been flexing their muscles by not allowing inspections, neglecting quality issues and raising prices. And Indian pharma seems to have finally decided that it needs to stop depending on China. Some Indian companies are integrating their operations backward to increase control over bulk drugs and intermediates. And, as price increases by Chinese manufacturers squeeze margins, Indian companies are trying to move up the value chain into the high-margin formulations business. Dependence on China has generated enough concerns for the Indian Drug Manufacturers' Association (IDMA) to call for anti-dumping duties on some bulk drugs and intermediates from China. IDMA also wants the government to set up a $700-million fund for bulk drug manufacturers. "Low-priced Chinese APIs are attractive, but this phenomenon can only be temporary," says Manish Doshi, President, IDMA.
"Nothing can stop them from raising prices once they know that Indian API manufacturers have closed down due to cut-throat competition. It is the government's duty to protect the industry from such dumping tactics by China." Doshi is also Managing Director at Amoli Organics and Umedica Laboratories, companies which were set up by his father and which make intermediates, bulk drugs and finished drugs. Naresh Gupta, who heads Lupin Laboratories's bulk drug unit, also argues that the government should try to level the playing field for Indian manufacturers. Incidentally, Lupin is the only Indian pharma major that exports bulk drugs to China.
Omkar Speciality Chemicals isn't waiting for the government act, however. Its strategy is to meet international standards. Its Badlapur factory has good manufacturing practices (GMP) status from the US Food and Drugs Administration. Regulatory authorities in many countries grant GMP status, but the most important for Indian companies are the US and British authorities, besides Indian regulators. Omkar will also seek GMP status for its factory coming up in Chiplun, Maharashtra. Herlekar says his advantage will be quality. "Indian formulations majors are increasingly sourcing from India, as they don't have to maintain large stocks and quality can be controlled," he says. "Most Indian API and intermediates manufacturers get their facilities audited by their customers, so quality isn't much of an issue."
Another strategy is backward integration. Shasun Chemicals and drugs, a Chennai-based Rs 1,000-crore company, has decided to manufacture some intermediates at its Andhra Pradesh plant, rather than importing them from China. Managing Director S. Abhaya Kumar says: "We have earmarked Rs 70 crore to move production of some of our key intermediates to India. The shift should be complete by December." He adds that intermediate prices in China have increased by 10 per cent in the last three months, because of rising petroleum prices and pressure on China to adhere to environmental norms. Shasun is the largest producer of ibuprofen in the world. It is developing 13 APIs for a few billion-dollar drugs whose patents expire in the next five years.
Another way to integrate backward is to acquire a bulk drug maker. For example, Mumbai-based Aanjaneya Lifecare bought intermediates manufacturer Apex Drugs in February for Rs 250 crore. The aim is to reduce dependence on third parties and reduce its vulnerability to fluctuations in price and supply. Similarly, Indoco Remedies, also based in Mumbai, acquired bulk drug maker La Nova Chem in 2006. The contribution of bulk drugs to overall revenues is negligible, but Indoco plans capital expenditure of Rs 55 crore over the next couple of years in its bulk drug factory at Patalganga, near Mumbai.
To counter the Chinese, big Indian drug makers such as Dr. Reddy's, Ranbaxy and Lupin have been moving up the value chain, from intermediates and bulk drugs to generics. But not everyone finds it easy to walk away from China.
"Only intermediates that have an impact on the quality of the finished product are manufactured in India or inhouse," says Sanjay Bhanushali, Head of International Business at Cipla. Procurement from China has increased five to eight per cent every year for the last three years." Cipla is looking at stronger alliances with other Indian or overseas companies to avoid sudden shocks. It is also open to dealing with companies in other markets, such as Brazil, Argentina, and Vietnam.
Lupin's Gupta says his company's Japanese operations are looking to shift all bulk drug manufacturing to India. "Despite price volatility in some inputs, the company was able to insulate itself due to hedging," he adds. Quality and research differentiate India from China. India has more than 175 plants approved by the US FDA - the highest number outside the US. Focus on quality has helped Indian companies increase their presence in developed markets. According to a report published in April by HSBC Global Research, half the Drug Master Files (DMF) in the first three months of this year are from Indian companies, compared to China's share of 14 per cent. DMF documents contain complete information about a drug's chemistry and manufacturing process, among other things, and enable a company to protect its intellectual property.
Many medium-sized bulk drug manufacturers have, with investments in research and development, shifted focus to late-stage intermediates and complex synthetic APIs. Chandigarh-based Parabolic Drugs , a Rs 900-crore company, recently commissioned a facility to manufacture bulk drugs in new therapy areas such as oncology and lifestyle ailments such as diabetes. The facility is likely to generate revenues of Rs 50 crore to Rs 75 crore in the current financial year and when fully operational, can generate up to Rs 300 crore.
But in the near future, it looks as if Chinese companies will continue to bleed Indian bulk drug makers. The capital-intensive nature of operations and extended working capital cycles have suppressed their return on capital. "Many bulk drug manufacturers are struggling financially," says Ajit Mahadevan, Partner - Life Sciences, Ernst & Young. "A lot of them are looking for funds and finding it difficult to manage them in these times." It may be a while before they are strong enough to fend off the dragon.
Article is located here.
Saturday, June 30, 2012
Corporate HGH Smuggler Gets Fine
From the Steroids Bodybuilding Peptides and SARMS Blog:
Corporate HGH Smuggler Gets Tiny Fine
Corporate HGH Smuggler Gets Tiny Fine
A Plattsburgh pharmaceutical company and
its president, a Canadian citizen, were fined $15,000 this week for mislabeling
more than $1 million worth of human growth hormone that was imported from China
and distributed to pharmacies around the country.
The case has ties to a 2007 investigation by the Albany County district attorney's office targeting pharmaceutical companies that illegally sold steroids and other anti-aging drugs.
Antonio Dos Santos, 63, of Montreal and Plattsburgh-based Medisca, Inc., also must forfeit $1.76 million to the U.S. government. Dos Santos and the company pleaded guilty to misdemeanor federal drug charges last October in Albany.
U.S. Magistrate David R. Homer this week ordered Dos Santos to pay a $5,000 fine and the company to pay $10,000.
A former Orlando pharmacy, Signature Compounding Pharmacy, whose owners and operators are under indictment, was among the customers of Medisca, Inc., which also has a corporate office in St. Laurent, Quebec.
John L. Pacht, an attorney from Burlington, Vt., entered a guilty plea on behalf of Medisca last fall.
Plea agreements signed by Dos Santos and Pacht said that between July 2004 and February 2007 Medisca imported 1,737 grams of human growth hormone from China. The criminal accusation is that the company marketed the drug as an "FDA approved drug" which is false, federal prosecutors said.
Dos Santos founded Medisca in 1989. The $1.76 million forfeiture represents the company's gross profits from the unlawful drug sales.
The company ceased importing human growth hormone in February 2007. That month, a multi-agency task force raided Orlando's Signature Compounding Pharmacy. The arrests of Signature's operators were made on warrants filed by Albany County prosecutors who obtained felony indictments against Signature's operators related to the alleged sale of performance-enhancing drugs, including steroids, to customers that included pro athletes and celebrities.
Albany County prosecutors have said Medisca was a primary supplier of Signature pharmacy.
Albany prosecutors allege in their charges that Signature was selling growth hormone to people nationwide who had no legitimate medical reason for the drug.
The plea agreements require Medisca face spot checks by the U.S. Food and Drug Administration for one year. The company must pay the costs of those inspections.
Dos Santos had faced up to a year in prison and a fine of up to $100,000.
Records show Dos Santos, who founded Medisca in 1989, pleaded guilty to a similar charge for illegally importing shipments of minoxidil (Rogaine), a hair-growing product, from Canada into the United States in 1989, when it was prohibited.
The Minnesota conviction was vacated in 2007 after Dos Santos' lawyers filed a motion arguing his plea was flawed and that minoxidil is now approved for distribution in the United States.
The case has ties to a 2007 investigation by the Albany County district attorney's office targeting pharmaceutical companies that illegally sold steroids and other anti-aging drugs.
Antonio Dos Santos, 63, of Montreal and Plattsburgh-based Medisca, Inc., also must forfeit $1.76 million to the U.S. government. Dos Santos and the company pleaded guilty to misdemeanor federal drug charges last October in Albany.
U.S. Magistrate David R. Homer this week ordered Dos Santos to pay a $5,000 fine and the company to pay $10,000.
A former Orlando pharmacy, Signature Compounding Pharmacy, whose owners and operators are under indictment, was among the customers of Medisca, Inc., which also has a corporate office in St. Laurent, Quebec.
John L. Pacht, an attorney from Burlington, Vt., entered a guilty plea on behalf of Medisca last fall.
Plea agreements signed by Dos Santos and Pacht said that between July 2004 and February 2007 Medisca imported 1,737 grams of human growth hormone from China. The criminal accusation is that the company marketed the drug as an "FDA approved drug" which is false, federal prosecutors said.
Dos Santos founded Medisca in 1989. The $1.76 million forfeiture represents the company's gross profits from the unlawful drug sales.
The company ceased importing human growth hormone in February 2007. That month, a multi-agency task force raided Orlando's Signature Compounding Pharmacy. The arrests of Signature's operators were made on warrants filed by Albany County prosecutors who obtained felony indictments against Signature's operators related to the alleged sale of performance-enhancing drugs, including steroids, to customers that included pro athletes and celebrities.
Albany County prosecutors have said Medisca was a primary supplier of Signature pharmacy.
Albany prosecutors allege in their charges that Signature was selling growth hormone to people nationwide who had no legitimate medical reason for the drug.
The plea agreements require Medisca face spot checks by the U.S. Food and Drug Administration for one year. The company must pay the costs of those inspections.
Dos Santos had faced up to a year in prison and a fine of up to $100,000.
Records show Dos Santos, who founded Medisca in 1989, pleaded guilty to a similar charge for illegally importing shipments of minoxidil (Rogaine), a hair-growing product, from Canada into the United States in 1989, when it was prohibited.
The Minnesota conviction was vacated in 2007 after Dos Santos' lawyers filed a motion arguing his plea was flawed and that minoxidil is now approved for distribution in the United States.
Tuesday, June 26, 2012
Prosecution for Introduction of Misbranded Prescription Drugs Imported From China
U.S. Department of Justice Press Release
|
|---|
For Immediate Release
June 14, 2012 |
United States Attorney
Southern District of Texas
Contact: Angela Dodge
Public Affairs Officer
(713) 567-9388
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Friday, June 22, 2012
China Cracks Down on Sale of Compounds Containing Ephedrine
China cracks down on illegal sales of drugs
Updated: 2012-05-31 13:24
BEIJING - China's drug watchdog has urged local authorities to mete out severe punishments on illegal sales of compound drugs containing ephedrine, calling for stricter control over these drugs that can easily be turned into meth.
In a circular published on its website earlier this week, the State Food and Drug Administration (SFDA) urged local drug authorities to seriously implement relevant laws and regulations on controlled drugs and strictly control the production and marketing of ephedrine-containing drugs.
Drug regulatory authorities will revoke the production or marketing licenses of pharmacies and enterprises that sell compound drugs containing ephedrine for making meth through illegal channels, regardless of the quantity, the circular said.
The circular came after a number of cases in which a great deal of compound drugs containing ephedrine, such as the cold remedy New Contac, were sold in some pharmacies around the country, giving rise to meth-making opportunities.
In Lishui county of East China's Jiangsu province, a pharmacy sold 400 boxes of New Contac to an unidentified person in June 2011, violating a regulation limiting the sale of ephedrine-containing drugs to 50 pills, or five 10-pill boxes. The drugs were used to make meth, and the pharmacy's marketing license has been revoked, the circular said.
The SFDA also called for strictly controlling ephedrine-containing compound drugs, widely publicizing and educating the public on the risks of ephedrine and raising enterprises' awareness.
In a circular published on its website earlier this week, the State Food and Drug Administration (SFDA) urged local drug authorities to seriously implement relevant laws and regulations on controlled drugs and strictly control the production and marketing of ephedrine-containing drugs.
Drug regulatory authorities will revoke the production or marketing licenses of pharmacies and enterprises that sell compound drugs containing ephedrine for making meth through illegal channels, regardless of the quantity, the circular said.
The circular came after a number of cases in which a great deal of compound drugs containing ephedrine, such as the cold remedy New Contac, were sold in some pharmacies around the country, giving rise to meth-making opportunities.
In Lishui county of East China's Jiangsu province, a pharmacy sold 400 boxes of New Contac to an unidentified person in June 2011, violating a regulation limiting the sale of ephedrine-containing drugs to 50 pills, or five 10-pill boxes. The drugs were used to make meth, and the pharmacy's marketing license has been revoked, the circular said.
The SFDA also called for strictly controlling ephedrine-containing compound drugs, widely publicizing and educating the public on the risks of ephedrine and raising enterprises' awareness.
Monday, June 11, 2012
FDA Warning Letter to Sichuan Pharmaceutical Co., Ltd./ API from China
Warning Letter
VIA UPS MAIL
WL: 320-11-019
September 09, 2011
Mr. Wang Gouping
General Manager
Sichuan Pharmaceutical Co., Ltd.
No. 189 Hualong Road
Pengzhou, Sichuan, China 611930
General Manager
Sichuan Pharmaceutical Co., Ltd.
No. 189 Hualong Road
Pengzhou, Sichuan, China 611930
Dear Mr. Gouping:
During our June 23 to 29, 2010 inspection of your active pharmaceutical ingredient (API) manufacturing facility, Sichuan Pharmaceutical Co., Ltd. located at No. 189 Hualong Road, Pengzhou, Sichuan, China, an investigator from the Food and Drug Administration (FDA) identified significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs. These deviations cause your API(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
We have reviewed your firm’s response of August 05, 2010 and December 13, 2010, and note that it lacks sufficient corrective actions.
Specific deviations observed during the inspection include, but are not limited, to the following:
Specific deviations observed during the inspection include, but are not limited, to the following:
1. Failure to have appropriate procedures in place to prevent cross-contamination.
From September 2008 to July 2009 your firm manufactured (b)(4) API in workshop (b)(4), which is adjacent to workshops (b)(4) and (b)(4) where you manufactured (b)(4) API and (b)(4) injection, respectively. However, you failed to have adequate controls and monitoring program to prevent cross-contamination between these adjacent workshops.
In addition, your firm manufactures a (b)(4) API ((b)(4) (API) in a facility that was previously used to manufacture (b)(4) without conducting adequate decontamination, renovation, and activation of the facility. Your firm has failed to conduct adequate assessment of the cross-contamination risks.
Please note that analytical testing of a product for possible contamination with (b)(4) is not sufficient to ensure adequate conditions for (b)(4) manufacture. In your response to this letter include your plans for decontamination, renovation, and reactivation (if appropriate) of your facility including the decontamination agent, decontamination plans, analytical methodology for environmental and product testing, and the data obtained to support the effectiveness of the decontamination plan.
The deviations detailed in this letter are not intended to be an all-inclusive statement of deviations that exist at your facility. You are responsible for investigating and determining the causes of the deviations identified above and for preventing their recurrence and the occurrence of other deviations. If you wish to continue to ship APIs to the United States, it is the responsibility of your firm to ensure compliance with all U.S. standards for CGMP and all applicable U.S. laws and regulations.
Additionally, your firm is neither registered nor has it listed every API in commercial distribution in the United States with FDA, as required by 21 C.F.R. § 207.40 and section 510(i) of the Act [21 U.S.C. § 360(i)]. Information on how to register and list is available at the following internet website:http://www.fda.gov/cder/drls/registration_listing.htm. You must complete the required registration and listing and provide evidence that you have fulfilled these requirements in your response to this letter.
Until all corrections have been completed and FDA has confirmed corrections of the deviations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer. In addition, failure to correct these deviations may result in FDA refusing admission of articles manufactured at Sichuan Pharmaceutical Co., Ltd. located at No. 189 Hualong Road, Pengzhou, Sichuan, China into the United States. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act [21 U.S.C. § 381(a)(3)] in that the methods and controls used in their manufacture do not appear to conform to Current Good Manufacturing Practice within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C. § 351(a)(2)(B)].
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct deviations. Include an explanation of each step being taken to prevent the recurrence of deviations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
Additionally, your response should state if you no longer manufacture or distribute (b)(4) API and provide the date(s) and reason(s) you ceased production. Please identify your response with FEI # 3002808073.
If you have questions or concerns regarding this letter, contact Milva E. Meléndez, Compliance Officer, at the below address and telephone number.
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (301) 796-0662
Fax: (301) 847-8741
Center for Drug Evaluation and Research
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (301) 796-0662
Fax: (301) 847-8741
Sincerely,
/Steven Lynn/
Steven Lynn
Director
Office of Manufacturing and Product Quality
Office of Compliance
Steven Lynn
Director
Office of Manufacturing and Product Quality
Office of Compliance
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
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.
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
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
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
OASIS Charge Code: DRUG GMPs
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
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
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
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
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
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
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
Notes:Aliases;Qingzhou United
61 L - - -- A-Coagulant
Date Published: 02/22/2012
Desc:Heparin and Heparin-related products
Notes:Aliases; Qingzhou United
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
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