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Data-integrity concerns in Europe at Teva & Interpharma raise the drug shortage versus quality debate

In June this year, PharmaCompass was the first to report that Teva’s newly-built sterile manufacturing facility in Hungary had been placed on FDA’s import alert list. The FDA warning letter to Teva, released this week, shares details of what went wrong. As has been seen with other sterile manufacturing facilities – such as that of Hospira (now Pfizer), Agila Speciaties (now Mylan) and Sun Pharma – Teva’s facility failed to “adequately investigate media fill and sterility test failures”. According to the FDA, “media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.” “These failures indicate that there is a lack of adequate sterility assurance in your manufacturing facility,” the warning letter to Teva said. Data integrity concerns not limited to Asia The warning letter makes it amply clear that data integrity concerns are not limited to India and China. While data integrity concerns at Asian companies have been hogging the news headlines, similar problems exist in Europe too. In the case of Teva’s Hungary plant, FDA’s investigators found “quality-related documents in a waste bin”. Investigators also found Teva’s “stand-alone computer systems” to have lacked controls (such as routine audit trail review and full data retention) to prevent analysts from deleting data. In addition, the warning letter said that the “colony counts for environmental and personnel monitoring” did not match the plant’s official records. “After an error was observed on the original data sheet, the record was torn and discarded with no written explanation,” the warning letter said. All drugs produced at Teva’s finished dosage forms facility in Hungary (barring antibiotics Amikacin and Bleomycin) were placed on the import alert list. Data manipulation at Otsuka’s Czech subsidiary While Teva’s facility was placed on an import alert, a Czech-based subsidiary of Otsuka Pharmaceuticals – Interpharma Praha, a.s. – also received a warning letter. Interpharma, which became a wholly-owned subsidiary of Otsuka in 2008, manufactures active pharmaceutical ingredients (APIs) and finished products. FDA inspectors found that while testing APIs, analysts “used to generate and analyze chromatographic data that allowed them to eliminate failing, atypical and satisfactory results with no notification; alter peak areas; and add or eliminate samples from sequences without authorization.” During inspection, the FDA reviewed an audit trail from its “Empower-2 system that stored 8,906 entries. Of these, well over half indicated some form of data deletion or manipulation, including at least 1,441 instances of deleted results,” the FDA said. Interpharma’s personnel confirmed “that these actions are common during chromatographic data processing.” While reviewing the finished products at Interpharma, FDA investigators uncovered “many deleted results” which made them question whether the quality unit was “presented with incomplete and inaccurate information”. Our three vital observations in the two cases PharmaCompass has made the following three observations pertaining to the inspections at Teva and Interpharma, and their outcomes: Both these inspections took place in Europe, as against Asia. Interpharma was not placed on FDA’s import alert, even though the FDA reached the same conclusion here, as it did in the case of Teva’s Hungarian plant – that the quality system did not adequately ensure the “adequacy and integrity of data to support the safety, effectiveness, and quality of drugs” it manufactures. The most interesting observation made by PharmaCompass is that while Teva’s products were banned from entering the United States within four months of the inspection – that occurred between January 21 and 29, 2016, nothing of the kind happened in the case of Interpharma. The inspection at Interpharma took place from October 12 to 16, 2015. And in July 2016, Interpharma’s new oral contrast reagent for abdominal scans got approved. Does data integrity have a relationship with product quality? This brings us to the statement made by Peter Werth some months back in our Speak Pharma series, which had raised the hackles amongst some in the pharma industry – that ‘Data integrity has no relationships with product quality’. Was Werth right in saying so? With a large chunk of drugs and drug ingredients being manufactured outside the US, the American regulator has had to increase its international oversight and ban products manufactured in plants that do not meet regulatory standards. However, these bans have led to drug shortages. In order to prevent drug shortages, the FDA has (sometimes) had to exempt products and allow imports from plants that it believes have a poor record. According to the FDA import alert records, since 2013 the FDA has allowed eight plants whose products are otherwise banned from the US to go ahead and import some drugs or ingredients to avoid drug shortages. Amikacin manufactured at Teva’s Hungary plant is once such drug. However, the FDA’s exemption to prevent a drug shortage suffered a setback when Teva announced a voluntary recall of seven lots of Amikacin Sulfate injection due to the potential for the presence of glass particulate matter. This announcement follows a similar announcement by Teva when one lot of Amikacin was recalled in March this year. ” Our view With all the compliance alerts that make headlines, if products still reach the market after regulators uncover concerns related to data integrity, it is worth investigating the link between data integrity violations and patient/product safety?

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27 Oct 2016

Compliance troubles emerge at Pfizer, Teva, Wockhardt and Xiamen Origin

It has been an unprecedented week where compliance glitches have emerged from almost all parts of the globe. This week, PharmaCompass brings you a compilation of such troubles to give you an idea about the nature of such compliance issues. And, the problems regulators are facing walking the tightrope between drug safety and drug availability. Pfizer halts production in India after joint inspection by four regulatorsPfizer recently halted production at a plant near Chennai in India, after a PIC/S (short for Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) joint inspection with regulators from four international agencies, MHRA (Medicines and Healthcare products Regulatory Agency of the UK), USFDA (United States Food and Drug Administration), TGA (Therapeutic Goods Administration of Australia) and Health Canada, found various quality control problems. A Pfizer spokesperson told The Economic Times: “A holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations.” The plant was acquired by Pfizer through its US $ 17 billion acquisition of Hospira, which had run into a fair share of manufacturing compliance problems with the FDA. Over the last few years, numerous Hospira plants — including those in the United States, Europe, Asia, and Australia — received warning letters and had to subsequently issue product recalls. The same facility in Chennai received an FDA warning letter in 2013. Pfizer’s own operations in Asia ran into problems when US FDA investigator Peter Baker uncovered data integrity malpractices at a finished dosage manufacturing facility in Dalian (China). Teva recalls product exempted from import alert on Hungarian facilityA little over two months ago, Teva’s largest sterile medicines plant in Hungary was placed on FDA’s import alert list. When the alert was announced, all drugs produced at the finished dosage forms facility – barring antibiotics Amikacin and Bleomycin – were placed on the import alert list. With a large chunk of drugs and drug ingredients being manufactured outside the US, the American regulator has had to increase its international oversight and ban products manufactured in plants that do not meet the regulatory standards. However, these bans have led to drug shortages. As a result, the FDA has had to (sometimes) exempt products and allow imports from plants that it believes have a poor record. According to the FDA Import Alert records, since 2013 the FDA has allowed eight plants whose products are otherwise banned from the US to go ahead and import some drugs or ingredients in order to avoid drug shortages. Amikacin manufactured at Teva’s Hungary plant was once such drug.However, the FDA’s exemption to prevent a drug shortage suffered a setback when Teva announced a voluntary recall of seven lots of Amikacin Sulfate Injection due to the potential for the presence of glass particulate matter. This announcement follows a similar announcement by Teva when one lot of Amikacin was recalled in March this year. Wockhardt back on FDA’s import alert listJust when it seemed Wockhardt was getting its compliance act together and putting its problems behind it, its bulk drug facility got placed on the FDA’s Red List. The bulk drug division in Ankleshwar (Gujarat) is the latest to join FDA’s import alert list, with Wockhardt’s Waluj and Chikalthana (Maharashtra) units already on the list. While Wockhardt recently said it had received establishment inspection reports (EIR) for the facilities with observations, it also mentioned that the “receipt of EIR does not materially change the status of import alert for the concerned manufacturing units for the US market.” The bulk drug facility in Ankleshwar had received a EU Written Confirmation from the Indian Central Drug Authority for the following seven products – dextromethorphan hydrobromide, adenosine, tamsulosin, nicardipine, cefuroxime axetil, fexofenadine and ceftriaxone sodium. FDA’s warning letter to China’s Xiamen reveals horrific details of GMP deficiencies Chinese drug maker Xiamen Origin Biotech (known as Attix Xiamen Pharmaceutical in North America) was placed on the FDA Import Alert list in May 2016. However, it was only recently that its warning letter was put up on the FDA website, bringing to light the magnitude of GMP deficiencies. According to the warning letter, the company “repeatedly falsified and omitted information on the certificate of analysis (CoA)” issued to customers and went to the extent of fabricating the name of an employee, which was used as a false signing authority on the CoA sent to customers.The company also included an ‘expiration date’ which exceeded the manufacturer’s labeled expiration date without any basis for the extension. In addition, the company made deceptive statements to the investigator, who also found dirty warehousing spaces and a rodent in the room adjacent to the warehouse.The FDA’s action in China follows an import alert which was placed on the North American operation of the company – Attix Pharmaceuticals – in Canada in February 2015. The warning letter issued to Attix Canada showed the company was packaging highly potent beta-lactam products “in a facility that is not dedicated to manufacturing beta-lactam drugs”. The practices created “an unacceptable risk of beta-lactam cross-contamination in other beta-lactams and in non-beta-lactam APIs”.An outcome of the North American inspection was a series of API recalls in both the United States and Canada. Japanese camphor producer refuses inspection; lands up on FDA’s Red ListWhile Wockhardt got placed on FDA’s import alert list as an outcome of an inspection, Nippon Fine Chemical in Japan appeared on the dreaded Red List for refusing to be inspected.Nippon Fine Chemical produces pharmaceutical grade Camphor, an active ingredient (along with menthol) in vapor-steam products, such as Vicks VapoRub. Inno Pharma’s Vitamin D drops with 75 times higher content recalled in DenmarkIn Denmark, Vitamin D drops made by Inno Pharma were recalled recently as the content was “75 times too high”. The product is marketed to infants and pregnant women in Denmark, and sold under the brand ‘Vitamin D3-draber’.The hazardous nature of the drops made the Danish Health Authority (Sundhedsstyrelsen) advise anyone who had taken ‘Vitamin D3-draber’ from Inno Pharma for a week or longer to see their doctor for a blood test to assess the risk posed to them of Vitamin D toxicity. Also known as hypervitaminosis D, this is a rare but potentially serious condition that occurs when you have excessive amounts of vitamin D in your body. The main consequence of vitamin D toxicity is a buildup of calcium in your blood (hypercalcemia), which can cause poor appetite, nausea, vomiting, weakness, frequent urination and kidney problems.

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11 Aug 2016

Data integrity has no relationship with product quality

Peter J. Werth, President and Chief Executive Officer, ChemWerth, a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company providing cGMP quality APIs to the regulated markets, is a proponent of removing data to a data-integrity (DI) file from data history, if it isn’t linked to product quality. According to Werth, FDA is unnecessarily obsessed with data integrity issues, and pharma companies have begun to fear FDA inspections. This needs to change, Werth tells PharmaCompass. Excerpts from the interview. Can you tell us about your journey in the world of pharmaceuticals? I began by supplying generic cough and cold APIs by setting up a chemical business back in 1975. There was a small group of companies (first generic companies) that mainly sold cough and cold products. These companies wanted to sell patent-expired generics and we developed select APIs for them. There was no real FDA (US Food and Drug Administration) approval process involved. By 1982, I realized the generic industry would be big business and API sourcing was key to success. Since I knew the API business, my wife and I formed ChemWerth – a company that supplied generic APIs. By 1988, ChemWerth was working with 10 American and three Chinese manufacturers. But the generic scandal changed everything. My American partner factories gave up the API business when new regulations came in. Chemical plants could no longer manufacture APIs. From my previous 11 years of dealing with China, I knew that almost all of the dosage form factories also produced APIs. This was especially important for the injectable grade products. By the early 1990s, ChemWerth was developing APIs for highly toxic oncology injection drugs and many antibiotics. We successfully introduced doxorubicin, daunorubicin, mitomycin, bleomycin, etoposide, ifosfamide and several antibiotics such as lincomycin, clindamycin phosphate, amikacin sulfate, tobramycin and vancomycin (all from China). Today, ChemWerth represents 25 Chinese factories for about 100 products. We still represent one American API supplier along with several Indian manufacturers. We recently expanded to supply veterinary drugs and partnered with a major supplier of polypeptides and a world-class supplier of heparin and related products. You have been working with China for many years now. When did you first come to China and how has the Chinese pharmaceutical industry transformed over the years? I first went to China in 1979. During that trip, I realized I could successfully deal with the Chinese. Most of my friends who went to China said it was impossible to deal with them. I always thought this gave me an advantage in China. Over the next seven years, I kept in touch with China, but did very little business. In 1986, I was running ChemWerth and was a consultant with a company to help its large pharmaceutical facility produce generic APIs. We targeted clindamycin phosphate for development, since the product had good sales, and was off patent. It also had no competition because Upjohn (an erstwhile US-headquartered pharma company that got merged with Pharmacia in 1995, which in turn got bought over by Pfizer) controlled all the key starting material – lincomycin hydrochloride. Using my contacts and my ability to deal with Chinese factory directors, I managed to break Upjohn’s stronghold in lincomycin. I convinced three factories to work with me so that I could file a DMF (Drug Master File). Clindamycin became a very good product for ChemWerth and gave me reason to visit China regularly to develop new business. In those days, factories were generally old and needed upgradation. Documentation was always good, and in detail. However, it was mostly in codes and therefore useless to most others. It was extremely difficult to convince the factory to provide a true and detailed process to ChemWerth to file a DMF with the FDA. There is still a tendency (amid factories in China) to hide important facts. As a result, it takes ChemWerth at least three versions/iterations before we think we have got the right process details. Today, the hardware in China’s pharmaceutical factories is excellent, and is usually purchased from the best overseas manufacturer. The software is good too and is likely to improve drastically as manufacturers realize software is equally important as hardware. In view of the current GMP concerns being uncovered at Chinese companies, are you still focused on China as a source of pharmaceuticals? In my mind, and in the ChemWerth representative factories, there are no GMP concerns, no quality concerns, and no data history concerns. The FDA's fascination with data integrity focuses on a problem that does not exist in more than 90 percent of the pharmaceutical factories. There are at least 18 reasons to remove data from data history. All of these 18 reasons are related to analyst error and equipment failures (laboratory gross errors) and not related to quality or GMP manufacturing. (Click here to read Werth’s 18 reasons to remove data). I agree that gross errors/laboratory gross errors should not be deleted. I also agree that deleted gross errors/laboratory errors not related to quality do not deserve a warning letter. However, the FDA should also know the main reason data is deleted is because the analyst (often) knows the result is not correct for reasons not related to quality (gross errors/laboratory gross errors). They do not want to conduct an expensive, time-consuming, and cumbersome OOS (out-of-specification) investigation. Therefore, they delete the data, weigh out new samples, fix the problem, analyze, and either receive acceptable results or rejection results. Today, China has the most modern manufacturing facilities and the money to invest in software to manufacture the highest quality with the best traceable records. The Chinese need to trust the FDA to treat them fairly and not rely on two and three-year-old DI information. They will do the job correctly now and in future. But they cannot change the past. As stated earlier, all DI product-related observations have proven that the product quality and product history were acceptable. China can only become a stronger API supplier. China’s volumes will increase and costs will decrease, because the domestic market is growing rapidly. The country will have cost/pricing pressures and will need to concentrate more on the difficult products that require expensive equipment. The standards set by the China FDA (CFDA) match the US FDA standards. And this will make it easier to operate under one quality and documentation system. Most importantly, they have the money to invest in the latest technology, best scientists, and equipment. In your view, what can pharmaceutical regulators and the industry do differently in order to communicate that the product quality is not at risk, given the environment where data-integrity violations have become commonplace? The FDA needs to understand that DI has no relationship with product quality. We have two recent examples. In the first case, DI issues applied to 70 batches. All 70 batches were retested and all were found to be in specification. The second case gave the same results – between two inspections over 100 batches were considered potentially fraudulent. All 100 batches were retested and were found to meet the specification. At both the factories, the data history showed all the batches are in specification – this implies 100 percent correlation to quality. The data integrity listed 100 batches and no batch failed specification – this shows 0 percent correlation to quality. From a DI perspective, FDA inspections in factories that only produce APIs for export should be different from inspections in pharmaceutical companies that export APIs and dosage form. In reality, API manufacturers cannot cheat. They sell their product to dosage form manufacturers, which in turn are responsible for the quality that goes into the dosage form. Off specification batches will be rejected and returned to the API manufacturer. While inspecting factories’ customer complaint file, it is rare to find batches being rejected and returned to the factory. The same does not apply to pharmaceutical companies that produce both API and finished dosage. They can hide information. Data integrity is more of an issue with companies that manufacture both API and dosage form. What steps is ChemWerth taking with its partners in China to improve compliance standards? ChemWerth is addressing this issue with the FDA and ChemWerth representative factories. In broad terms, data history should be paramount, since it is related to product quality. Data integrity is a part of data history. ChemWerth has prepared a standard operating procedure (SOP) to handle electronic data.(Click here to read ChemWerth’s SOP). A simple version is that when one or both samples are out-of-specification, the analyst’s supervisor (who committed the error) reviews the data with the analysts. If they determine that one of the 18 reasons for analyst error or equipment failure is the cause of the failure, then this is noted. Three new samples are prepared, the error is corrected, and the samples are run and if all samples pass then these results are retained in data history and the product is passed. The previous bad result is documented and removed to the data integrity file. No lengthy, time-consuming, and expensive OOS report is conducted. This makes the procedure factory-friendly. In the above example, if one of the three new samples fails, then all results are retained in the data history. The batch is rejected for rework or reprocessing. I believe the present atmosphere between the FDA and API manufacturers is at an all-time low. The industry feels the FDA inspectors are looking at mostly irrelevant data to prove that the factory operates fraudulently. Factories no longer welcome FDA inspections, out of fear of DI failure. Factories feel the FDA is using DI to point out fraud where there is none (excluding Hisun and Ranbaxy). In the past, we always welcomed FDA inspections as part of doing business. We need to get back to that time and place.

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07 Jul 2016

GMP problems at Teva’s Hungary plant place it on FDA’s import alert list; Alibaba halts online sale of medicines

This week, Phispers covers news about David Cameron urging the G7 to fight superbugs, FDA regulatory action against Corden Pharma’s Italian facility and a new implant that fights opioid addiction.Teva’s largest sterile medicines plant in Hungary placed on FDA import alert listTeva Pharmaceutical’s facility in Hungary was placed on the US Food and Drug Administration’s import alert list. The action was taken after an FDA inspection found that the plant was not conforming to the current good manufacturing practices (GMPs). All drugs produced by the finished dosage forms facility – barring antibiotics Amikacin and Bleomycin – have been placed on the import alert list. Teva had commissioned the US $ 110 million plant in Gödöllő, Hungary, in 2012. At the time, Teva had announced that the facility was one of the largest sterile medicines plants in the world. The plant has an annual production capacity of 160 to 200 million units of injectables and the six production lines can produce six different products simultaneously. It supplies medicines to patients in over 70 countries in Europe, North America, and the Far East. The FDA import alert is bad news for Teva and comes at a time when investors believe the US $ 41 billion it paid for Allergan’s generic business was too high a price. FDA inspection in Corden Pharma’s Italy plant uncovers ‘black grime and filth’ While details about Teva’s GMP shortcomings are awaited, an inspection by the FDA of Corden Pharma Latina’s active pharmaceutical ingredients (API) facility in Italy revealed that “black grime and filth were visible” on tiles and stagnant water was found collecting under aseptic filling machines. Meanwhile, Corden Pharma said it will respond to FDA’s warning letter and stressed that the supplies of APIs and finished dosage forms manufactured at its Italy plant will not be impacted. The FDA also posted on its website the long-awaited warning letter for Megafine Pharma in India, which had been placed on FDA’s import alert list in October 2015. The warning letter revealed the usual data-integrity concerns. On a positive note, Granules India shared it has successfully addressed FDA’s observations during a recent inspection. It would be worthwhile to have more companies share such positive news so that the ‘noise’ about non-compliances gets balanced. This comes at a time when the Indian drug regulator is introducing a risk-based inspection model to address concerns at manufacturing plants in India. Cameron urges G7 nations to step up fight against superbugsBritain has asked G7 nations to do more to fight killer superbugs. This was after the United States reported the first case in the country of a patient with bacteria resistant to a last-resort antibiotic – colistin. The antibiotic is reserved for nightmare bugs. The patient, a 49-year old woman from Pennsylvania, succumbed to the truly pan-drug resistant bacteria. In Japan, David Cameron, Britain’s Prime Minister, said leading countries need to tackle resistance by reducing the use of antibiotics and rewarding drug companies for developing new medicines. “In too many cases antibiotics have stopped working. That means people are dying of simple infections or conditions like TB (tuberculosis), tetanus, sepsis, infections that should not mean a death sentence,” he said at a conference in Japan. “If we do nothing about this there will be a cumulative hit to the world economy of US $ 100 trillion and it is potentially the end of modern medicine as we know it,” he said. FDA approves implant that dispenses opioid addiction medicationThe FDA has approved an implant that continuously dispenses an opioid addiction medication – buprenorphine – for six months. Branded as Probuphine, the device will cost less than US $ 1,000 per month, said the spokesperson for Braeburn Pharmaceuticals – the company that has the commercial rights to the implant in the United States. That’s a lot more expensive than other forms of buprenorphine existing in the market, such as a daily pill or a dissolvable film. But it’s cheaper than Vivitrol, another form of opioid medication, priced at around US $1,100 a month. However, doctors have cautioned that the implant, originally developed by Titan Pharmaceuticals, needs to be supplemented with counseling and other forms of support. Sun Pharma subpoenaed for information on drugs it sells in the USIndia’s largest pharmaceutical company – Sun Pharmaceutical Industries – was subpoenaed by the US Department of Justice (DoJ). The DoJ sought more information about the pricing and marketing of the generic drugs Sun Pharma sells in the US. The DoJ, through its antitrust division, has also asked Sun Pharma’s US unit for details related to communications with competitors, employee and corporate records. The subpoena is part of a wider probe by American regulators into the steep increase in prices of generic drugs in the recent past. The investigation had been prodded by US Senator Bernie Sanders and Democratic Representative Elijah Cummings. Other generic drug manufacturers like Dr. Reddy’s Laboratories and Allergan also received subpoenas from regulators seeking similar information last year. Alibaba tells vendors to stop online sales of medicines in ChinaAlibaba Group Holding has told vendors on its Tmall website to stop selling drugs online. The Chinese e-commerce company cited an “urgent” directive issued by a local regulator that halts drug sales through third-party platforms. A Reuters news report mentioned a circular issued by the Hebei province branch of the China Food and Drug Administration (CFDA) on “urgent control measures relating to drug products”. No reasons for such a directive had been cited.

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02 Jun 2016

Zhejiang Hisun’s FDA import alert; a new chapter in the fight against data integrity

A few months ago, PharmaCompass covered the Health Canada request to quarantine drugs linked to leading Chinese drug maker, Zhejiang Hisun Pharma (Hisun) due to data integrity concerns.The “interim precautionary measure” was taken “in light of recent findings from a trusted regulatory partner that raised concerns about the reliability of the laboratory data generated at this site”.Last week, the trusted regulatory partner – i.e. the United States Food and Drug Administration (FDA) – announced it had placed Zhejiang Hisun Pharma on its import alert list. Regulators unite against data integrity violations International regulatory agencies are collaborating with each other at an unprecedented pace. Health Canada’s decision to quarantine drugs from Hisun almost three months before FDA’s official action indicates an extremely low level of tolerance for companies that fail to maintain data integrity. Health Canada has also taken similar action against companies who have recently failed European inspections (e.g. India’s Polydrug Laboratories and China’s Jinan Jinda Pharmaceutical Chemistry). Polydrug Laboratories was also included in the most recent FDA Import Alert list indicating a growing impatience in international regulatory agencies against non-compliant firms. Last week, Brazilian Health Surveillance Agency (ANVISA) announced suspending import of all APIs from India’s Parabolic Drugs. ANVISA’s resolution was driven by Parabolic’s failure of a European Good Manufacturing Practices (GMP) inspection in July this year Hisun’s importance in the pharmaceutical supply chainThe FDA decision to ban almost all products coming from the Hisun facilities into the United States is going to create significant disruption in the pharmaceutical supply chain, given the colossal scale of Hisun Pharma’s operations.Zhejiang Hisun Pharma qualifies as one of the most prominent active pharmaceutical ingredients (API) manufacturers in the business, with more than 93 Drug Master Files submitted with the FDA, four approved finished products listed in the FDA Orange Book and 35 Certificates of Suitability issued by the European Directorate of Quality Medicine,.Hisun’s core operations in Taizhou city cover a very large area and are divided into three parts (the Yantou campus; Waisha Campus; and East Factory) which are separated by public roads. The Taizhou site employs approximately 4,000 people and focuses on fermentation-based anti-infectives, cardiovascular products (e.g. statins) along with synthetic anti-cancer products. Hisun’s branded generic player ambitions Two years ago, Hisun’s ambitions to transform itself from an API maker to a branded generic company were announced through the launch of Hisun-Pfizer Pharmaceutical Co., a joint venture with Pfizer where Hisun has a controlling stake of 51 percent while Pfizer has the balance 49 percent.With a vision to become “a widely respected international pharmaceutical company,” Hisun exports more than “80 percent of its API products” to more than 30 nations and regions. Hisun will not disappear post the import banHowever, Hisun’s importance in the supply chain is demonstrated by the number of exemptions which the FDA had to make in order to ensure that there are no drug shortages created as an outcome of the import alert. Fourteen products have been excluded from the import alert. Bleomycin, Capreomycin, Daunorubicin Citrate Liposomal, Doxorubicin Hydrochloride, Mitomycin, Tazobactam, Granisetron, Cladribine, Cyclophosphamide finished form and API, Cytarabine, Floxuridine, Fludarabine, Ivermectin and Adenosine will still be allowed entry into the United States from the Hisun plant. Our viewLast month we analyzed if “speedy action by European agencies suggest revival of API production in the West” and suggested that the era where companies were securing their supply of APIs by looking for low-cost players in Asia appears to be waning away.With a major Chinese player like Hisun now running into severe compliance problems and the number of alternatives available being quite limited, we foresee a significant shift in the pharmaceutical supply chain.

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17 Sep 2015