Zhejiang Hisun's FDA Import Alert; A New Chapter in the Fight Against Data Integrity

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 chain

The 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 ban

However, 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 view

Last 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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Image Credit : Olympic torch relay, Great Wall of China by Edwin Lee is licensed under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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