FDA Blocks Products Made By API Supplier

FDA Blocks Products Made By API Supplier

September 21st, 2011 // 4:39 pm @

In yet another bid to get tough on foreign manufacturers, the FDA has not only issued a warning letter to an active pharmaceutical ingredients supplier based in India, but has also imposed a so-called Import Alert, which means its products will not be allowed into the US.

NEW WEBINAR – What You’ve Got to Know About the Incoming Bombshell – FDA’s 2011 Process Validation Guidance

The action is being taken against Yag Mag, which supplies such APIs as platelet aggregation inhibitor Clopidogrel bisulphate BP (see this). If this sounds familiar to some, this particular API is used to manufacture generic versions of Plavix, the best-selling bloodthinner that is marketed as a brand-name treatment by Sanofi and Bristol-Myers Squibb.

A Sanofi spokesman says this has no bearing on its operations, because its API is generated internally. And the FDA import restriction will not have an impact on the US market, since generic Plavix is not expected in the US until next year. To what extent this will affect generic manufacturers that supply generic Plavix to other markets is unclear.

In the September 12 warning letter, the FDA notes that Yag Mag failed to perform some basic functions, such as documenting manufacturing operations at the time they are performed. Its facility was not adequately designed to facilitate cleaning and minimize the potential for contamination. There was a failure to have appropriate procedures or practices in place to prevent cross-contamination. There was also a failure to prepare, review and approve documents for making APIs in accordance with written procedures.

In short, an FDA inspection this past summer made clear that Yag Mag has little idea how to follow proper procedures. Hence, the agency “until such time as your manufacturing practices are verified to comply with CGMPs (good manufaturing practices), your firm will remain under FDA Import Alert and FDA will continue to refuse admission of all articles manufactured at Yag-Mag Labs Private Limited, India into the United States.”

This is hardly the first time that the FDA has imposed an Import Alert, although the agency is under pressure to act more forcibly against foreign-based suppliers of APIs in the wake of the heparin scandal. And the Ranbaxy Laboratories unit of Daiichi Sankyo is still chafing to get out from under such an alert in time to ship generic Lipitor this fall; the FDA placed import restrictions on the Indian supplier
three years ago for a host of infractions

Source: Pharmalot


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner