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1676 errors in 15 Ranbaxy filings: US FDA audit

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Wednesday, March 4, 2009, 12:15 This news item was posted in Industry category and has 0 Comments so far.

Ranbaxy refrigerated drugs instead of storing them under room temperature, reveals a US FDA release. Drug samples are usually stored in over a period of time to test thier stability in normal conditions of temperature, humidity etc. The US drug regulator which hauled up India’s leading generic maker for repeatedly violating manufacturing norms since atleast 2006, found out 1,676 errors in the audit of 15 applications approved for the US market.

FDA conducted an inspection in Ranbaxy’s Paonta Sahib facility in Himachal Pradesh during 2008. Following these findings, the regulator has decided to revoke licences of 25 products made in this factory, FDA also stopped a number of apllication from this facility pending approval. This might include the 6-months’ exclusive marketing rights for Ranbaxy’s version of world’s largest selling anti-obesity drug Lipitor, a worldwide best-seller, which comes off patent in 2011.

However, Ranbaxy (now part of the Japanese drug major Daiichi) says the recall may not affect much as it has a larger product basket in the US. The company has 141 FDA-approved products in its US portfolio, and 84 pending at FDA.

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