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Sun Pharma to revise guidance after FDA’s raid on Caraco

Dilip Shanghvi, chairman and managing director, Sun Pharmaceutical Industries, and Sudhir Valia, director held a conference call held to discuss the FDA raid on its US subsidiary Caraco Pharmaceutical Laboratories. This event has come as big blow for Sun. It has withdrawn its current guidance and will issue a revised one, in due course. The issue is expected to have a significant short term impact on Caraco and some adverse impact on Sun’s short term performance too.

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FDA sidewinder hits Caraco, Sun Pharma suffers collateral damage

Caraco Pharmaceutical Laboratories, a 74% subsidiary of Sun Pharmaceutical Industries, has come under fire from the FDA. American enforcement officials raided Caraco’s plants, seized medicines and ingredients used in their production. The seizure has been attributed to Caraco’s continued failure to meet cGMP norms (current good manufacturing practices). The FDA had warned Caraco in October 2008 and had given it time to rectify the deficiencies. Continue Reading →

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What made the US FDA issue a warning letter to Sun Pharma’s subsidiary Caraco?

The US FDA had issued a warning letter to Sun Pharma’s subsidiary Caraco Pharmaceutical Laboratories on Oct 31, 2008. The letter is now available on the FDA site detailing the reasons why the warning was issued. It points out deviations from current Good Manufacturing Practice (CGMP) regulations for medicines. These deviations were detected in an inspection between May 1 to June 11 2008, and are mainly due to issues related to quality control. Continue Reading →

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Cipla gets approval for generic pamidronate disodium

The FDA has given approval to Cipla to sell generic pamidronate disodium, a drug used to treat high blood calcium levels caused by cancer, protecting from bone problems caused by cancer and Paget’s disease of the bone. The drug was sold under the brand Aredia belonging to Novartis but is now off patent. Cipla has got approvals for the 30mg, 60mg and 90mg injection dosages of this drug. There are many generic players in the market; in early November Strides Akorn LLC (a joint venture between Akorn and Strides Arcolabs) too had got FDA approval for this drug. Continue Reading →

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