Lupin plant clears US FDA hurdle

Lupin’s key manufacturing plant in Mandideep cleared what could have become a hurdle, after it addressed concerns raised earlier by the drug regulator. Earlier, the US drug regulator had issued a warning letter to the company for its cephalosporins facility, asking it to rectify deficiencies or face action. Unlike Ranbaxy Laboratories, Lupin’s drug supplies to the US were not affected. But approvals for drugs to be made in this plant may have been held up, as the FDA warning letter recommended disapproval of any new applications or supplements for formulations or bulk drugs from this facility. This warning letter was issued in May 2009.

Lupin said in a statement that it has taken corrective actions, before the plant was inspected again in November 2009. Pharmaceutical companies have said that the US FDA has become stricter in enforcing compliance, which has resulted in such warning letters, and companies are investing in improving compliance. The green signal from the FDA means that if any approvals were held up, these will be processed. Also, Lupin said that in the December quarter, the US FDA has inspected two of its sites in Aurangabad and Indore. The first plant did not get any observations while one observation was made for the second plant, which has now been resolved. US FDA clearance is essential for companies to be able to manufacture drugs for the US market.

Developed markets are key for Lupin, with about 40% of overall sales being contributed by formulation sales to markets like USA, Europe and Japan. The company has got filed for 95 abbreviated new drug applications and has got approval for 35, as reported in its September 2009 results. The December quarter results are expected on January 29. The stock price was up by about 0.7% at the time of posting.

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