India's Alkem says the FDA has approved upgrade plans for cited API plant

Alkem Laboratories says the FDA has signed off on its plans to upgrade a facility in Ankaleshwar that had been cited last year with three observations.

After a year of nothing but bad news about FDA citations of its plants, India’s Alkem Laboratories has announced something positive.

The Indian drugmaker said that the FDA has issued an Establishment Inspection Report, signing off on Alkem’s plans to upgrade operations at its API plant in Ankaleshwar, India. The plant had been cited with a Form 483 with three observations during a visit by the FDA in December.

The drugmaker has 14 manufacturing sites in India and the FDA has been doing a series of inspections after being alerted to problems by U.K. regulators who claimed the drugmaker had used fake data in clinical trials of an unspecified antibiotic and brain disorder drug. That alert came after the FDA had serious issues with Alkem shipping unapproved drugs to the U.S.


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Related: FDA sends marshals in to seize drugs from unit of Alkem

Last year the FDA cited an Alkem plant in Daman with more than a dozen observations after a two-week inspection.  Alkem at the time said it was responding to the findings. After that came the inspection at its Ankaleshwar, Gurat plant.

But while the drugmaker has made progress there, it faces more recent issues with the FDA over concerns at a plant in Badi. Last month, without providing details, the company said the FDA had cited the facility with three observations following an inspection that had just concluded.

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