The U. S. drug regulator is conducting a surprise audit at Cadila Healthcare Ltd.'s largest facility in Moraiya, Gujarat after multiple recalls of a drug made at the unit, two people aware of the development told BloombergQuint requesting anonymity.
Inspectors from the U. S. Food and Drug Administration began inspecting the site on Feb. 5, the people said. It stems from recalls of the epilepsy seizures drug Divalproex Sodium last year because of stability failure—or not maintaining its chemical and therapeutic specifications. The inspection was conducted on a short notice.
Replying to a clarification sought by exchanges after this article was published, Cadila Healthcare confirmed the audit being underway by the U.S. FDA in a filing.
...it is not a surprise inspection and the U.S. FDA had intimated us about the same. The company has several manufacturing facilities which get inspected by health authorities of different countries, including the U.S. FDA. So far as the inspection by U.S.FDA is concerned, as per our our normal practice, we communicates to the stock exchanges the outcome of such inspection.Cadila Healthcare Exchange Filing
Moraiya is the drugmaker's largest facility that makes key anti-inflammatory drugs like gLialda and gAsacol HD for the U.S. market, that contributed about 40 percent to its revenue in the year ended March 2017. The unit was issued a warning letter in December 2015, and was reinspected in February 2017 with no observations.
The inspection comes at a time when Indian generic drugmakers' margins are under pressure because of competition in the U.S., one of their largest markets.
Shares of Cadila Healthcare fell over 3 percent to Rs 390.85 intra-day on the NSE, before closing at Rs 396.35.
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