Cadila Healthcare says it is ‘responding' to FDA strictures

India's Cadila Healthcare Ltd said today it is responding to certain observations the US Food & Drug Administration made after conducting a "product specific" inspection of its plant in Moraiya, Gujarat.

"This was a product specific review and the inspection was limited to the review of documents for filed ANDA before its approval and the observations are being responded to," the Cadila spokeswoman said in a statement.

Reports say the FDA is concerned over the manufacturing process of at least one product at the Moraiya facility.

ANDA (Abbreviated New Drug Application) is an application drugmakers file with the FDA seeking approval to launch a new generic drug.

There is no business impact from the FDA action and Cadila has not received any observations on the standard manufacturing practices at the Moraiya plant, the spokeswoman said.

She did not immediately respond to a request seeking details on the inspection.

The FDA communicated its concern to Cadila in a Form 483, the company spokeswoman said. A Form 483 is a letter the agency issues after completing an inspection to outline conditions that the FDA believes violate standard regulations.

Once a Form 483 is issued by the FDA, the company has 15 days to respond before the FDA takes further action.

Cadila, among India's top 10 drug makers, has one of the largest pipelines of 158 generic drugs awaiting approval from the FDA, according to company filings.