July 31, 2014 / 7:30 AM / in 3 years

RPT-FDA raises concern over drug production process at India's Cadila-sources

(Repeats to add sources to headline)

MUMBAI, July 31 (Reuters) - The U.S. Food and Drug Administration (FDA) has expressed concerns over the manufacturing process of at least one product at Indian drugmaker Cadila Healthcare Ltd’s Moraiya facility, two sources with direct knowledge of the matter said.

The FDA has not expressed concerns over the entire facility, said the sources. The U.S. agency communicated its concern to Cadila in a Form 483, a letter in which the agency typically outlines violations of standard manufacturing practices.

Once the Form 483 is sent, the company has 15 days to respond before the FDA takes any further action.

The FDA inspected the Moraiya plant, based in the western Indian state of Gujarat, in the second week of July, one of the sources said.

The sources declined to be named as the information is not public yet. A Cadila spokeswoman declined to comment.

Cadila’s shares dropped as much as 10.5 percent on Thursday and were trading down 4 percent at 1,120.90 rupees at 0705 GMT, while the main market index was down 0.1 percent. (Reporting by Abhishek Vishnoi and Zeba Siddiqui; Editing by Sumeet Chatterjee and Matt Driskill)

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