FDA raises concern over drug production process at Cadila

MUMBAI Thu Jul 31, 2014 4:20pm IST

Related Topics

Stocks

   

MUMBAI (Reuters) - Cadila Healthcare Ltd (CADI.NS) is responding to certain observations the U.S. Food and Drug Administration (FDA) made after conducting a "product specific" inspection of its Moraiya manufacturing plant, a company spokeswoman said on Thursday.

Sources with direct knowledge told Reuters earlier that the FDA expressed concerns over the manufacturing process of at least one product at Cadila's Moraiya facility in the western Indian state of 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.

ANDA 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 drugmakers, has one of the largest pipelines of 158 generic drugs awaiting approval from the FDA, according to company filings.

Cadila's shares dropped as much as 10.5 percent on Thursday. The stock ended down 4.5 percent at 1,116.15 rupees, while the Nifty fell 0.9 percent.

Separately, Citigroup on Thursday downgraded Cadila's stock to "sell" from "buy", saying the company's valuations have moved well ahead of its fundamentals. Indian brokerage IDBI Capital also cut its rating on Cadila stock to "accumulate" from "buy".

(Editing by Sumeet Chatterjee and Matt Driskill)

FILED UNDER:
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.

  • Most Popular
  • Most Shared

REUTERS EXCLUSIVE

REUTERS SHOWCASE

Modi In U.S.

Modi In U.S.

Obama, Modi work to deepen improving U.S.-India ties  Full Article | Related Story 

Factory Activity

Factory Activity

Factories expand at slowest pace this year in September  Full Article 

Videocon d2h IPO

Videocon d2h IPO

Videocon d2h files for up to $113 million IPOs  Full Article 

Asian Economy

Asian Economy

Asian factories slow in Sept, push inflation ever lower  Full Article 

EBay Divests PayPal

EBay Divests PayPal

EBay follows Icahn's advice, plans PayPal spinoff in 2015  Full Article 

New 'Windows'

New 'Windows'

Microsoft names next operating system 'Windows 10'.  Full Article 

Reuters India Mobile

Reuters India Mobile

Get the latest news on the go. Visit Reuters India on your mobile device.  Full Coverage