FDA raises concern over drug production process at Cadila

Written By Unknown on Kamis, 31 Juli 2014 | 23.25

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

The US Food and Drug Administration (FDA) has expressed concerns over the manufacturing process of at least one product at 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 US 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 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 5.3 percent to 1,106.50 rupees at 1:01 p.m., while the broader Nifty was down 0.22 percent.

Also read:  Cadila Health Q1 profit up 23% to Rs 240 cr led by US sales

Cadila Health stock price

On July 31, 2014, Cadila Healthcare closed at Rs 1118.55, down Rs 46.9, or 4.02 percent. The 52-week high of the share was Rs 1195.00 and the 52-week low was Rs 631.00.


The company's trailing 12-month (TTM) EPS was at Rs 43.13 per share as per the quarter ended March 2014. The stock's price-to-earnings (P/E) ratio was 25.93. The latest book value of the company is Rs 177.28 per share. At current value, the price-to-book value of the company is 6.31.


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