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BUZZ-India's Cipla falters on US FDA letter, snapping 2-day rally
October 20, 2015 / 10:49 AM / 2 years ago

BUZZ-India's Cipla falters on US FDA letter, snapping 2-day rally

(Updates share price, adds company comment)

** Cipla Ltd, India’s fourth-largest drugmaker by sales, closes down 2.1 pct; snaps two-day rally of 2.6 pct

** Traders cite a letter, a so-called ‘form 483’, the U.S. Food and Drug Administration sent to Cipla in August, highlighting issues with one of its drug manufacturing units in Indore in central India

** The letter, seen by traders on Tuesday, highlights nine ‘observations’, or concerns, with Cipla’s quality control procedures at the Indore facility, traders say

** Letter was sent after FDA officials conducted an inspection of the Indore plant between July and August, traders say

** Cipla spokeswoman confirms receiving the letter but declines to comment directly on it

** “To date, the company has successfully responded to past observations, and continues to work towards implementing all corrective actions on high priority,” the spokeswoman says

** Cipla’s sales from the United States made up about 8 percent of its total revenue in the fiscal year 2015 (Reuters messaging:zeba.siddiqui.thomsonreuters.com@reuters.net)

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