Moneycontrol News
Shares of Indoco Remedies touched 52-week low of Rs 209, plunges 16.4 percent intraday Monday post warning letter received by company from USFDA.
The company has got a warning letter from United States Food & Drug Administration (USFDA) for two of its facilities in Goa, as the drug regulator wasn't fully convinced with the drug maker's response for its earlier observations.
The USFDA had inspected company's manufacturing facilities Plant II and Plant III located in Verna Industrial Estate Area, Goa, between August 31 and September 4, 2016 and issued six observations in Form 483.
The Plant II manufactures ophthalmic and injectables, while Plant III makes tablets.
"Based on the review of compliance response, FDA accepted our response to 4 observations. However, FDA remains concerned with respect to 2 observations, pertaining to one specific product, for which we are contract manufacturer, for one of our customers and consequently we have received a warning letter from USFDA dated March 27,2017, today," as per company release.
"We as a company are fully committed in resolving the issue and will respond at the earliest," it added.
The USFDA has been issuing Form 483 observations and warning letters to Indian drug makers for failing to meet good manufacturing practice (GMP) standards laid down by it.
At 09:28 hrs Indoco Remedies was quoting at Rs 215.50, down Rs 34.45, or 13.78 percent on the BSE.
Posted by Rakesh Patil
Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
