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IPCA Labs Shares Crash on Warning Letter from USFDA

IPCA Labs Shares Crash on Warning Letter from USFDA

IPCA Laboratories shares crashed 16.27 per cent on Monday after the drugmaker said it has received a warning letter from US drug regulator highlighting manufacturing quality lapses at three of its units.

The three plants at Ratlam (Madhya Pradesh), SEZ Indore (Pithampur) and Piparia (Silvassa) have already been banned from supplying active pharmaceutical ingredient (API) to the United States after the FDA inspected them in July 2014, January 2015 and March 2015, and first highlighted the lapses. APIs are used in making medicines.

"...these manufacturing units received certain inspection observations in Form 483 and which subsequently resulted in issuance of import alert on these manufacturing units... US FDA has now issued a warning letter to these manufacturing units," said IPCA Labs in a statement to the Bombay Stock Exchange.

"The company is fully committed to resolving these issues at the earliest," IPCA said. 

As of 12:58 p.m., shares of IPCA Labs traded 4.46 per cent lower at Rs 639, underperforming the Nifty which was 0.12 per cent.