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USFDA finds company's SEZ Indore unit acceptable: Ipca Labs

Last Updated: Wednesday, September 4, 2013 - 13:56

New Delhi: Drug firm Ipca Laboratories on Wednesday said US health regulator has found its manufacturing facility in SEZ Indore acceptable after an inspection.

"US Food and Drug Administration (USFDA) following an inspection, has found acceptable the company's oral solid dosage formulations manufacturing facility situated at Pharmazone SEZ Indore, Madhya Pradesh," Ipca laboratories said in a filing to BSE.

This will enable the company to commercialise oral solid dosage formulations in the US market from this manufacturing facility, it added.

Ipca Laboratories in an earlier filing in November 2012 had said that during the course of the internal quality assurance review, it had noticed a few non-conformances at the said manufacturing unit and had voluntarily referred these to the USFDA.

"Till such time this issue is resolved to the satisfaction of the USFDA, no dosage formulations manufactured at this manufacturing unit will be commercialised for the US market," it added.

Shares of Ipca Laboratories were trading at Rs 683.60 per scrip in the afternoon trade on BSE, up 5.72 percent from its previous close.


First Published: Wednesday, September 4, 2013 - 13:56
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