US health regulator finds Silvassa unit non-compliant with CGMP: Ipca Labs

NEW DELHI: Pharmaceutical firm Ipca Laboratories on Tuesday said the US health regulator has found its manufacturing unit in Silvassa, Gujarat, non-compliant with the current good manufacturing practices.

However, the company said that since this manufacturing facility is already under USFDA import alert and presently not doing any US business, this will have no impact on company’s current on-going business activities.

“We have now received a communication from the USFDA that they have determined the inspection classification of this manufacturing facility (Silvassa) as ‘Official Action Indicated (OAI)’ and that this facility is considered to be in an unacceptable state of compliance with regards to current good manufacturing practice (CGMP),” the company said in a regulatory filing to BSE.

The United States Food and Drug Administration (USFDA) inspection of its Piparia (Silvassa) formulations manufacturing unit in August resulted in three observations, it added.

Shares of Ipca Labs were trading at Rs 1,108 apiece on BSE in afternoon session.