Ipca Labs Gujarat facility red-flagged by USFDA for non-compliance with CGMP

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

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 the company's current on-going business activities.

Read Also: Ipca Labs gets 3 USFDA observations for Silvassa unit

"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.

Read Also: Ipca Labs to acquire Ramdev Chemical for Rs 108 crore