USFDA action on Granules does not affect existing products, but new approvals may be impacted

USFDA's classification of Granules India's Gagillapur facility in Hyderabad as 'Official Action Indicated' (OAI) does not impact the ongoing manufacturing, distribution, or sale of existing products from the site, the company clarified on December 4. Granules added that it has sought a meeting with the USFDA to present the progress, and seek a potential re-inspection of the facility.

However, the regulator rap may impact the process of review of pending submissions from the facility for approval of new products, till the time the OAI status is not resolved, the company added. Shares of Granules India has taken a severe knock of 10% on December 3 after US drug regulator's actions were informed.

The pharma company has already said that it intends to work with the US drug regulator and is confident of securing compliance for the facility soon.

Granules India said it has undertaken a 'proactive, voluntary and comprehensive' remedial plan to address the six form 483 observations that have been raised by the USFDA. The company said it had voluntarily paused manufacturing and dispatches in September, in order to conduct a thorough risk assessment. Operations and dispatches have since resumed following this assurance, Granules added.