Granules India's paracetamol facility passes USFDA inspection

NEW DELHI: Drug firm Granules India's paracetamol manufacturing facility at Bonthapally in Andhra Pradesh has passed an inspection by the US health regulator.

The company's paracetamol facility has successfully passed a United States Food and Drug Administration ( USFDA) inspection without any '483 observations', Granules India said in a filing to the BSE.

"The facility has the world's largest single active pharmaceutical ingredient ( API) production line by volume," it added.

An FDA Form 483 is issued to the firm's management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and other related acts.

The company's four API facilities have passed the USFDA inspections in the past 12 months, Granules India said.

Hyderabad-based Granules India has facilities for APIs, pharmaceutical formulation intermediates (PFIs) and finished dosages, serving customers in over 60 countries.

Shares of Granules India were trading at Rs 401.75 per scrip in the afternoon trade today, up 1.40 per cent from its previous close, on the BSE.