Aurobindo Pharma's US facility gets nine observations from USFDA

Pharmaceutical company, Aurobindo Pharma announced today that its wholly-owned subsidiary AuroLife Pharma LLC's oral solid manufacturing facility located at Dayton, New Jersey was inspected by United States Food and Drug Administration (USFDA) and thereafter, issued a Form 483 with nine observations. Geographically, nearly 48.6 per cent of the company's Q4FY20 consolidated revenue is accounted for by the US region.

USFDA conducted its inspection of the facility from January 13 to February 12, 2020. The company further informed that such inspection was classified as "Official Action Indicated" (OAI) as detailed in a letter it received from USFDA. The company generates almost about two per cent of its overall revenue from the said production plant. Nonetheless, it predicts that the OAI classification is unlikely to have any material impact at this point in time, on the existing revenues and the supplies of its US business or pipeline products.

The company filed a total of 55 ANDAs including 19 injectables in FY20, of which 17 ANDAs including 10 injectables were filed in Q4FY20. It has been granted approval for 6 ANDAs in Q4FY20 and 22 ANDAs including 8 injectables in the whole of FY20.

The company declared its Q4 result of FY20 on Wednesday. It reported a growth of 16.4 per cent YoY growth to Rs 6,158 crore while its PAT grew by 45.2 per cent YoY to Rs 850 crore.