Aurobindo Pharma shares drop as USFDA issues three observations to Andhra Pradesh unit

The USFDA inspected the company's Unit XI, an Active Pharmaceutical Ingredient non-antibiotic manufacturing facility at Pydibhimavaram in Andhra Pradesh's Srikakulam district, from July 25 to August 2, 2022.

“We have been issued a 'Form 483' with three observations, and none of these observations is related to data integrity,” Aurobindo Pharma said in an exchange filing.

This comes after the unit was classified as official action indicated on May 17, 2019, and was subsequently given a warning letter dated June 20, 2019.

Official Action Indicated (OAI) means objectionable conditions were found, and regulatory and administrative sanctions by the USFDA are indicated.

The company had responded to the warning letter and carried out the committed corrections, it had said in the filing.

“We will respond to the USFDA within the stipulated timeline and work closely with the regulators to address the observations at the earliest,” the company added.

The pharma company had earlier been served with a warning letter by the capital markets regulator, Securities Exchange Board of India (SEBI), regarding insufficient disclosures for another unit. The letter observed that the company had disclosed very limited and restricted information and did not consider observations of the USFDA as serious.

Aurobindo Pharma is India's fifth largest drug maker by sales, after Sun Pharma, Dr Reddy's Laboratories, Cipla and Lupin.