Zydus Lifesciences arm gets 2 observations from USFDA

Zydus Lifesciences on Friday announced that Zydus Animal Health and Investments, a wholly owned subsidiary of the firm received two observations after the pre-approval inspection by USFDA at its Ahmedabad manufacturing facility.

The company said that the manufacturing facility at SEZ, Ahmedabad was inspected by United States Food and Drug Administration (US FDA) from 23 September 2022 to 29 September 2022.

At the end of the inspection, the pharmaceutical company was issued with two observations by the US drug regulator. None of the observations are related to data integrity, the drug maker stated.

The Ahmedabad manufacturing facility is set up for the animal health business which will cater to US and other regulated markets.

The pharma major added that it will address the observations within a stipulated timeline working with the regulators.

None of the observations are related to data integrity and management believes that they are addressable, the drug maker stated.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company's consolidated net profit fell 11.7% to Rs 518.3 crore on a 1.8% increase in total income from operations to Rs 4,072.7 crore in Q1 FY23 over Q1 FY22.

The scrip rose 0.55% to currently trade at Rs 385.65 on the BSE.

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