The drugmaker stated that the US Food and Drug Administration (USFDA) conducted an inspection at its manufacturing facility SEZ-1 in Pharmez, Ahmedabad, from March 20 to March 24, 2023.
The inspection was both a pre-approval inspection (PAI) and a good manufacturing practise (GMP) audit, and it resulted in three observations.
According to the pharmaceutical company, no data integrity issues were discovered. The company is looking into these observations and will respond within the time frame specified.
Zydus Lifesciences is a global lifesciences company focused on discovery that discovers, develops, manufactures, and markets a wide range of healthcare therapies.
In Q3 FY23, the company’s consolidated net profit increased by 24.5% to Rs 622.90 crore on a 17.9% increase in net sales to Rs 4,159.80 crore compared to Q3 FY22.
Zydus Lifesciences’ stock rose 0.61% to Rs 483.45 on the BSE.