|
The inspection was conducted from 16 March to 24 March 2023. The USFDA issued a Form 483 with 2 minor procedural observations.
None of the observations are related to data integrity and management believes that they are addressable, the company said in exchange filing.
The company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period.
Meanwhile, the company has successfully completed the Brazilian Health Regulatory Agency (ANVISA) good manufacturing practice (GMP) audit at API-III facilty at Karakhadi, Gujarat, without any observations for its 56 APIs. The inspection was conducted from 20th March to 24th march 2023.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.
The drug maker reported 29% drop in consolidated net profit to Rs 121.92 crore despite a 18.7% rise in net sales to Rs 1,509.02 crore in Q3 FY23 over Q3 FY22.
Shares of Alembic Pharmaceuticals were down 0.92% on Friday, 24 March 2023.
|