According to a regulatory filing, the USFDA conducted an unannounced and routine current good manufacturing practices (cGMP) inspection at the company’s API-I and API-II facilities located at Panelav from 26 May 2025 to 31 May 2025.
The USFDA issued a form 483 with four observations and none of the observations are related to data integrity and management believes that they are addressable.
The company will provide comprehensive response to USFDA for the observations within the stipulated period.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.
The company’s consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24.