Alembic Pharma Gets 2 USFDA Observations for Karakhadi Injectable Facility
Vadodara: Alembic Pharmaceuticals Limited has informed that the United States Food and Drug Administration (USFDA) conducted an unannounced cGMP inspection at its Injectable Facility (F-3) located at Karakhadi from 9th February, 2026, to 18th February, 2026.
In a communication dated February 18, 2026, addressed to BSE Limited and the National Stock Exchange of India Limited, the company stated that the USFDA conducted an unannounced current Good Manufacturing Practices (cGMP) inspection at the Karakhadi facility from February 9, 2026 to February 18, 2026.
The inspection concluded with two observations. The company clarified that none of the observations are related to data integrity.
Alembic Pharmaceuticals further stated that it will respond to the observations within the stipulated time frame prescribed by the USFDA.
Reiterating its commitment, the company said it continues to remain focused on maintaining the highest quality standards and regulatory compliance across its manufacturing operations.
The disclosure was made under applicable regulatory requirements to the stock exchanges for taking the information on record.
