Alembic Pharmaceuticals announced the completion of an unannounced cGMP inspection by the United States Food and Drug Administration (USFDA) at its Injectable Facility (F-3) in Karakhadi. The inspection took place between February 9th and February 18th, 2026. The company confirmed that the inspection concluded with two observations, none of which are related to data integrity. Alembic assures stakeholders of its commitment to quality and timely response to the observations.
USFDA Inspection Concluded at Karakhadi Unit
Alembic Pharmaceuticals Limited has formally informed stock exchanges regarding the successful conclusion of an inspection conducted by the United States Food and Drug Administration (USFDA). The inspection targeted the company’s key Injectable Facility designated as (F-3), which is located in Karakhadi.
Inspection Timeline and Findings
The USFDA conducted this inspection on an unannounced basis. The audit period officially ran from 9th February, 2026, through 18th February, 2026. Following the completion of the site visit, the company confirmed receiving a final status report. The inspection resulted in the recording of two observations.
Crucially, the management emphasized that none of the noted observations pertained to data integrity, a key compliance benchmark for regulatory agencies. Alembic stated its commitment to addressing all observations promptly, ensuring compliance is maintained within the stipulated timeframes.
Commitment to Quality
The filing concluded with an affirmation that Alembic Pharmaceuticals continues to uphold the highest quality standards and regulatory compliance across all its manufacturing operations. The company has requested that the stock exchanges take this information on record.
Source: BSE
