Alembic Pharmaceuticals Limited has successfully concluded a scheduled inspection by the United States Food and Drug Administration (USFDA) at its API-III manufacturing facility located in Karakhadi, Gujarat. The Good Manufacturing Practices (GMP) inspection was conducted over five days, from March 17 to March 21, 2025.
In a regulatory filing made on Friday, the company confirmed that the inspection was completed without any Form 483 observations, a clear indication that the facility complies with USFDA standards and no objectionable conditions were found. This positive outcome underscores Alembic Pharma’s strong commitment to maintaining global regulatory compliance and quality assurance across its production units.
The company stated that the development further strengthens its regulatory standing for exports to the US market and supports its active pharmaceutical ingredients (API) business. The API-III unit is among Alembic’s key facilities contributing to its growing presence in regulated markets.
