Alembic Pharma's Karakhadi API Facility Clears USFDA Inspection

Alembic Pharmaceuticals Ltd. said its active pharmaceutical ingrediant (API) plant in Gujarat's Karakhadi cleared an inspection from the United States Food and Drug Administration.

The inspection was conducted from March 17 to 21 at the API-III facility located at Karakhadi, according to a stock exchange filing. "This was a scheduled GMP inspection and was successfully completed without any Form 483 observation," it said.

A USFDA Form 483, or "Inspectional Observations," is a notice issued by the drug regulator following an inspection, highlighting potential regulatory violations or areas of concern found during the inspection. These observations can relate to various aspects of a company's operations, including facilities, equipment, processes, controls, products, employee practices, and records. 

Alembic Pharma manufactures and markets generic products all over the world. It has three API facilities in Gujarat.

Alembic Pharma's US pipeline for fiscal 2026 looks interesting with launch expectations for Sacubitril, Ticagrelor, Dasatinib and Rivaroxaban, which can potentially add $40-50 million combined sales, according to a note from IIFL Capital. These will aid Alembic to deliver a robust 15-20% growth in the world's largest pharma market.

Over the medium-term, the company's managment expects its US sales to double to $400 million by FY29 driven by oncology launches.

Alembic’s API business sales declined 13.5% year-on-year in the first nine months of the current fiscal on account of price erosion and loss of certain key customers. IIFL Capital expects 13% API revenue growth over four years aided by recovery from lost customers.

So far in 2025, the company's promoter entities have bought over one lakh shares from the open market as per BSE disclosures.

Shares of Alembic Pharma closed 13.6% higher at Rs 947.75 apiece, ahead of the announcement on Friday, compared to 0.73% gain in the benchmark BSE Sensex.