Alembic Pharmaceuticals Ltd announced on Wednesday, 18 June, that it received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its API-III facility located in Karakhadi, Gujarat.

The USFDA carried out the inspection between 17 March and 21 March 2025, and Alembic confirmed its completion on 21 March. The EIR, a detailed report issued following inspections of facilities involved in the manufacturing, processing, or distribution of pharmaceutical products, signifies the conclusion of the review process.

Last month, the Vadodara-based drugmaker received USFDA approval for its Bosutinib Tablets (100 mg and 500 mg), a medication used to treat blood cancer. 

With this, Alembic Pharma’s cumulative Abbreviated New Drug Application (ANDA) approvals reached 223, including 200 final and 23 tentative approvals.

In the final quarter of FY25, the company reported a 12% decline in consolidated net profit to Rs 157 crore compared to the previous year. However, revenue rose by 16.7% year-on-year. Meanwhile, its EBITDA margin fell to 15.4% from 17.1% in the same period last year.

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