Drugmaker Alembic Pharma Ltd. announced on Wednesday, June 18, that the United States Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for the company’s API-III facility in Gujarat’s Karakhadi.The USFDA had conducted this inspection between March 17, 2025, to March 21, 2025. The company announced the completion of the inspection on March 21, 2025.
An EIR here is a detailed document prepared by the USFDA after inspecting a facility that manufactures, processes, or distributes regulated pharmaceutical products.
Last month that the Vadodara-based company announced that it had received approval for Bosutinib Tablets (Bosutinib Tablets, 100 mg and 500 mg), a drug used in the treatment of blood cancer, from the US FDA.
The company has received a cumulative total of 223 Abbreviated New Drug Application (ANDA) approvals (200 final approvals and 23 tentative approvals) from the USFDA so far.For the final quarter of financial year 2025, Alembic Pharma’s consolidated net profit declined by 12% from last year to ₹157 crore. Revenue though, increased by 16.7% from the year-ago period.In addition, the EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortisation) margin narrowed to 15.4% from 17.1% a year earlier.Shares of Alembic Pharma are trading 0.9% lower on Wednesday at ₹961.7. The stock has declined 6.5% in the last month.Also Read: Standard Chartered faces RBI scrutiny over lapses in derivatives sales
