India Pharma Outlook Team | Thursday, 19 June 2025
Alembic Pharmaceuticals Ltd reported on Wednesday, June 18, that it has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its API-III manufacturing site, at Karakhadi, Gujarat.
The report follows an inspection that took place over the duration of March 17, 2025 to March 21, 2025, and confirms the conclusion of the USFDA's review process from the inspection. The EIR is a necessary compliance step in confirming the site's manufacturing and quality standards for pharmaceutical production.
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This is hot on the heels of Alembic receiving USFDA approval for Bosutinib Tablets (100 mg and 500 mg), used in the treatment of chronic myelogenous leukemia. This brings the total number of Abbreviated New Drug Application (ANDA) approved and Luing to 223, including 200 final approvals, and 23 tentative approvals, thus enhancing its Portfolio of generics products in the US market.
Despite the regulatory success, the overall financial results for Alembic in the final quarter of FY35 give a mixed picture, with consolidated net profit down 12% at ?157 crore y-o-y. On the other hand, total revenue was up 16.7% for the same period showing strong top-line results. The EBITDA margin was down at 15.4% versus 17.1% a year ago, suggesting that the operational challenges are putting pressure on margins.
