Alembic Prescription drugs Ltd introduced on Wednesday, 18 June, that it obtained an Institution Inspection Report (EIR) from the US Meals and Drug Administration (USFDA) for its API-III facility positioned 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, an in depth report issued following inspections of services concerned within the manufacturing, processing, or distribution of pharmaceutical merchandise, signifies the conclusion of the assessment course of.
Final month, the Vadodara-based drugmaker obtained USFDA approval for its Bosutinib Tablets (100 mg and 500 mg), a medicine used to deal with blood most cancers.
With this, Alembic Pharma’s cumulative Abbreviated New Drug Utility (ANDA) approvals reached 223, together with 200 last and 23 tentative approvals.
Within the last quarter of FY25, the corporate reported a 12% decline in consolidated internet revenue to Rs 157 crore in comparison with the earlier yr. Nevertheless, income rose by 16.7% year-on-year. In the meantime, its EBITDA margin fell to fifteen.4% from 17.1% in the identical interval final yr.
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