ALFA Filings
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4 announcements with these filters
Alembic Pharmaceuticals completed an unannounced USFDA onsite inspection at its Vadodara Bioequivalence Facility. The inspection concluded with zero Form 483 observations, a positive regulatory signal.
Alembic Pharmaceuticals Limited received USFDA final approval for Prucalopride Tablets (1 mg and 2 mg). The product addresses a US$ 100 million market for chronic idiopathic constipation.
Alembic Pharmaceuticals' partner NATCO Pharma received USFDA tentative approval for Olaparib tablets (100mg and 150mg). Alembic will distribute the product in the U.S. market.
Alembic Pharmaceuticals submitted its Business Responsibility and Sustainability Report for FY 2025-26. The report includes a Reasonable Assurance Report provided by Bureau Veritas.