Pharma Industrial India Magazine - July - August 2024

Alembic Gets FDA Approval for Betamethasone Valerate Foam Lupin Secures Tentative Approval from FDA for Brimonidine Tartrate Ophthalmic Solution Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam, 0.12 percent. The approved ANDA is therapeutically equivalent to the refer - ence listed drug product (RLD), Luxiq Foam, 0.12 percent, of Norvium Bioscience, LLC (Norvium). Betamethasone valerate foam, 0.12 percent, is a medium po - tency topical corticosteroid indicated for relief of the inflamma - tory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp. Alembic has a cumulative total of 213 ANDA approvals (185 final approvals and 28 tentative approvals) from USFDA. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufac - tures and markets generic pharmaceutical products world - wide. Alembic’s research and manufacturing facilities are ap - proved by regulatory authorities of many developed countries including the USFDA. Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.025 percent (OTC), to market a generic equiva - lent of Lumify Ophthalmic Solution, 0.025 percent, of Bausch & Lomb Incorporated. This product will be manufactured at Lupin’s Pithampur facility in India. Brimonidine Tartrate Ophthalmic Solution, 0.025 percent (OTC) is indicated to relieve redness of the eye due to minor eye irritations. Brimonidine Tartrate Ophthalmic Solution (RLD Lumify) had an estimated annual sale of USD 39 million in the US. Lupin Limited is a global pharmaceutical leader headquar - tered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, in - cluding branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredi - ents. Trusted by healthcare professionals and consumers global - ly, the company enjoys a strong position in India and the US across multiple therapy areas, including respiratory, cardio - vascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 re - search centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diag - nostics, Lupin Digital Health, and Lupin Manufacturing Solu - tions. FDA APPROVAL PHARMA INDUSTRIALINDIA · JUL-AUG 24 19