Alembic Pharmaceuticals Receives USFDA Approval for Bromfenac Ophthalmic Solution

On July 9, 2024, Alembic Pharmaceuticals announced that it had received final approval from the US Food & Drug Administration (USFDA) for its Bromfenac Ophthalmic Solution, 0.07%.

This medication treats inflammation and pain following cataract surgery and is equivalent to Bausch & Lomb’s Prolensa Ophthalmic Solution, 0.07%. According to IQVIA, the market size for Bromfenac Ophthalmic Solution, 0.07%, is estimated at US$168 million as of March 2024. Alembic has now accumulated a total of 207 ANDA approvals from the USFDA, including 180 final approvals and 27 tentative approvals.

In their recent press release, Alembic Pharmaceuticals announced that they have received tentative approval from the US Food & Drug Administration for Ivosidenib Tablets, 250 mg. These tablets are therapeutically equivalent to Tibsovo Tablets, 250 mg, marketed by Servier Pharmaceuticals LLC. Ivosidenib is an IDH1 inhibitor used to treat certain forms of acute myeloid leukaemia and cholangiocarcinoma. According to IQVIA, the market size for Ivosidenib Tablets, 250 mg, was estimated at US$114 million for the 12 months ending March 2024.

Financial Highlights

Alembic Pharmaceuticals reported a significant increase in consolidated income for the March quarter of FY 2024, rising by 30.7% to ₹51 crore compared to ₹39 crore in the same period last year. Sequentially, there was a 24.3% increase from ₹41 crore in Q4FY23. The company’s net profits also saw substantial growth, jumping by 425% to ₹21 crore in Q4FY24 from ₹4 crore in Q4FY23. On a quarter-on-quarter basis, net profits rose by 110% compared to ₹9.9 crore in the December quarter of FY24.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited, established in 1907, is a global pharmaceutical company based in India. Specialising in research and development, Alembic manufactures and sells generic medicines worldwide. Its advanced research and manufacturing facilities are accredited by regulatory bodies like the USFDA and other developed countries’ authorities. Alembic is a leader in branded generics within India, known for its widely recognised brands promoted by a large marketing team of over 5000 professionals, trusted by doctors and patients alike.

On July 9, 2024, Alembic Pharmaceuticals Limited’s share price opened at ₹986.00, touching the day’s low at ₹969.50 as of 03:27 PM on the NSE.

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