Alembic Pharmaceuticals Limited receives USFDA Tentative Approval for Bimatoprost Ophthalmic Solution, 0.03%.

Sanjay Krishna | Myequity news | Date : 06-08-2018 15:00:00 IST

Alembic Pharmaceuticals Limited today have announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New DrugApplication (ANDA) for Bimatoprost Ophthalmic Solution, 0.03%. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLQ), LA'.ISSE®ophthalmic solution, 0.03% of Allergan.

Alembic now has a total of 76 ANDA approvals (64 final approvals and 12 tentative approvals)from USFDA.

About Alembic Pharmaceuticals Limited:

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquarteredin India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research andmanufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic'sbrands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.


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