Alembic Pharmaceuticals has receivedapproval from the US Food & Drug Administration (USFDA) for its Abbreviated NewDrug Application (ANDA) Bimatoprost Ophthalmic Solution, 0.03%. The approvedANDA is therapeutically equivalent to the reference listed drug (RLD), Lumigan, 0.03%of Allergan Sales, LLC (Allergan). Bimatoprost Ophthalmic Solution, 0.03% isindicated for the reduction of elevated intraocular pressure in patients with open angleglaucoma or ocular hypertension.

Bimatoprost Ophthalmic Solution, 0.03% have an estimated market size of US$ 76million for twelve months ending December 2018 according to IQVIA.

Alembic now has a total of 90 ANDA approvals (78 final approvals and 12 tentativeapprovals) from USFDA.


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