Alembic Pharmaceuticals receives USFDA Approval for Pramipexole Dihydrochloride Extended-Release Tablets

Deepthi | Myequity news | Date : 03-01-2019 11:40:00 IST

Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Pramipexole Dihydrochloride Extended-Release Tablets, 0.375 mg, 0.75 mg, 1.5 mg, 2.25mg, 3 mg, 3.75 mg, and 4.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Mirapex ER Tablets, 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer). Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease.

Pramipexole Dihydrochloride Extended-Release Tablets, 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg have an estimated market size of US$ 38.6 million for twelve months ending December 2017 according to IQVIA.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in 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 and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India.


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