Alembic Pharma receives USFDA approval for Pramipexole Dihydrochloride tablets


Alembic Pharmaceuticals has received final USFDA approval for Pramipexole Dihydrochloride extended-release tablets used for the treatment of Parkinson’s disease. The drug will be marketed in in the strengths of 0.375 milligram (mg), 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg.

The approved product is a therapeutic equivalent to the reference listed drug product (RLD) Mirapex ER tablets, of Boehringer lngelheim Pharmaceuticals Inc. According to market estimates, Pramipexole Dihydrochloride extended-release tablets have an estimated market size of $38.6 million for twelve months ending December 2017.

Company Profile : Alembic Pharmaceuticals Ltd

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