Alembic Pharma bags approval for Parkinson drug

The integrated pharma R&D company has received USFDA nod for pramipexole dihydrochloride extended-release tablets in various dosages. 

The US Food & Drug Administration (USFDA) has given Alembic Pharmaceuticals approval for its Abbreviated New Drug Application (ANDA) for 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. The company has a total of 84 ANDA approvals of which 71 are in final approvals stage, while 13 are tentative approvals from USFDA. 

The drug is therapeutically equivalent of Mirapex ER Tablets available in same dosages sold by Boehringer lngelheim Pharma and is used for the treatment of Parkinson's disease. According to IQVIA, pramipexole dihydrochloride ED tablets have a forecasted market size of US$ 38.6 million for the calendar 2018. 

Earlier in December, the US FDA had completed the inspection of Alembic's API Facility At Panelav and the company had received Form 483 with zero observation.

At lunch hours on Thursday, the stock of Alembic Pharmaceuticals was at Rs. 588.90 per share, up by 1.36 per cent on the BSE. Meanwhile, the benchmark index the BSE Sensex was at 35,667.75, down by 223.77 points or 0.62 per cent.