The company has received USFDA (US Food & Drug Administration) approval 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.
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Shares of Alembic Pharmaceuticals rose 1.5 percent intraday Thursday after company received USFDA approval.
The company has received USFDA (US Food & Drug Administration) approval 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 approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Mirapex ER Tablets of Boehringer lngelheim Pharmaceuticals, Inc.
Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease.
Alembic has a cumulative total of 84 ANDA approvals (71 final approvals and 13 tentative approvals) from USFDA.
At 10:47 hrs Alembic Pharmaceuticals was quoting at Rs 589.50, up Rs 8.50, or 1.46 percent on the BSE.First Published on Jan 3, 2019 10:56 am
