Alembic Pharmaceuticals gets USFDA approval for Carbidopa, Levodopa extended-release Tablets

06 Jun 2019 Evaluate

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbidopa and Levodopa Extended-Release Tablets USP, 25 mg/100 mg and 50 mg/200 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sinemet CR Tablets, 25 mg/100 mg and 50 mg/200 mg, of Merck Sharp & Dohme Corp. Carbidopa and Levodopa Extended-Release Tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

According to IQVIA, Carbidopa and Levodopa Extended-Release Tablets USP, 25 mg/100 mg and 50 mg/200 mg have an estimated market size of $ 24 million for twelve months ending December 2018. Alembic now has a total of 95 ANDA approvals (83 final approvals and 12 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

Alembic Pharma Share Price

852.30 -4.95 (-0.58%)
26-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1719.20
Dr. Reddys Lab 1269.05
Cipla 1505.05
Zydus Lifesciences 911.50
Lupin 2112.95
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×