Aurobindo Pharma receives USFDA approval for Rivastigmine Tartrate Capsules

29 Mar 2016 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Rivastigmine Tartrate Capsules USP, 1.5 mg, 3 mg, 4.5 mg and 6 mg. This product is expected to be launched in Q1 FY16-17.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Exelon Capsules, 1.5 mg, 3 mg, 4.5 mg and 6 mg, of Novartis Pharmaceuticals Corporation.

Rivastigmine Tartrate Capsules is used in the treatment of mild moderate dementia of the Alzheimer's and Parkinson's disease. The approved product has an estimated market size of US$ 26.7 million for the twelve months ending January 2016 according to IMS.

This is the 67th ANDA (including 14 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. The company now has a total of 246 ANDA approvals (211 Final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.

Aurobindo Pharma Share Price

1144.55 -22.65 (-1.94%)
20-Jan-2026 15:44 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1612.00
Dr. Reddys Lab 1166.90
Cipla 1381.00
Zydus Lifesciences 872.95
Lupin 2160.60
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×