Aurobindo Pharma receives USFDA approval for Hydromorphone Hydrochloride Tablets

17 May 2016 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg, and 8 mg. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Dilaudid (hydromorphone hydrochloride) Tablets, 2 mg, 4 mg, and 8 mg of Purdue Pharma L.P.

Hydromorphone Hydrochloride Tablets is used to relieve moderate to severe pain in patients where the use of an opioid is appropriate. The approved product has an estimated market size of $50 million for the twelve months ending March 2016 according to IMS.

This is the 12th ANDA to be approved out of Aurolife formulation facility in New Jersey, USA for manufacturing Non-Antibiotic products & Controlled substances. Aurobindo now has a total of 263 ANDA approvals (225 Final approvals including 12 from Aurolife Pharma LLC and 38 tentative approvals) from USFDA.



Aurobindo Pharma Share Price

1171.50 -9.70 (-0.82%)
01-Jan-2026 10:25 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1713.05
Dr. Reddys Lab 1251.30
Cipla 1503.05
Zydus Lifesciences 909.40
Lupin 2083.35
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.

×