August 25, 2026 09:56 am (IST)
Follow us:
Aurobindo Pharma receives USFDA approval for pain reliever tablets
Hyderabad, May 17 (IBNS) Aurobindo Pharma Limited, manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, announced on Tuesday that it 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.
Hydromorphone Hydrochloride Tablets is used to relieve moderate to severe pain in patients where the use of an opioid is appropriate, the company release said.
The company said that 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.
Quoting IMS, the company said that the approved product has an estimated market size of US$ 50 million for the twelve months ending March 2016.
The company also said this is the 12th ANDA to be approved out of Aurolife formulation facility in New Jersey, US for manufacturing non-antibiotic products and 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.
Support Our Journalism
We cannot do without you.. your contribution supports unbiased journalism
IBNS is not driven by any ism- not wokeism, not racism, not skewed secularism, not hyper right-wing or left liberal ideals, nor by any hardline religious beliefs or hyper nationalism. We want to serve you good old objective news, as they are. We do not judge or preach. We let people decide for themselves. We only try to present factual and well-sourced news.
Support objective journalism for a small contribution.
Latest Headlines
Tata Power Renewables marks a major milestone with the commissioning of 190.5 MW FDRE project in Rajasthan. All details inside
Mon, Aug 24 2026
Samsung's big AI push in India: New Pune facility to power next-gen data centre cooling
Mon, Aug 24 2026
Best Indicators For Futures Trading
Mon, Aug 24 2026
China orders massive EV recall: Nearly 3 million Teslas among 4.3 million vehicles affected
Mon, Aug 24 2026
Yes Bank launches ‘YES Essence’ for women. How can you avail it?
Fri, Aug 21 2026
Aditya Birla Capital enters gold loans: What consumers should know
Fri, Aug 21 2026