June 30, 2026 01:30 am (IST)
Follow us:
facebook-white sharing button
twitter-white sharing button
instagram-white sharing button
youtube-white sharing button
India overtakes Taiwan, South Korea to become world's fifth-largest equity market again | Pakistan strikes terror hideouts near Afghan border after Karachi bloodshed, 29 killed | Israel strikes back: Top October 7 militant “eliminated” in precision operation | Radharaman Das, who defended Bengal's vegetarian mid-day meal plan, loses ISKCON post | Fresh paper leak rocks India: Maharashtra TET postponed a day before exam, over 4 lakh aspirants affected | Pune fort murder case: Siya Goyal's brother says family would have called off marriage if she had objected | Donald Trump gets a road named after him in India, says 'Thank You!' | Fresh setback for Gautam Adani? US judge asks DoJ to justify dropping criminal charges | Ram Mandir Trust chief Champat Rai resigns as alleged donation siphoning row escalates | Ram Mandir fund row deepens: 8 arrested days after BJP called allegations 'false narrative'

Aurobindo Pharma receives USFDA approval for pain reliever tablets

| | May 17, 2016, at 07:19 pm
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.
# US Food & Drug Administration # Hydrochloride Tablets USP

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.
Related Images
Nirmala Sitharaman presents Budget 2025
Nirmala Sitharaman presents Budget 2025 Feb 01, 2025, at 03:41 pm
Veedol signs former Indian skipper Sourav Ganguly as brand ambassador
Veedol signs former Indian skipper Sourav Ganguly as brand ambassador Jun 29, 2024, at 06:38 am
In Images: Glimpses from Bengali film Fatafati's premiere
In Images: Glimpses from Bengali film Fatafati's premiere May 13, 2023, at 08:39 pm
Related Videos
RBI announces repo rate cut Jun 06, 2025, at 10:51 am
FM Nirmala Sitharaman presents Budget 2025 Feb 01, 2025, at 03:45 pm
Nirmala Sitharaman on Budget 2024 Jul 23, 2024, at 09:30 pm