Glenmark Pharma gets USFDA nod for Acetaminophen and Ibuprofen tablets

New Delhi: Glenmark Pharmaceuticals Ltd has received final approval from the United States Food Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets, 250 mg/125 mg (OTC).

The regulatory authority has determined these tabletes as bioequivalent to Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), of Haleon US Holdings.

Currently Glenmark’ portfolio consists of 195 authorized products authorized for distribution in the market while 52 ANDAs (new drug applications) more are awaiting approval by the USFDA.

According to the US State department records Acetaminophen tablets are used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, reactions to vaccinations (shots), and to reduce fever as well.

Related Posts

National Pharmaceutical Pricing Authority fixes retail price of 37 new drugs

The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 37 new drugs in its recent meeting, under the provisions of the Drugs Prices Control Order (DPCO), 2013,…

Massive Drug Bust in Bijnor: CBN Seizes Over 6.5 Lakh Tablets

The Central Bureau of Narcotics seized over 6.5 lakh tablets and injections of regulated drugs in Bijnor district, marking a significant crackdown on narcotic trafficking. The operation, based on intelligence,…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

National Pharmaceutical Pricing Authority fixes retail price of 37 new drugs

National Pharmaceutical Pricing Authority fixes retail price of 37 new drugs

Massive Drug Bust in Bijnor: CBN Seizes Over 6.5 Lakh Tablets

Massive Drug Bust in Bijnor: CBN Seizes Over 6.5 Lakh Tablets

Sun Pharma unit recalls 17,000-plus bottles of antifungal shampoo in US

Sun Pharma unit recalls 17,000-plus bottles of antifungal shampoo in US

Strides Pharma Science arm New York facility gets 4 USFDA observations

Strides Pharma Science arm New York facility gets 4 USFDA observations

SSI Mantra, Made in India Robot, bats a Thousand by completing 100 Telesurgeries

SSI Mantra, Made in India Robot, bats a Thousand by completing 100 Telesurgeries

Bihar drug bust: Rs15 million narcotics seized in major trafficking crackdown

Bihar drug bust: Rs15 million narcotics seized in major trafficking crackdown