Marksans Pharma gets USFDA nod for Acetaminophen ER Tablets

Written by Ruchika Sharma Published On 2021-08-26T13:00:46+05:30 | Updated On 26 Aug 2021 6:10 PM IST

Marksans Pharma gets USFDA nod for Acetaminophen ER Tablets

Mumbai: Marksans Pharma Limited today announced that U.S. Food and Drug Administration (USFDA) has granted approval for an Abbreviated New Drug Application (ANDA) for Acetaminophen Extended-Release Tablets USP, 650 mg (OTC).

Acetaminophen Extended-Release Tablets are bioequivalent to the reference listed drug, Tylenol Extended-Release Tablets, 650 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.

"This product approval endorses the capability of Marksans to develop and deliver products on a high barrier platform technology of extended release tablets," the company stated.

Extended release is an advanced technology and is a solution to patient compliance to avoid repeated dosages at short intervals.

Marksans will manufacture the products at its USFDA approved state-of-the-art solid oral dosage facility located at Goa, India.

Marksans Pharma, headquartered at Mumbai (India) is a global pharmaceutical company.

The company's key focus areas lie in the OTC & prescription drugs that have wide-ranging applications across fields like Oncology, Gastroenterology, Antidiabetic, Antibiotics, Cardiovascular, Pain Management, Gynaecology, among others.

Read also: Zydus Cadila gets USFDA nod for Tofacitinib ER tablets

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751