Marksans Pharma gets USFDA nod for Acetaminophen ER Tablets

Published On 2021-08-26 07:30 GMT   |   Update On 2021-08-26 12:40 GMT
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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.

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"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.

Read also: Marksans Pharma appoints Dr Meena Rani Surana as Independent Woman Director

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.



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