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.

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