Marksans Pharma gets approval from USFDA for Acetaminophen Extended-Release Tablets

26 Aug 2021 Evaluate

Marksans Pharma has received approval from USFDA 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. 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 together with its subsidiaries operates as an integrated international pharmaceutical company. The company’s business is distribution of pharmaceutical products.

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