Marksans Pharma announced that 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. 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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