By: IPP Bureau
Last updated : August 27, 2021 11:33 am
The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India
Marksans Pharma Limited has announced that US FDA 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 US FDA approved state-of-the-art solid oral dosage facility located at Goa in India