Granules India receives USFDA approval for Ibuprofen tablets

14 Oct 2016 Evaluate

Granules India has received approval from the US health regulator for anti-inflammatory drug Ibuprofen tablets in the US market. The regulator has approved Abbreviated New Drug Application (ANDA) for Ibuprofen tablets USP, 200 mg (OTC) filed by the pharma major. The approved ANDA is the bio-equivalent to the reference listed drug product (RLD), Motrin IB Tablets, 200 mg, of Johnson & Johnson Consumer, Inc.

Granules India produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) for quality conscious customers in the regulated and semi-regulated markets.



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