Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
Company introduces bioequivalent version of Edarbi for hypertension treatment following U.S. FDA approval; product recorded annual U.S. sales of USD 53.5 million
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
Pharmaceutical R&D veteran brings over 20 years of expertise in formulation development, ANDA filings, and regulated-market product innovation to strengthen MSN Laboratories’ global growth ambitions
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
The approved product is therapeutically equivalent to Haldol tablets of Ortho McNeil Pharmaceutical
Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials is the bioequivalent to the reference listed drug (RLD) Halaven injection of Eisai, Inc.
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism
The approval has been secured in partnership with Yabao Pharmaceuticals, a major player in China’s paediatric medicine segment
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