Shilpa Medicare Receives USFDA Approval for Generic Varenicline Tablets, Targeting 203 M USD Market

Shilpa Medicare Ltd has announced that it has received approval from the US Food and Drug Administration (USFDA) for Varenicline Tablets, 0.5 mg and 1 mg. The total US market for this product is approximately 203 M USD. The approved product is a generic version of Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. Varenicline Tablets are indicated for smoking cessation, helping people to quit smoking. Shilpa Medicare Limited is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations, and a biological portfolio. The company also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments.