Shilpa Medicare Limited, a Raichur-based pharmaceutical company, announced on April 9 that it has received the much-anticipated approval from the U.S. Food and Drug Administration (USFDA) for its Varenicline tablets in 0.5 mg and 1 mg strengths. These tablets are intended to aid smoking cessation and are a generic version of the innovator drug Chantix, developed by PF Prism C.V.
The approved drug opens the door for Shilpa to compete in the lucrative U.S. market for Varenicline tablets, which is estimated to be worth approximately $203 million. This move further consolidates Shilpa’s position as a significant player in the pharmaceutical exports market.
Varenicline works by affecting nicotine receptors in the brain, thereby reducing cravings and withdrawal symptoms in people trying to quit smoking.
The approval reinforces Shilpa’s growing footprint in the U.S. generic drug space. The company is known for its strong R&D infrastructure, niche expertise in oncology and non-oncology APIs, as well as differentiated finished dosage formulations such as novel injectables, oral dispersible films, and transdermal patches.
In addition to its wide portfolio, Shilpa also provides end-to-end CDMO (Contract Development and Manufacturing Organization) services to global pharmaceutical companies, supported by four R&D units and seven manufacturing facilities.
With this new approval, Shilpa Medicare is poised to leverage its global capabilities and integrated pharmaceutical solutions to capture a meaningful share of the U.S. smoking cessation market.
