Shilpa Medicare receives US approval for Varenicline Tablets, 0.5 mg and 1 mg

Shilpa Medicare receives US approval for Varenicline Tablets, 0.5 mg and 1 mg

By: IPP Bureau

Last updated : April 10, 2025 10:24 am



Shilpa’s product has been approved as a generic version to the innovator - Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF Prism)


Shilpa Medicare Limited, headquartered at Raichur, Karnataka, India, has received approval from USFDA for Varenicline Tablets, 0.5 and 1 mg.

The total US market for this product is around  US $203 million.

Shilpa’s product has been approved as a generic version to the innovator - Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF Prism).

Varenicline Tablets are indicated for smoking cessation; it helps people to quit smoking.

Shilpa is an integrated pharmaceutical group with business interests in niche oncology & non-oncology APIs, peptides, polymers, differentiated finished dosage formulations including novel injectables, orally dispersible films & transdermal patches along with a carefully crafted biological portfolio.

Shilpa Medicare Limited Chantix Tablets

First Published : April 10, 2025 12:00 am