Shilpa Medicare bags USFDA approval for Varenicline Tablets for smoking cessation

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-04-10 07:47 GMT   |   Update On 2025-04-10 07:47 GMT
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Karnataka: Shilpa Medicare Limited has received approval from the US Food and Drugs Administration (USFDA) for Varenicline Tablets, 0.5 and 1 mg.

The total US market for this product is around 203 M USD.

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.

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

Read also: Shilpa Medicare receives European marketing authorization for Tadalafil Orodispersible Films for erectile dysfunction

Medical Dialogue team had earlier reported that Shilpa Medicare's marketing partner, Amneal Pharmaceuticals, had launched BORUZU, (Bortezomib for injection 3.5mg/1.4ml), a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration.

Read also: Shilpa Medicare marketing partner Amneal Pharma unveils multiple myeloma treatment Boruzu

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 carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.

Read also: Shilpa Medicare Gets CDSCO Panel Nod for Novel NAFLD Drug, Advances to Marketing Approval Stage

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