Shilpa Medicare receives USFDA approval for Varenicline tablets

Shilpa Medicare said that it has received approval from United States Food and Drug Administration (USFDA) for Varenicline tablets, 0.5 and 1 mg.

Varenicline helps people quit smoking by blocking the effect of nicotine on the brain. Nicotine is a substance found in cigarettes and other tobacco products that makes smoking feel good. Varenicline blocks this good feeling and can help prevent cravings to smoke cigarettes.

The total US market for varenicline products is around $203 million.

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

Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India.

The company had reported a consolidated net profit of Rs 31.78 crore in Q3 FY25, which is significantly higher as compared with the PAT of Rs 4.58 crore posted in Q3 FY24. Revenue from operations for the third quarter was at Rs 319.32 crore, up 11.35% year on year.

Shares of Shilpa Medicare tumbled 3.64% to Rs 620.10 on the BSE.

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