Indoco Remedies Ltd. announced the final approval of the Company’s Abbreviated New
Drug Application (ANDA) for Varenicline Tablets, 0.5 mg and 1 mg, to market a generic equivalent to the reference listed drug (RLD), Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF) from USFDA.
Varenicline Tablets, 0.5 mg and 1 mg bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF).
This product, Varenicline Tablets, 0.5 mg and 1 mg will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India. Varenicline is used to aid smoking cessation treatment.
Commenting on the achievement, Ms. Aditi Panandikar, Managing Director said, “Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US.”
Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence. The Company’s turnover is US$ 212 million with a human capital of over 6000 employees, including over 400 skilled scientists and field staff who are the strength of the organization.
