Indoco Remedies has received final Abbreviated New Drug Application (ANDA) approval from United States Food and Drug Administration (USFDA) 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).
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, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India. Varenicline is used to aid smoking cessation treatment.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
