Lupin’s US subsidiary, Lupin Pharmaceuticals, Inc, has received tentative approval for its Diclofenac Capsules USP, 18 mg and 35 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Iroko Pharmaceuticals LLC's Zorvolex Capsules 18 mg and 35 mg.
Lupin's Diclofenac Capsules USP, 18 mg and 35 mg are the AB rated generic equivalent of Iroko Pharmaceuticals LLC's Zorvolex Capsules 18 mg and 35 mg. It is indicated for management of mild to moderate acute pain and management of osteoarthritis pain. Zorvolex Capsules had US sales of USD 39.6 million as per IMS MAT September 2016.
Lupin is a pharmaceutical company and is engaged in formulation of drugs and active pharmaceutical ingredients (APIs), generics, biotechnology, novel drug discovery and development, drug delivery systems and specialty pharmaceuticals.
