Pharma major Lupin Ltd. has announced that its US subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for its Duloxetine Hydrochloride Delayed-release (HCl DR) capsules 20 mg, 30 mg and 60 mg from the United States Food and Drugs Administration (FDA) for the company's Abbreviated New Drug Application (ANDA) to market a generic version of Eli Lily & company's Cymbalta Delayed-release capsules.

Lupin's Duloxetine HCl DR capsules are the AB-rated generic equivalent of Eli Lily's Cymbalta Delayed-release capsules 20 mg, 30 mg and 60 mg strengths. Duloxetine HCl DR Capsules is indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), management of neuropathic pain (DPNP)associated with diabetic peripheral neuropathy, management of fibromyalgia (FM) and management of chronic musculoskeletal pain.

Cymbalta HCl DR Capsules 20 mg, 30 mg, 60 mg had annual US sales of approximately US$ 3.5 billion for the twelve months ending September 2011 (IMS Health data).

Lupin is an innovation led transnational pharmaceutical company producing a wide range of generic and branded formulations and APIs. The company has significant presence in the cardiovascular, diabetology, asthama, paediatrics, CNS, GI, anti-infectives and NSAID space in addition to holding global leadership positions in the anti-TB and cephalosporin segments.