Lupin gets US FDA nod for anti-depressant
MUMBAI: Drug maker Lupin has received US Food and Drug Association (FDA) approval for anti-depressant, it said on Wednesday. Lupin can now make Imipramine hydrochloride tablets of 10 mg, 25 mg and 50 mg strengths, as per the abbreviated new drug application (ANDA) approval, the company said. Shipments for the product are already on way, Nilesh Gupta, group president and executive director, told ET.
The company estimates the market size for the product at $21 million (approximately Rs 95 crore) in the US. Lupin had filed 105 ANDAs as on December 31, 2009, and has received approval for 36.
The approval marks the company’s fifth drug approval since January, when the FDA cleared its objections to Lupin’s Mandideep facility. While the curb on the Mandideep facility didn’t bar most of the product approvals Lupin has sought, there could have been a sentimental impact at the regulators end, analysts said.
Indian pharmaceutical companies have been under heightened scrutiny lately, even as the Obama administration seeks to liberalise the use of generic drugs and lower costs of the country’s social security programme. Others like Ranbaxy and Sun Pharmaceutical’s US unit Caraco Pharmaceutical Laboratories continue to face warnings against manufacturing processes.
March 22, 2010