DRUGMAKER Lupin has received US Food and Drug Associationâ€™s (FDAâ€™s) approval to sell anti-depressants, it said.
Lupin can now make imipramine hydrochloride tablets of 10 mg, 25 mg and 50 mg strengths, according to the abbreviated new drug application, or ANDA, approval, the company said. Shipments for the product are already under way, Nilesh Gupta, group president and executive director said.
The company estimates the market size for the product at $21 million (approximately Rs 95 crore) in the US. Lupin had filed 105 ANDAs till December 31, and has received approval for 36.
The approval marks the companyâ€™s fifth since January, when the FDA cleared its objections to Lupinâ€™s
Mandideep facility. While the curb on the Mandideep facility did not bar most of the product approvals Lupin has sought, there could have been a sentimental impact at the regulatorsâ€™ 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 countryâ€™s social security programme. Others like Ranbaxy and Sun Pharmaceuticalâ€™s US unit Caraco Pharmaceutical Laboratories continue to face warnings against manufacturing processes.
Sarabjit Kour, vice-president, research at Angel Broking said there may be an earnings re-rating for Lupin. The brokerage currently estimates next fiscal,
ending March 2011, revenue at Rs 4,707 crore, and net profit Rs 630 crore. In the nine months of this fiscal, the companyâ€™s revenue was Rs 3,537 crore and
net profit Rs 461 crore. Lupin also said it has filed for 11 oral contraceptive products already and plans to file another 12-13 this year. â€œWe set up a dedicated oral contraceptive facility in Indore a year ago to prepare our entry into the highly profitable segment,â€ Mr Gupta said. â€œOral contraceptive could very well account for $100-150 million of revenues for Lupin in a couple of years.â€
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