Indian drug maker gets USFDA nod to market pain relievers

Indian drug maker gets USFDA nod to market pain relievers

The approved product, which has an estimated market size of $56 million, will be launched by Q4 FY 2015-16

The Dollar Business Bureau

Indian drug major Aurobindo Pharma, on Friday, got an approval from the United States Food and Drug Administration (USFDA) to manufacture and market drugs used in the long-term treatment of moderate-to-severe pain in adults. “The company has received final approval from the USFDA to manufacture and market Tramadol Hydrochloride Extended-release Tablets USP, 100 mg, 200 mg and 300 mg (ANDA 204421). This product will be launched by Q4 FY 2015-16,” said an official release. The approved product, having an estimated market size of $56 million for the twelve months ending August (according to IMS), is the 50th Abbreviated New Drug Application (ANDA-US generic drug approval for an existing licensed medication) to be approved at ‘formulation facility for manufacturing Oral Non-Antibiotic products’, in Hyderabad. The company now has acquired a total of 217 ANDA approvals (189 Final approvals including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA. Aurobindo Pharma Ltd. and Lupin Pharmaceuticals Ltd. have now received the highest number of 21 ANDA approvals each, followed by Alembic Pharmaceuticals Ltd., Glenmark Pharmaceuticals Ltd. and Hetero Laboratories Ltd. with 8 ANDA approvals each, during the first nine months this year. With the rising scope of investments in research and development sectors, Indian pharma companies and their subsidiaries seem to be betting high on achieving as many USFDA approvals as possible in the current year. They are said to have already secured final approvals for 113 ANDAs and tentative approvals for 32 ANDAs – accounting for over 30% of the total approvals - during the first nine months till September. The USFDA approved 372 final ANDAs and 102 tentative ANDAs during January-September 2015. The overall approval rate in the current year is likely to be higher than that of 2014, during which Indian companies secured 122 final ANDA approvals out of 416 ANDAs.  

October 23, 2015 | 2:54pm IST

The Dollar Business Bureau - Oct 23, 2015 12:00 IST