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Strides Shasun share price gained as much as 2.2 percent in morning on Tuesday after its subsidiary received approval from the US health regulator for the painkiller drug.
"The wholly owned subsidiary Strides Pharma Global Pte Ltd has received final approval for Ibuprofen tablets USP, 200 mg (OTC) from the United States Food & Drug Administration (USFDA)," the company said in its filing.
Ibuprofen is a generic version of Motrin IB tablets, 200 mg, of Johnson & Johnson Consumer, Inc.
"The approval further strengthens Strides Ibuprofen franchise for the US markets that now comprises of 7 approved products addressing a combined Rx and OTC opportunity of $900 million as per IMS and IRi data," the company said.
Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID).
The product will be manufactured at the company's Oral dosage facility at Puducherry and will be marketed by Strides Pharma Inc in the US market, it added.
The company has 75 cumulative ANDA filings with US FDA of which 51 ANDAs have been approved as of date and 24 are pending approval.
At 09:40 hours IST, the stock price was quoting at Rs 392.00, up Rs 3.70, or 0.95 percent on the BSE.
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