Strides Pharma receives USFDA nod for Ibuprofen OTC oral suspension
On Wednesday, Strides Pharma informed that its wholly-owned subsidiary, Strides Pharma Global Pte Ltd (Singapore) has received approval for Ibuprofen oral suspension USP, 100 mg/5 ml (OTC) from United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to reference listed drug (RLD), Children’s Motrin® oral suspension, 100 mg/ml of Johnson & Johnson Consumer Inc. Strides is about to build a private label business in the US via leveraging its portfolio of products across soft gels, tablets, capsules, topicals, powders, and oral solutions. Ibuprofen oral suspension USP, 100 mg/5 ml (OTC), used as an analgesic for the relief of mild to moderate muscular pain, post-immunisation pyrexia, symptomatic relief of headache, earache, dental pain, and backache contributes to the leveraging of the portfolio.
According to the data of IRi, US market for Ibuprofen oral suspension USP, 100 mg/5 ml (OTC) is approximately US$ 133 million. The product is planned to be manufactured at the company’s facility in Bengaluru. The company records to have 127 cumulative abbreviated new drug application (ANDA) filings with USFDA of which, 99 ANDAs have been approved while 28 are still awaiting approval.
Strides Pharma is a vertically integrated global pharmaceutical company, which is engaged in the development & manufacturing of active pharmaceutical ingredients (APIs) and formulations as well as Biotech.
On Wednesday, the share of Strides Pharma was trading at Rs 857.45, up by 0.44 per cent at 11.11 am on BSE.