Drug firm Strides Pharma Science on Wednesday said its step-down wholly-owned subsidiary, Strides Pharma Global, has received approval from the US health regulator for Ibuprofen Oral Suspension, used to relieve pain.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Children's Motrin Oral Suspension, 100 mg/mL, of Johnson & Johnson Consumer Inc.
Strides Pharma Global Pte. Limited, Singapore, has received approval for Ibuprofen Oral Suspension USP, 100 mg/5 mL from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.
Strides said it is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, tablets, capsules, topicals, powders and oral solutions.
Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC) further strengthens the company's private label portfolio for the US market, the company added.
Ibuprofen OTC Oral Suspension Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, muscle aches. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu
Quoting IRi data, Strides Pharma Science said the US market for Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC) is approximately USD 133 million.
The product will be manufactured at the company's facility at Bengaluru, the company added.
The company has 127 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 99 ANDAs have been approved and 28 are pending approval.
Shares of Strides Pharma Science were trading 0.32 per cent higher at Rs 856.50 apiece on BSE.