Strides gets USFDA nod for Ibuprofen OTC Oral Suspension

Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Ibuprofen Oral Suspension USP,100 mg/5 mL (OTC) from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Children’s Motrin Oral Suspension, 100 mg/mL, of Johnson & Johnson Consumer.

Ibuprofen is a nonsteroidal 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.

Strides 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 company’s private label portfolio for the US market. According to IRi data, the US market for Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC) is approximately $133 million. The product will be manufactured at the company’s facility at Bengaluru.

The company has 127 cumulative ANDA filings with USFDA of which 99 ANDAs have been approved and 28 are pending approval.