Strides Pharma Science’s arm gets approval for Ibuprofen Oral Suspension

24 Feb 2021 Evaluate

Strides Pharma Science’s step-down wholly owned subsidiary -- Strides Pharma Global 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 Inc.

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.

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.

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.

Strides Pharma Scien Share Price

878.65 -7.00 (-0.79%)
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