Strides Pharma receives approval for ibuprofen from USFDA

Bengaluru, Feb 24: Strides Pharma Science Limited (Strides), wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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 bio-equivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Children’s Motrin Oral Suspension, 100 mg/mL, of Johnson & Johnson Consumer Inc., according to a release here on Wednesday. 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 USD 133 Mn. 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. (UNI)