Strides Pharma Science arm gets USFDA nod for Ibuprofen OTC Oral Suspension
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, muscle aches.
Bengaluru: Strides Pharma Science Limited has recently announced that its step-down 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 bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Children's Motrin Oral Suspension, 100 mg/mL, of Johnson & Johnson Consumer Inc.
The product will be manufactured at the company's facility at Bengaluru.
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 US$ 133 Mn.
The company has 127 cumulative ANDA filings with USFDA of which 99 ANDAs have been approved and 28 are pending approval.
Strides is a global pharmaceutical company headquartered in Bengaluru, India. The Company mainly operates in the regulated markets and has an "in Africa for Africa" strategy along with an institutional business to service donor-funded markets.
The Company's global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (Florida).