Bengaluru, April 3 Strides Pharma Global Pte. Ltd, a wholly owned subsidiary of Strides Shasun, has received approval for Ibuprofen capsules, 200 mg OTC, from the US Food & Drug Administration (FDA).
According to a company statement, the approval further strengthens Strides global Ibuprofen portfolio that now includes multiple products in oral dosage format. Further, this is a pre-GDUFA (Generic Drug User Fee Amendments) file for the company and the approval has come through after a long approval cycle of almost 6 years, the statement added.
Ibuprofen capsule is a generic version of Advil Liqui-Gels, 200 mg, of Pfizer, and is a non-steroidal anti-inflammatory drug, used to treat headache, flu among others.
The development comes at a time when recently there have been supply chain disruptions, which have led to a significant shortage for Ibuprofen API globally. The product will be commercialised in Q4 FY 19 post completion of API source change process.
The company expects to garner 20 per cent of the private label market share. The product will be manufactured at the company’s oral dosage facility at Bengaluru.
According to IRi data, the US OTC market for Ibuprofen capsules is approximately $300 million, including a private label market of $60 million. Strides has 74 cumulative ANDA filings with USFDA of which 45 ANDAs have been approved till date and 29 are pending approval.