Strides Pharma Science today announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received
approval for Naproxen Sodium Softgel Capsules, 220 mg (OTC) from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma Inc.
Strides is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, tablets, capsules and other formats. The approval for Naproxen Sodium OTC Softgel Capsules further strengthens Strides OTC portfolio for the US markets.
The US OTC market for Naproxen Sodium Softgel Capsules, 220 mg (OTC) is approximately ~US$100 Mn.
The product will be manufactured at the company's facility at Bengaluru.
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