The launch aligns with Lupin’s strategic push into injectables, biosimilars, and inhalation therapies, supported by robust R&D and manufacturing capabilities
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This is eligible for 180 days of generic drug exclusivity. The company will manufacture the product at its facility situated in India.
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The tablets will be made at the company’s Goa facility, a site that has previously cleared global regulatory inspections and supports Lupin’s key exports.
The company said this deal fits into its larger strategy of expanding respiratory therapies beyond its home markets.
StainCares added that partnership plans to enhance its biosimilar portfolio and back cost-effective healthcare in Latin America.
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The drug will be manufactured at Lupin's facility in Nagpur, India, and the company has announced plans for a near-term launch in the U.S. market.
The clearance is on the back of a four-day USFDA inspection between June 10 and June 13, 2024.
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