India Pharma Outlook Team | Friday, 12 December 2025
Glenmark Pharmaceuticals announced today that its U.S. subsidiary will roll out Leucovorin Calcium for Injection USP, 350 mg/vial in December 2025.
The drug is a single-dose vial and is both bioequivalent and therapeutically equivalent to Hospira Inc.’s reference listed product. With this move, Glenmark strengthens its position in the institutional market and extends its reach in critical-care therapies.
The company highlighted that the Leucovorin Calcium product is approved only for the uses listed on its FDA-approved label. It will not be marketed for every indication associated with the reference drug. Even with these limits, Glenmark expects solid demand.
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Citing IQVIA data covering the 12 months ending October 2025, the firm noted that the U.S. market for the 350 mg/vial strength generated about $16.8 million in annual sales, including the brand and all generic equivalents.
Marc Kikuchi, President & Business Head, North America said, We are pleased to announce the upcoming launch of Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial, further expanding our portfolio of products within the institutional channel, while also strengthening our commitment to bring to market quality and affordable alternatives for patients.
The launch caps Glenmark’s ongoing push to broaden its injectable portfolio in the United States. The company develops, manufactures, and markets a wide range of pharmaceutical products across regulated and semi-regulated regions. With the introduction of Leucovorin Calcium for Injection USP, Glenmark underscores its focus on expanding access to essential medicines while competing in a market shaped by pricing pressure, hospital demand, and steady growth in oncology and supportive-care treatments.
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