Glenmark Pharma's U.S. arm to launch Leucovorin Calcium Injection in the U.S. Market

Glenmark Pharmaceuticals announced that its U.S.-based subsidiary, Glenmark Pharmaceuticals Inc., USA, has unveiled plans for the upcoming launch of Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Leucovorin Calcium for Injection, 350 mg/vial, marketed by Hospira Inc. Glenmark stated that distribution of the product will begin in December 2025.

Citing IQVIA sales data for the 12 months ending October 2025, the company said the U.S. market for Leucovorin Calcium for Injection, 350 mg/vial recorded annual sales of approximately $16.8 million, including the brand product and all available therapeutic equivalents.

 

Glenmark emphasized that its Leucovorin Calcium for Injection USP, 350 mg/vial is approved only for the indications listed on its FDA-approved label and is not marketed for all RLD indications.

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.

Glenmark Pharmaceuticals is engaged in the business of development, manufacturing, and marketing of pharmaceutical products, both formulations and active pharmaceutical ingredients, to regulated and semi-regulated markets.

Glenmark Pharmaceuticals, the company, reported a 72.3% jump in consolidated net profit to Rs 610.25 crore on a 76.6% increase in revenue from operations to Rs 6,003.79 crore in Q2 FY25.

The counter rose 0.24% to Rs 1,957.60 on the BSE.

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