News

Glenmark Pharmaceuticals Inc., USA (Glenmark) announced the launch of Olanzapine for Injection, 10 mg/vial, Single-Dose Vial. Glenmark`s Olanzapine for Injection is bioequivalent and therapeutically equivalent to the reference listed drug, Zyprexa�2 IntraMuscular Injection 10 mg/vial, of Cheplapharm Registration GmbH [NDA 021253]. According to IQVIA� sales data for the 12-month period ending May 2026, the Zyprexa� IntraMuscular Injection market achieved annual sales of approximately $25.4 million.

Glenmark Specialty S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals (Glenmark) announced the advancement of its multi-country Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811), a HER2-targeted antibody drug conjugate (ADC), for patients with platinum-resistant ovarian cancer (PROC). India will serve as the first country in Glenmark`s licensed markets to initiate patient enrollment for the Phase 3 clinical trial, following the approval of Drugs Controller General of India (DCGI). Glenmark also plans to enroll patients in Australia and South Korea, subject to regulatory approvals. The study is aligned with Jiangsu Hengrui Pharmaceuticals Co.`s ongoing parent Phase 3 trial in China. Glenmark aims to generate clinically relevant data across broader and more diverse patient populations, supporting the development of Trastuzumab rezetecan across Glenmark`s licensed markets. The randomized, controlled, multi-centre, Phase 3 trial is designed to evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab rezetecan in patients with HER2-expressing platinum-resistant ovarian cancer, a difficult-to-treat disease where treatment options remain limited, and outcomes continue to be poor. Conducting the trial across multiple geographies is expected to support the generation of evidence from diverse patient groups and strengthen the clinical data package for the therapy across Glenmark`s licensed markets.

Glenmark Pharmaceuticals Inc., USA (Glenmark) today announced the launch of Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL) Single Dose Vial. Glenmark`s Methylene Blue Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug, ProvayBlue� Injection, 50 mg/10 mL (5 mg/mL), of Provepharm SAS [NDA 204630]. Commenting on the launch, Marc Kikuchi, President & Business Head, North America said, �The launch of Methylene Blue Injection USP reflects Glenmark`s ongoing commitment to expanding access to quality, affordable medicines for healthcare institutions and the patients they serve. This addition further strengthens our institutional portfolio and reinforces our focus on delivering reliable treatment options across the U.S. market.�

 Glenmark Specialty S.A (GSSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals, today announced the launch of Winlevi� (clascoterone 10 mg/g cream) across key markets in Europe. This follows the grant of marketing authorization of the product for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years (with usage in adolescents limited to facial application) by the European Commission to Cassiopea S.p.A., a subsidiary of Cosmo N.V. (SIX: COPN) (Cosmo) in October 2025. Glenmark has initiated direct launches in several European markets, including the Nordics, Central and Eastern Europe, and Spain. In Portugal, the Company has launched the product through a strategic partner. Glenmark is also advancing additional launches through strategic partnerships across other European markets. The product is authorized in the European Union for the treatment of acne vulgaris in adults and adolescents. The product has been developed by Cassiopea, which holds rights across Europe and collaborates with regional partners for commercialization.

Glenmark Pharmaceuticals Inc., USA (Glenmark) announced the launch of Lacosamide Injection USP, 200 mg/20 mL (10 mg/mL), Single-Dose Vials. Glenmark`s Lacosamide Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug, Vimpat�2 Injection, 200 mg/20 mL (10 mg/mL), of UCB, Inc. [NDA 022254]. According to IQVIA� sales data for the 12-month period ending April 2026, the Vimpat� Injection market3 achieved annual sales of approximately $15.2 million. Commenting on the launch, Marc Kikuchi, President & Business Head, North America said, �The launch of Lacosamide Injection USP reflects the disciplined execution of our strategy to build a broader, differentiated product portfolio in the United States. By expanding our injectable product portfolio, we are enhancing our ability to meet the evolving needs of healthcare providers while advancing our commitment to improving patient access to quality, affordable treatment options.�