GLENMARK PHARMACEUTICALS EUROPE LIMITED

Glenmark Pharmaceuticals has received approval from India's DCGI to begin a multi-country Phase 3 clinical trial for Envafolimab, a novel subcutaneous PD-L1 inhibitor, in patients with resectable Stage III non-small cell lung cancer.

Glenmark Pharmaceuticals Inc., USA announced the September 2025 launch of its generic Eribulin Mesylate Injection, marking the company's first complex generic product entry.

The FDA issued a warning letter to Glenmark Pharmaceuticals citing serious manufacturing violations at its Madhya Pradesh factory, including delayed safety testing that contributed to recalls of potentially deadly medications.

Glenmark Pharmaceuticals has launched Tevimbra (tislelizumab), marking the company's first entry into immuno-oncology in India following CDSCO approval.

Glenmark Pharmaceuticals has received DCGI approval to launch zanubrutinib (BRUKINSA) in India, marking the first BTK inhibitor approved for treating five distinct B-cell malignancies.

Glenmark Pharmaceuticals will launch a generic version of Adderall tablets in five dosage strengths starting May 2025, providing a bioequivalent alternative to the reference drug by Teva Women's Health.

Glenmark Pharmaceuticals Inc., USA has launched Vancomycin Hydrochloride for Injection USP in three dosage strengths: 750 mg, 1.25 g, and 1.5 g single-dose vials.

Glenmark Therapeutics has launched Polyethylene Glycol 3350 powder (17 grams/capful) as an over-the-counter constipation treatment in the US market, comparable to MiraLAX®.

Glenmark Pharmaceuticals has acquired and launched Acetylcysteine Injection (6 gm/30 mL) in the US market, expanding its presence in the hospital segment through the ANDA acquisition from Aspen Pharma USA.

Glenmark Pharmaceuticals has initiated a recall of approximately 1.5 million bottles of an ADHD medication from the US market following FDA oversight.