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- Gland Pharma Limited secured FDA approval for its generic version of olopatadine hydrochloride 0.7% ophthalmic solution, equivalent to Alcon's Pataday Once Daily Extra Strength. - The over-the-counter eye drops treat ocular itching associated with allergic conjunctivitis and provide 24-hour relief with once-daily dosing. - This approval marks the second generic version of a Pataday formulation to receive FDA clearance, following Glenmark's approval for the 0.2% concentration in 2025. - The company's shares gained 0.99% following the announcement, reflecting investor confidence in Gland Pharma's expanding ophthalmic portfolio.
- Glenmark Specialty S.A. has signed an exclusive licensing agreement with Jiangsu Hansoh Pharmaceutical Group for Aumolertinib, a third-generation EGFR-TKI designed to treat non-small cell lung cancer. - The partnership grants Glenmark development and commercialization rights across multiple regions including the Middle East, Africa, Southeast Asia, Australia, New Zealand, and Russia/CIS. - Hansoh Pharma will receive an upfront payment in the low double-digit millions with potential milestone payments and royalties that could eventually exceed $1 billion. - Aumolertinib has already received marketing authorization from the UK MHRA and approval for four indications in China, marking it as the first China-developed EGFR-TKI to be launched internationally.
- Glenmark Pharmaceuticals has recalled more than 11,000 bottles of bisoprolol fumarate and hydrochlorothiazide tablets (brand name Ziac) after testing revealed cross-contamination with ezetimibe, a cholesterol medication. - The FDA classified this as a Class III recall, indicating the contamination is not likely to cause adverse health consequences, though the products are being removed from distribution as a precautionary measure. - The recall affects multiple dosage strengths and bottle sizes with expiration dates ranging from November 2025 through May 2026, manufactured at Glenmark's facility in Madhya Pradesh, India. - Patients currently taking the medication are advised to continue use unless directed otherwise by their doctor, while pharmacies and healthcare providers are urged to check their inventory for affected lots.
- Glenmark Pharmaceuticals has launched the world's first nebulized, fixed-dose triple therapy combining Glycopyrronium, Formoterol, and Budesonide for COPD treatment. - The therapy, available as Nebzmart GFB Smartules and Airz FB Smartules, offers a new standard of care particularly for patients who struggle with traditional inhalers. - Clinical studies conducted in India demonstrated rapid improvement in lung function and better control of breathlessness among COPD patients. - This single, easy-to-use nebulized treatment minimizes the burden of multiple medications while reducing airway obstruction and inflammation.
- China's National Medical Products Administration approved RYALTRIS nasal spray for treating moderate to severe allergic rhinitis in adults and children, marking a significant regulatory milestone for Glenmark. - RYALTRIS represents a first-of-its-kind fixed-dose combination therapy combining olopatadine hydrochloride and mometasone furoate in a single nasal spray formulation. - The approval was granted with zero supplementation requests following successful Phase III trials involving 535 patients across multiple Chinese centers. - RYALTRIS demonstrated superior efficacy compared to monotherapy comparators while meeting all safety and tolerability endpoints in clinical studies.
- Glenmark Pharmaceuticals' US subsidiary will launch generic Ropivacaine Hydrochloride injection in November 2025, offering a bioequivalent alternative to Fresenius Kabi's Naropin. - The long-acting anesthetic drug is indicated for producing local or regional anesthesia in surgical procedures for adults, with the reference product generating $20.9 million in sales over the past twelve months. - The generic version will be available in three single-dose vial strengths (40 mg/20 ml, 150 mg/30 ml, and 200 mg/20 ml), expanding Glenmark's injectable portfolio. - This launch reinforces Glenmark's commitment to providing quality and affordable medical alternatives to patients in need across the US market.
- Alembic Pharmaceuticals received FDA approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, therapeutically equivalent to the reference drug. - The approved product targets hypoprothrombinemia due to vitamin K deficiency and vitamin K-deficiency bleeding in neonates, entering a $44 million market. - This approval brings Alembic's total ANDA approvals to 225, positioning the company to capitalize on the growing generic sterile injectables market projected to reach $251.03 billion by 2030.
- 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. - The randomized, multi-center trial will expand to Russia, Brazil, and Mexico, assessing the drug's efficacy and safety in Stage IIIA and IIIB NSCLC patients where five-year survival rates remain poor at 36% and 26% respectively. - Envafolimab's unique subcutaneous administration allows for faster delivery within 30 seconds, potentially making immunotherapy more accessible in resource-constrained healthcare settings. - The drug is already approved in China for advanced solid tumors with MSI-H/dMMR and has benefited over 40,000 cancer patients, representing a significant advancement in convenient immunotherapy delivery.
- 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 generic formulation is bioequivalent and therapeutically equivalent to Eisai's Halaven injection, targeting a market worth approximately $66.3 million annually. - This launch represents Glenmark's strategic expansion into the institutional channel and commitment to providing affordable cancer treatment alternatives for patients in need.
- The FDA quietly permitted more than 150 exempted products from officially banned foreign factories to continue shipping to the United States for over a dozen years to prevent drug shortages. - ProPublica's investigation revealed that most exempted drugs came from factories in India, with additional facilities in China and Hungary, despite dangerous manufacturing failures that led to import bans. - The agency did not regularly test these exempted drugs or proactively monitor safety reports describing products with foul odors, abnormal taste, or consumers experiencing unexplained health problems. - Several factories remain banned but continue receiving exemptions, while the FDA kept this practice largely hidden from the public without releasing a comprehensive list until now.
