Indian multinational pharmaceutical company manufacturing generic drugs and active pharmaceutical ingredients; develops proprietary medicines in oncology, dermatology and respiratory treatments across India, North America, Europe and emerging markets.
Clinical Trials
33
11 active
Approvals
56
Total approvals
Agencies
4
Regulatory bodies
Founded
1977
Active, not recruiting
3
9.1%
Completed
22
66.7%
Not yet recruiting
8
24.2%
- India's Ministry of Health and Family Welfare has restricted the manufacture, sale, and distribution of fixed-dose combinations containing chlorpheniramine maleate and phenylephrine hydrochloride for children under four years of age. - The restriction, issued under Section 26A of the Drugs and Cosmetics Act, 1940, requires a prominent warning on labels, package inserts, and promotional materials stating the combination must not be used in children below four. - The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board, which found safer alternatives exist and the combination may pose risks such as excessive drowsiness, agitation, and rapid heartbeat. - The Delhi High Court clarified the ban is not retrospective, allowing existing stock manufactured before the notification to continue being sold, reducing potential financial losses for manufacturers.
- Glenmark Pharmaceuticals received U.S. FDA approval for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray (50 mcg/spray), expanding its respiratory portfolio in the U.S. market. - The product is bioequivalent and therapeutically equivalent to Flonase Nasal Spray, the reference listed drug marketed by Haleon US Holdings LLC. - According to IQVIA data for the 12 months ended June 2026, the Flonase Nasal Spray market recorded approximately US$295.2 million in annual sales. - The approval follows Glenmark's marketing nod for the OTC version of the drug in March, positioning fluticasone as a key U.S. sales driver.
- The FDA has expanded the indication for Ryaltris (olopatadine hydrochloride/mometasone furoate) nasal spray to include pediatric patients aged 6 to under 12 years with seasonal allergic rhinitis. - The approval was supported by a phase 3 randomized, double-blind, placebo-controlled trial enrolling 446 pediatric patients aged 6–11 years, demonstrating greater nasal symptom improvement versus placebo. - Ryaltris is a fixed-dose combination of an antihistamine (665 µg olopatadine) and a corticosteroid (25 µg mometasone furoate), initially approved in 2022 for patients aged 12 and older. - The most common adverse reactions included dysgeusia, epistaxis, and nasal discomfort; the prescribing information includes warnings for epistaxis, nasal ulceration, immunosuppression risks, and potential growth velocity reduction in pediatric patients.
- Nevada Attorney General Aaron Ford and a coalition of 43 states announced a $400 million settlement in principle with Sandoz Inc. over allegations of widespread generic drug price manipulation. - The settlement resolves claims that Sandoz and its international affiliates engaged in long-running conspiracies to artificially inflate prices and reduce competition on numerous generic prescription drugs. - Sandoz has agreed to injunctive terms including internal reforms to ensure fair competition and compliance with antitrust laws, with a trial anticipated in 2027. - The broader multistate antitrust litigation, ongoing since 2016, has now secured settlements totaling approximately $565.5 million across multiple generic drug manufacturers.
- Mississippi will receive $236,595.47 as part of a $29.6 million multistate settlement with Glenmark Pharmaceuticals over generic drug price manipulation allegations. - The settlement resolves claims of anti-competitive practices and artificially inflated prices for generic prescription drugs, according to Attorney General Lynn Fitch. - This agreement follows prior settlements with Lannett, Bausch, Apotex, and Heritage, bringing the combined total to $66.95 million. - Consumers who purchased generic drugs from these manufacturers between May 2009 and December 2019 may be eligible for compensation.
- Glenmark Specialty S.A. has advanced its multi-country Phase 3 clinical trial of trastuzumab rezetecan (SHR-A1811), a HER2-targeted antibody-drug conjugate, for patients with platinum-resistant ovarian cancer. - India becomes the first country in Glenmark's licensed markets to initiate patient enrollment following approval from the Drugs Controller General of India, with Australia and South Korea planned next. - The randomized, controlled, multi-centre trial will evaluate efficacy, safety, and pharmacokinetics in HER2-expressing platinum-resistant ovarian cancer, a disease with limited treatment options and poor outcomes. - Trastuzumab rezetecan has already received conditional approval in China for NSCLC and has been included in the NMPA's Breakthrough Therapy Designation list for nine indications.
- Ichnos Glenmark Innovation has announced ISB 2301, a first-in-class multispecific immune cell activator targeting three tumor-associated antigens simultaneously for solid tumor treatment. - The drug candidate engages both T cells and NK cells to activate the immune system while inducing antibody-dependent cellular cytotoxicity and checkpoint inhibition. - ISB 2301 was developed using IGI's proprietary BEAT platform technology and is designed to address the biological complexity of solid tumors that conventional immunotherapies have struggled with. - The company plans to file an Investigational New Drug application by the end of 2026 and begin clinical studies in 2027.
- AcuCort and the FDA have reached agreement on an Initial Pediatric Study Plan (iPSP) for Zeqmelit®, a prerequisite for submitting a New Drug Application in the United States. - The iPSP agreement marks a significant regulatory milestone that had been a prolonged process delaying the company's US application timeline. - AcuCort plans to submit its NDA later in 2026, following an application for a renewed Small Business Waiver to exempt the approximately SEK 16 million filing fee. - The company is also expanding its European presence through a commercial agreement with Glenmark Pharmaceuticals covering six markets with approximately 200 million people.
- Glenmark Pharmaceuticals received final FDA approval for Progesterone Vaginal Inserts, 100 mg, determined to be bioequivalent and therapeutically equivalent to Ferring's Endometrin. - The generic product enters a market worth approximately $59.2 million in annual sales according to IQVIA data for the 12-month period ending February 2026. - The approval strengthens Glenmark's women's healthcare portfolio and supports the company's mission to expand access to quality and affordable medicines in the U.S. market.
- Glenmark Pharmaceuticals will launch its Potassium Phosphates Injection USP in the US market in March 2026, targeting the treatment and prevention of hypophosphatemia in adults and pediatric patients. - The injectable product will be available in three formulations including single-dose vials and pharmacy bulk packages, with the company claiming bioequivalence to the reference drug from Fresenius Kabi. - The launch represents Glenmark's strategic expansion into the US institutional injectable market, which generated approximately $50.7 million in sales for potassium phosphates injections in the past year. - The company emphasizes its commitment to providing quality and affordable alternatives to patients in need through this addition to their North American product portfolio.
