Glenmark Pharmaceuticals Inc., USA has secured a second tentative approval from the United States Food and Drug Administration (FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg. The product that has been approved is the generic version of type 2 diabetes drug Onglyza Tablets. 2.5 mg, and five mg, from AstraZeneca. The first tentative approval […]
Glenmark Pharmaceuticals has agreed to sell certain brands from its dermatology segment in India and Nepal to Eris Oaknet Healthcare, a fully-owned subsidiary of Eris Lifesciences. The consideration for the deal is INR 340.48 crores, stated the Indian pharma company. The brands being divested are Onabet, Sorvate, Halovate, Demelan, Luligee, Aceret, Revize, Dosetil, and Powercort, […]
Glenmark Pharmaceuticals said that it has rolled out the sacubitril + valsartan tablets for the treatment of heart failure in India under the brand name Sacu V. According to Glenmark Pharmaceuticals, Sacu V should be taken daily two times under doctor’s prescription. The approved indication of sacubitril + valsartan tablets is for reduction of the […]
Glenmark Pharmaceuticals said that its US-based subsidiary has launched Bumetanide Injection USP, 1 mg/4 mL (0.25 mg/mL) SingleDose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multi-Dose Vials. The launched product is the generic version of Validus Pharmaceuticals’ Bumex Injection, 0.25 mg/mL. Bumex is indicated for the treatment of swelling and high blood pressure. As per […]
India-based Glenmark Pharmaceuticals said that its subsidiary Glenmark Pharmaceuticals Inc., USA has introduced its Fingolimod Capsules, 0.5 mg in the US market. The product is the generic version of Gilenya Capsules, 0.5 mg, a multiple sclerosis drug from Novartis Pharmaceuticals. Sanjeev Krishan — Glenmark North America President said: “We are very pleased to bring to […]
Glenmark Pharmaceuticals said that it has bagged final approval for Sodium Phenylbutyrate Tablets USP, 500 mg by the US Food and Drug Administration (FDA). The approved product is a generic version of Buphenyl Tablets (sodium phenylbutyrate), 500 mg, of Horizon Therapeutics and is indicated for the treatment of urea cycle disorders. According to Glenmark Pharmaceuticals, […]
Glenmark Pharmaceuticals has launched Zita D the brand name for Teneligliptin (20mg) + Dapagliflozin (5mg/10mg) fixed dose combination in India for the treatment of Type 2 diabetes in adult patients, especially those with comorbidities. According to Glenmark Pharmaceuticals, Zita D has to be taken daily once by Type 2 diabetic patients under prescription for enhancing […]
Glenmark Pharmaceuticals Limited said that the US Food and Drug Administration (FDA) has indicated that the inspection of the company’s Goa facility has been classified as “Official Action Indicated” (OAI). The FDA inspection was carried out from 12 May to 20 May 2022 following which the regulator issued Form-483 with five observations. Under the OAI […]
Glenmark Pharmaceuticals has launched a topical Minocycline 4% Gel under the brand name MINYM in India for the treatment of moderate to severe acne. According to the Indian pharma company, MINYM is a potent antibacterial gel which provides a strong anti-inflammatory action. Compared to the available topical antibacterial formulations, its topical Minocycline 4% Gel offers […]
Glenmark Pharmaceuticals, a global pharmaceutical company based in India, announced that it has been issued Form 483 with 17 observations by the United States Food and Drug Administration (FDA) following an inspection of its formulation manufacturing facility in Monroe, North Carolina. The inspection, which took place from April 4, 2022, to May 19, 2022, identified […]