Category: Pharma Articals
Shanghai MicuRx Pharmaceutical Co. (MicuRx) announced that MRX-5, its self-developed anti-infection drug, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of non-tuberculous mycobacteria (NTM) infections. This designation marks a significant milestone for MicuRx in the field …
Anthem Biosciences Limited, an innovation-driven and technology-focused Contract Research, Development and Manufacturing Organization (CRDMO) with fully integrated operations spanning across drug discovery, development and manufacturing has filed the draft red herring prospectus (DRHP) with capital markets regulator, SEBI to raise funds through an initial public offering …
Akums Drugs & Pharmaceuticals Ltd., India’s largest Contract development and manufacturing organization (CDMO), announces its new state-of-the-art sterile manufacturing facility, dedicated to producing lyophilized products. In addition to lyophilized injectables, the facility is equipped to manufacture vials, ampoules, Form-Fill-Seal (FFS) products, and eye and ear drops. …
Merck announces FDA acceptance of biologics license application for Clesrovimab An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season Merck today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab …
Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited, has been granted …
Glenmark Pharmaceuticals Inc., USA (Glenmark) announces the launch of Lacosamide Oral Solution, 10 mg/mL. Glenmark’s Lacosamide Oral Solution, 10 mg/mL is bioequivalent and therapeutically equivalent to the reference listed drug, Vimpat Oral Solution, 10 mg/mL of UCB, Inc. According to IQVIATM sales data for the 12-month …
Fredun Pharmaceuticals Limited, a leading provider of Pharmaceuticals and innovative healthcare solutions for veterinary applications. Fredun Pharmaceuticals is coming up with a cutting-edge manufacturing facility in Palghar, Maharashtra, which will be dedicated to the production of functional foods for pets. Conceptualized and construction is underway, it …
Senores Pharmaceuticals and Dr. Reddy’s Laboratories announced the launch of Ivermectin Tablets USP, 3 mg, which is bioequivalent and therapeutically equivalent to STROMECTOL Tablets of Merck Sharp and Dohme LLC in the U.S. market. The product will be marketed by Dr. Reddy’s. “We are pleased to …
Shilpa Medicare’s Joint Venture Oncosol (50:50 JV with Liqmeds Lifecare Limited, a Zydus group company and Koana Healthcare Limited, Shilpa Medicare group company) along with its partner Shorla Oncology announces that the USFDA has approved IMKELDI (imatinib oral solution), the first oral liquid form of imatinib …
Glenmark Pharmaceuticals Inc., USA (Glenmark) announces the launch of Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). Glenmark’s Travoprost Ophthalmic Solution USP, 0.004% is bioequivalent and therapeutically equivalent to the reference listed drug, Travatan Z Ophthalmic Solution USP, 0.004% of Sandoz. According to IQVIATM sales data …
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