Prime Minister Narendra Modi inaugurated Lyfius Pharma’s flagship Penicillin-G manufacturing facility in Kakinada, Andhra Pradesh, marking a major milestone for India’s pharmaceutical industry. The facility, with a production capacity of 15,000 metric tonnes, is set to bolster domestic output of key starting materials (KSMs), drug intermediates (DIs), and active pharmaceutical ingredients (APIs) crucial for antibiotics. […]
In a major development within the pharmaceutical industry, Aurobindo Pharma Limited (Aurobindo) announced it has received final approval from the US Food & Drug Administration (USFDA) for the manufacture and market of Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray. This approval positions Aurobindo to launch the product in the first quarter of the fiscal year […]
CuraTeQ Biologics Private Limited, a fully integrated arm of Aurobindo Pharma Ltd, has announced significant progress in its biosimilar program, revealing that its Omalizumab biosimilar candidate, BP11, has successfully met the primary endpoints in a Phase 1 trial. The study, engaging 165 healthy volunteers across Australia and New Zealand, was designed to compare BP11 with […]
Aurobindo Pharma Limited, a leading player in the pharmaceutical sector, has announced its consolidated financial results for the quarter ended December 31, 2023. The company reported a robust 14.7% year-on-year increase in revenue from operations, amounting to INR 7,352 Cr, showcasing growth across multiple business segments. The US formulations segment, excluding Puerto Rico, witnessed a […]
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Darunavir Tablets, 600 mg and 800 mg. These tablets are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Prezista Tablets, of Janssen Products, L.P. The product is scheduled for launch on November 29, 2023. […]
Evive Biotech, a global biopharmaceutical company and a subsidiary of Yifan Pharmaceutical Co. Ltd., along with New Jersey-based Acrotech Biopharma, a wholly-owned subsidiary of Aurobindo Pharma USA Inc., announced the U.S. Food and Drug Administration (FDA) approval of Ryzneuta (Efbemalenograstim alfa). The medication is indicated to decrease the incidence of infection as manifested by febrile […]
In a significant development for the pharmaceutical industry, Aurobindo Pharma Limited’s dedicated subsidiary, Eugia Pharma Specialities Limited, has triumphantly gained the final nod from the US Food & Drug Administration (USFDA). This monumental approval permits the manufacture and marketing of the Testosterone Cypionate Injection USP in multiple dosage configurations, which stand as bioequivalent and therapeutically […]
In a pivotal move bolstering its footprint in the global pharmaceutical landscape, Aurobindo Pharma Limited’s subsidiary, Eugia Pharma Specialities Limited, has achieved final authorization from the US Food & Drug Administration (FDA) to produce and commercialize their Icatibant Injection, 30 mg/3 mL. This development comes as a significant milestone as the injection stands as a […]
Aurobindo Pharma Limited has achieved a significant milestone by securing the US Food and Drug Administration (FDA)’s tentative nod under the PEPFAR program for its generic dispersible tablet, a fixed-dose combination of Abacavir 60mg, Lamivudine 30 mg, and Dolutegravir 5 mg (pALD). This formulation is pivotal for treating children afflicted with HIV, particularly those weighing […]
Eugia Pharma Specialities Limited, a fully-owned subsidiary of India-based Aurobindo Pharma Limited, has received final approval from the US Food and Drug Administration (FDA). This nod enables the pharmaceutical company to manufacture and market the Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), in a Single-Dose Vial. This product has been demonstrated to be bioequivalent and […]
