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 […]
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 […]
Aurobindo Pharma, along with its subsidiary Eugia Pharma Specialities has announced a voluntary sub-licensing agreement with Medicines Patent Pool (MPP) to develop and market Nilotinib Capsules. Originally developed by Novartis, Nilotinib Capsules are used for the treatment of chronic myeloid leukemia (CML) in 44 low and middle-income countries (LMIC). This agreement covers seven countries where […]
Aurobindo Pharma said that its fully-owned subsidiary — Eugia Pharma Specialities has secured final approval for Amphotericin B Liposome for Injection, 50 mg from the US Food & Drug Administration (FDA). The approved product is bioequivalent and therapeutically equivalent to Astellas Pharma US’ AmBisome Liposome for Injection, 50 mg/vial. Amphotericin B Liposome for Injection is […]
Aurobindo Pharma said that its subsidiary Eugia Pharma Specialities has secured approval from the US Food and Drug Administration (FDA) for the new drug application for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials. Cyclophosphamide Injection is indicated in the US for malignant lymphomas, multiple myeloma, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, […]
