In a major coup for Strides Pharma Science Limited, the company’s stepdown wholly-owned subsidiary, Strides Pharma Global Pte. Limited in Singapore, has scored approval from the United States Food & Drug Administration (FDA) for its Sevelamer Carbonate for Oral Suspension USP, 0.8g and 2.4g. The approval secures Strides Pharma’s position in the Sevelamer Carbonate market, […]
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 […]
Lupin Limited said that it has secured approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Sevelamer Carbonate for Oral Suspension, 0.8 g and 2.4 g packets. Sevelamer Carbonate is a generic equivalent of Renvela for Oral Suspension, 0.8 g and 2.4 g Packets of Genzyme. Lupin […]