USFDA nod to Caplin Steriles Rocuronium Bromide Injection
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Mumbai: Pharma major Lupin Limited has announced that its alliance partner Caplin Steriles Limited has received final approval from the United States Food and Drug Administration (U.S.FDA) for its Abbreviated new Drug Application (ANDA) Rocuronium Bromide Injection, 10mg/mL in 5 mL and 10 mL Multi-Dose Vials.
The injection is a generic version of Zemuron Bromide Injection, 50 mg/5 mL and 100 mg/10 mL of Organon USA Inc.
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