Caplin receives USFDA approval for Rocuronium Bromide Injection
Drug Approval

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)

  • By IPP Bureau | March 21, 2023

Global 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 (USFDA) for its Abbreviated new Drug Application (ANDA) Rocuronium Bromide Injection, 10mg/mL in 5 mL and 10 mL Multi-Dose Vials, to market a generic version of Zemuron Bromide Injection, 50 mg/5 mL and 100 mg/10 mL of Organon USA Inc.

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022).

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

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