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Lupin's Partner Caplin Receives USFDA Nod for Rocuronium Bromide Generic

8 Nov 2023 , 02:34 PM

Lupin Limited’s alliance partner, Caplin Steriles Limited, has obtained final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) Rocuronium Bromide Injection.

This approval allows Caplin to market a generic version of Zemuron® Bromide Injection by Organon USA Inc. The original Rocuronium Bromide Injection, Zemuron®, generated around USD 53 million in annual sales in the U.S. as of December 2022, according to IQVIA.

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Related Tags

  • ANDA
  • Lupin
  • USFDA
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