Filgrastim - Zarzio; Granulocyte Colony Stimulating Factor, recombinant -- Product Record

G-CSF, rDNA/Sandoz

    Nomenclature:
      G-CSF, rDNA/Sandoz [BIO]
      Zarzio [TR]
      Filgrastim [USAN INN BAN MESH]
      colony-stimulating factor (human clone 1034) , N-L-methionyl- [CAS]
      135968-09-1 [CAS RN]
      granulocyte colony stimulating factor, recombinant [SY]
      NSC 614629 [SY NCI]
      r-metHuG-CSF [SY]

    molecular weight (kDa) = 19

    FDA Class:  Biologic BLA

    Annual sales (2011, $millions) = $52

    Annual sales (2009, $millions) = $8

Index Terms:

  • Product Class Index:
      biopharmaceutical products
      Biorex-70 resin
      exempt from CBER lot release requirements
      growth factors, hematopoietic
      recombinant DNA
  • Biological Index:
      bacterial culture <!-- bacterialculture -->
      Escherichia coli (E. coli)
  • Chemical Index:
      glutamate
      somatropin, recombinant
  • Source/Host/Expression System: E. coli micbacecoli
  • Regulatory/Status Index:
      BHK-21 (C-13)
      EU200 Currently Approved in EU EU777
      UM999 Not Available/Not Marketed in US
      US000 never filed/no plans
      EM001 Marketed Product in EU