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ANFARM HELLAS S.A. sell "Isavuconazole Pd.C.So.In 200mg/Vial (under development)"

y = mx + b

Basic Information

520
18
8
4.0(77)

Trade Type

Sell

Service Name

Isavuconazole Pd.C.So.In 200mg/Vial (under development)

Service Provider(s)

Specifications

  • Purity: Under development to meet the reference product's (Cresemba®) compendial purity specification
  • Impurity Profile: Being characterized against the originator reference standard as part of the generic dossier development
  • Clarity of Solution: Reconstituted solution expected to be clear, in line with parenteral powder-for-infusion requirements

Other Information

Additional Description:

This isavuconazole 200 mg powder for concentrate for solution for infusion is being developed as a generic version referencing Cresemba® (Basilea Pharmaceutica/Pfizer). Isavuconazole is an antifungal indicated in adults for invasive aspergillosis and for mucormycosis when amphotericin B is unsuitable. The dossier is currently in progress, with stability data generated at 2-8°C long term and 25°C/60% RH accelerated conditions; the originator's shelf life is four years, and batch and pack sizes (originator pack: 1 vial x 10 ml per carton) are yet to be finalized.
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