bendamustine pharmaceutical composition, lyophilized preparation, pharmaceutical dosage form, method for obtaining official approval for a bendamustine product, process for making a lyophilized bendamustine preparation, bendamustine pre-lyophilization solution or dispersion, lyophilized powder, method for preparing a lyophilized preparation of bendamustine, formulation for lyophilization, and use of a pharmaceutically acceptable solution

摘要

PHARMACEUTICAL COMPOSITION OF BENDAMUSTIN, LYOPHILIZED PREPARATION, PHARMACEUTICAL DOSAGE FORM, METHOD FOR OBTAINING OFFICIAL APPROVAL FOR A BENDAMUSTIN PRODUCT, PROCESS FOR MANUFACTURING A LIOFILIZED PREPARATION, BIOFILIZED PREPARATION, BIOFILIZED PREPARATION BIOFILIZED PREPARATION OF BENDAMUSTIN, FORMULATION FOR LYOPHILIZATION, AND USE OF A PHARMACEUTICALLY ACCEPTABLE SOLUTION. The present invention provides lyophilized bendamustine pharmaceutical formulations suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. Pharmaceutical formulations may be used for any disease that is sensitive to bendamustine treatment, such as neoplastic diseases.