tiotropium bromide inhalation (CXF11)
/ Chance Pharma
- LARVOL DELTA
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July 01, 2021
Hangzhou Chance Pharmaceuticals Announces NMPA Acceptance of Marketing Authorization Application for CXF11
(GlobeNewswire)
- "...National Medical Products Administration (NMPA) of China has accepted its Marketing Authorization Application for CXF11 for the treatment of chronic obstructive pulmonary disease (COPD). The application is based on the results of a series of well-designed and successful formulation identification, process development and in vitro studies including a comprehensive comparison to the reference drug at each of its critical quality attributes, a more than 2 years stability study, and more importantly, the bioequivalence (BE) study."
Non-US regulatory • Chronic Obstructive Pulmonary Disease • Respiratory Diseases
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