News | April 20, 2026
Rusan Pharma secures Japan PMDA GMP approval for API, FDF facilities
PMDA is regarded among the most stringent regulatory bodies globally
PMDA is regarded among the most stringent regulatory bodies globally
The inspection has concluded successfully on 1st September 2023 without any critical/major observation
The company has also started working with a large pharma company on the API supply of a recently launched animal and human health product
The upcoming multi-center, multinational Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and early signs of efficacy
Price of the starting dose of Ozempic and Wegovy reduced by 36% and 48% respectively
The Taipei facility boasts 10 GMP API production lines, with a total reactor volume exceeding 350,000 liters
Neupharma gains exclusive rights to develop and commercialize corticorelin for peritumoral brain edema
CHOMax integrates cell line development, process development, analytics, and GMP manufacturing under robust quality processes
The inspection concluded with one minor observation in Form 483
The study, which enrolled 35 Japanese patients, evaluated the percent change from baseline in the 24-hour urine protein-to-creatinine ratio
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