Post by Curia

Taking your final dosage form into China? Curia’s RA team has helped secure multiple “A status” approvals for API in China (e.g., Aztreonam, Betamethasone Dipropionate Micronized). Our new guide turns that experience into steps you can act on. Quick pointers: • Submit the complete DMF (applicant + restricted) in Chinese to CDE • Expect NIFDC testing to verify compliance • Include a GMP certificate; have paperwork notarized/apostilled • Budget the ~USD 50k DMF activation fee and keep sites inspection ready 👉 For full information, download now: https://hubs.li/Q04ly__00 #NMPA #CDE #NIFDC #RegulatoryAffairs #APIs #China