Original Manufacturer Epirubicin HCl Anthracycline Compound with US DMF 19818 and USP EP BP JP Standard

Original Manufacturer: Shandong New Time Pharmaceutical Co., Ltd.
US DMF: Active — DMF 19818 
CEP: Not Available for Epirubicin 
EU GMP Status: Company holds EU GMP certification
FDA Inspection Status: VAI (July 2024) 
Standard: USP / EP / BP / JP
Annual Capacity: Please contact us for details 

Disclaimer: All detailed product information shall be subject to the issued final COA. US DMF Letters of Authorization (LOA) are available to qualified buyers upon request. CEP is not available for this product; buyers targeting EU markets should contact us to discuss alternative regulatory pathways. The manufacturing site's FDA inspection status (VAI, July 2024) is disclosed for buyer awareness. Buyers are responsible for verifying regulatory eligibility for their target market.