SICHUAN QINGMU PHARMACEUTICAL CO., LTD.

Sichuan Qingmu Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Chengdu Easton Biopharmaceutical Co., ltd(Stock Code: 688513), is a high-tech enterprise specializing in the R&D, manufacturing and sales of APIs and advanced pharmaceutical intermediates. Qingmu pharmaceutical is designed by international well-known companies and constructed in strict accordance with FDA, EU GMP standards and national safety, environmental protection and other relevant regulations. More than 30 APIs have passed the on-site inspection of NMPA and obtained GMP certificates. In September 2021, Qingmu pharmaceutical accepted and successfully passed the inspection of FDA. In addition to its own APIs and intermediates, Qingmu pharmaceutical also undertakes CMDO / CMO business. Qingmu Pharmaceuticals was established in 2011, with more than 30% of staffs in R&D unit, more than 30 products are commercialized till now. Our facility is fully designed and operated as per EU/US/Japan GMP and EHS requirements, QC lab is equipped with HPLC, GC and ICP-MS, GC-MS, Malvern particle sizer, XRD, TGA, DSC, etc., which leads to GMP certificates for more than 30 APIs, 3 J-MFs, 8 USDMF/USVMF, and 3 CEP, and also passed the USFDA on-site inspection. Advantages of R&D: 1) Process design based on the concept of QbD & Green chemistry to strengthen in-process quality control and EHS compliance. 2) Comprehensive quality research system which can meet the registration requirements in both Chinese and main regulatory markets (Japan, USA, EU, etc.). 3) Experienced in patent challenging on polymorphism form and synthesis process of APIs. Advantages of facility: 1) 23 production lines and 6 independent clean areas for regular APIs with reaction volume 50~5000L. 2) OEB-4 workshop equipped with 4 production lines and 1 clean area, reaction volume 20~1000L. 3) 3 special reaction production lines, equipped with devices which suitable for 6 dangerous processes: hydrogenation, oxidation, chlorination, sulfonation, diazotization, and alkylation. 4) Qualified to produce Schedule II Controlled Substance APIs, and 3 products have been filed for registration. 5) Cytotoxic oncology APIs workshop is under construction. 6) Reaction temperature: -100℃~250℃; Pressure range: 0~8MPa. CDMO successful cases: 1) One National Class 1 New drugs (NCE) had been approved in 2020, realizing commercial supply of API. 2) Process validation of one patent challenge project has been successfully completed, and ASMF to be filed in EU by middle of 2021.