SICHUAN QINGMU PHARMACEUTICAL CO.,LTD.

SICHUAN
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Company Profile
SICHUAN

Sichuan Qingmu Pharmaceutical Co.,Ltd., as a wholly owned subsidiary company of Easton Pharmaceuticals. Chengdu Easton Biopharmaceuticals Co.,Ltd. was founded in 2009, with 5 wholly owned subdsidiary companies and more than 1000 staffs. Easton Biopharmaceuticals was listed in the Shanghai Exchange Stock Sci-Tech Innovation Board (SSE START market) in September, 2020 (Stock code: 688513). Easton Biopharmaceuticals focused on Anesthetic/Analgesics, Oncology, Cardiovascular, Anti-diabetes and Pediatric drug, already Launched 28 chemical finished dosages and 18 generics APIs.

Sichuan Qingmu Pharmaceuticals Co., Ltd. was established in 2011,which is mainly engaged in research, production and marketing of APIs and advanced intermediates. CMO/CDMO business of APIs & advanced intermediates in also included in the business scope.


Qingmu Pharmaceuticals covers 71200㎡ with a annual production capacity of 200MT. More than 30% of staffs in R&D unit and18 products are commercialized till now. Qingmu 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 10 APIs, 3 J-MFs, 1 USDMF, 2 USVMF and 1 CEP, and also passed the USFDA 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) 16 production lines and 4 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.

 

 

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Year of Establishment: 2011

Total Assets(USD): More than 99,999,999

Total Number of Staff: more than 1000

Main Competitive Advantages: Brand Name,International Approvals/Standards,Experienced R&D Staff,Delivery Term,Production Capacity,Large Product Line,Contract Manufacturing (CRO,CMO),Buyers' Specifications Accepted,Small Orders Accepted,Reputation,Quality Service

Other Competitive Advantages: R&D Employees: around 27% in total In which: Ph.D. /Master degree: >41% Outside supporting experts: 15+ Senior scientists: 20+ · Input ~16% of annual sales in R&D every year · Launch 3+ products per year · Process designed from concept of QbD & Green chemistry · Comprehensive quality research system as requirements from both China and main regulatory markets (Japan, USA, EU, etc.). · Experienced in patent challenging on polymorphism form, new salts and synthesis process of APIs.

Patents and Copyrights: 82 domestic and foreign authorized patents, including 15 internationally authorized patents

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