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SICHUAN QINGMU PHARMACEUTICAL CO.,LTD.
9
Years
Shop
- Shop
- All
Company Profile of SICHUAN QINGMU PHARMACEUTICAL CO.,LTD.
Basic Information
Company Name
SICHUAN QINGMU PHARMACEUTICAL CO.,LTD.
Year of Establishment
2011
Enterprise Size
more than 1000
Annual Turnover（USD）
More than 99,999,999
Company Introduction
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 10 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 API, Qingmu pharmaceutical also undertakes CMDO / CMO business.
Qingmu Pharmaceuticals was established in 2011, with more than 30% of staffs in R&D unit, 18 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 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.
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,
Postal Code
611731
Website
http://www.eastonpharma.cn
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 Copyright
82 domestic and foreign authorized patents, including 15 internationally authorized patents
Milestone
2020 Easton Biopharmaceuticals is listed in the Shanghai Exchange Stock Sci-Tech Innovation Board (SSE START market) (Stock code: 688513)
2019 Ranked 71st in the TOP100 of Pharmaceutical Enterprises in China; Class 1 new drug Ugretin tablets proceed into Phase II clinical trials
2018 Chengdu Unovel Pharmaceutical Co., Ltd. was established.
2017 Easton Biopharma was certified the first CEP (R0-CEP 2016-139-Rev 00) for Bisoprolol Fumarate; Qingmu recognized as "National High-tech Enterprise"; Winning the honorary title "Outstanding Enterprise of Chengdu Intellectual Property"
2016 Shuode Pharmaceutical was founded; Small-volume injection workshop 201 has been certificed with GMP again
2015 The company name was changed to Chengdu Easton Biopharmaceuticals Co., Ltd. from formerly Chengdu Easton Pharmaceutical Co., Ltd.
2014 lyophillization facility is certified with new GMP; APIs site Sichuan Qingmu is certified with new GMP.
2012 Easton Pharma recognized as "Industry Technical Center of Chengdu"; Mingyang site got GMP certificates of API Ibandronate Sodium, Olanzapine and Naloxone HCl;
2011 Qingmu site established; Injection line of Easton Pharma approved by CFDA;
2010 Tablets, Capsule line of Easton Pharma approved by CFDA;
2009 Easton Pharma established as the formulation site;
2008 Mingyang site established as the API site;
2006 Sunheal established and got GSP qualification; R&D center established;
Trading Ability
Business type
Manufacturer
Main Sales Market
North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa,
R&D Capacity
OEM,ODM,Own Brand,
Contract Customization
CMO,CDMO,
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