Year Established :
2000
Total Assets(USD) :
choose not to disclose
Total Number of Staff :
40 to 49
Other Competitive Advantages :
1.Product Registration in China
Imported and domestic finished drugs, more than 40 cases
Imported and domestic APIs, more than 30 cases
Imported and domestic excipients, more than 10 cases
Imported packaging materials/containers, more than 5 cases
Health foods including imported, more than 30 cases
2. International drug registration
US ANDA/OTC/NDC, 6 cases
US-DMFs filed, more than 100 cases
EU MA application, 4 cases
COS/CEPs obtained, more than 50 cases
EDMF/ASMF filed, more than 60 cases
Australia ARTG, 5 cases
3.Plant Design & GMP Compliance
China and international GMP inspection, more than 200 successful cases including:
Small volume injection
Tyophilized powder for injection (including biologies, blood products)
Big volume injection
Solid dosage forms
Non-sterile API Sterile API
4.Training and Meeting Activities
Successfully held international meetings and training activities,
Together with both China and International regulatory authorities.
Business Type :
Agent,Service Provider
Annual Turnover(USD) :
choose not to disclose
Main Sales Markets :
North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa
Main Product Categorise :
Outsourcing Contract, Custom service, Consultation
Product Range :
Services & Solutions We Provide
1.Product Registration in China
Human/Veterinary Drug Registration, Domestic and Imported
Formulation/Finished Product, API, Excipient , Packaging Material/Container
Health Food Registration, Domestic and Imported
Health Food, New Resource Food
Medical Devices, Domestic and Imported
Class I, II, III and IVD
Functional Cosmetics Registration, Domestic and Imported
2. International Registration/Application
US NDA/ANDA/OTC/Dietary Supplement, Including DMF Filing
EU/Member State MAA pplication, including CEP/COS, ASMF/EDMF Preparing
Australia ARTG for Prescription/OTC/Complimentary Drug
Also, in Canada, Russia, Japan, India, Korea, Brazil and others
3.GMP Compliance & New Plant Design
From new plant/workshop design to authority inspection/audit
Cover pharmaceuticals, foods/supplements and medical devices
Include China, US, EU/Member state, Australia, WHO, USP, PIC/s, Brazil, and others
4.Strategic Planning and Business Consulting
Strategic Planning and Business Consulting for
Marketing registration/application in China and overseas
New plant establishing and GMP compliance & certification, also include
Recommending/qualifying suppliers and looking for partners
Eight years of qualification
Audited Supplier
Pharma Sources Insight January 2025
