If you have any question, please feel free to email us. We will touch with you as soon as possible.
Tosun registration team owns a team member of over 15 staffs, with the management staffs for over 10 years experience in API importing registration. The RA team focus on pharmaceutical regulatory compliance, pharmaceutical registration consulting services. It provides professional registration and application services for oversea characteristic APIs listed in China market.
Tosun Pharmaceutical Ltd, founded in 1999, is a pharmaceutical company with its base in Huangpu District, Guangzhou, China. The company has over 20 years experience in importation & exportation of active pharmaceutical ingredients, chemical raw materials, intermediate, excipients, herbal extracts, formulations of Chinese and Western Medicine for R&D all over the world. It is the leading API registration agency in China
Its registration team owns a team member of over 15 staffs, with the management staffs for over 10 years experience in API importing registration. The RA team focus on pharmaceutical regulatory compliance, pharmaceutical registration consulting services. It provides professional registration and application services for oversea characteristic APIs listed in China market. The registration service includes:
1.API DMF review: base on the provided dossier, the team share gap analysis and guidelines according to the Chinese Registering Rule to the API applicants/manufactures to guide them prepare documents which complies with NMPA/CDE’s requirements very swiftly.
2.Translation: The translation will be finished by the specified translators who’s major is professional English in pharmacy to ensure the accuracy of translation. Moreover, with the help of Trado Studio, the team can finish the translation more effectively and avoid repeat work. The typo errors or the inconsistent of the description in provided DMF documents will also be found while translation and will be sent to the API applicants/manufacturers for correction. The translated documents will then be compiled and prepared(Module1,2 and3)into an effective, professional document for submission to CDE.
3. Registration progress following up: including specification verification, deficiency letter, review and approval process. The team maintain good communication with CDE, NIFDC and institute for drug control, timely feedback problems occurred in the registration process, and provide relevant solutions to the manufacturers to ensure the registration goes on smoothly.
4.The RA team also serves to submit annual reports for APIs in A status as well as administration and technical changes applications.
Since founded in 1999, Tosun has successfully registered 13 imported APIs, 18 items are under reviewing, and many projects are under discussion.
Tosun has established an extensive and long-term cooperation relationship with oversea API manufacturers. The companies we are cooperating: Hetero, Glenmark, Par, CTX, Cambrex, Fleming, Kreative Organics, Aurore, Loba, Biocon, Archimica,Polpharma, ect.
In order to help API manufacturer’s better understanding the registration in China, and improve the registration efficiency, RA team work out the registration flowchart and registration overview in accordance with the latest registration rules and policies. Details please see documents below:
Hot Tags: api registration, China, suppliers, manufacturers, factory, customized, price, pricelist, in stock, Pregabalin API, Celecoxib API, Clofarabine API, Linagliptin API, Fondaparinux API, Bosentan API
Tel:+86-020-61855200-902
Fax:+86-020-66392525
Email:info@upharm.cn
Address:12th floor, No. 181, Kexue Avenue, Huangpu District, Guangzhou, China
