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Wuhan Calmland Pharmaceuticals Co., Ltd. was incorporated in January 2014, BuildingC7, No.388 Gaoxin 2 Road, East Lake Hi-tech Development Zone, Wuhan, China. Calmland mainly focuses on the R&D, manufacturing and business operation of bio-medical products. The main R&D and manufacturing direction is oncology drugs , high-tech and high-value drugs. The R&D and manufacturing factory established according to the GMP cGMP and EUGMP standard was completed and put into production in September 2014.Calmland has estabilshed oncology workshop and multifunctional workshop according to the cGMP standard.The purified water system with capacity of 1T/H uses the two-stage reverse and EDI treatment. The factory is equipped with adequate analysis and testing system to perform the chemical analysis, instrument analysis, microbial and sterility test, stability study and so on.The analysis and testing center is equipped with advanced analysis and testing instruments such as HPLC(Agilent 1260, SSI1500), GC (Agilent 7890B/7697A,GC2020), IR(USA PerkinElmer), UV(TU-1810), automatic constant temperature polarimeter(SGW-2) and other related instruments meeting other analysis and testing requirement.

Calmland has established the scientific and adequate system files for materials warehouse management, manufacturing management, quality management, facility management, hygiene management , R&D and registration management according to the GMP, cGMP and EUGMP standard. The factory is operated and managed strictly according to the GMP, cGMP and EUGMP standard from the R&D to the manufacturing, ensuring that the products manufactured by Calmland are qualified, safe and complying with the GMP, cGMP and EUGMP requirements.

 

 

The international registration

Calmland pharmaceutical management team has a wealth of international registration and official site certification inspection experience, can provide the DMF/EDMF file research advisory guidance; documentation of the cGMP management system establishment and operation management consulting and training and guidance; certification examination site official training and consulting.