1. Hualida overview
Hualida, established in 1992, is a leading enterprise in the industrialization of recombinant products in China with the registered capital of USD 300 million. Shareholders are divided into 60% and 40% owned by TEVA pharmaceutical Group of Isreal which is top 15 pharmaceutical companies in the world and Zhongxin Pharmaceutical group of China which is listed in Singapore and China Shanghai. During 20 years development, Hualida became the high and new tech enterprise with powerful biotechnology medicine downstream development and industrialization transformation.
Hualida is located in the new economic growth pole of China- Tianjin Binhai new developed area which is also called Technology Economic Developing Area (TEDA). The total area of Hualida biotech is 76,000©Oand the building area is 18,000©O. Hualida owns excellent equipped R&D, QC, post-doctor station and the international top-ranking production facility for injection, external finished products and synthetic drugs. Hualida is a manufacturing-base enterprise which complies with international cGMP standard involved in industrialization development of bioengineering products and chemical anti-cancer products. Hualida could carry the cooperation business like trial production, contract manufacturing and marketing sales etc. for home and abroad enterprises.
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The main production of Hualida is Alfaron which is the second-generation Recombinant ¦Á-2b interferon. The key quality index could meet the Europe pharmacopeia, the production technique level and quality level could meet the international level. Alfaron has a wide spectrum of anti-virus, anti-tumor and immunomodulating effects. It is the doctors' first choice for treating chronic virus hepatitis and leucocythemia; it's also widely used |
in the treatment of other virus infection or tumorous diseases. It has the characters of high purity, activity, stable curative effect, low adverse reaction and stable quality. In the whole producing process, that no ingredient is abstracted from animal or human blood, and absolutely avoids the latent danger of virus contamination. The marketing of Alfaron is distributed across of China and also sales to Europe, Asia etc. for almost 10 countries. The domestic sales is listed in the top 3. It has the honor of Tianjin famous brand products in successive 6 years and has also been the famous brand in the bio-medicine field.
2. Base construction and achievement transformation
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In 1995, Hualida was undertook the construction of National genetic engineering pharmaceutical pilot plant test production base. After 3 years hard-working, Hualida achieved the project successfully and passed the national inspection in 1999. This base adopted the advanced |
| technique project evaluation and management system which has been keeping touch with home and abroad research institutions and universities. It afforded many national projects and scientific research project of Tianjin Committee of Science and Technology. In 1997, Hualida succeeded to develop and launch the ¦Á£2b IFN Lyo. After that Hualida mainly devote itself to the research of IFN series of products, and produced the first IFN |
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pre-filled syringe (PFS) which was the 2003 national torch project and key scientific &
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research project of Tianjin Committee of Science and Technology. The spray¡ªJaferon is the first spray IFN in the world which was researched together with Tianjin Institute of Pharmaceutical Research. It is the key project of Tianjin high and technique industrialization and Tianjin Committee of Science and Technology. Hualida has the proprietary intellectual property rights. |
In 2003, Hualida Bio-park was built and further promoted the National genetic engineering pharmaceutical pilot plant test production base. Hualida introduced plentiful state of art advanced facilities, including 9 fermentation tanks from B.BRAUN of Germany and Bioengineering of Switzerland which are 5L¡¢42L¡¢90L¡¢450L and 1500L. The tanks could meet the requirement from test scale, pilot scale and industrialization production. The purification system for pilot scale includes AKTAexplorer 100 Chromatograph system of GE, multi-Chromatograph column with different specification, PALL¡¢Millipore Proflux M12 ultrafiltration system etc. The HAVC system is from SINKO of Japan. Hualida has fermentation, purification production lines, 2 freeze-dryer powder production lines, PFS filling line. And also has the capacity to produce 200 batches biomass, 50 batches API, 200 batches finished products, 200 batches PFS, 200 batches solution per year. The GMP standard workshop and facilities could meet the top level in the world.
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In the beginning of 2010, Hualida cooperated with Tianjin International Joint Academy of Biotechnology & Medicine (TJAB) which was built by National Ministry of Science and Technology, Ministry of commerce, Ministry of Health, SFDA and TEDA of Tianjin. The achievement of the cooperation is afforded and finished the project of Eleventh Five-Year Plan and significant new |
medicine development which is the construction of integrity platform for national bio-medicine development. Meanwhile, Hualida became the Biopharmaceutical GMP Pilot Plant Platform and afforded the development of upstream technique and downstream biotechnology development of Biopharmaceutical, and also the research on new finished products and its industrialization.
Hualida has a registration team who has more than 8 years' experiences in the field of R&D and registration. They are familiar with the current situation of medicine industrialization and medicine management regulations, familiar with registration process and the skill. Hualida's team could perform the registration for chemical drug, bio-pharmaceutical and import products.
Hualida's registration team has good relationship with external, and communication, coordinate capability. They could organize the production, quality, purchase process to initiate the registration rapidly, and good at combine the products situation and marketing situation to perform the registration which could make the product launch into the market at the soonest.
Hualida has the state of art test facilities in the quality test and also has the capability to test from raw material, API to finished products which could meet the standard of Chinese pharmacopoeia and Europe pharmacopoeia. Hualida has a professional and experienced test team who could master the up to date technique trend, and strong test service capability. We could provide the test from basic chemical analysis to biochemistry test, especially in potentiometric titration, HOLC, strains identify, animal cell culture and protein electrophoretic analysis etc. Hualida used to do the analysis of new type protein drug molecular weight and biology activation analysis for TEVA which is the world famous pharmaceutical company and obtained the approval and appraise from them. Meanwhile, Hualida also provided the test service to many other enterprises. Due to the extraordinary test ability, Hualida was authorized by Tianjin institute for drug control to perform the biology activation analysis for export products.
3. Extraordinary team
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Hualida built an international standard management system and a high skill and experienced team under 20 years' hard-working with the enterprise philosophy of "Human oriented, Teamwork, Practicality & innovation, and Excellence", and guided by the quality policy of "Providing users with medicines |
of the highest quality in the world". 10% of the staff has the master degree and 50% of the staff has the bachelor degree. The team of Hualida including marketing support, R&D, registration, production, quality, management, financial, HR, marketing etc. There is 30% of the master degree staff engaged in the core work which is marketing support, R&D, registration, production and quality which is professional, young, high quality. They are the elites in the field of biopharmaceutical. Hualida not only cultivate the internal staff, but also introduce the talents from external to involve in the R&D work. Hualida has built the post-doctor station in 1999 after the approval from National ministry of personnel. And also cooperate with Peking University, Nankai University, Tianjin medical university, Chinese Academy of Medical Sciences, Tianjin medical research institution. In the marketing aspect, Hualida has a sales group with 170 sales reps, 21 local offices across of China except Tibet, Hongkong, Taiwan. Till 2010, the sales of Hualida IFN keep in the top 3 of domestic marketing.
4. External services and related customers
Hualida is not only focusing on the industrialized development of owned products, but also active in the external cooperation and services by taking advantage of National genetic engineering pharmaceutical pilot plant test production base and Biopharmaceutical GMP pilot plant platform.
The main carried projects are as follow:
Enzymatic resolution of Amino Acid project (test scale) cooperated with Tianjin Pharmaceutical company which obtained the third prize of Tianjin science and technology progress award.
Cooperated with Fusu Biotech to prepare the samples for AIDS clinical trials.(Pilot plant project)
Produce IFN products for Pakistan CCL Pharmaceuticals Ltd which is the third big pharmaceutical company in Pakistan.
Performed the Contract manufacture for Biotechna of Lithuania. |
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The state of art facilities, extraordinary team provided the superior service which also gained the unanimous appraise from the customers. Hualida has passed the quality audit from Brazil, Pakistan, Lithuania, Egypt and Israel etc.
Looking forward to the business cooperation from the friends home and abroad.
Contact us£º
Address£ºNo. 203, Huanghai Rd, TEDA, Tianjin
P.C.£º300457
Phone£º0086-022-25328897
0086-022-25324850
Fax£º0086-022-25329624
Http://www.hualida.com
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