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Shanghai United Cell Biotechnology Co., Ltd. (hereinafter referred to as "SUCB") was founded in 1995 by Unilab Inc.. Currently, it is affiliated to Brilliance Group and Hillhouse Capital is the major investor of this company. Located in Jinqiao Biotechnology Industrial Park of Shanghai Pilot Free Trade Zone, SUCB is a high-tech enterprise committed to the R&D, production and marketing & sales of genetically engineered vaccines and therapeutic biological products. In 2022, it was recognized as a “Specialized, special and new enterprise” in Shanghai, with a registered capital of $61.15 million. The factory covers an area of 20,000 square meters, the factory building area of 24,000 square meters, with an annual output of 15 million freeze-dried powder injection, 13 million cartridge injection, 9 million capsules and 5.6 million bags of granule preparation production line.
With the growth of its sales in the market, business expansion, and increase in production line, SUCB invested in the Zhuhai High-tech Industrial evelopment Zone and established Zhuhai United Cell Biotechnology Co., Ltd. (“ZUCB” or “the Expansion Company”) in 2015. With a registered capital of RMB 50 million, the Expansion Company’s manufacturing facility is located at the Science and Technology Innovation Coast of the Zhuhai High-tech Zone. Shanghai United Cell Biotechnology Co., Ltd. will leverage its strong multinational network which the Company has built for over 20 years, in order to accomplish the goal of bringing China's biotechnology products to an international scale and providing opportunities and resources for China's biotechnology industry to achieve globalization.
Phase III plant had be completed
Shareholder change of SUCB
Second generation of recombinant growth hormone for injection marketed
Recombinant Teriparatide for injection marketed
Foundation of Zhuhai United Cell Biotechnology Phase I plant was laid
SUCB had participated in the establishment of Zhuhai United Cell Biotechnology
Recombinant B-subunit/Cholera vaccine (Enteric-coated capsule)for Children marketed
Phase II plant completed and started production
The indication of prevention to Diarrhea caused by ETEC for recombinant B subunit/ cholera vaccine (enteric capsule) was approved
Recombinant B subunit/ cholera vaccine (enteric-coated capsule) marketed
Recombinant growth hormone for injection marketed
Shanghai United Cell Biotechnology Co., Ltd established
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Quality Management and Production
SUCB has 5000 square meters production facility that has been approved by China’s GMP (Good Manufacturing Practice) 2010 version which includes workshops for gene process liquid raw material, vibrio cholera, lyophilized powder for injection, capsule preparation and solid preparation. Major equipments are state-of-the-art biotechnology instruments purchased domestically and imported from Europe to make sure that product quality is stable and reliable.
GMP Certifications and Quality Certificates
SUCB continuously adheres to a great importance of quality management that creates a healthy life and contributes to mankind. SUCB’s quality management system covers pharmaceutical production, inspection and distribution, continuously linking towards international standard. The independent quality assurance department closely monitors the implementation of the quality management system and strictly controls the entire process from material entering the facility to product release.
The National Drug Administration does random inspection checks and batch release inspection for vaccine products, SUCB’s random inspection quality performance rate and OraVacs®’ batch release inspection quality rate have reached 100%. Company’s production, quality and other technical personnel are all well trained professionals and regularly receives comprehensive professional and management training knowledge and skills to maintain technological improvement and management.
