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Founded in 1999, Chengda Pharmaceutical Co., Ltd. is a high-tech enterprise with R&D, production and sales of pharmaceutical intermediates, chemical ingredients, food and feed additives as its main business. It was listed in Shenzhen Stock Exchange in 2022 (stock code :301201).

Chengda Science

The company is committed to providing CDMO services such as process development and optimization, quality research and customized production of key pharmaceutical intermediates and bulk drugs for multinational pharmaceutical enterprises and pharmaceutical R&D institutions in the clinical trial and commercialization stage of drugs. Terminal drugs involve anti-tumor, antiviral, neurologic, diabetes and other therapeutic fields. The core value of CDMO business of the company is reflected in the development and optimization of pharmaceutical process and industrial application.

History

1999year
Zhejiang Jiashan Chengda Pharmaceutical Chemical Co., Ltd. was established
2000year
Start CDMO&CMO business
2003year
L-carnitine product was awarded "National Key New Product"
Passed ISO9001 quality management system certification
2007year
Passed ISO9001, ISO22000, FAMI-QS quality and safety management system certification
"3-ATMA Project" is included in the National Torch Plan
2008year
Passed ISO14,001 and OHSAS18,001 environmental and occupational health and safety management system certification
Set up Zhejiang Provincial High tech Enterprise Research and Development Center
2009year
Renamed Chengda Pharmaceutical Co., Ltd.
It was recognized as a national high-tech enterprise for the first time
2011year
Register the trademark of "Chengda Pharmaceutical"
"2 - (trimethylsilyl) ethoxymethyl chloride project" was included in the industrialization demonstration project of the National Torch Plan
2012year
Pass HALAL system certification
2013year
It passed the on-site inspection on GMP compliance by the US Food and Drug Administration (FDA) for the first time
2014year
Passed FSSC22000 food safety management system certification
2015year
For the first time, it passed the GMP compliance inspection of the Japanese independent administrative legal person Pharmaceutical and Medical Device Agency (PMDA)
2016year
Passed the FDA GMP compliance inspection for the second time
2017year
Passed the on-site inspection of GMP compliance by the National Drug Administration of Malaysia (NPRA).
2018year
Complete the overall relocation of the plant
Set up Zhejiang Provincial Enterprise Technology Center Passed the certification of "Made in Zhejiang"
2019year
Set up Zhejiang Postdoctoral Workstation
2020year
It passed the FDA GMP compliance inspection for the third time
Establish a joint laboratory with Zhejiang University of Technology
Passed the certification of the integration management system
2021year
Set up Zhejiang Provincial Enterprise Research Institute
Passed the GMP compliance inspection of China National Drug Administration (NMPA)
For the second time, it passed the GMP compliance inspection of the Japanese independent administrati
2022year
Listed on the Growth Enterprise Market of Shenzhen Stock Exchange, the development entered an important milestone and passed the second level standardized safety production acceptance of hazardous chemical enterprises

Cultures

Honors

Jiashan County Scientific and Technological Innovation Team with Outstanding Contribution (Top Ten Scientific and Technological Innovation Advanced Teams)

Zhejiang specialized, special and new small and medium-sized enterprises

Jiaxing gazelle cultivation enterprise

Jiaxing honest and trustworthy enterprise

One of the top ten demonstration enterprises of Jiaxing hazardous chemical enterprises in safe production

Jiaxing Trade Secret Protection Base (Demonstration Site)

Jiashan County Top Ten High quality Development Leading Enterprise

Jiashan County Specialized and Special New (Invisible Champion) Enterprise

Zhejiang Invisible Champion Cultivation Enterprise

EHS Management System

environment protection

Actively develop green chemistry and cleaner production technology, and put this technology and concept into practice in new product development, process development and optimization, technical improvement and other aspects, and commit to reducing pollution sources from the source by using chemical basic principles and technologies.

A complete sewage collection pipe network, rainwater collection pipe network and circulating water pipe network have been established, which can achieve the general goal of "zero direct sewage discharge" of rainwater sewage separation and clean sewage separation.

Sewage treatment capacity 1500m ³/ d. The process of "air flotation+hydrolytic acidification+AO+oxidation" is adopted to realize "DCS" automatic control in the whole process.

Advanced regenerative thermal oxidizer (RTO) and mechanical vapor recompression evaporator (MVR) are equipped for the treatment of waste gas and liquid.

healthy

With the fundamental purpose of protecting the physical and mental health of all employees of the company, comprehensively improve the comprehensive prevention and control ability of occupational disease hazards of the company.

Provide protective facilities that meet the requirements of occupational disease prevention and occupational disease protective articles for personal use to improve working conditions.

Protect employees' right to occupational health protection, and conduct physical examination for employees before, during, after and after work.

Carry out occupational health education for employees, and monitor and control the toxic and harmful factors on the labor site.

security

Adopt multiple risk identification methods, improve safety design, improve safety protection facilities to the maximum extent, and reduce and control risks.

Do a good job in the "three simultaneities" management of the construction project, and implement the management requirements for the trial production of the construction project.

Various safety management systems and procedures are formulated, and management contents, responsibilities and work procedures are clarified.

The procurement, storage and use of raw materials and the classification, collection and disposal of waste realize the whole process and life cycle management.

With the standardization of work safety and the construction of occupational health and safety management system as the starting point, a dual prevention mechanism of safety risk hierarchical management and control and accident hidden danger investigation and management has been established.

Quality Management System

Quality policy: to produce high-quality products, provide the best service, and ensure the sustainable development of the company.

Quality management system: integrating the requirements of drug cGMP (ICH Q7), ISO9001, FSSC22000, FAMI-QS, etc., a quality management system meeting the requirements of drugs, food, feed, etc. has been established to support the sustainable development of the company's businesses.

Quality audit history: The company successfully passed the on-site inspection of FDA APIs in 2013, 2016 and 2020 respectively; The company has successively passed the on-site inspection by Chinese NMPA, Japanese PMDA, Malaysia NPRA and other medical regulatory agencies. The company receives 30-50 quality audits from customers in Europe, America and other countries every year, and is widely recognized. The process of "air flotation+hydrolytic acidification+AO+oxidation" is adopted to realize "DCS" automatic control in the whole process.

Product registration: The company's API registration application has passed the technical review of drug regulatory authorities in various countries, such as FDA, EDQM, PMDA of Japan, CDE of China, HC of Canada, AIFA of Italy, etc. Based on the requirements of the ICH registration technical guidelines, the company has established a scientific and rigorous quality control strategy to serve the terminal preparation customers with superior product quality.

Social Responsibility

Service hotline (9:00-18:00)

0573 - 8460 1188

No. 36, Huanghe Road, Huimin Street, Jiashan County, Zhejiang Province