诚达药业股份有限公司成立于1999年，是一家以医药中间体、化学原料药、食品及饲料添加剂的研发、生产和销售为主营业务的高新技术企业，于2022年在深交所上市（股票代码:301201)。
公司致力于为跨国制药企业及医药研发机构在药物临床试验和商业化阶段提供关键医药中间体、原料药的工艺研发及优化、质量研究和定制生产等CDMO服务，终端药物涉及抗肿瘤、抗病毒、神经类、糖尿病等多个治疗领域。公司CDMO业务的核心价值体现为制药工艺的开发优化和产业化应用。
公司是国内最早实现左旋肉碱系列产品产业化的企业之一，也是全球左旋肉碱主要供应商之一,产品广泛应用于药品、食品添加剂及饲料添加剂领域,销往全球30多个国家和地区,市场份额位居全球前列。
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.
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.
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 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.
