Beijing xinyitai Pharmaceutical Technology Development Co., Ltd
Founded in 2006, ISO 9001:2000 Quality Management System Certification Enterprises, National High-tech Enterprises, Zhongguancun High-tech Enterprises, Beijing Economic and Technological Development Zone Key Technological Innovation Support Enterprises, Beijing Science and Technology Research and Development Institutions.
-Our career
Beijing Xinyitai takes the pharmaceutical industry technology research and development and API intermediate production and sales as the core. Based on the company's leading advantages in new drug research and development and international cooperation, Beijing Xinyitai is committed to innovative research and contract services related to medical technology. Specialized in the discovery, research, and registration of new drugs; technology development, research, and registration of new preparations; technology development, consistency evaluation research, and registration of generic drugs; research on the qualification of reference preparations; pharmaceuticals (raw materials, preparations, pharmaceutical excipients, pharmaceuticals) Packaging materials) import registration agency and consulting; new API and intermediate process development, production and sales; custom compound synthesis and process development.
-Our configuration
Beijing Xinyitai has a registered capital of 24.75 million yuan, an existing R & D center of more than 2,000 square meters and an API pilot production base of more than 1,500 square meters. It has a full set of new drug research experiments and new equipment R & D functional departments with comprehensive production equipment, and internationally qualified cooperative BE tests platform. The R & D team with multiple doctoral masters as its core focuses on chiral synthesis research, synthetic process research, and pharmaceutical industry formulation technology research. Our research on new drugs and generic drugs is based on international regulatory requirements, adheres to international perspectives, and faces the international market. We have conducted exchanges and cooperation with many domestic and foreign pharmaceutical companies and scientific research institutions, and have passed the research and production qualification audits of many foreign cooperative customers. Instead of sharing resources in technology and information, complement each other's advantages, accelerate the transformation of scientific research results, and extend to innovative drug research.
-Our results
Since the establishment of the company, through unremitting efforts, we have successfully developed and applied for dozens of new drugs (most of which are domestic first or exclusive varieties), covering multiple fields, including digestive system drugs, nervous system drugs, antibacterial drugs, and anti-inflammatory drugs. , Antihypertensive drugs, lipid-lowering drugs, vascular disease treatment drugs, ophthalmic drugs, etc., most of which have not been approved for approval.
In addition, the company can industrially supply more than ten multi-step multi-chiral center APIs and intermediates, most of which have passed the supplier qualification audit of foreign cooperative customers.
-Our Features
The company has many years of domestic and foreign registration experience and has in-depth understanding of international and domestic registration regulations.
Has many years of international cooperation research and development experience, overseas cooperation resources are abundant.
Can provide one-stop research services for the consistency evaluation of generic drugs, including reference preparation determination and acquisition, pharmaceutical research (pre-validation and subsequent process optimization), BE pre-evaluation, BE evaluation
-Our goal
With first-class understanding of laws and regulations, first-class equipment, first-class synthetic technology, first-class registration documents, and first-class market awareness, we provide relevant partners with worry-free professional services for new drug development / discovery.
In the future, we will gradually introduce strategic investors, further improve the company's pharmaceutical industry chain, and enable the company to grow rapidly into a comprehensive pharmaceutical enterprise integrating science, industry and trade.