
2010-08-05
Medium-sized
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ConnectType:
T - Technology & Patents
Industry:
Pharmaceuticals and Chemical IntermediatesChemical Engineering Technology Research and Development and Process Package
Country / Region:
China
Company Type:
OtherListed companySpecialized refined distinctive and innovative enterprises
Registered Capital:
300 million RMB
Company Capability: Process Technology Development、Technology Transfer
Jiangsu Ruikke Pharmaceutical Technology Co., Ltd. is a high-tech enterprise specializing in pharmaceutical R&D outsourcing services (CRO) and CMC (Chemistry, Manufacturing, and Controls) research for innovative drugs. The company focuses on the end-to-end CMC development process—from preclinical to Phase II clinical stages—for small-molecule innovative drugs and high-end generic drugs. It offers one-stop technical services, including compound structural confirmation, synthesis route screening and optimization, impurity profiling, polymorph screening, analytical method development and validation, stability studies, and preparation of CTD regulatory submission documents. Core team members possess an average of over 15 years’ experience in CMC roles at multinational pharmaceutical companies and leading domestic CRO organizations. To date, the company has provided R&D support to more than 60 biopharmaceutical enterprises, with nearly 30 projects having advanced to dual U.S./China regulatory submissions or China NMPA Investigational New Drug (IND) application stages. The company holds five invention patents (e.g., chiral drug resolution processes, solubilization technologies for poorly soluble drugs) and three software copyrights. Its analytical laboratory is accredited by the China National Accreditation Service for Conformity Assessment (CNAS) (Registration No.: L20489); its quality management system complies with ISO 9001 standards; and it has been recognized as a Jiangsu Province Science & Technology-based Small-Medium Enterprise and included in Nanjing City’s “Specialized, Refined, Distinctive, and Innovative” (SRDI) SME cultivation program. Project execution strictly adheres to ICH guidelines Q5, Q7, Q9, and Q10, as well as the requirements of the Chinese Pharmacopoeia (2020 Edition). Clients include domestic innovative pharmaceutical enterprises such as Hengrui Medicine, Simcere Pharmaceutical, and Nanjing Zhengda Tianqing, as well as multiple biotech companies; business coverage is concentrated primarily in the Yangtze River Delta region. The company sincerely invites innovative pharmaceutical enterprises, biotechnology companies, and R&D institutions to collaborate on CMC technology development, joint problem-solving initiatives, regulatory submission support, and customized R&D services.
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