Recently, Suzhou Jingye Medicine & Chemical Co., Ltd. (Jingye) successfully obtained the "Approval Notice for the Market Launch of Chemical Raw Materials" (Notice No. 2024YS00864) issued by the National Medical Products Administration (NMPA) for its gadopentetate chemical raw material.
The approval of the gadopentetate raw material is not only another milestone in Jingye's research and development capabilities but also further evidence of the deep collaboration and shared success between Jingye and Shanghai Medicilon Inc. (Medicilon). With its outstanding technical expertise and extensive experience in the CMC (Chemistry, Manufacturing, and Controls) field, Medicilon provided process development, quality research, and stability studies for the development of the gadopentetate raw material. This support laid a solid foundation for the efficient completion of the application process.
Gadopentetate, as a crucial raw material in the pharmaceutical field, is highly favored for its unique properties that enhance drug solubility and bioavailability. As a solubilizer, it can significantly enhance the solubility of drugs, particularly those with a pKa value between 2 and 7. In clinical practice, gadopentetate exhibits antiarrhythmic properties, protects cardiovascular health, and improves myocardial metabolism. It can be used in the treatment of diseases such as coronary heart disease, cardiomyopathy, and myocarditis. With the global trend of aging and the expanding population of cardiovascular disease patients, the market demand for gadopentetate is expected to continue rising. The recent approval of gadopentetate raw material by Jingye will undoubtedly boost market supply, better meeting the health needs of patients.
The approval of Jingye's gadopentetate dimeglumine active pharmaceutical ingredient (API) not only once again proves its strong research and development capabilities, demonstrating a spirit of continuous innovation and pursuit of excellence in the field of APIs, but also reaffirms Medicilon's professionalism and efficiency in API services.
With the reshaping and enhancement of the generic drug market value, the quality standards for APIs have also been elevated to unprecedented heights. As one of the few one-stop preclinical biopharmaceutical research and development service platforms in China, Medicilon has established cGMP-level API production lines that meet international IND filing standards (including dual submissions for China and the US). This production line spans every stage from preclinical small-scale synthesis and process optimization to commercial production. It meets diverse production needs at milligram, gram, and kilogram scales, ensuring the excellence and stability of product quality.
Additionally, Medicilon's analysis and quality control team offers comprehensive and high-precision analytical services. From the innovative development and rigorous validation of analytical methods to in-depth process validation, precise impurity identification and efficient separation, and stability testing of active pharmaceutical ingredients (APIs), Medicilon offers comprehensive and high-precision analytical services. The Medicilon process department provides services for the research and development, analytical testing, and stability studies of generic drugs, meeting the needs for clinical Phase I and II development, production, analytical testing, and stability research for innovative drugs.
Medicilon congratulates Jingye on the approval and market launch of gadopentetate dimeglumine API. We look forward to collaborating in the future to achieve more research and development successes together! Medicilon will continue to leverage its over twenty years of experience in empowering global innovative and generic drug development, offering one-stop, customized R&D service solutions to pharmaceutical partners worldwide. We are committed to advancing the biopharmaceutical industry towards higher quality, greater efficiency, and enhanced sustainability.
Jingye Medicine & Chemical Co. was established in 1998 in the Suzhou High-Tech Zone Incubator. It primarily produces pharmaceutical active ingredients, pharmaceutical intermediates, and provides CDMO project services. The company covers an area of nearly 80 acres and currently employs 282 people. It has 9 commercial production workshops, including 3 GMP workshops and 1 CDMO workshop. The main products include intermediates for meglumine, trimetazidine hydrochloride, quetiapine fumarate, paroxetine hydrochloride, nateglinide, and others. In 2008, the company successfully passed the ISO 9001 Quality Management System certification, ISO 14001 Environmental Management System certification, and ISO 18001 Occupational Health and Safety Management System certification, all at once. In 2014, it received the Level 2 Safety Standardization certification from Jiangsu Province, and in 2021, it obtained a pharmaceutical manufacturing license. To date, the company has developed 36 high-tech products, applied for 25 invention patents, and received authorization for 15 patents. In 2023, Jingye achieved an output value of RMB 230 million.
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. By the end of June 2024, Medicilon has provided new drug R&D services to more than 2,000 clients around the world, and participated in the R&D of 490 new drug projects that have been approved for clinical trials. Medicilon is proud to contribute to human health in the globe.
Relevant News
marketing@medicilon.com
