跳至主要内容

Empowering API Quality Enhancement! Medicilon Received the 'Best Collaboration Award' from Jingye Medicine & Chemical Co., Ltd

On the journey of drug development, each collaboration is a profound test of professional competence and a severe test of professionalism.  Recently, Medicilon USA Corp. (Medicilon) is honored to have received a thank-you letter from Jingye Medicine & Chemical Co., Ltd (Jingye Medicine) and was awarded the "Best Collaboration Award". This not only recognizes the professional capabilities and service level of Medicilon, but also reflects the result of the joint efforts and tacit collaboration between the two parties.

Best Collaboration Award.webp

Medicilon and Jingye Medicine
Work together to overcome difficulties and achieve fruitful collaboration

Jingye Medicine, as a secondary safety production standardization enterprise for hazardous chemicals, continues to demonstrate outstanding professional capabilities and profound industry accumulation in the fields of pharmaceutical raw materials, pharmaceutical intermediates and CDMO project services.  In collaboration with Jingye Medicine, the Medicilon team has always upheld professionalism, closely collaborating with Jingye Medicine's process and analysis teams to jointly face and successfully overcome a series of technical challenges in the research and development process, ultimately ensuring the smooth progress of the project.

Currently, Medicilon has been involved in five projects with Jingye Medicine, with three of them are under development.  These successful collaboration cases not only demonstrate the outstanding capabilities of both parties in the pharmaceutical research and development field, but also establish a solid foundation for future in-depth collaboration between the two parties.

Medicilon one-stop API CDMO service platform

In the field of APIs, Medicilon currently possesses cGMP-compliant production lines for APIs that meet the requirements for IND filing in both the United States and China. From preclinical small-scale synthesis and process development to commercial production, Medicilon integrates deeply with the entire supply chain system of enterprises, including research and development, procurement, and production. The production scales could be flexibly adjusted ranging from milligrams to kilograms. Meanwhile, Medicilon possesses a rigorous and experienced analysis and quality inspection team, providing precise analysis services and strict quality control throughout the project.

The Medicilon's Process Department not only provides clients with services in the R&D, analysis testing, and stability research of generic drugs, but also offers services for the R&D, production, analysis testing, and stability research of innovative drugs in Phase I and Phase II clinical trials, gradually transitioning from R&D process development to industrial commercial production, and from CRO to CDMO.

About Jingye Medicine

Jingye Medicine & Chemical Co., Ltd. was established in 1998 in the Suzhou High-tech Zone Incubator, mainly producing APIs, pharmaceutical intermediates, and CDMO project services. The company covers an area of nearly 80 acres, currently employing 282 people, and owns 9 commercial production workshops, including 3 GMP workshops and 1 CDMO workshop.  The main products include intermediates for Pemetrexed, Quetiapine Hydrochloride, Quetiapine Fumarate, Paroxetine Hydrochloride, and Sitagliptin intermediates. In 2008, the company passed the ISO9001 Quality Management System Certification, ISO14001 Environmental Management System Certification, and ISO18001 Occupational Health and Safety Management System Certification. In 2014, it obtained the Jiangsu Province Safety Standardization Level II Certification. In 2021, it obtained the Drug Production License. So far, the company has 36 high-tech products, applied for 25 invention patents, and obtained 15 authorized patents. In 2023, Jingye Medicine achieved a production value of RMB 230 million.

评论

此博客中的热门博文

Custom Synthesis

Medicilon has synthesized over 10,000 individual compounds from gram to kilogram quantities, and many compounds are synthesized with more than ten synthetic steps. The overall synthesis success rate is over 95%. High quality products from mg to kg scale Reagents, intermediates, building blocks, and scaffolds Preparation of API or reference standards Development of synthetic routes for impurities and metabolites   On-site analytical support Product delivered with COA Medicilon offers integrated drug discovery services -- Chemistry, Biology & Preclinical Services

In Vitro Enzyme Activity Assay

  Kinases play extensive and important roles in signal transduction and co-ordination of complex functions. Currently, about 300 kinase inhibitors have been approved for marketing, among which receptor tyrosine kinase (RTK) inhibitors are the main ones. Medicilon provides high-quality kinase profile screening and has one-stop kinase research services from assay development, high-throughput screening to selectivity analysis. In addition, Medicilon provides many other enzyme activity screens. Wide Variety Provides 200+  in vitro  enzymatic detection methods; 100+ kinases, including CTK, RTK, AGC, CMGC and other kinase families as well as important common mutations Project Flexibility Various types of plates for screening, such as 96 and 384; Multiple flexible kinase profiles, including TK kinase family, CDK kinase family, etc., to meet different customer customization needs. Various Methods Fluorescence detection; Chemiluminescence detection; Absorbance detection LanthaScr...

Pharmacokinetics Services

Pharmacokinetics Services Our pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, ranging from small molecules to large molecules, such as protein and antibody. The animal species involved in our services are non-human primate, canine, mice, rat, rabbit and hamster. Meanwhile, non-human primate experimental platform and isotope platform for protein/antibody are certified by the Shanghai government. Preclinical Pharmacokinetics Method development and validation (GLP,Non-GLP) Bioanalysis Pharmacokinetics (Tumor bearing rodents, Bioavailability, Crossover studies, Cassette (N in 1) dosing and analysis, effects of gender on pharmacokinetics, BBB penetration ) Stability in vehicles and plasma Drug interaction studies In vitro metabolic stability CYP 450 inhibition Plasma protein binding studies Distribution studies Excretion studies Prediction an...