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Custom Chemicals Department

Overview

Finetech Development Plant

Nissan Chemical Corporation is advancing "solution proposal business" that novel value is developed by progressive and unique technology in order to meet the diverse demands in the life-science fields such as active pharmaceutical ingredients, animal pharmaceuticals, diagnostic agents and so on. We have various technologies for fine organic synthesis like chiral synthesis, oxidation reaction by organocatalysts represented by AZADOL® and Pre-MIBSK and high-purity purification by column technology based on our developing and manufacturing experiences for pharmaceuticals and agricultural chemicals. In recent years, we have developed, manufactured and sold high-potency generic APIs like prostaglandin derivatives and VD3 derivatives by using our fine organic synthesis platform. Additionally, we have been focusing synthesis of middle molecules represented by peptides and nucleotides. We have developed a cost-competitive and innovative liquid-phase synthesis platform "SYNCSOL™", we offer extensive support from low molecules to middle molecules.

Utilizing foregoing technologies, we are carrying on contract business and joint-business of developing manufacturing process at each stage from preclinical to commercial production and manufacturing APIs, intermediates and a part of pharmaceuticals under GMP control. Furthermore, we also offer various services related to drug applications such as quality design including test method development and specification settings based on API specificities, stability tests, synthesis of impurity standards and metabolite standards and preparation of Drug Master Files.

With the mottos of "timely", "reasonable price" and "high quality", we would solve customer’s problems and offer "safety" and "trust".

 

Our Business Outline

Manufacturing of APIs and Intermediates
We manufacture APIs and intermediates by establishing manufacturing methods that are applicable for scale-up;
・Manufacturing of APIs and intermediates from pre-clinical trial to commercial manufacturing;
・Manufacturing under GMP conformity (we have experiences in receiving audit from PMDA and organizations outside of Japan, such as FDA and EU);
・Manufacturing of high potency active pharmaceutical ingredients requiring containment;
・Purification using large-scale preparative columns.
Peptide Synthesis
We are also focused on the synthesis of peptides and nucleic acids. Notably, we are engaged in the development of price competitive liquid phase synthesis methods for peptide synthesis.
Product Lineup
We sell the following products.
・Oxidation catalysts(AZADOL®Pre-MIBSK
・Generic medical substances
Process Research
We will establish manufacturing methods that are applicable for scale-up by conducting quantitative reaction analysis and stability tests at each process.
We offer APIs that are manufactured in price competitive synthetic methods by being disclosed the structural formula only.
・Development of novel synthetic routes
・Optimization of reaction conditions
・Scale-up research
Related Services
We provide the following services related to our manufacturing services and process research services.
・Analysis method development, standard setting
・Stability test
・Impurity identification
・Metabolic preparation synthesis
・DMF preparation
 

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Handling division

  • Pharmaceuticals Division Custom Chemicals Department
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