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Healthcare Business: Custom Chemicals

Business Overview

Finetech Development Plant

Nissan Chemical Corporation engages in Solution Proposal Businesses and Joint Development Businesses that offer new values (including new services) by our progressive and unique technology in order to meet the diverse demands in the life-science fields such as active pharmaceutical ingredients, animal pharmaceuticals and diagnostic agents.

Nissan Chemical Corporation has abundant experiences in in-house development & manufacturing of pharmaceuticals and agricultural chemicals and possesses rich basic technologies related to various technologies for fine organic synthesis such as chiral synthesis, oxidation reaction by organocatalysts (represented by AZADOL® and Pre-MIBSK) and high-purity purification by column technology. In recent years, we have developed, manufactured and sold high-potency generic APIs like prostaglandin derivatives and vitamin D3 derivatives by using our fine organic synthesis platform. Additionally, we have been devoted to the synthesis of middle molecules represented by peptides. We have developed a cost-competitive and innovative liquid-phase synthesis platform "SYNCSOL®" and offer extensive support from small molecules to middle molecules.

Utilizing these technologies, we engage in contract businesses and joint businesses of manufacturing process development at each stage of preclinical through commercial production, as well as manufacturing of APIs, intermediates and drug formulations (part of the entire process) under cGMP conformity. Furthermore, utilizing our abundant experiences in drug applications in Japan and other countries, we offer various related services, such as quality design based on API specificities (including test method development and specification settings), stability tests, synthesis of reference metabolite standards and impurities, preparation of Drug Master Files (in correspondence with Chemistry, Manufacturing and Control-CMC), etc.

With our mottos of "timely," "reasonable price" and "high quality," we will solve customers’ problems and offer "safety" and "trust."

 

Consignment

Manufacturing of APIs and Intermediates
・Manufacturing of APIs and intermediates from pre-clinical stage to commercial production;
・Manufacturing under cGMP (we have experiences receiving audit from PMDA, FDA, EU and other organizations outside of Japan);
・Manufacturing of high potency active pharmaceutical ingredients requiring containment;
・We have the capacity of bulk manufacturing of hundreds of kilograms and small scale manufacturing of several grams;
・Purification using large-scale preparative columns.
Peptide Synthesis
We are also devoted to the synthesis of medium-molecule pharmaceuticals (e.g., peptides and nucleic acids). We are particularly engaged in peptide synthesis using the liquid phase synthesis method that is price competitive and a method that we developed.
Product Lineup
We sell the following products:
・Oxidation catalysts (AZADOL® and Pre-MIBSK);
・Generic APIs.
Process Research
We establish manufacturing methods that are applicable for scale-up by performing quantitative reaction analysis and holding stability tests at each point of the procedure.
We can establish a high quality, safe manufacturing method by discovering price competitive synthetic routes, even if the chemical structure is the only information provided.
・Development of novel synthetic routes;
・Optimization of reaction conditions;
・Scale-up research.
Related Services
We offer various services related to process research:
・Analysis method development, standard setting;
・Stability test;
・Impurity identification;
・Synthesis of metabolite standards;
・DMF preparation.
 

Contact Us

Handling division

  • Healthcare Division, Custom Chemicals
  • Contuct Us

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