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CMO/CDMO
- Categories:CMO/CDMO
- Time of issue:2021-05-06 16:37:31
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Huapont Shengchem provide custom process R&D strategy for APIs and intermediates from preclinical to commercialized production.
R&D, Optimization and Scale-up of API and Intermediates
20 years experience of API process development and optimization
Over 100 APIs and intermediates are finished, among which 47 APIs have been approved in China and 9 APIs acquired approval of Europe, US, Korea and Japan
Outstanding R&D team and sufficient equipment for the need of R&D and optimization
Production of APIs and Intermediates
Rich experiences for accepting transferred products and carrying out scale-up validation (ahead of marketing)
Over 300 reactors ranging from 50L to 8,000L, could support production of APIs and intermediates from grams, kilograms to tons
Multiple successful experiences of process scale-up based on market demand in accordance with regulatory requirements during the production process (after marketing)
Full control of supply chain management from raw material purchasing to international shipping.
Technology Platform
Micronization and particle size control
Photochemical chemical reaction
High pressure hydrogenation
High potent compound
Quality & Comprehensive Impurity Files
Comprehensive Impurity Files based on production process from starting raw materials to final APIs
Genotoxic impurities
Nitrosamine impurities and assessment
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Time of issue:2020-07-27 00:00:00
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Time of issue:2019-05-10 00:00:00
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Time of issue:2019-05-10 00:00:00
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