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R&D £¾ Research Activities £¾APIs Development Lab |
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In order to develop NCE or generic new products in pharmaceutical industry, efforts and co-operation of various research field like pharmacy, chemistry, bioengineering, chemical engineering, and so on, should be accompanied.
Among them, APIs Development research and Analysis research field are important scientific area that are required in all department of new drug development such as API synthesis for IND (investigational New Drug) and clinical study for NCE research and development, even though at an earlier stage, generic API synthesis, their scale-up study for commercialization, in-process analytic methodological study and related support for registration etc.
Especially, APIs Development Lab. of ChoongWae carries on series research like lab-scale synthesis route development, process optimization and scale-up studies from lab-scale into real-production for industrialization of APIs & their key intermediates.
In 2006, we have improved on abbreviation of research period & cost-cutting through real-timely matching of both APIs Development Lab. and Analysis Lab, and have carried out analytical method development, validation, isolation & structure identification of related substances, and other various analysis methods development for APIs. And also, for observance of international regulations ( ICH and FDA guideline ), we are helping all other departments make regulatory documents and analyze. |
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Advanced Organic Chemistry
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Asymmetric Synthesis with Chirotechnologies |
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Enhanced Separation & Purification Technologies
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Pharmaceutical Engineering
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GMP Regulatory & Documentation Technologies |
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Analytical Method Development of New compound and drug |
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Identification of unknown compound |
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Chiral Separation |
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Small quantity extraction & quantity analytical method setup |
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Analytical Method Validation |
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Quality control of APIs and drug in Process development research |
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Cephamycin antibiotics |
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7-MAC DPM(7-Methylaminochphalosporanic
Acid & DPM): Key intermediate |
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7-BMAC(7-Bromomethylaminocephalosporanic
Acid & DPM): Key intermediate |
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APIs: Cefmetazole, Cefminox, Cefotetan |
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Compliance (IDL) : Cefmetazole, Cefuroxime |
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Antifungal agents |
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Bromo-ketal: Key intermediates
of Ketoconazole & Itraconazole |
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AHPP: Key intermediate
of Itraconazole |
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APIs: Ketoconazole, Itraconazole, Fluconazole |
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Compliance (DMF, COS): Ketoconazole, Itraconazole, Fluconazole
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Anti Hyperlipidemia (HMG-CoA Reductase inhibitors) |
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BAED, BHMD: Key intermediates |
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APIs: Simvastatin, Atorvastatin |
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Carbapenem antibiotics |
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Azidone(4-Acetoyazetidinone) : Key intermediate of Carbapenems |
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PNB-Thienamycin: Key intermediate
of Carbapenems |
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M2 Phosphate: Key intermediate
of 1¥â-Methyl carbapenems |
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Imipenem, Cilastatin (¥â-lactamase Inhibitor of Imipenem ), Panipenem, Meropenem |
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Compliance (DMF, IDL) : Imipenem, Prepenem (Brand name of Imipenem) |
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General analysis |
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Instrumental analysis( NMR, MS, LC, GC, etc)
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Operation, maintenance and user education of high-tech instruments |
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Analytical research |
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Analytical method development of new compound & drug substance |
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Compliance
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Analytic method identification and validation |
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Physico-chemical studies for new compound & drug substance |
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Specification and test method development and evaluation |
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Analytical technology transfer to production site |
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Qulification of drug and related substances |
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Documentation for domestic and oversea registrations |
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Quality control of APIs and drug in process development research |
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Pilot plant (25L to 200L G/L, SUS reactor, Thermal oil system.
Non-GMP facility)
Hydrogenator (20L SUS), Ozone generator, 20L Buchi evaporator, Multi-purpose reactor etc.
FT-NMR(300MHz, 500MHz), LC-MS(LC/MS. LC/MS/MS), GC/MS, GC(Headspace, SPME), HPLC(UV, ELSD, CD, PDA, RI, ECD, Conductivity, Fluorescence ), IC, Prep- LC, EA, MP, Titrator, Fluorometer etc. |
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