l Qualifications:
• Full GMP system, in compliance with requirements of CN-EU-FDA.
• With GuangDong-FDA certificate of <Pharmaceutical Production License>.
l Characteristics:
• Focus on
• high-potency (HP-API, OEB4/5), with long-step,complex-structure, multi-chiral-center products.
• Focus on Deuterated Drug API products.
• Batch-scale from g to kg, Pilot-Intermediate-Large,with process optimization if necessary.
• For New-Drug R&D, satisfy from lab-stage to PreClinical(IND) till Phase2-stage requirement.
• For Commercial-Supply, from Early-stage toValidation-batch, in comply with GMP regulations.
l CMC System:
• Workshop: Synthesis: 101#, 102# . Clean: 1#,2#, 5#.
• Equipment: 50-200L Reactor, Rotary-Evaporator, DAC50-200 Prep-HPLC, 3in1 Reactor, Isolator.
• QC Exam: Micro-Balance,UV, NIR, GC, HPLC, Microbiol-Lab, etc.
l EHS
• Full EHS（Environment,Health, Safety）management system.
Customservice for impurities
l Servicecontent:
• Product types:
• drug reference standards,
• impurity controls, special intermediates, etc.
• for quality research and subsequent commercialproduction QC testing,
• Customized synthesis, separation and preparationstructural analysis, and the traceability and mechanism research of impurities services.
• Offering complete nuclear magnetic resonance (NMR),mass spectrometry (MS), infrared (IR), and ultraviolet (UV) spectra, to supportthe research, registration, and production of customers to ensure productquality and complete qualification.
l Contact to:
• T/F: +86-20-3264-0673,
• M: +86-18027191740;
• Email: Miss Mia, Sales01@kemrocmed.com; Dr. Wang, wangt@kemrocmed.com,
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