Company Introduction
Business Areas:
Our business covers high difficulty sustained-release and controlled-release preparations, generic drug development based on patent challenges, consistency evaluation of oral and injectable preparations, CMC for innovative drugs/improved new drugs/generic drugs, regulatory filing, and MAH (Marketing Authorization Holder). We have comprehensive, full-lifecycle, process-oriented R&D and technical service capabilities — from early formulation design evaluation and preclinical studies to pilot-scale production, commercial manufacturing, and regulatory submission.
Advantageous technical platform
Advantageous Technology Platforms:
· Innovative Drug Technology Platform（synthesis/preparations improvement, innovative drugs）
· Sustained-Release and Controlled-Release Preparations Technology Platform（extended-release, enteric‑coated, osmotic pump）
· Solubility Enhancement Technology Platform for Poorly Soluble Drugs（spray drying, hot melt extrusion）
· Topical Preparations Technology Platform（suppositories, ointments, gels）
· Orally Disintegrating Preparations Technology Platform（orally dissolving films, orally disintegrating tablets）
· Soft Capsule Preparations Technology Platform
· Liquid Preparations Technology Platform（oral solutions, injections (including lyophilized products), eye drops）
Narcotic and Psychotropic Substance R&D Platform
R&d and service advantages
R&D and Service Advantages
Expert-level R&D Team
• Technical expert team–Includes an academician in pharmacokinetics, along with professors in preparations and pharmaceutical analysis from China Pharmaceutical University, with over 30 years of experience in tackling innovative R&D challenges.
• Drug review experts are engaged to review and assess technical dossiers, ensuring both technical feasibility and regulatory compliance.
Three Centers Equipped with High-End R&D Instruments
• R&D Center–Approximately 5,700 m², housing the Synthetic Drug Center, Modern Preparations Research Center, Pharmaceutical Analysis Center, and Drug Quality Research Center.
• High-end preparations and analytical instruments – All equipments have passed 3Q qualification.
Robust Quality Management System
• Equipped with networked chromatography data acquisition systems (Shimadzu, Chromeleon, Agilent), supported by a full quality management system that meets "data integrity" requirements.
• Certified under ISO 9001:2015, and has successfully passed nearly 20 regulatory on-site inspections for drug development and for issuance/amendment of MAH license (Type B).
Service Guarantee
• Project experience– Over 100 projects in R&D and regulatory filing (in China, US, and Europe)
• Approval experience– Over 50 approvals
• Innovative drugs– 6 obtained registration approvals, 5 obtained clinical trial approvals
Please contact us for more detailed information.
Kangchuanji Pharmatech looks forward to working with you and jointly creating a bright future!
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Nanjing Kangchuanji Pharmatech Co., Ltd.
Contact Us：18020149597（HR）
Recruitment Email:recruit@kcjpharma.com
Address: 2nd Floor, Building 5, No.199 Wenfang Road, Jiangning District, Nanjing, Jiangsu Province, China（Jiangning High-tech Park）
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