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Aktin Pharmaceuticals Co., Ltd as a wholly-owned subsidiary of the pharmaceutical division of Aktin Chemicals, Inc., focuses on providing integrated services (CRDMO) for the entire life cycle of drug research, development and production for global pharmaceutical and biopharmaceutical companies. We deeply serve innovative drug R&D enterprises and drug marketing authorization holders (MAHs), offering CRO and CMO solutions spanning from the early clinical stage (covering hit compound and lead compound research) to commercial drug production.
As a natural medicine manufacturer and CRDMO partner, we are committed to rapidly and efficiently transforming natural compounds into compliant drugs. We empower our clients to enhance drug R&D efficiency, accelerate the market launch process, and ultimately benefit human health earlier.
API: We provide comprehensive solutions covering the entire active pharmaceutical ingredient (API) lifecycle, including: innovative synthetic route design and process development, impurity profile studies and identification, process optimization and scale-up, analytical method development and validation, as well as commercial-scale production in compliance with ICH guidelines and cGMP standards.
CMC: We offer end-to-end Chemistry, Manufacturing, and Controls (CMC) services, including: preparation and submission of CTD-formatted registration documents, technology transfer, clinical and commercial manufacturing, and global registration support (including the preparation and submission of DMFs/ASMFs, as well as IND/IMPD filing support).
FDF: We provide formulation development and manufacturing services, including: pre-formulation studies, formulation design and optimization, process scale-up, stability studies, packaging strategy, and commercial production of oral solid dosage forms, sterile injectables, and specialized advanced formulations.
We have independently established and continuously expanded a high-performance nucleic compound library with over 2,000 compounds, growing at a rate of dozens per month. This library significantly accelerates the drug discovery process from hit to lead optimization.
Our two R&D centers strictly follow the ICH guidelines and GMP regulations, and master a number of leading technologies including natural drug development, drug crystallization and solid-state chemistry research, biocatalytic and biotransformation technology, ADC drug development, Highly Potent Active Pharmaceutical Ingredient (HPAPI) development, and continuous flow manufacturing (Microchannel Continuous Reaction). The perfect Quality Management System (QMS) and EHS (Environment, Health and Safety) system provide guarantees for project compliance, personnel safety and environmental friendliness. With reliable project execution capabilities and a good delivery records, we ensure efficient progress of customer projects.
The modern factory compliant with international cGMP standards has end-to-end production capabilities for natural drugs, small molecule APIs and preparations from lab-scale, pilot-scale to commercialization, providing customers with comprehensive customized production solutions. Relying on a strict quality control system and advanced production technologies, we ensure the entire process from R&D to release meets standards and adapts to customized requirements at different stages.
Mission
To be the global leading supplier of natural nutritional ingredients, natural personal care ingredients and natural APIs in the industry.
Vision
May all diseases have a cure.
Core Value
Create Value for customers by technology progressing and production management.
Culture
Customer Interest & social responsibilities comes first, Employee growth comes second and company profit comes last.