AKTINPHARM® Pharmaceutical
Focusing 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.
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.
*A library of 2,000+ standby high-performance compounds for drug discovery candidates.
*Integrated CRO/CDMO Services for Natural Drugs, Small Molecule APIs, ADC and Formulations.
*Two R&D centers, dual layout of Non-GMP & GMP factories, meet customer’s varying needs for R&D and commercial scale production
*Three Technical Platforms for all production reactions.
Phytopower® Development Platform of Bioactive Molecules & Ingredients from Global Medicinal Plants
Aktinsyn^® Technical Platform of Synthetic Chemistry
Aktinbio^® Development Platform of Biotechnology