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Design, development and optimization of process routes for innovative and generic drugs.We provide quality research, process validation, product life cycle management, process safety assessment services based on QbD concept.
Aktinpharm provide customers with CRO&CDMO services for APIs, empowering the MAH(marketing authorization holder).
R&D services
Through our professional chemical technology platform to provide pre-clinical drug candidate discovery services and solutions for global pharmaceutical industries.
More than 20+ years of experience in R&D,2 R&D center, 1000+Active clients worldwide
Development and Manufacturing services
Developing& manufacturing the quality bioactive ingredients & molecules and offer CMO/CDMO solutions for global pharmaceutical industries from the preclinical to the commercial stage.
4 R&D and Manufacturing base with EHS
Integrated CMC platform for APIs and Formulations
GMP industrial production experience
Flexible multi-functional production workshop
Production line from Kgs to Tons
Continuous optimization of commercial production projects
Aktinpharm currently features a cGMP-based API production line based on IND requirements. From preclinical laboratory-scale testing and process development to commercialized production, we meet the needs of our clients throughout the comprehensive supply chain, including R&D, purchase and production. From the mg- and g-level to kg level, our processes allow flexible adjustments to fit in client innovative process R&D and scale production.
From QBD-oriented process design to process R&D in laboratories, commercialized production to data-based filings, our analysis and quality inspection teams promise professional services and comprehensive analytical research, including method development and verification, process verification, impurity identification and separation, API and intermediates research, and API stability tests.
With years of experience and the construction of laboratories, the Aktinpharm Process Department can not only perform R&D, testing and stability studies of generic drugs for customers, but also R&D, production, testing and stability studies of innovative drugs in clinical phase I and phase II, gradually developing from process R&D to industrial commercial production and provide customers with CRO&CDMO services for APIs, empowering the MAH(marketing authorization holder).
Route Selection
We help our clients select and develop reliable, low-cost, safe, and environment-friendly mass-production API process routes for the selection of both emergency routes in the early stages of drug development and the economic routes for formal drug development.
Production Process Optimization
Our Process Department employs the principle of QBD in API process development ,and strives to select the best route suitable for our clients, optimizing the API production process to improve product quality and manufacturing efficiency.
Clinical Sample Production
We offer API production services, including production for laboratory-scale testing, batch production for safety evaluations, production for pilot-scale testing, and GMP-based production. Our lab can support the production of clinical API for phase I and phase II, as well as advanced intermediates.
Impurity Traceability & Control
We offer API related services including impurity identification and separation, as well as quality research and stability testing,and can meet regulatory and ICH guidelines.
Generic Drug Process Study & Filing
Synthetic process development, optimization,and commercial of Generic Drug API and DMF filing.