Products and Services
Products and Services
CMDO
Custom Development and Manufacturing Organization
With over 15 years of experience in pharmaceutical R&D and manufacturing, Ausun has established production facilities and a clinical department in China, along with sales offices in the Czech Republic, Germany, Switzerland, Turkey, and Cyprus. This global footprint enables Ausun to serve clients in more than 20 countries worldwide.
Our professional teams are on hand to deliver your custom small molecule API and Polypeptides API projects, especially complex chemical, analytical and technical challenges, on time and within budget to the highest quality standards.
Our "one-stop" mode ensures the smooth transfer of process technology and production scale, not only for small molecules compounds but also polypeptide compounds.
API Development
Process Development and Optimization
The R&D team of nearly 300 people composed of doctors and masters covers the tracking and analysis of market patents, forward-looking research on advanced technology, new process research and development, scale-up production, process optimization, analytical method development, product quality testing , impurity analysis and so on.
We identify and evaluate the most suitable synthetic pathways, balancing efficiency, regulatory requirements, and scalability. CEO remains head of R&D, who will be responsible of internal project-review.
Scale-up Activities and Pre-Validation
We adapt laboratory-scale processes for industrial production, ensuring reproducibility, robustness, and safety. Key supporting activities encompass solid form studies, impurity identification and reference standard synthesis, process safety assessment, analytical method development and validation. Thorough assessments during development to minimize risks in scale-up. Appropriate scale-up factors will be determined before scale-up to achieve a timely and robust process, which is critical for our customers’ success in their development stage.
API manufacturing Workshop
Our global network of API production facilities offers customers the flexibility to optimally align with their program requirements, while ensuring a secure and reliable supply chain.
Kilo-lab (10-20 L) and Small-Scale Production (20-200 L)
Kilo-lab: supply of kilogram-scale samples for toxicity studies and qualification activities.
Once the process is established, it is scaled up and transferred to the production unit.
Raw Material Availability
Most raw materials are available in China within weeks. Critical raw materials are manufactured in-house.
Scale-Up Capability and Expertise
More than 200 process steps have been successfully scaled up over the past 8 years.
Core Competencies-Available Technologies
Grignard Reaction
Oxidation reaction (H2O2、TEMPO)
Prostaglandin Chemistry
Nitration & Diazotization
Friedel Crafts reaction (resin, Lewis acid, trifluoromesylate)
Catalytic Reduction (Pd/C, Ni, KBH4, NaBH4, Zn, Fe, BF3, ZnCl2, ZnBr2, AlCl3, CaCl2)
Halogenation (Br2, Cl2, SOCl2, POCl3, PCl3, PCl5, HF, KF, ISHIKAWA, TCCA, DBDMH, DCDMH)
Alkylations (N-, O-, C-)
Phosgene substitution
Low Temperature Reaction
BuLi Reaction
Esterification & Hydrolization (resin、enzyme & normal)
Lyophilizer
Spray dryer
Project management
We support continuous process improvements, optimize productivity, cost optimization, regulatory updates, and analytical advancements to maintain efficiency and compliance throughout the product lifecycle.
Project-Management
Every Project has a Project-Manager as the primary contact-person for the customer, who coordinates all internal activities, and is responsible for the project- schedule and ensures proper follow-up.
Project-team
For every project a team from the necessary departments and functions gets defined, based on the requirements of the project.
Cooperation and reporting
Important is a timely and transparent communication and reporting.
The reporting frequency and way of communication is aligned with the requirements and expectations of the customer.
Email:
Company Address:
No.5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Taizhou,Zhejiang,China
