EUROPEAN PARTNER FOR PHARMA AND MEDTECH COMPANIES WORLDWIDE
cGMP contract manufacturing for drug substances and drug products
YOU CAN RELY ON OUR EXPERIENCE
Proven expertise
for our customers
We are a globally acting CDMO and have been developing and producing pharmaceuticals in Austria for more than 30 years. Our strengths include customized contract development and manufacturing of sterile liquid dosage forms, small molecule active pharmaceutical ingredients and drop-on-demand biochip printing.
Quality Made in AUSTRIA
Not a question of quality
Pharmaceutical quality management and compliance with cGMP rules are our top priorities. Regular external audits and official inspections ensure our promise to deliver top quality.
Scalable solutions.
Our offers are tailor made
For us, contract manufacturing means a complete service. We enable flexible and scalable solutions, tailored to the respective need.
Experienced and efficient team.
We act hands-on
Our experts provide support with regulatory, technical and process expertise – from development through production to authorization management.
Key metrics-based supply planning.
On the safe side
Planning- and production reliability is an important aspect for the success of our customers. With our delivery promises, we create the basis for long-term and trusting cooperations.
UNDER ONE ROOF
Pharmaceutical manufacturing and active ingredient production
At our company, chemists and pharmacists work closely together. Partners benefit from the experience of both fields in the development of active ingredients and drug products. Our GMP services for logistics and packaging complete the range of services.
Drug Products
Contract manufacturing of sterile and low-bioburden injectables from 5-500 ml
Drug Substance
Contract manufacturing of small-molecule active ingredients as well as excipients
GMP Services
GMP-compliant pharmaceutical and medtech logistics and co-packing services
Quality,
that convinces
Industrial expertise and “state of the art” development and production facilities enable us to comply with all GMP (Good Manufacturing Practice) requirements in production, analytics and packaging. We also place high demands on drug safety. Seamless documentation in the manufacturing process is a matter of course and ensures safe and reproducible quality. At the same time, we stand for supply reliability throughout the entire life cycle of a pharmaceutical product. Regular external controls and comprehensive quality management ensure these promises.
Our TRAIN concept in the area of pharmaceutical production allows flexible production at a very high quality level while avoiding cross-contamination. During production, all product-specific equipment and product-contacting parts are used for only one product group at a time.
CDMO DRUG PRODUCT
Pharmaceutical production
of parenterals
Sanochemia specializes in the production of injectable pharmaceuticals. We offer our partners a comprehensive range of filling and finishing options for both terminally sterilized parenterals and aseptic oral liquids. GMP-compliant pharmaceutical products from 5 to 500ml are manufactured at our facility. With our know-how, we support as needed in development, scale-up processes, technology transfers, and regulatory affairs to produce high-quality products and bring them to market as quickly as possible.
Production
- Commercial
- Small batch sizes
- Clinical batches
Container
- Glass Vials
- Bottles
Processes
- Fill and Finish
- Terminal sterilisation
- Low bioburden liquids
- Highly viscous fluids
- Automated and manual packaging
CDMO DRUG SUBSTANCE
Small molecule
drug substance synthesis
As a manufacturer, we support our partners in the GMP-compliant production of small molecule active ingredients according to given specifications. In addition, our experienced chemists develop and optimize processes in the laboratory and carry out technical transfers up to production on a ton scale. In-house development and release analytics as well as the corresponding regulatory support for the preparation of registration documents complete the range of services. Our facilities support small batches as well as scaling up to commercial quantities that can grow with the respective API (Active Pharmaceutical Ingredients) demand.
Production
- From 100 grams to multiple tons
Capabilities
- Complex multi-step synthesis
- Analytical method development
- Low Temperature Chemistry
- Process optimization and scale-up
- Process transfers
- Kg-lab
CMO BIOCHIP PRINTING
Drop-on-Demand
Biochip Production
Molecular biology meets industrial automation. Sanochemia supports companies as CMO in the field of biochip production. The chips produced by Sanochemia can be used as bioanalytical tools in a wide range of scientific fields – for example for sophisticated multiplex POC tests. The core of the technology used enables extremely fast reaction times, with controlled dosing volumes and precise positioning.
Production
- Drop-on-Demand- dosing
- 10 pL to 100 μL
- High Scale Batch production
- Up to 1 array per second
Automation
- Miniaturisation and multiplexing of assays
- Industrial commercialisation
Services
- Proof-of-concept
- Sample preparation
- Process control
- Quality control
- Packaging
GMP SERVICES: WITH US, YOU’RE CAREFREE ON THE ROAD
Optimized value creation with logistics and contract packing services
In addition to our contract manufacturing services, we also offer logistics and packaging services for medical devices and pharmaceuticals. Optionally also GMP-compliant. This optimizes logistics processes and improves efficiency. External requirements such as “right-on -time” or “in full” are no longer an obstacle with us.
We take over the establishment of logistics infrastructure, packaging optimization, compilation, assembly or packaging and support the establishment of scalable processes. All stages can be covered by the existing state-of-the-art pharmaceutical quality management system.
Competent advice on critical supplier qualification steps, regulatory assistance, and appropriate quality control are an important part of our services. If required, we support with comprehensive GMP documentation as well as with the registration of new products.
Supply chain services
- Procurement of raw materials
- Supplier qualification
- Optimize packaging materials
- Warehousing and managed premises
Packaging
- Repackaging
- Visual inspection
- Assembly
- Printing of labels
- Packaging clinic samples
- Serialise
Support
- Quality management and release
- GMP documentation
- Regulatory support
BUSINESS DEVELOPMENT
Customized solutions – already convinced?
We are happy to convince you with competent advice and help to increase entrepreneurial flexibility on the customer side. Benefit from our in-depth know-how and contact us today.