Licensing & Contract manufacturing
Achieving more together
Since 1886, DR. KADE has been developing, producing and marketing high-quality prescription and non-prescription medicines and medical products. In doing so, it combines its vast experience and exceptional German quality with a great openness towards new ideas. This also applies to product development and working together with international partners. Whether in-licensing or out-licensing, we focus on effective healthcare solutions that allow people to enjoy a higher quality of life.
Our flexible production facilities allow us to respond swiftly to customer demands and changes in the market. In manufacturing, we have focused on technology relating to semi-solid forms and have high-performance lines for producing creams, ointments, gels and suppositories. We also offer the option of contract manufacturing.
Why DR. KADE?
- Tradition and experience
- Pharmaceutical quality from Germany
- Market-leading products and brands
- Marketing and sales know-how
- Medical and scientific support through in-house teams of experts
- International presence
Reliable and certified contract manufacturing
Our full-service approach supports you comprehensively. While you focus on sales and the market, we manage the safe and efficient manufacturing of your product, if required all the way through of market release. You benefit from integrated processes, the highest quality standards, and flexible solutions across the entire value chain.
Manufacturing
We manufacture your semi-solid products in batches ranging from 200 L to 2,000 L.
- Manufacture of pharmaceuticals and medical devices
- Creams, ointments, pastes, and gels in batch sizes up to 2,000 L, as well as suppositories and ovules (melting and dissolving suppositories/ovules) in batch sizes up to 500 L
- Manufacturing of hormone preparations in compliance with substance-specific PDE values and defined exposure limits
- EX protection and production under a nitrogen atmosphere possible
Filling and Packaging
On four packaging lines, we offer flexible filling of tubes as well as suppositories and ovules according to your specifications.
- Filling into aluminum tubes in various formats, for example stand-up tubes with fill volumes from 10 g to 100 g
- Primary packaging for suppositories and ovules made of aluminum or plastic foil
- Filling into Intermediate Bulk Containers (IBCs) with volumes ranging from 50 L to 1,000 L
- Automated insertion of various inserts and application aids possible
- Additional packaging formats available flexibly upon request
Quality Control
Chemical, physical, and microbiological testing - tailored to your product specifications.
- Comprehensive chromatographic analysis (HPLC, GC, TLC)
- Spectroscopic testing methods (UV/Vis and IR spectroscopy)
- Wet chemical and physical testing methods (viscosity, penetrometry, pH, density, and refractive index)
- Titration methods, including Karl Fischer titration and content analysis
- Particle size analysis using laser light scattering
- Microbiological testing methods in collaboration with a certified testing laboratory
- Stability testing in accordance with ICH guidelines, including long-term and accelerated stability studies
- Drug release studies for semi-solid dosage forms in accordance with Ph. Eur. 2.9.3 / USP 4 (under implementation, available as of 09/26)
- Biochemical methods, including ELISA and flow cytometry
- Method development, validation, and optimization in accordance with ICH Q2(R1)
Tech-Transfer
We provide comprehensive coordination of technology transfer and support you in optimizing your products and processes.
- Flexible adjustment and scaling of batch size
- Targeted process optimization and systematic evaluation of critical process parameters (CPPs)
- Guidance on process validation strategy
- Modern process validation in accordance with current regulatory requirements
- Product lifecycle management, e.g., OPV, implementation of alternative API sources, and process design optimization
- Galenic support, e.g., laboratory-scale process equipment
- Supporting analytical methods, e.g., digital 3D microscopy, viscosity and rheology measurements, spreadability and density determination, as well as differential Scanning Calorimetry (DSC)
Regulatory approval
Our team of experts advises you on all regulatory matters relating to your product.
- Preparation and maintenance of regulatory dossier updates, including Modules 2.3 and 3, eCTD packages, and well-documented justification documents
- Assistance in responding to regulatory deficiency letters
- Development of regulatory transfer plans
- Regulatory impact assessment of changes, including a deviation matrix for transparent evaluation and decision-making
- Preparation and maintenance of artwork documentation
Your contact:
Simone Kunze
Head of Contract Manufacturing & Transfer
M +49 160 95738973
E contractmanufacturing@kade.de
New perspectives for your products
Interested in breaking into new markets with your healthcare solutions? We at DR. KADE believe in strong partnerships. As a company that is always open to digital approaches and new forms of treatment, we are interested in joining forces with other specialists to create healthcare solutions that make a difference and that offer sustainable prospects and greater quality of life.
We are looking for outstanding products, especially in our strategic healthcare fields:
- Women’s health and
- proctology
Come and talk to us!
Our Business Development & Licensing team is the first port of call for any questions relating to in-licensing, out-licensing or M&As. We look forward to hearing from you – after all, healthcare needs good ideas and people who can put them into practice.
Contact: +49 (30) 7 20 82-0
Licensing with a promise of quality
We are always on the lookout for reliable partners for long-term cooperation and licensing agreements. We offer you proven German quality for your markets together with sales and marketing know-how and medical and scientific expertise.
International presence
Our products are already distributed in more than 25 countries by more than 25 partners. We generate 20% of our sales revenue outside our core market of Germany – especially in the growing markets of Asia and Eastern Europe. We are a reliable partner to many companies – in fact, we have one of the oldest German-Japanese business ties on record with Japanese firm Maruho, a partnership that dates back as far as 1923.
Products:
If you have any questions, please let us know.
We look forward to hearing from you – and growing together!
Contact: +49 (30) 7 20 82-0