Lundbeck Custom Development & Manufacturing
Lundbeck CDM is what we call the services and expertise that we extended to existing and new partners. Our services range from development, scale-up and production of small-molecule active pharmaceutical ingredients and fine chemical intermediates to drug product formulations and packaging.
With our chemical synthesis facilities in Lumsås (Denmark) and Padova (Italy) and our pharmaceutical production sites in Valbonne (France) and Valby (Denmark), we have decades of experience in active pharmaceutical ingredients (API), drug products (DP) and custom manufacturing services of both.
We provide our partners with a complete range of development and production services, from route screening, process development and optimization, manufacturing of clinical trial batches to industrialization and large-scale commercial production.
>60
Years of experience
>50
Number of projects successfully developed
In Lundbeck Our Beliefs constantly drive the way we work. Both in process development and production, our patient-driven approach underpins why you should choose Lundbeck CDM as your partner.
Sustainability and Compliance
Being part of a pharmaceutical group operating world-wide, Lundbeck CDM has committed itself to the highest standards within quality and environmental, social and governance targets. Our tradition of ethical and sustainable initiatives and behavior is long, and we are devoted to continuously develop sustainable solutions. As part of our Sustainability commitment, we have a Carbon Net-zero Plan and a plan to minimize our environmental impact. Lundbeck achieved a Carbon Disclosure Project (CDP) Leadership scoring an A score over years and supports the most ambitious target described in the Paris Agreement pursuing efforts to limit global warming to 1.5°C. When developing new production processes, we carefully select environmentally sustainable solutions guided by Green Chemistry principles.
Reliability
Our culture is focused on maintaining a high reliability on everything from process development, production, project execution and delivery to the customer. Our supply chains are robust with appropriate contingencies established in material sources, timelines, and safety-stock according to customer requirements.
Our facilities are certified by local and international health and drug agencies such as FDA, EMA, PMDA, ANVISA and MFDS.
Ingenuity
Key players in the pharmaceutical industry, ranging from big pharma to biotech, have entrusted Lundbeck CDM with the development of their new drugs. Relying on our expertise, experience and technological capabilities in process development and industrialization to support clinical development and launch, our partners have been profiting from the innovations and optimizations developed by Lundbeck CDM to expand their portfolios and their know-how.
Our Process and Analytical R&D teams are highly skilled and well-equipped for the identification of innovative chemical solutions, which are so appreciated by our many partners. Each project is assigned to a dedicated team of chemists, engineers, and technicians with the required set of expertise in process development, analytical development, Process Analytical Technology, Design of Experiments, process calorimetry and safety evaluation, impurity profile investigation and characterization. Our process development capacity allows for 6-10 projects annually.
Your drug product and packaging operation is in safe hands with our highly skilled team that can support you in development of your drug product, manufacturing of clinical trial batches or commercial products, along with all analytical and primary and secondary packaging services including serialization and aggregation solutions.
Active Pharmaceutical Ingredients |
Drug Products & Packaging |
|
|
|
Padova | Lumsås |
|
---|---|---|
Employees |
140 | 215 |
Reactors, stainless steel | 20 (100 - 6000 litres) | 49 (300 - 6000 litres) |
Reactors, glass-lined | 18 (100 - 9000 litres) | 25 (500 - 5000 litres) |
Reactors, hastelloy | 6 (200 - 3000 litres) | - |
Total reactor capacity | 140 m³ | 200 m³ |
Temperature range | -50 to +300°C | -25 to +150°C |
Pressure range | Up to 12 bar | Up to 10 bar |
Dryers | 10 | 12 |
Milling / delumping equipment | 9 | 3 |
Special strengths | Micronization Bromination High vacuum thin-film distillation Hydrogenation Highly confined operation units Reaction calorimetry & process safety |
Simulated Moving Bed Chromatography Continuous Production Flow-Chemistry Controlled Substances
|
Safety, health & environment | ISO14001 / 45001 / IPPC | ISO14001 / 45001 |
GMP accreditations | EMA, FDA, PMDA, MFDS | EMA, FDA, PMDA, MFDS |
Pilot plant | ✓ | ✓ |
Key capacities and capabilities of our API sites.
Lundbeck CDM produces the following generic APIs:
CAS NUMBER | PRODUCT NAME |
INDICATION |
---|---|---|
141396-28-3 |
Argatroban Monohydrate |
thrombosis |
132810-10-7 |
Blonanserin | psychosis |
59729-32-7 |
Citalopram Hydrobromide | depression |
17321-77-6 |
Clomipramine Hydrochloride | depression |
80-08-0 |
Dapsone* | acne/dermatitis |
58-28-6 |
Desipramine Hydrochloride | depression |
364-98-7 |
Diazoxide | hypertension |
219861-08-2 |
Escitalopram Oxalate* | depression |
10075-24-8 |
Imipramine Pamoate | depression |
59-63-2 |
Isocarboxazid | depression |
26786-32-3 |
Lofepramine Hydrochloride | depression |
54143-57-6 |
Metoclopramide Hydrochloride | nausea |
16590-41-3 | Naltrexone | alcohol dependence/opioid dependence |
23239-51-2 | Ritodrine Hydrochloride | premature labor |
521-78-8 | Trimipramine Maleate | depression |
706779-91-1 | Pimavanserin | parkinson disease - psychosis |
202825-46-5 | Safinamide Mesylate | parkinson disease - motor symptoms |
* may not be available for all markets