Lundbeck CDM

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.

Our long heritage

>60

Years of experience

>50

Number of projects successfully developed

Why choose Lundbeck CDM as your long-term partner?

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.

Core Technology & Expertise

Active Pharmaceutical Ingredients
            Drug Products & Packaging
  • 20+ years of experience in Analytical, Process Development and Production of Customized APIs and Intermediates
  • Green Chemistry: we create value improving the environmental footprint of your process
  • Flow Chemistry: used in 5+ commercial productions with volumes >10 MT. Available also for Grignard reactions
  • Simulated Moving Bed (SMB): in use for commercial productions
  • Jet-Mill Micronizer (capacity >50MT): no presence of metallic foreign matters and limited thermal stress
  • High Pressure Reactions: hydrogenation, amination
  • Broad Temperature Range: from -50°C to 300°C
  • Organometallic Reactions: Grignard, lithiation, metal catalyzed cross-coupling reactions
  • Handling of Toxic Substances: cyanide salts, bromine
 
  • Solid dose technologies (tablets, micro-tablets)
  • Packaging technologies (blisters, bottles, vials, kit, prefilled syringes)
  • In-house analytical services (development, validation, transfer, ICH stability)
  • Serialization and aggregation

Facilities

Lumsås

Padova

Valbonne

             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.

Proprietary Portfolio

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