Integrated pharmaceutical contract manufacturing: API, bulk, device assembly and packaging in one global network.
Grünenthal GmbH – Grünenthal PRO Contract Manufacturing
Aachen, Germany · Origgio, Italy · Mitlödi, Switzerland · Santiago, ChileNew on Amplifa
About Grünenthal PRO
Grünenthal PRO is the contract manufacturing division of Grünenthal GmbH, headquartered in Aachen. The integrated pharmaceutical manufacturing platform network connects API production, bulk manufacturing, device assembly and pharmaceutical packaging within Grünenthal's Global Operations. Active ingredients such as tramadol, betahistine and oxatomide are manufactured in highly automated multi-purpose facilities in Aachen (Germany) and Mitlödi (Switzerland); in 2024, 390 tonnes of API and intermediates were delivered to more than 50 customers in 17 countries. Additional sites cover nasal spray manufacturing (compounding, filling, assembly, packaging) in Origgio (Italy) as well as the production of hormone-based products for oral solids and topical gels in Santiago (Chile). Services also include assembly and packaging for injectable products (pre-filled syringes, pens, auto-injectors) including cold-chain handling, release testing, serialization and aggregation, as well as primary and secondary packaging in formats such as blisters, wallets, alu-alu, patches, bottles and ampoules.
- Site
- Aachen
- Processes
- Biopharma services – assembly and packaging for injectable products (pre-filled syringes, pens,, Manual, semi-automated and automated assembly operations for injectable products, Kit packaging for injectable products, Cold-chain handling, Release testing, Nasal spray compounding and filling (unit-dose, bi-dose, multi-dose), Nasal spray device assembly, Analytical services and testing methods for nasal sprays
- Materials
- Tramadol, Betahistine, Oxatomide, PVC, PVDC, Aclar, Aluminium, Glass
- Certificates
- Certification by global health authorities, Release testing
- Employees
- 2000+
- Industries
- Pharmaceutical industry, Biotech, Pain therapy, Women's Health, Biosimilars/Biologics
- 01
Sourcing
- 02
API production
- 03
Bulk manufacturing
- 04
Device assembly
- 05
Primary and secondary packaging
- 06
Serialization and aggregation
- 07
Release testing
- 08
Distribution support
Products and Packaging Materials
Tramadol
API for opioid-based pain therapies in tablets, capsules, drops and injectable formulations.
Betahistine
API for the treatment of Ménière's disease symptoms such as vertigo, tinnitus and nausea.
Oxatomide
Antihistamine API for the treatment of allergic conditions such as rhinitis, dermatitis and eczema.
PVC
Blister foil material for pharmaceutical primary packaging.
PVDC
Barrier foil for blisters with elevated protection requirements.
Aclar
High-barrier film for demanding blister packaging.
Aluminium
Used for alu-alu blisters, alu strips and wallet packaging.
Glass
Bottle material for solids in pharmaceutical packaging.
Plastic
Material for bottle packaging and device components.
Locations
Aachen
DEHeadquarters and API production
- Materials
- Tramadol, Betahistine, Oxatomide
- Highly automated multi-purpose API production facilities
Origgio
ITNasal spray manufacturing (compounding, filling, assembly, packaging)
- Materials
- Pharmaceutical formulations
Mitlödi
CHAPI production
- Materials
- APIs and intermediates
Santiago
CLManufacturing of hormone-based products (Women's Health)
- Materials
- Hormone-based products
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Biopharma services – assembly and packaging for injectable products (pre-filled syringes, pens,Assembly | – | – | – | Flexible batch sizes from small | Pharmaceutical products (biologics, biosimilars) |
| Manual, semi-automated and automated assembly operations for injectable productsAssembly | – | – | – | – | – |
| Kit packaging for injectable productsAssembly | – | – | – | – | – |
| Cold-chain handlingSurface | – | – | – | – | – |
| Release testingTesting | – | – | – | – | – |
| Nasal spray compounding and filling (unit-dose, bi-dose, multi-dose)Casting | – | – | – | – | Pharmaceutical formulations |
| Nasal spray device assemblyAssembly | – | – | – | – | – |
| Analytical services and testing methods for nasal spraysTesting | – | – | – | – | – |
| Primary and secondary pharmaceutical packaging – blisters (PVC, PVDC, Aclar), alu-alu, wallet, aluAssembly | – | – | – | – | PVC, PVDC, Aclar, Aluminium |
| Packaging – patchesAssembly | – | – | – | – | – |
| Packaging – solids in glass and plastic bottlesAssembly | – | – | – | – | Glass, Plastic |
| Liquid and semi-solid primary packagingAssembly | – | – | – | – | – |
| Ampoules packagingAssembly | – | – | – | – | – |
| Serialization and aggregation servicesAssembly | – | – | – | – | – |
| Envelopes, bundling and sealingAssembly | – | – | – | – | – |
| API manufacturing – highly automated API production (multi-purpose equipment)Casting | – | – | 390 tonnes/year (delivered 2024) | – | Tramadol, Betahistine, Oxatomide |
| Starting material productionCasting | – | – | – | – | – |
| Hormone products manufacturing – oral solid dosage formsCasting | – | – | – | – | Hormone-based products |
| Topical gels manufacturingCasting | – | – | – | – | Hormone-based products |
| Analytical services and testing methods (hormone products)Testing | – | – | – | – | – |
| Regional distribution support (Latin America)Engineering | – | – | – | – | – |
Additional services
Quality
The sites meet pharmaceutical standards and are certified by leading global health authorities. Unified quality and regulatory systems of Grünenthal Global Operations apply, complemented by release testing and analytical services.
| Evidence | Aachen | Origgio | Mitlödi | Santiago |
|---|---|---|---|---|
| Certification by global health authorities | ||||
| Release testing |
History
- 2024
Delivery of 390 tonnes of API and intermediates to more than 50 customers in 17 countries; 33% market share in global tramadol production.