Our global footprint
Headquartered in the Netherlands, Ofichem is a family-owned global CDMO and API production and supply partner with an international footprint.
Today, our group unites five European development and manufacturing sites with a global network for sourcing and distribution.
Across every location, our teams work closely together to provide the right service at the right time, building quality into every detail, keeping your programs moving, and delivering consistently.
Ter Apel, Heembadweg HQ
Our headquarters in Ter Apel, Netherlands, is home to Ofichem’s drug substance development and manufacturing plant. From here, close to the university city of Groningen and with strong cross-border connections to both German and Dutch cities, we combine scientific excellence with steady, hands-on support. This is the place where ideas are shaped into compliant, scalable solutions.
The drug substance development laboratories focus on synthetic route scouting and process development, analytical method development and validation, and in-house translation from R&D to GMP production.
More about Ter Apel HQ
The state-of-the-art analytical laboratory performs both in-house and external tests for raw materials, APIs, and drug products in accordance with pharmacopoeia (EP/USP/BP, etc.) or any required specifications.
All commonly required analytical techniques can be performed, such as: identity testing, assay and related substances (HPLC/GC), chemical testing (pH/density/conductivity etc), optical rotation, residual solvents (HPLC/GC), impurity identification, water content (KF), limits of detection (LOD), and particle size distribution (Laser diffraction/sieve method).
cGMP and FDA approved, providing material for phase I, II, II, IV and commercial purposes via multiple regulatory pathways (NDA, 505b2, ASMF, DMF, CEP, JMF)
Small-scale production
- 5 multi-purpose production suites
- Temperature range -75 to +250°C
- Fully glass (lined) manufacturing equipment (20 to 100 L)
- Fluidized bed drying, flash chromatography, isolator, and jet milling options
Mid-scale production
- 4 multi-purpose production suites
- Temperature range -50 to +150°C.
- Fully glass-lined manufacturing equipment (200 to 700 L)
- Dedicated jet milling and sieving capabilities
- Fluidized bed and tray drying options
Large-scale production
- 5 multi-purpose production suites
- Temperature range -50 to +250°C/+15 to +90°C.
- Glass-lined (250 to 750 L) and stainless steel (1000 to 2000 L) manufacturing equipment
- Fluidized bed drying, nutsche filtration and hammer milling capabilities
Ter Apel, Drenthweg
Our site at the Drenthweg in Ter Apel is our API sourcing and distribution facility and also houses our repackaging and release services.
Leiden
Our drug product development and manufacturing facility is based in the Bio Science Park in Leiden, Netherlands, a vibrant hub of academic, biotech, and pharmaceutical innovation.
Here, we combine flexibility with proven expertise to keep your program moving, from R&D through small- and large-scale oral solid dose manufacturing, analytical testing, and packaging.
Through it all, our mission is clear: to reduce medicine shortages and improve patient access to both innovative and generic medicines.
More about Leiden
Tableting and film coating
- Manufacturing area of 4,200 m2
- 6 tabletting areas
- Tableting speeds up to more than 200,000 tablets per hour
- Manufacturing tailored to customer needs, with staff and equipment suited for small and large quantities
- Annual capacity of 1.5 billion tablets per year
- Film coating and dragee technology
- Clinical trial GMP production of tablets, powders, and granulates
- R&D scale equipment for faster tech transfer and process optimization
Packaging
- Packaging area of 1,200 m2
- 4 high-speed blister lines
- 1 bottle line
- Serialization via Trace Link
- Packaging for small (clinical) batches and commercial product quantities
- Annual packaging capacity of 1 billion tablets in bottles and 1.5 billion tablets in blisters
Laboratory services
- EU batch release
- Stability studies
- Raw materials and FDF testing
- High-capacity laboratory with 15 (U) HPLCs
- All equipment in-house for testing, including various dissolution systems
Uppsala
Our preclinical drug substance development site in Uppsala, Sweden, near Stockholm, is part of a city with a proud life sciences tradition and home to the oldest university in the Nordics.
From purpose-built facilities at Uppsala Business Park, we provide a full package of preclinical services, from medicinal chemistry and process development up to kg-scale, to (bio)analytical development and pre-formulation.
ISO9001 certified and experienced in new modalities such as ADCs, PROTACs, peptides, and oligonucleotides, the site is focused on keeping programs moving with quality built in from the start.
Services at Uppsala
- Medicinal chemistry
- Custom synthesis
- Process development up to 60 L scale
- Analytical services
- Impurity identification and synthesis
- Pre-formulation services
- Bioanalytical services
- Extractables and leachables studies
Nijmegen
Our drug product development site at the Novio Tech Campus in Nijmegen specialises in taking your product ideas further, from product evaluation through formulation and analytical development. The team also provides excipient characterisation, reverse engineering, dissolution testing, stability studies.
With deep expertise in formulation development and advanced analytical method development, the team supports the developed of new drug products, generics and branded life-cycle management.
Services at Nijmegen
- Formulation development
- Analytical development
- Excipient analysis
- Dissolution testing
Hamburg, Germany
Incopharm GmbH, located in Hamburg, Germany is a trading company for APIs for the human and veterinary markets, specialised in the Eastern European market.
Incopharm is partly owned by Ofichem and distinguishes itself in the market by its good connection with its customers and suppliers. There is an emphasis on maintaining long-term relationships and this has resulted in a high level of trust and engagement with both customers and suppliers.
As such, Incopharm can provide fast, reliable service while fully complying with legal requirements.
Hangzhou, China
Our site in Hangzhou supports reliable sourcing across Asia and plays a key role in strengthening our global supply chain.
The team maintains close contact with trusted manufacturers, tracks market developments and helps secure high-quality raw materials for our European operations. Their local insight supports stable, traceable supply and helps keep your projects moving with confidence.
WINSTON-SALEM, USA
Our office in Winston-Salem, NC, is our US registration office.
Our team
Ready to take your innovation to market?
Work shoulder-to-shoulder with a family-owned CDMO and pharmaceutical supplier that answers quickly, solves early, and keeps your progress steady. Decisions feel clearer with us beside you.
