Drug Substance and API Manufacturing Services

API CONTRACT MANUFACTURING

With over 50 years of experience in sourcing, process development and analytics, we accelerate your project into manufacturing.

From early discovery to commercial production, we’ve got the right hands on deck to keep every handover smooth and every timeline tight.

All drug substance manufacturing takes place in our FDA-approved GMP facility in Ter Apel, the Netherlands. Our integrated approach to R&D, production, analytical, and regulatory support reduces friction and handoffs, saving you time and energy.

We routinely produce GMP material from just a few grams up to several hundred kilograms per batch, with expertise in the full range from R&D, phase-appropriate upscaling, process validation, analytical method validation, stability testing, and regulatory documentation.

Our regulatory team is experienced in supporting with all necessary documentation for both clinical trials and the commercial ASMF/DMF writing and filing. We strive for continuous improvement and have in-depth knowledge to comply with GMP, GDP, ICH and ISO guidelines at every stage of development.

We apply the highest standards of quality and safety.

We are the partner who answers, solves, and remembers — even for the most complex projects. Many of our products are orphan drugs for rare diseases, where unique challenges demand speed with integrity.

By bypassing friction with technical proficiency, we deliver straight answers and steady progress at every stage.

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What We Offer

We build strong foundations for your molecule — ensuring every step from API synthesis and process development to GMP production is compliant, scalable, and dependable.

Synthetic route scouting & process development:
Smarter pathways to reduce risk and improve efficiency.
Analytical method development & validation:
Robust analytical methods and phase appropriate validation.
Reactor capabilities:
15 manufacturing workshops ranging from small scale (20Lm 60L, 100L) up to multi-MT production (1500L, 2x 2000L)
Equipped analytical department:
HPLC, GC, LC-MS, NMR, and more state of the art analytical department and Uppsala capabilities.
Scale-up flexibility: from 20 L up to 1,800 L per batch, aligned with clinical and commercial needs.

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Let’s keep it moving

When your priorities shift, so do we. At Ofichem, flexibility means adapting without delay, keeping your timelines steady and your project on track.

Our integrated teams — from R&D to GMP production, QA, and Regulatory Affairs — work as one partner with one standard, ensuring compliance with ICH Q7 and supporting ASMF/DMF submissions worldwide.

The result: progress without pressure — a seamless path through development and GMP, with the confidence that nothing will fall through the cracks.

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Secure Your Supply Chain With Ofichem

As a stable, family-owned company with a proven history of regulatory compliance, we deliver reliability you can count on.

With modern GMP facilities in the Netherlands and continuous improvement driven by knowledge and technology, we keep your supply steady, responsive, and ready.

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