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Drug Substance

Every molecule, every milestone, every moment matters. From early API development through GMP manufacturing, we bring consistency and confidence to the APIs and drug substances that move your program forward.
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Explore Our API & Drug Substance Services

Our teams support programs from synthetic route scouting and medicinal chemistry through process development, analytical method development and scale-up to GMP production, ensuring each stage progresses toward a robust, scalable manufacturing process.

Drug Substance Development

Preclinical medicinal chemistry, process development and regulatory support from discovery to scale-up for diverse drug modalities, with seamless transition into our GMP facility.
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Drug Substance & API Manufacturing Services

Tailor-made small molecule APIs and excipients for pre-clinical, clinical and commercial programmes — from early production to full registration.
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Catalog API

Our API catalog offers a reliable source of high-quality APIs, you can count on every batch we deliver. We commercially produce about 50 APIs in the Netherlands. All production takes place in an FDA approved site under EU-GMP and all APIs can be delivered with an CTD-ASMF and/or CEP.
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Drug Substance Analytical Services

Physical and chemical analyses of a wide range of pharmaceutical raw materials and drug substances.
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Why Choose Ofichem for Drug Substance & API

  • Experience you can trust
    Nearly five decades in API development and manufacturing, from complex small molecules to emerging modalities such as ADCs, PROTACs, peptides and oligonucleotides, give you confidence at every milestone.
  • Inspection-ready quality
    EU-GMP and FDA-approved facilities ensure your program stays compliant and always audit-ready.
  • Progress without pressure
    Integrated development, manufacturing and analytical method development and validation, including seamless translation from R&D to GMP production, reduce handovers and keep timelines steady.
  • Answers without delays
    Direct access to our scientists means faster solutions and fewer bottlenecks in development, process optimisation or scale-up.
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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.

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