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API manufacturing

We manufacture over 80 commercial molecules and produce more than 1,000 tons annually, giving innovative pharma and biotechs the scale, reliability and proven experience needed to advance complex therapies with confidence.

Reliable global supply

You need a partner who guarantees scale and security. Novasep CDMO delivers with a European network of five cGMP sites producing more than 1,000 tons of APIs each year. Supported by a strong commercial presence in North America, we provide the resilient, dependable supply chain your most complex projects demand.

Why partner with us?

  • >250 projects successfully completed.
  • Expert handling of complex chemistries and HPAPIs (up to OEB6).
  • >30 years of experience in API manufacturing
  • >98% compliant batches
  • >10 years average relationship length with key customers
  • >30 years of experience in cGMP manufacturing
  • 100% successful inspection rate by FDA and European authorities
  • >600 m³ of reactor capacity

Scale without compromise

From clinical to commercial scale, we deliver APIs without compromising quality or timelines. Our flexible facilities and experienced teams ensure a smooth transition as your program advances.

Explore related services

Learn more about our broader CDMO services and expertise.

API Development

Supported by 140+ process development specialists and over 150 analytical method validations annually,  we ensure effortless technology transfer and comprehensive regulatory support.

HPAPI Manufacturing

From Omega‑3s to LNPs, we produce more than 280 tons of lipids each year at >95% purity, powered by advanced high‑pressure chromatography.

Latest updates

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Partner with Axplora for reliable, scalable API manufacturing.