hAPIs and catalysis for a better quality of life

Proper active pharmaceutical ingredient (API) selection is crucial to many medicinal products and to fulfill these needs, we offer an array of catalysts.

Whether you’re a highly potent anti-cancer drug manufacturer or your challenge is ring closure metathesis for your large member ring, palladium chemistry for your amination reaction or your need is a homogeneous catalyst, we have your solution.

high potency APIs manufacturing

Reliable partner, reliable quality

Umicore has been producing and marketing high potency APIs (hAPIs) for more than 20 years – complying with cGMP requirements, ICH guidelines and all applicable regulations in the pharmaceutical industry.

Opened in 2009 in Buenos Aires, Argentina, our state-of-the-art hAPI facility produces in compliance with cGMP requirements for global markets. The facility has been inspected and endorsed by a variety of health agencies and customers. In 2014, an independent, third-party audit in accordance with DIN/ISO14001 norms verified the facility's high standards and in 2016 it underwent a successful inspection by the USFDA.

Managed under European standards and values, the Argentinian site offers our customers an advantageous cost competitiveness as well as unique and innovative options to develop launch strategies for generic molecules.

We also offer exclusive contract development services at our dedicated R&D group in Hanau-Wolfgang, Germany. Our expertise spans from extensive synthesis and manufacturing to specialized intellectual property (IP) and regulatory affairs support.

Major process development and manufacturing competencies include:

  • Inorganic, organic, precious metal based and organometallic chemistry
  • Processing of highly pure, sensitive, toxic or pyrophoric materials
  • Process development and manufacturing in high containment facilities (OEB5)
  • Integrated analytics expertise

Exclusive synthesis services include:

  • Dedicated project management under strict confidentiality and IP control
  • Customized support from pre-clinical development to commercial phase
  • Non-GMP development labs
  • cGMP manufacturing facility
  • In-house QA and QC expertise and services
  • Global IP strategy support
  • Specialized regulatory affairs team

Contact us to start talk about our next development or supply cooperation.

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Catalysts for fine chemicals and intermediates manufacturing

Your health matters to us.

We value customer collaboration because you know your business best. Our long-term collaborative approach to R&D and commercial manufacturing makes your innovative creations come to life.

The combination of our novel homogeneous catalysts, our innovative approach to metal based chemistry, our flexible commercial scale manufacturing and our metal recycling expertise give you a solid foundation upon which to develop and manufacture your high value chemicals and active intermediates in the most sustainable manner – anywhere in Europe, the Americas or Asia.

Whether your synthesis embeds a ring closure metathesis, a complex amination reaction, a selective cross-coupling reaction or a stereoselective hydrogenation, we have the solution.

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