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Critical Raw Materials

Quality control of critical raw materials in active pharmaceutical ingredient (API) synthesis

Our Chemiflex™ Critical Raw Materials Program allows you to customize all aspects of active pharmaceutical ingredient (API) synthesis for small molecule drug manufacture, from non-clinical through commercial phases. You can save time and prevent regulatory setbacks during scale-up with an assured source of high-quality raw materials, intermediates, and documentation – all available in quantities and qualities suitable for current good manufacturing practices (cGMP). Benefits include:

  • Accelerated time to market
  • Supply chain transparency
  • Extensive regulatory support

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Custom Manufactured API Starting Materials and Intermediates

In addition to a comprehensive raw materials portfolio, we also offer custom manufacturing services to meet your exact needs.

  • API starting materials that include qualification documentation for areas such as change control, supplier/supply chain qualification, residual solvents/EI, and BSE/TSE
  • Intermediates that meet ICH Q7 GMP standards, with documentation on an API level

The Tailored Fit for Your API Synthesis

Our portfolio of critical raw materials is custom tailored to your application needs and regulatory requirements with assured quality and transparency.

Emprove® Program for Solvents and Reagents

Ensuring the compliance of pharma and biopharma products involves the compilation of a vast amount of data, which can be time- and resource-intensive. To accelerate this process, we developed our Emprove® Program. All solvents and reagents in the portfolio are complemented by dossiers designed to help you speed your way through the regulatory maze.

  • Qualification documentation for areas such as change control, supplier/supply chain qualification, residual solvents/EI, and BSE/TSE

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