Experience unrivaled speed, quality and efficiency in API manufacturing when you partner with Element. Flexible, personal, cost-effective services kilo lab synthesis of tox. enabling to clinical API supplies and small-scale commercial manufacturing of APIs.

You'll benefit from a single CDMO partner throughout the product lifecycle, starting with the identification of synthetic routes for early-phase active pharmaceutical ingredient (API) supply, through small-scale commercial API supply. Solve the most challenging chemical development issues and leverage our decades of experience in the industry and proven track record of delivering complex APIs. Looking to talk about your API manufacturing needs? Start the conversation.

The Element advantage

Make the most of our seamless, integrated service platform that allows for a single, trusted CDMO partner to support your therapeutic from discovery to commercialization.

Leverage our depth and breadth of expertise, which extends to regulatory guidance and beyond - including vast knowledge of regulatory requirements. Explore a partnership with Element today.

  • Route scouting and raw material sourcing
  • IND enabling tox batches
  • cGMP API synthesis
  • DEA analytical (Schedule II, II N, III, III N, IV and V) and bulk manufacturing (Schedule II-III)
  • Process development
  • Clinical supply manufacturing with QA release
  • Manufacturing of regulated starting material (RSM)
  • Generation of reference materials for analytical needs
  • Process validation
  • Reference standard qualification
  • Analytical development and validation
  • Stress studies
  • Stability studies
  • Full QC release of GMP materials

Our team of over 9,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.