Active Pharmaceutical Ingredients (APIs)

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Quality Products. No Loose Ends.

As an authorized United States Regulatory Agent, Interchem sets high standards.
We’re very selective about the partners with whom we work.

Those we partner with share several traits, among them:

  • Decades of collaboration – we know their products, their people, and their processes
  • FDA compliance – audited regularly by Interchem Regulatory staff
  • Service – Fast responses to questions and requests

Relentless Support

  • Need a Letter of Access for a DMF by 9 AM tomorrow?
  • Need someone to fly to your manufacturing facility to support an FDA inspection?
  • Need a DMF sent electronically to meet a GDUFA deadline?

For over 40 years, Interchem personnel  have done this and more because that’s what pharmaceutical development requires. We know the API supply issues that could slow development and how to avoid them, and we sweat the details—which ports of entry provide faster FDA release, for example—to help speed your product to market.

Why we’re implementing electronic DMFs? Contact Stephanie


More Products Available

If you don’t find what you need, contact the API team’s Michele Scrofani or Bob Golle from the Custom Manufactured Services group.

If your API is available from a quality source, we’ll find it for you.
If it’s not, Interchem can produce it for you.