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Active Pharmaceutical Ingredients (APIs)
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 – and audited regularly by Interchem Regulatory staff
• Service – fast responses to questions and requests
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• 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 30 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.
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