All GRAS Materials: The Hidden Advantage in Speed, Quality, and Compliance

Pharmaceutical development depends on selecting the right materials. The use of FDA-approved excipients listed in the Inactive Ingredient Database (IID) reduces regulatory risk, prevents costly delays, and enables faster advancement through development milestones. Ascendia Pharmaceutical Solutions applies an all-GRAS materials strategy that ensures every excipient used is supported by regulatory safety data from the vendors. This disciplined approach provides measurable advantages in speed, quality, and GMP compliance.

Understanding GRAS and FDA-Approved Materials

GRAS stands for “Generally Recognized as Safe,” a designation used most often in food and nutraceutical applications. In pharmaceuticals, the equivalent standard is excipients listed in the FDA Inactive Ingredient Database. These materials have been evaluated by regulators and accepted for use in drug products.

Using novel or unlisted excipients introduces risk. Regulatory authorities require extensive safety data before approving their use, which can create roadblocks. By relying only on FDA-accepted excipients, Ascendia Pharmaceutical Solutions removes this uncertainty.

Industry Pitfalls in Materials Selection

Excipient cost is negligible compared to drug substance cost, yet the consequences of poor material selection are substantial. Regulatory authorities review excipients early in every IND, NDA, or ANDA submission. If a material is not listed in the IID or used above the approved IID level, questions arise that stall applications.

This results in delays, additional testing, and costly reformulation. For generic developers, such delays can compromise first-to-file opportunities. For innovators, they can extend development timelines by months or longer.

The Ascendia Advantage: An All GRAS Materials Strategy

Ascendia Pharmaceutical Solutions exclusively uses excipients in a particular dosage that are FDA-approved and IID-listed. This practice delivers critical benefits:

Faster Progression from Early Phase to IND

Exclusively using FDA-approved excipients avoids delays, for example, during IND review. Programs move from early-stage testing into clinical development with fewer regulatory questions.

Higher Quality and Reduced Reformulation Risk

Formulations built with vetted excipients are less likely to encounter compatibility or safety issues later in development, reducing the likelihood of reformulation and expediting the drug development.

Streamlined GMP Compliance

Using IID-listed excipients aligns with GMP requirements, simplifies regulatory filings, and supports faster approvals.

Differentiation in the CDMO Market

Many CDMOs apply inconsistent standards to excipient selection. Ascendia Pharmaceutical Solutions takes a disciplined approach that avoids regulatory pitfalls while keeping programs on track. This consistent use of IID-listed excipients protects clients against unnecessary safety risk.

Why Materials Strategy Determines Speed and Success

Every delay in regulatory approval adds significant cost. IND, NDA, and ANDA submissions carry high fees, and resubmissions caused by new or novel excipient issues waste both time and capital. With an all-GRAS strategy, Ascendia Pharmaceutical Solutions eliminates hidden risks and keeps drug development timelines intact.

Partner with Ascendia Pharmaceutical Solutions

Material selection shapes the success of every pharmaceutical program. Ascendia Pharmaceutical Solutions applies an all-GRAS strategy that accelerates development, enhances quality, and ensures compliance. Contact Ascendia Pharmaceutical Solutions today to schedule a meeting and discuss how this approach can strengthen your next program.