To date, CyDex's experience is that the FDA has viewed cyclodextrin containing formulations as containing a separate drug and an excipient.
There is no approval process for pharmaceutical excipients in the U.S., only the products that contain them. Regulatory filings for drug products containing Captisol® have been filed with, and reviewed by, several divisions in the FDA.
All Captisol® sold is produced under strict adherence to USP and IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients. Each lot is thoroughly analyzed and must meet analytical specifications before release.
A Type V DMF was filed in the U.S. in August 1999 and contains a summary of the safety data package for Captisol®. A Type IV DMF was filed in the U.S. in July 2007 and contains a summary of CMC information for Captisol®. Updates are filed on an annual basis. With a license agreement and letter of authorization, clients can reference the DMFs in their regulatory filings. CyDex can also provide clients additional Captisol® information that may be used to supplement their regulatory filings.
GRAS status is only applicable to food additives. While a GRAS excipient can be used in a pharmaceutical product, its application is as a food additive.
View our easy-to-use PDF for more information on how to use Captisol®
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