Comment from XeCare LLC
AnonymousSupportBusiness
Summary: XeCare LLC is submitting formal nominations for several bulk drug substances, including Ashwagandha root extract, Eurycoma Longifolia root extract, Fenugreek seed, Saffron, Berberine Hydrochloride, and Menaquinone-4, to be included on the FDA's 503A Bulks List. The company provides specific extraction methods, constituent concentrations, and clinical evidence to support the inclusion of these substances for treating various conditions.
Please see the attached files for a submission on behalf of XeCare LLC in response to the request for information pertaining to XeCare's previously submitted nominations (Document ID: FDA-2015-N-3534-0469).
Attachments
- Submission from XeCare LLC re Document FDA-2015-N-3534-0469 (PDF)
- Attachment 1 - Extraction Process Diagram for Ashwagandha Root Extract (PDF)
- Attachment 2 - Supporting Clinical Studies for Ashwagandha Root Extract (PDF)
- Attachment 3 - Certificate of Analysis for Eurycoma Longifolia Root Extract (PDF)
- Attachment 4 - Supporting Clinical Studies for Eurycoma Longifolia Root Extract (PDF)
- Attachment 5 - Extraction Process Diagram for Fenugreek Seed (PDF)
- Attachment 6 - Supporting Article for Fenugreek Seed (PDF)
- Attachment 7 - Extraction Process Diagram for Saffron (PDF)
- Attachment 8 - Certificate of Analysis for Saffron (PDF)
- Attachment 9 - Supporting Article for Saffron (PDF)
- Attachment 10 - Certificate of Analysis for Berberine HCL (PDF)
- Attachment 11 - Supporting Clinical Studies for Berberine HCl (PDF)
- Attachment 12 - Supporting Clinical Studies for Menaquinone-4 (PDF)