Dear Sales Team,
We are currently sourcing Silymarin API (Milk Thistle Dry Extract) for a pharmaceutical project in the European Union.
Our requirements are very specific:
API Standard: The material must be manufactured according to EU GMP standards and be suitable for use as an Active Pharmaceutical Ingredient in a medicinal product (not food/nutraceutical grade).
Extraction Solvent: We strictly require an extract obtained using ethyl acetate as the primary extraction solvent (consistent with the reference standard of Legalon 140, e.g., DER 36-44:1).
Regulatory Support: We require a valid CEP (Certificate of Suitability) or a complete ASMF/DMF (Active Substance Master File) to support our marketing authorization process in the EU.
Could you please confirm if you have this specific grade in your portfolio?