99.9% Bulk L Ergothioneine Powder Ingredient For Tablets Capsules Supplement

For nutraceutical and dietary supplement manufacturers requiring a technically verified, globally certified antioxidant active, DR.ERGO® L-Ergothioneine delivers ≥99.9% purity in a GMP-grade crystalline powder with a complete regulatory documentation package. Produced at the ISO 22000 / ISO 9001 / HACCP-certified facility of Anti-aging Ingredients LLC in Shanghai, China, DR.ERGO® is formulated from the ground up for B2B supply reliability: consistent lot-to-lot purity via proprietary green biofermentation (patented by the Chinese Academy of Sciences), full CoA provision, and compliance documentation for FDA, EFSA, and Asian market submissions. Suitable for all solid dosage forms — tablets, capsules, gummies, gels, powders, and jellies — it is the benchmark-grade EGT ingredient for manufacturers seeking clinical credibility, supply chain stability, and multi-market regulatory clearance.

• FDA GRAS (USA) — Generally Recognized as Safe for dietary supplement use
• EU Novel Food authorization — compliant for European market supply
• NSF GMP Registered Dietary Ingredients — manufacturing quality assurance
• ISO 22000 / ISO 9001 / ISO 14001 / ISO 45001 — full management system certification
• HACCP Certified — food safety hazard control at production level
• Halal Certified — compliant for Muslim-majority market formulations
• Vegan Certified (LBD) — suitable for vegan and plant-based product lines

• Full CoA provided per batch — purity, microbiological, and heavy metal testing
• Regulatory documentation package available — FDA GRAS dossier, EFSA Novel Food authorization
• Technical team support for formulation inclusion rate optimization
• OEM / white-label consideration available for qualified customers
• Contact: salesl@egt.bio | www.egt.bio | +86 021-60410486

What regulatory submissions is DR.ERGO® already cleared for, and which markets can I formulate for?

DR.ERGO® holds FDA GRAS status for the USA, EU Novel Food authorization for European markets, and NSF GMP registration for North American quality assurance compliance. Additionally, Halal and Vegan certifications support formulation for Middle Eastern and specialty retail markets. ISO 22000 and HACCP certifications underpin food safety compliance for Asian and broader international markets.

What documentation does Anti-aging Ingredients LLC provide to support my label claims?

Standard documentation includes a Certificate of Analysis (CoA) per production lot covering purity, microbiology, heavy metals, and allergen status. Additional regulatory support documentation — including the FDA GRAS dossier and EU Novel Food file — is available on request. We can also provide reference to published peer-reviewed clinical trial data supporting sleep quality, cognitive health, and anti-aging benefit claims for your regulatory and marketing teams.

What is the shelf life and recommended storage condition for bulk DR.ERGO® ingredient?

DR.ERGO® in ultra-stable crystalline form maintains integrity under standard pharmaceutical raw material storage conditions (cool, dry, away from direct light and moisture). Specific shelf life data and stability study results are available in the product technical dossier. Please contact our technical team at salesl@egt.bio for detailed stability documentation.