Why Supplement NDA and IP Protection Matter for Brands
At SREKE, we understand that intellectual property (IP) is the cornerstone of a successful supplement brand. A New Dietary Ingredient (NDI) notification or proprietary formula protection ensures your product stands out in a crowded market while complying with FDA and EFSA regulations.
Without proper IP safeguards, competitors can replicate formulations, dilute brand value, and erode market share. We prioritize confidentiality and legal compliance to help you protect your innovations from formulation to final packaging.
Key Manufacturing Considerations at SREKE
- GMP Certification: Our Guangzhou facility operates under cGMP standards aligned with FDA and EU requirements, ensuring every batch meets quality and safety benchmarks.
- Formulation Confidentiality: All proprietary blends are stored in encrypted systems with restricted access. NDIs are developed under strict non-disclosure agreements (NDAs).
- Regulatory Compliance: We handle FDA NDI notifications, EFSA health claim substantiation, and ISO 22000-certified documentation to reduce your regulatory burden.
- Packaging Customization: Private-label bottles, blister packs, and child-resistant closures feature tamper-evident seals and barcoded serialization for authenticity tracking.
How SREKE Helps You Get to Market Faster
We streamline development without compromising IP security. Our ODM team offers rapid prototyping—typically within 15–21 days—for softgels, capsules, tablets, gummies, and powders. MOQs start as low as 5,000 units per SKU, ideal for emerging brands.
Our lead time averages 4–6 weeks from approval to shipment, including third-party COA testing and label review. We coordinate directly with your legal team to ensure all IP filings align with manufacturing timelines.
Industry Trends and Market Opportunities
According to Grand View Research, the global dietary supplements market reached $151.9 billion in 2023, with functional ingredients driving innovation. Brands leveraging patented delivery systems (e.g., liposomal, sublingual) report 30% higher customer retention.
We observe rising demand for clinically backed formulations—especially adaptogens, nootropics, and microbiome-supporting compounds. At SREKE, we support R&D with access to peer-reviewed studies and in-house stability testing to validate claims under FDA 21 CFR 101.93 and EFSA Journal guidelines.
Frequently Asked Questions
Can I trademark my supplement formula?
While formulas themselves cannot be trademarked, unique names, logos, and branding elements can be. We recommend filing a trademark with the USPTO or EUIPO before public launch to prevent infringement.
Does SREKE sign NDAs for new clients?
Yes. All partners sign a comprehensive NDA covering formulations, packaging designs, and business processes before any technical collaboration begins.
What is your minimum order quantity (MOQ)?
MOQs vary by format: 5,000 units for softgels/capsules, 3,000 for tablets, and 10,000 for gummies. Bulk discounts apply beyond 20,000 units.
Do you provide COA for each batch?
Every production run includes a Certificate of Analysis (COA) verifying potency, microbial safety, and heavy metals—aligned with USP <51>/<62> and ISO 17025 standards.
Protect Your Innovation Partner With SREKE
From concept to shelf, we combine GMP-grade manufacturing with rigorous IP protocols. Whether you're launching an NDI-based supplement or scaling a private-label line, our team ensures compliance, speed, and security.
Ready to launch your supplement brand? SREKE provides GMP-certified OEM/ODM manufacturing for softgels, capsules, tablets, powders, gummies, and liquids. Contact us for a free quote or email [email protected] — we respond within 24 hours.