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Explore our cGMP-compliant, formulator-grade custom capsule manufacturing solutions. Specializing in advanced botanical extracts, targeted nutrients, and fully compliant private label packaging designed for premium global brands.

Importing Custom Capsules Safely: FDA Compliance, Quality Control, and Low MOQs Explained

OEM_Supplement_Maker2026-05-31FAQ910

1. Are your manufacturing facilities FDA-registered and compliant?

Answer: Yes, absolutely. To export Dietary Supplements to the United States, a foreign manufacturer must be officially registered with the US FDA. Our advanced manufacturing facility maintains an active FDA Registration and strictly adheres to cGMP (Current Good Manufacturing Practice) standards under 21 CFR Part 111. To ensure uninterrupted compliance and seamless customs clearance, we update our registration bi-annually as required by US federal law.

2. How can I trust the quality and purity of raw ingredients from China?

Answer: We enforce a zero-compromise quality control system. Every single batch of raw materials entering our facility undergoes strict vetting and quarantine. We provide a comprehensive Certificate of Analysis (COA) for both the raw ingredients and your finished final product. Furthermore, our in-house laboratory conducts rigorous identity, potency, and heavy metal testing. 

3. What is your Minimum Order Quantity (MOQ) for custom capsule formulations?

Answer: While traditional US factories lock out startups with massive requirements of 3,000 to 5,000 bottles, we specialize in helping flexible brands scale. Our Low MOQ for Custom Formula capsules generally starts at just 500 to 1,000 bottles (depending on your specific ingredients and capsule selections). This industry-leading low threshold allows you to test the US market, launch trending formulations, and preserve your cash flow with minimal financial risk.


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