Over 1 million tablets sold annually! Customized FDA-compliant natural astaxanthin solutions for a premium North American brand.

1. Demand Communication and Rapid Response

In the early stage of cooperation, we held multiple rounds of online meetings with the customer to analyze their specific needs. They required each capsule to contain 12mg of high-purity natural astaxanthin extracted from Haematococcus pluvialis and to meet North American FDA registration standards. Additionally, due to a tight market window, the customer demanded that the cycle from formula confirmation to delivery be controlled within 50 days.

To address the customer's core demands—"high quality, fast delivery, and strong compliance"—we quickly set up a dedicated team, which included raw material traceability experts, formula engineers, compliance consultants, packaging designers, and supply chain managers. A preliminary cooperation plan was delivered within 24 hours, clearly outlining the timeline and division of responsibilities, which was initially approved by the customer.

2. Traceability of Natural Astaxanthin Raw Materials

Silymarin is the key active ingredient in milk thistle extract, and its activity retention rate is crucial to the product’s liver-protecting efficacy. Our technical team focused on this critical issue by conducting in-depth research:

• Extraction Process Selection: We analyzed various extraction methods, such as supercritical CO₂ extraction and ethanol extraction. Ultimately, we chose supercritical CO₂ extraction due to its ability to extract active ingredients under low temperature and low pressure, preserving the activity of silymarin.

• Parameter Optimization: Through extensive experimentation, we optimized extraction parameters—pressure, temperature, and time—to increase the activity retention rate of silymarin from the industry average of 85% to 92%.

• Synergistic Formulation: The team scientifically compounded milk thistle ingredients, adjusting the ratio of silymarin and other components based on their synergistic effects to further enhance liver-protecting properties.

Throughout this phase, we maintained close communication with the customer, providing regular updates and experimental data, and invited them to review the progress at key milestones to ensure alignment with their expectations.

3. Capsule Stability and Bioavailability Testing

Considering the oxidizable nature of astaxanthin and North American consumers’ high demands for product absorption, our formula engineering team focused on two core tests:

1. Stability Test: We simulated storage conditions (high temperature, humidity, light) from various regions in North America and tracked the capsule’s appearance, hardness, and astaxanthin content over 3 months. As a result, we adopted a special coating technology that effectively isolates oxygen and light, ensuring stable activity within the product’s shelf life.

2. Bioavailability Test: In vitro simulated digestion experiments were conducted to optimize the capsule excipient formula. This improved the dissolution and absorption efficiency of astaxanthin in the human intestine. Test results showed a 30% increase in bioavailability compared to ordinary formulas, meeting the customer’s high product efficacy requirements.

North American Compliance Light-Proof Packaging Design

The packaging design had to meet both North American regulatory requirements and high-end aesthetic standards:

• Material and Functionality: We used brown pharmaceutical-grade capsule bottles with excellent light-proof properties, paired with sealed aluminum foil gaskets to prevent astaxanthin oxidation.

• Label Design: The label design strictly followed FDA guidelines, including bilingual English and Spanish descriptions covering ingredients, content, efficacy, administration methods, and warnings. It also featured raw material traceability codes and the FDA registration mark.

• Brand Aesthetics: The packaging incorporated the customer’s brand identity, using simple gold lines and an ocean blue background to highlight a high-end, premium texture. The packaging plan was approved in a single review, which significantly shortened the design cycle.

4. Full Support for FDA Registration and Import Customs Clearance

FDA registration is essential for North American market entry. Our compliance consultant team, with over 10 years of experience in dietary supplement compliance, provided comprehensive support:

1. Registration Materials: We collated all necessary materials for FDA registration, including raw material test reports, product formula sheets, stability test reports, and packaging safety certificates, ensuring full compliance with the latest FDA requirements.

2. Registration Process: We assisted in completing the electronic registration, tracked progress in real-time, and resolved issues that arose during the review. The FDA registration was successfully completed in just 15 days.

3. Customs Clearance: We provided a full set of import customs clearance documents (including the certificate of origin, packing list, commercial invoice, and FDA registration certificate). Our logistics team optimized the customs clearance process, ensuring that the first order smoothly entered North America.

Rapid Delivery and Follow-Up Services

To meet the customer’s urgent delivery request within 48 days, we implemented a "parallel operation" model: raw material traceability and formula testing were carried out simultaneously, while packaging production ran in parallel with FDA registration. As a result, we completed production and quality inspection 2 days ahead of schedule and delivered the first order by air to the North American warehouse.

After the product launch, we continued to support the customer by analyzing sales data and consumer reviews on Amazon North America. We assisted in optimizing product keywords and promotion strategies. Additionally, in response to the customer’s request for an "anti-aging compound formula," we initiated R&D work to add ingredients like collagen and vitamin E to the existing astaxanthin formulation, further expanding the product lineup.