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Supplement factory

FAQs

REGULATORY COMPLIANCE AND PRODUCT CERTIFICATION

Yes, our facility is fully certified under GMP (Good Manufacturing Practice) and ISO 22000 (Food Safety Management System), ensuring compliance with global quality and safety standards for dietary supplement manufacturing.

Yes. As a contract manufacturer, we adhere to all U.S. FDA requirements for dietary supplements Facility Registration: All manufacturing facilities must register with the FDA under the Food Facility Registration System. We ensure timely registration and biennial renewals.

Yes, we provide comprehensive ingredient safety documentation to ensure compliance with international regulations and transparency for clients.

Yes, our factory holds comprehensive export certifications and has extensive cross-border logistics expertise to ensure seamless global distribution. Here’s a detailed overview:

  1. We maintain internationally recognized certifications critical for compliance and market access.
  2. We partner with leading logistics providers to optimize efficiency and compliance:
    • ​Multi-Modal Transport:
      • ​Air Freight: Fast-track delivery via dedicated cargo routes.
      • ​Ocean & Rail: Cost-effective bulk shipping with customs pre-clearance support.
    • ​​Customs Compliance:
      • Automated documentation for real-time tracking and reduced clearance delays.
      • Expertise in handling country-specific requirements.

QUALITY MANAGEMENT AND CONTROL SYSTEM(QMCS)

To ensure ingredient consistency and stability in our dietary supplements, we implement a rigorous, science-driven protocol aligned with FDA, EU, and ICH (International Council for Harmonisation) guidelines. Here’s our systematic approach:

  1. Supplier Compliance: All raw material suppliers undergo strict audits (ISO 22000 criteria) and must provide Certificates of Analysis (CoA) with purity, potency, and contaminant testing (e.g., heavy metals, microbials).
  2. Standardized Production: GMP-mandated batch records, validated equipment, and real-time monitoring (e.g., humidity, temperature) ensure uniformity across tablet hardness, capsule fill weight, or powder blend homogeneity.
  3. Accelerated & Real-Time Stability Studies
    • Accelerated Testing: Products are stored at 40°C/75% RH for 6 months to simulate 2–3 years of shelf life, with checks for degradation, discoloration, or dissolution changes.
    • Long-Term Testing: Ongoing 25°C/60% RH studies validate expiration dates and detect drift in potency (e.g., vitamins, probiotics).
    • Climatic Zone Adaptability: Customized stability protocols for Zone II (EU/USA) or IV (tropical markets) to ensure global compliance.
  4. Traceability & Documentation: Full documentation of raw material lot numbers, manufacturing dates, and stability results for audit readiness.
  5. Custom Formulation Support
    • Our R&D team preempts stability risks during product design by:
    • Selecting excipients compatible with actives (e.g., avoiding moisture-sensitive ingredients in gummies).
    • Validating packaging (e.g., UV-blocking bottles for light-sensitive compounds).

Yes, we provide third-party test reports from ISO 17025-accredited labs (EU/US-certified) for contaminants, potency, stability, and label claims. Critical for FDA/EFSA compliance, customs clearance, and retailer acceptance. Reports available upon request.

We resolve quality issues via discounts, replacements, or re-production based on product assessment:

  • Immediate Action: Offer discounted pricing, expedited replacements, or batch re-manufacturing.
  • Documentation: Provide updated COAs and incident reports for customs/retailer compliance.
  • Prevention: Strengthen QC checkpoints (GMP/ISO 22000) to avoid recurrence.
  • Guarantee: Full traceability and liability coverage for seamless export operations.

MINIMUM ORDER QUANTITY(MOQ) AND DELIVERY TIME

MOQ: 5,000 bottles (standard for most bottled supplements). Supported for custom formulations, R&D samples. GMP/ISO 22000 facility ensures compliant production with faster turnaround.

Standard production cycle: 30–45 days post-order confirmation. Includes GMP/ISO 22000-compliant manufacturing, stability testing, and export documentation (COA, COO). Expedited options available for urgent orders.

Yes, NDAs are mandatory to legally protect your formula, brand IP, and R&D data. Our contracts enforce strict confidentiality (GDPR-aligned) with breach penalties. Trusted by global clients for secure OEM/custom production.

PRODUCT DEVELOPMENT AND PRODUCTION CAPABILITY

Yes, we specialize in custom formula development with an in-house R&D lab (ISO 22000/GMP-certified). Our team handles ingredient optimization, stability testing, and regulatory compliance (FDA) to accelerate your market entry.

Yes, full raw material traceability and batch-specific COAs are provided. Suppliers are audited (GMP/ISO 22000), with third-party testing for purity, contaminants, and allergens. Ensures EU/US compliance and customs clearance.

We specialize in full-spectrum dosage forms: tablets, capsules, powders, gummies, and softgels. All produced under GMP/ISO 22000 standards with stability-validated formulations for global compliance. Customization supported via in-house R&D.

Yes, we handle enteric coatings, sustained-release systems, and gastric-resistant formulations. Custom solutions supported by in-house R&D and stability testing.

COSTS AND COMMERCIAL TERMS

Packaging/label design included (GMP/ISO 22000-compliant). Shipping costs vary by destination and order volume. We optimize logistics (DDP/DAP) and advise on region-specific certifications (e.g., EU nutrition labeling).

Our pricing is transparent, but let me highlight potential custom costs:

  • ​Formula Development: Charged separately if you require a unique formulation.
  • ​Mold Fees: Applicable for custom packaging (e.g., softgel shapes). Costs vary by design complexity but can be amortized over large orders.
  • ​Compliance Testing: Required for your target market (e.g., FDA lab fees).

We provide a detailed cost breakdown upfront and suggest bulk orders to optimize expenses. Shall we discuss specifics?

T/T payment terms: Deposit ratio 40–50% (negotiable), balance pre-shipment. Flexible terms for small/large orders. GMP/ISO 22000 compliance ensures secure, transparent transactions with audit-ready documentation.

Yes. Full customs clearance support (COA, COO, Certificates of Free Sale) and FDA/CE-compliant documentation to minimize delays. Logistics tailored to your market’s regulations.

PACKAGING AND LABELING

Yes, we provide full custom packaging design (labels, bottles, blister packs) compliant with GMP/ISO 22000 and FDA/CE regulations. Includes child-resistant, eco-friendly, or market-specific solutions. Artwork proofing and regulatory review ensured.

Yes, we produce multi-language labels compliant with FDA/EU/regional regulations (e.g., ingredient lists, allergen warnings). Artwork proofing and legal review by our team ensure accuracy. Supports seamless customs clearance and market entry.

Yes, we are HALAL-certified by accredited Islamic authorities, ensuring compliance in raw materials, production, and packaging. Certification documents (including traceability) are provided for Middle East, SEA, and faith-based markets.

FACTORY INSPECTION AND AUDIT

Yes, we welcome third-party audits and on-site inspections . Clients or accredited agencies verify processes, hygiene, and documentation. Virtual/physical options ensure transparency for EU/US compliance.

Yes, real-time updates (photos, QC data, video snippets) via secure portals.