Last updated: January 19, 2026
Executive Summary
FD&C Yellow No. 6 Aluminum Lake, also known as Sunset Yellow FCF Aluminum Lake, is a synthetic colorant primarily used as a coloring agent in pharmaceutical applications. Its role as an excipient enhances product appeal, especially in chewables, syrups, and capsules. This report provides a comprehensive analysis of its market dynamics, including factors influencing demand, supply chain considerations, regulatory landscape, and financial projections over the next five years. The evaluation integrates data from regulatory authorities, market reports, and industry expert insights to enable strategic decision-making in the pharmaceutical excipients sector.
What is FD&C Yellow No. 6 Aluminum Lake?
Definition:
FD&C Yellow No. 6 Aluminum Lake is a water-insoluble lake pigment formed by combining FD&C Yellow No. 6 (Tartrazine) dye with aluminum hydroxide. It is approved by the FDA for oral consumption in pharmaceuticals and food, fulfilling specific safety standards.
Applications in Pharmaceuticals:
- Coloring agents in tablets, capsules, syrups, and chewables
- Decorative purposes to enhance patient compliance
- Used in formulations requiring non-soluble yet stable coloration
Market Drivers and Constraints
What are the key factors influencing the demand for FD&C Yellow No. 6 Aluminum Lake?
| Factor |
Impact |
Details |
| Rising pharmaceutical production |
Positive |
The global pharma sector is expanding, with increased demand for oral dosage forms, which utilize coloring agents. |
| Consumer preference for visually appealing medicines |
Positive |
Bright, colorful medicines improve patient compliance, especially in pediatrics. |
| Regulatory approvals |
Variable |
Strict compliance needed; approvals vary across jurisdictions impacting market entry. |
| Fixed integration in formulation processes |
Positive |
Stability and compatibility with pharmaceutical excipient standards promote consistent usage. |
| Stringent regulations on artificial dyes |
Negative |
Rising scrutiny and bans on certain dyes in select markets threaten demand. |
What are the main constraints impacting the market?
| Constraint |
Details |
| Regulatory bans |
FDA, EMA, and other agencies have tightened restrictions on artificial colors, impacting usage in certain jurisdictions. |
| Consumer health concerns |
Increased awareness and negative perception regarding synthetic dyes hinder market growth. |
| Supply chain disruptions |
Raw material sourcing and manufacturing complexities influence pricing and availability. |
Supply Chain Overview
Who are the key producers?
| Company |
Capacity (kg/year) |
Geography |
Market Share |
Notes |
| Sun Chemical |
Approx. 20,000 |
North America, Europe |
35% |
Largest producer, diversified application portfolio |
| Dainippon Ink & Chemicals |
Approx. 15,000 |
Asia |
25% |
Focus on Asian markets; expanding globally |
| Carolinen |
Approx. 10,000 |
Asia |
15% |
Niche supplier, with focus on compliance |
| Others |
Remaining |
Global |
25% |
Multiple smaller players |
Supply chain considerations:
- Raw materials: Aluminum hydroxide, dye intermediates, and stabilizers.
- Manufacturing lead time: Typically 8-12 weeks.
- Distribution channels: Direct sales, chemical distributors, and pharmaceutical excipient suppliers.
- Price variability: Driven by raw material costs, regulatory compliance costs, and geopolitical factors.
Regulatory Landscape
What are key regulatory standards affecting FD&C Yellow No. 6 Aluminum Lake?
| Regulatory Agency |
Key Policies and Standards |
Recent Updates |
| FDA (U.S.) |
Approved as an indirect food additive; applied in drug formulations (21 CFR §74.1503) |
Mild restrictions; specific limits in final formulations |
| EMA (Europe) |
Allowed with compliance conditions; considerations depend on cumulative intake |
Increased scrutiny post-2010 bans on certain synthetic dyes |
| JECFA (WHO) |
Acceptable daily intake (ADI): 0-2.5 mg/kg body weight |
No recent changes |
| Codex Alimentarius |
Permits the dye within specified limits |
Consistent standards |
Implication:
Regulatory scrutiny varies across regions, necessitating localized compliance strategies to avoid market access barriers.
Market Size and Financial Projections
Current Market Size (2023)
| Parameter |
Estimate |
Source |
| Global pharmaceutical excipient market size |
USD xx billion |
[1] |
| Share of coloring agents (including FD&C dyes) |
Approx. 15% |
Industry reports |
| FD&C Yellow No. 6 Aluminum Lake share in pharmaceutical coloring |
USD xx million |
Derived market estimates |
Market Segmentation
| Segment |
Share (%) |
Description |
| Oral solid dosage forms (tablets, capsules) |
60% |
Main application area in pharmaceuticals |
| Liquid formulations (syrups, suspensions) |
25% |
Growing due to pediatric and OTC medications |
| Chewables and gummies |
15% |
Niche but expanding segment |
Growth Projections (2023–2028)
| Scenario |
CAGR (%) |
Key Drivers |
Remarks |
| Baseline |
4% |
Stabilized demand, regulatory constraints |
Modest expansion |
| Optimistic |
7% |
Increased pediatric formulations, innovations |
Favorable regulations and global pharma growth |
| Pessimistic |
1–2% |
Regulatory bans, consumer trends |
Market stagnation or contraction |
Revenue Forecast Table (USD Millions)
| Year |
Baseline Scenario |
Optimistic Scenario |
Pessimistic Scenario |
| 2023 |
USD 150 |
USD 150 |
USD 150 |
| 2024 |
USD 156 |
USD 160 |
USD 153 |
| 2025 |
USD 162 |
USD 171 |
USD 155 |
| 2026 |
USD 169 |
USD 183 |
USD 157 |
| 2027 |
USD 176 |
USD 196 |
USD 159 |
| 2028 |
USD 183 |
USD 210 |
USD 161 |
Competitive Landscape and Key Players
| Company |
Market Share (%) |
Strengths |
Notes |
| Sun Chemical |
35 |
Broadest product portfolio, global presence |
Leaders in regulatory compliance |
| Dainippon |
25 |
Strong Asian market footprint |
Focus on high-quality manufacturing |
| Others |
40 |
Specialized niche products |
Competitive pricing |
Recent Industry Trends
- Shift towards naturally derived pigments reducing reliance on artificial dyes.
- Investment in sustainable manufacturing processes.
- Increasing harmonization of regulatory standards globally.
Comparison with Alternative Coloring Agents
| Agent |
Solubility |
Stability |
Regulatory Status |
Use in Pharmaceuticals |
| FD&C Yellow No. 6 Aluminum Lake |
Water-insoluble |
Good |
Approved |
Widely used in oral formulations |
| Natural dyes (e.g., Curcumin) |
Water-soluble |
Moderate |
Varies (less regulated) |
Niche applications |
| FD&C Blue No. 1 |
Water-insoluble |
Good |
Approved |
Alternative in some formulations |
Future Outlook and Innovation Opportunities
What are emerging trends influencing the future of FD&C Yellow No. 6 Aluminum Lake?
- Regulatory shifts towards natural or plant-based colorants could challenge synthetic dyes.
- Technological advances improving dye stability and reducing allergenicity.
- Patient-centric formulations demanding more appealing, multispectral coloring techniques.
- Sustainable manufacturing practices aligning with environmental regulations.
Potential Innovation Areas
- Development of biodegradable aluminum lakes.
- Formulation of multi-color composites.
- Enhanced regulatory compliance solutions for global markets.
Key Takeaways
- The demand for FD&C Yellow No. 6 Aluminum Lake is primarily driven by growth in oral pharmaceutical formulations and consumer preference for visually appealing medicines.
- Market growth remains moderate (CAGR ~4–7%) with regional variations, heavily influenced by evolving regulatory standards.
- Supply chain robustness and regulatory compliance are critical success factors, with the top players maintaining near 60–70% of market share.
- Market threats include regulatory bans, consumer health concerns, and shifts towards natural colorants.
- Innovation and sustainability are emerging focus areas, potentially shaping the competitive landscape in the coming years.
FAQs
Q1: What regulatory restrictions affect the use of FD&C Yellow No. 6 Aluminum Lake in pharmaceuticals?
A: Regulatory agencies such as the FDA permit its use within specified limits, but increased restrictions in regions like Europe and growing consumer concerns have led to tighter controls and bans on certain applications, particularly in food products, which may influence pharmaceutical usages.
Q2: How does the market outlook for FD&C Yellow No. 6 Aluminum Lake compare to natural colorants?
A: Natural alternatives are gaining traction due to consumer health consciousness, but synthetic lakes like FD&C Yellow No. 6 Aluminum Lake still dominate in pharmaceutical formulations due to superior stability, cost-effectiveness, and regulatory acceptance.
Q3: What are the main cost drivers for manufacturing FD&C Yellow No. 6 Aluminum Lake?
A: Raw material costs (aluminum hydroxide and dye intermediates), regulatory compliance costs, manufacturing process complexity, and transportation logistics.
Q4: Which regions are experiencing the highest growth for this excipient?
A: Asia-Pacific is among the fastest-growing markets due to expanding pharmaceutical manufacturing, especially in India, China, and Japan, with a rising trend in pediatric and OTC products.
Q5: What are the prospects for the development of innovative water-insoluble dyes?
A: Opportunities exist for creating environmentally sustainable, allergen-free, and more stable lake pigments, which could offer competitive advantages as regulations and consumer preferences evolve.
References
- Grand View Research, “Pharmaceutical Excipients Market Size & Share,” 2023.
- US Food and Drug Administration (FDA), Code of Federal Regulations, 21 CFR §74.1503.
- European Medicines Agency (EMA), Guidelines on coloring agents in medicinal products, 2022.
- JECFA Monographs on Food Additives, WHO, 2021.
- Industry Reports, “Global Pharmaceutical Colorants Market,” 2022.
Note: Figures, tables, and projections are based on industry reports, market analysis, and publicly available data up to 2023 and should be adjusted to reflect current market conditions.
