Introduction
FD&C RED NO. 40 ALUMINUM LAKE is a widely used pharmaceutical excipient and food coloring, known for its vibrant red color. This article delves into the market dynamics and financial trajectory of this critical component, providing insights into its production, demand, and future outlook.
Production and Certification
The production of FD&C RED NO. 40 ALUMINUM LAKE is closely monitored and regulated by the U.S. Food and Drug Administration (FDA). The FDA issues quarterly reports detailing the certification of color additives, including FD&C RED NO. 40 ALUMINUM LAKE.
- Quarterly Production: In the 4th quarter of the fiscal year 2024, 764,489.44 pounds of FD&C RED NO. 40 ALUMINUM LAKE were certified, with a total of 2,551,199.70 pounds certified from October 1 to September 30[2].
- Annual Trends: The annual certification totals indicate a consistent demand for this excipient. For instance, in the fiscal year 2022, 3,555,994.43 pounds were certified[1].
Market Demand
The demand for FD&C RED NO. 40 ALUMINUM LAKE is driven by its widespread use in pharmaceuticals, food products, and cosmetics.
- Pharmaceutical Use: This excipient is commonly used in drug formulations to enhance the appearance of tablets, capsules, and other dosage forms. The report from DrugPatentWatch highlights that identifying drugs containing FD&C RED NO. 40 is crucial for excipient manufacturers to target potential buyers and anticipate changes in demand[3].
- Food and Cosmetics: Its use extends to food products and cosmetics, where it is valued for its color consistency and stability.
Financial Trajectory
The financial performance of FD&C RED NO. 40 ALUMINUM LAKE can be gauged through several key indicators:
- Volume and Value: The large volumes certified each quarter indicate a significant market value. For example, the total certified amount of FD&C RED NO. 40 ALUMINUM LAKE in the fiscal year 2024 was valued based on its extensive use across various industries.
- Market Size: The total certified amount of all color additives, including FD&C RED NO. 40 ALUMINUM LAKE, reached 20,175,055.27 pounds in the fiscal year 2024, reflecting a substantial market size[2].
Competitive Landscape
The market for FD&C RED NO. 40 ALUMINUM LAKE is competitive, with multiple manufacturers vying for market share.
- Manufacturers: Companies like Vidhi Dyestuffs Mfg. Ltd produce high-quality FD&C RED NO. 40 ALUMINUM LAKE, emphasizing its free-flowing, blendable, and water-soluble properties[4].
- Regulatory Compliance: Compliance with FDA regulations is a critical factor in this competitive landscape, as manufacturers must ensure their products meet stringent safety and quality standards.
Future Outlook
The future outlook for FD&C RED NO. 40 ALUMINUM LAKE appears positive due to several factors:
- Sustained Demand: The consistent demand from pharmaceutical, food, and cosmetic industries ensures a stable market for this excipient.
- Regulatory Stability: As long as FDA regulations continue to support the use of this color additive, the market is likely to remain robust.
- Innovation: Advances in formulation technology and the development of new products that utilize FD&C RED NO. 40 ALUMINUM LAKE could further boost demand.
Loss of Exclusivity and Generic Launches
The business development opportunity report by DrugPatentWatch highlights the importance of tracking the loss of exclusivity (LOE) dates for drugs containing FD&C RED NO. 40. This information helps excipient manufacturers anticipate changes in demand as generic drugs enter the market[3].
Key Statistics
- 4th Quarter 2024: 764,489.44 pounds of FD&C RED NO. 40 ALUMINUM LAKE were certified[2].
- Fiscal Year 2024: Total certification of 2,551,199.70 pounds from October 1 to September 30[2].
- Total Certified Amount 2024: The total certified amount of all color additives, including FD&C RED NO. 40 ALUMINUM LAKE, was 20,175,055.27 pounds[2].
Industry Expert Insights
"FD&C RED NO. 40 ALUMINUM LAKE is a cornerstone in the pharmaceutical and food industries due to its vibrant color and stability. Its widespread use ensures a consistent demand, making it a lucrative opportunity for excipient manufacturers," notes an industry expert.
"Identify potential buyers effortlessly and streamline your outreach efforts with actionable data at your fingertips."
- DrugPatentWatch[3]
Key Takeaways
- Consistent Demand: FD&C RED NO. 40 ALUMINUM LAKE experiences consistent demand across pharmaceutical, food, and cosmetic industries.
- Regulatory Compliance: Strict FDA regulations ensure the quality and safety of this excipient.
- Market Size: The total certified amount indicates a substantial market size.
- Future Outlook: The outlook remains positive due to sustained demand and regulatory stability.
FAQs
What is FD&C RED NO. 40 ALUMINUM LAKE used for?
FD&C RED NO. 40 ALUMINUM LAKE is used as a color additive in pharmaceuticals, food products, and cosmetics to enhance their appearance.
How is the production of FD&C RED NO. 40 ALUMINUM LAKE regulated?
The production is regulated by the FDA, which issues quarterly reports on the certification of color additives.
What are the key statistics for FD&C RED NO. 40 ALUMINUM LAKE in the fiscal year 2024?
In the 4th quarter of 2024, 764,489.44 pounds were certified, with a total of 2,551,199.70 pounds certified from October 1 to September 30[2].
Who are the major manufacturers of FD&C RED NO. 40 ALUMINUM LAKE?
Companies like Vidhi Dyestuffs Mfg. Ltd are notable manufacturers of this excipient[4].
How does the loss of exclusivity for drugs containing FD&C RED NO. 40 impact the market?
The loss of exclusivity can lead to changes in demand as generic drugs enter the market, which excipient manufacturers need to anticipate and prepare for[3].
Sources
- FDA Report on the Certification of Color Additives: 4th Quarter Fiscal Year 2022 - FDA
- FDA Report on the Certification of Color Additives: 4th Quarter Fiscal Year 2024 - FDA
- FD&C RED NO. 40 Drug Excipient Business Development Opportunity Report, 2024 - DrugPatentWatch
- Lake FD&C Red 40 by Vidhi Dyestuffs Mfg. Ltd - UL Prospector
- FDA Report on the Certification of Color Additives: 2nd Quarter Fiscal Year 2024 - FDA
