Introduction to D&C Red No. 28
D&C Red No. 28, also known as Disodium 2',4',5',7'-tetrabromo-4,5,6,7-tetrachlorofluorescein, is a color additive approved by the FDA for use in drugs and cosmetics. It is not approved for use in foods[1].
Regulatory Framework
The FDA performs rigorous regulatory reviews for color additives used in various products, including drugs, cosmetics, and medical devices. D&C Red No. 28 must meet the specifications outlined in the Code of Federal Regulations, Title 21 Part 74.1328 and 74.2328, to ensure safe use[4].
Applications in Pharmaceuticals and Cosmetics
D&C Red No. 28 is utilized in a variety of pharmaceutical products, including tablets and capsules, to provide a distinct color. Some examples of medications that contain D&C Red No. 28 include Amoxicillin Trihydrate, Atomoxetine Hydrochloride, Cefadroxil Monohydrate, and Doxycycline Hyclate, among others[1].
In the cosmetics industry, D&C Red No. 28 is used in products such as soaps and detergents, enhancing their visual appeal[4].
Market Demand and Trends
The global market for pharmaceutical excipients, including color additives like D&C Red No. 28, is experiencing significant growth. The market was valued at $9.2 billion in 2023 and is expected to grow to $12.4 billion by 2029, with a compound annual growth rate (CAGR) of 5.1% from 2024 to 2029. This growth is driven by the increasing demand for effective and patient-friendly drug formulations, particularly for chronic diseases such as diabetes, hypertension, and cancer[3].
Quantitative Market Data
The FDA's certification reports provide insights into the volume of D&C Red No. 28 used in the market. For instance, in the second quarter of the fiscal year 2023, 165.38 pounds of D&C Red No. 28 were certified, with a total of 3,494.38 pounds certified from October to March of the same year[2].
In the first quarter of the fiscal year 2024, the certification for D&C Red No. 28 repacks was 77.18 pounds[5].
Financial Trajectory
The financial trajectory of D&C Red No. 28 is closely tied to the overall pharmaceutical excipients market. As the demand for innovative and safe excipients increases, the market value of D&C Red No. 28 is expected to rise. Here are some key financial indicators:
- Market Value: The growing demand for pharmaceutical excipients, including color additives, contributes to the increasing market value. The global market for pharmaceutical excipients is projected to reach $12.4 billion by 2029[3].
- Certification Volumes: The volumes of D&C Red No. 28 certified by the FDA indicate a steady demand. For example, the total certified pounds of D&C Red No. 28 and its lake form in the second quarter of FY 2023 were significant, reflecting ongoing usage in pharmaceutical and cosmetic products[2].
Key Players and Innovation
Leading companies in the pharmaceutical excipients market, such as ADM, BASF SE, Roquette Frères, Ashland Global, and Croda International Plc, play a crucial role in driving innovation and sustainability. These companies invest in research and development to enhance the properties and safety of excipients like D&C Red No. 28, ensuring they meet stringent regulatory standards[3].
Challenges and Opportunities
Regulatory Compliance
Ensuring compliance with FDA regulations is a critical challenge. Manufacturers must adhere to the specifications outlined in the Code of Federal Regulations to maintain certification and market approval[4].
Sustainability
There is an increasing focus on sustainability in the pharmaceutical industry. Companies are looking for eco-friendly and sustainable excipients, which presents an opportunity for manufacturers to develop and market more environmentally friendly versions of D&C Red No. 28[3].
Market Expansion
The availability of D&C Red No. 28 is currently limited to North America, presenting an opportunity for expansion into other markets. However, this would require compliance with local regulatory standards and market acceptance[4].
Conclusion
D&C Red No. 28 is a vital color additive in the pharmaceutical and cosmetics industries, with a growing market driven by the increasing demand for effective and safe drug formulations. The financial trajectory of this excipient is positive, aligned with the overall growth of the pharmaceutical excipients market.
Key Takeaways
- Regulatory Approval: D&C Red No. 28 is approved by the FDA for use in drugs and cosmetics but not in foods.
- Market Growth: The global market for pharmaceutical excipients is expected to grow to $12.4 billion by 2029.
- Applications: Widely used in pharmaceuticals and cosmetics.
- Certification Volumes: Significant volumes certified by the FDA indicate steady demand.
- Innovation and Sustainability: Key players drive innovation and focus on sustainability.
FAQs
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What is D&C Red No. 28 used for?
D&C Red No. 28 is used as a color additive in pharmaceuticals and cosmetics.
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Is D&C Red No. 28 approved for use in foods?
No, D&C Red No. 28 is not approved for use in foods[1].
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What are the key applications of D&C Red No. 28?
It is used in various medications and cosmetic products such as soaps and detergents[1][4].
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How is the market for D&C Red No. 28 expected to grow?
The market is expected to grow as part of the overall pharmaceutical excipients market, projected to reach $12.4 billion by 2029[3].
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Who are the key players in the pharmaceutical excipients market?
Key players include ADM, BASF SE, Roquette Frères, Ashland Global, and Croda International Plc[3].
Sources
- Drugs.com: D&C Red No. 28: What is it and where is it used?
- FDA: Report on the Certification of Color Additives: 2nd Quarter, Fiscal Year 2023
- BCC Research: Understanding the Future of Pharmaceutical Excipients
- Chromatech Incorporated: D&C Red #28 Powder
- FDA: Report on the Certification of Color Additives: 1st Quarter, Fiscal Year 2024
Last updated: 2024-12-20
