Bulk Pharmaceutical API Sources for VITAMIN A SOLUBILIZED

Bulk Pharmaceutical API Sources for VITAMIN A SOLUBILIZED

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		R1512_SIGMA
Sigma-Aldrich		R3375_SIGMA
NovoSeek		5280531
MolPort		MolPort-003-666-488

Bulk Active Pharmaceutical Ingredient (API) Sources for Vitamin A Solubilized

Last updated: July 30, 2025

Introduction

Vitamin A, also known as retinol, is a vital fat-soluble vitamin essential for vision, immune function, cell growth, and differentiation. Given its widespread therapeutic and nutritional applications, the manufacturing of pharmaceutical-grade Vitamin A in its solubilized form—commonly as emulsions or in lipid-based formulations—necessitates sourcing high-quality Active Pharmaceutical Ingredients (APIs). This article provides a comprehensive review of global API suppliers specializing in bulk Vitamin A, focusing on solubilized forms suitable for pharmaceutical formulations.

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Overview of API Manufacturing for Vitamin A

The production of Vitamin A APIs demands rigorous adherence to quality standards, including Good Manufacturing Practices (GMP), to ensure purity, stability, and bioavailability. Solubilized Vitamin A APIs typically involve retinol, retinyl esters, or derivatives processed with solubilizers or formulated within lipid matrices to enhance bioavailability. Such formulations are crucial for oral supplements, ophthalmic solutions, or parenteral applications.

Major API producers are concentrated in regions with advanced pharmaceutical manufacturing infrastructure, including North America, Europe, and Asia. Their offerings often include crystalline retinol, retinyl palmitate, and customized solubilized formulations tailored for pharma clients.

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Key Global API Suppliers for Vitamin A (Solubilized)

1. Capsugel (Lonza Group)

• Overview: A leading supplier of specialty pharmaceuticals, Capsugel offers retinol in bulk, complying with pharmacopeial standards, suitable for formulation into solubilized or emulsified products.
• API Scope: They provide retinol ester and retinol powder, with capabilities for custom formulations to facilitate solubilization.
• Quality Standards: GMP-certified manufacturing, with extensive quality testing for purity (>99%), residual solvents, and microbiological limits.
• Application Areas: Nutraceuticals, ophthalmic solutions, and injectable preparations.

2. DSM Nutritional Products

• Overview: A global leader in nutritional ingredients, DSM supplies high-purity retinyl acetate and retinyl palmitate, suitable for solubilized formulations.
• API Scope: They provide bulk APIs with certification in pharmacopoeial standards. Their retinol derivatives are often processed to enhance solubility, stability, and bioavailability.
• Quality Standards: Strict adherence to GMP and ISO standards, with detailed characterization and consistent supply.

3. BASF

• Overview: BASF manufactures and supplies retinol and derivatives for pharmaceutical and nutraceutical applications.
• API Scope: Their retinol APIs, often supplied as retinol ester forms, are compatible with solubilization and emulsification processes.
• Unique Features: Emphasis on stability-enhanced formulations with options for lipid-based delivery systems.
• Regulatory Compliance: Meets international pharmacopeial standards, with comprehensive documentation.

4. Zhejiang NHU Pharmaceutical Co., Ltd. (China)

• Overview: One of the prominent Chinese suppliers of retinol and vitamin A derivatives.
• API Scope: Offers retinol powders, with some options for encapsulated or solubilized forms.
• Quality Standards: GMP-certified manufacturing facilities, providing products conforming to USP, EP, and other pharmacopeias.
• Market Position: Competitive pricing and large-scale supply capabilities.

5. Boehringer Ingelheim

• Overview: An established pharmaceutical company with a long history of Vitamin A API production.
• API Scope: Provides retinol in highly purified forms, with some custom formulations designed for enhanced solubility.
• Research & Development: Focuses on stability and bioavailability improvements via proprietary formulations.

6. Shanghai Harvest Pharmaceutical Co., Ltd.

• Overview: Chinese manufacturer offering a range of vitamin A derivatives and APIs.
• API Scope: Supplies retinyl palmitate and retinol API powders suitable for solubilized formulations.
• Quality & Standards: GMP-accredited with export to multiple regions requiring strict quality assurance.

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Special Considerations in API Sourcing for Solubilized Vitamin A

Quality and Purity

For pharmaceutical applications, API purity typically exceeds 99%, with low residual solvents and heavy metals. Suppliers should provide comprehensive certificates of analysis (CoA) aligned with USP, EP, or JP standards.

Regulatory Compliance

APIs must conform to regional regulatory standards, including GMP certifications and international pharmacopoeias. Traceability and documentation are critical when integrating APIs into pharmaceutical formulations.

Formulation Compatibility

API suppliers often offer retinol derivatives compatible with lipid-based formulations, emulsifiers, or solubilizers. Engaging suppliers with expertise in formulation support enhances product stability and bioavailability.

Supply Chain Security

Given vitamin A's sensitivity to oxidation, suppliers offering stabilized or encapsulated retinol APIs reduce degradation risks during storage and handling.

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Emerging Trends and Future Outlook

Bioavailability Enhancement

Innovations in API formulation, such as nanoemulsions and lipid nanoparticles, aim to improve vitamin A absorption. Some manufacturers are developing customized APIs to facilitate these formulations directly.

Sustainable Production

Particularly in China and India, efforts toward greener synthesis processes have increased, reducing environmental impact and improving supply chain sustainability.

Regulatory Challenges and Opportunities

The increasing regulatory scrutiny emphasizes transparent sourcing, clear documentation, and compliance with global standards—factors that influence procurement strategies.

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Conclusion

Sourcing high-quality, pharmaceutically compliant bulk APIs for solubilized Vitamin A remains pivotal for pharmaceutical companies aiming to develop effective, stable, and bioavailable formulations. Leading suppliers like Lonza (Capsugel), DSM, BASF, and regional manufacturers in China provide a spectrum of retinol APIs suited for various applications. Strategic partnerships, rigorous quality assurance, and adherence to regulatory standards are vital to ensure the integrity of Vitamin A APIs and the success of subsequent formulations.

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Key Takeaways

• The global API landscape for Vitamin A solubilized forms includes major suppliers in North America, Europe, and Asia, offering high-quality, GMP-compliant products.
• Vendors provide retinol and derivatives suitable for formulation into emulsified or lipid-based solubilized products, with options for customized processing.
• Strict quality control, regulatory compliance, and supply chain stability are critical factors influencing supplier selection.
• Innovations in formulation technologies are increasingly integrated with bulk API sourcing to improve bioavailability and stability.
• Sourcing decisions should consider regional regulatory requirements, lead time, cost, and the supplier’s expertise in pharmaceutical applications.

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FAQs

1. What are the primary forms of Vitamin A APIs suitable for solubilized pharmaceuticals?
Retinol, retinyl esters (retinyl palmitate), and retinoic acid derivatives are the main forms. Their selection depends on formulation needs, stability, and bioavailability considerations.

2. How do quality standards such as USP or EP affect API sourcing?
APIs conforming to USP or EP standards ensure purity, potency, and safety, which are essential for pharmaceutical formulations. Suppliers providing certification aligned with these standards facilitate regulatory approval.

3. Can retinol APIs be directly formulated into solubilized or emulsified products?
Raw retinol APIs often require further processing or formulation. Some suppliers offer APIs pre-encapsulated or stabilized to enhance solubility and shelf life in lipid-based formulations.

4. What are the key criteria for selecting a Vitamin A API supplier?
Purity, regulatory compliance, manufacturing capacity, stability of the API, supply reliability, and technical support are primary selection criteria.

5. Are there regional differences in API quality and availability?
Yes. Western suppliers tend to have strict regulatory approval and higher quality standards, while Chinese and Indian manufacturers offer competitive pricing and large-scale production but require rigorous quality verification.

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Sources:

[1] Lonza Group. "Vitamin A APIs." accessed 2023.
[2] DSM Nutritional Products. "Retinyl Acetate and Retinyl Palmitate." 2022.
[3] BASF. "Vitamin A Derivatives for Pharmaceutical Use." 2023.
[4] China National Pharmaceutical Database. "Regional API Manufacturers." 2023.
[5] Pharmaceutical Business Review. "Sourcing Strategies for Vitamin A APIs." 2022.