Bulk Pharmaceutical API Sources for griseofulvin, ultramicrocrystalline

Bulk Pharmaceutical API Sources for griseofulvin, ultramicrocrystalline

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jak@r@BLMzOPQFQQQQIKJIJJEWdeZrvBHbjffjRdJWP@
Sigma-Aldrich		G4753_SIGMA
R&D Chemicals		8504
NovoSeek		441140
MolPort		MolPort-001-739-410
NIH Clinical Collection		SAM002589940

Bulk Active Pharmaceutical Ingredient (API) Sources for Griseofulvin and Ultramicrocrystalline Cellulose

Last updated: July 27, 2025

Introduction

The procurement of high-quality active pharmaceutical ingredients (APIs) remains a critical element in pharmaceutical manufacturing, impacting efficacy, safety, and regulatory compliance. Two prominent APIs in the industry are Griseofulvin, an antifungal agent, and Ultramicrocrystalline Cellulose (UMC), a widely used excipient. This report delineates the primary bulk sources for these substances, emphasizing supplier reputation, manufacturing standards, and geographic distribution to assist decision-makers in strategic sourcing.

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Griseofulvin API: Global Suppliers and Market Overview

1. Overview of Griseofulvin Production

Griseofulvin, a more than 60-year-old antifungal compound, is predominantly produced through fermentation or semi-synthesis. Its complex molecular structure necessitates strict control over raw materials and fermentation conditions. Leading pharmaceutical-grade griseofulvin suppliers are primarily located in India, China, and Europe, where manufacturing facilities adhere to Good Manufacturing Practices (GMP).

2. Major API Suppliers

• Hutchison MediPharma Ltd. (China): A key producer with established fermentation technology, supplying pharmaceutical-grade griseofulvin globally. Their facilities conform to both Chinese GMP standards and international quality benchmarks, serving markets across Asia, Europe, and North America.

• Gobi Pharma (India): A prominent manufacturer with an extensive portfolio of antifungal APIs, including griseofulvin. Gobi Pharma emphasizes compliance with WHO-GMP and provides APIs suitable for generic drug manufacturing.

• Amneal Pharmaceuticals (USA): While focusing mainly on finished dosage forms, Amneal sources APIs from approved international manufacturers compliant with US and European GMP standards, including verified suppliers of griseofulvin.

• SANDOZ (Switzerland): SANDOZ’s global sourcing network includes authorized third-party manufacturers producing griseofulvin under strict quality guidelines, often sourcing from India and China.

• Sun Pharmaceutical Industries Ltd. (India): A major Indian pharmaceutical producer supplying various APIs, including griseofulvin, with GMP compliance aligned with global standards.

3. Regulatory and Quality Considerations

Suppliers adhering to USP, EP, or BP standards are preferred. Verification of batch consistency, impurity profiles, and stability data is essential. Contract manufacturing organizations (CMOs) with WHO-GMP or FDA-validated facilities offer added assurance.

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Ultramicrocrystalline Cellulose (UMC): API and Excipient Source Landscape

1. Nature and Applications of UMC

Ultramicrocrystalline Cellulose is a refined, highly purified form of microcrystalline cellulose engineered to have particle sizes typically below 10 micrometers. Its primarily applications include as an excipient in direct compression, binder in tablets, and as a stabilizer.

2. Leading Suppliers of UMC

• JRS Pharma (Germany): One of the world’s leading suppliers of pharmaceutical excipients, including ultramicrocrystalline cellulose. JRS’s UMC products are recognized for high purity, consistent particle size, and compliance with international pharmacopeias.

• FMC Corporation (USA): Offers UMC under the brand Avicel. Their UMC grades are produced via proprietary processes ensuring high surface area and flow properties, suitable for direct compression.

• Asahi Kasei Corporation (Japan): Supplies UMC derivatives with high purity, supported by extensive R&D, and compliant with global GMP standards.

• Rettenmaier & Söhne (Germany): Provides a broad portfolio of microcrystalline and ultramicrocrystalline celluloses, emphasizing bioavailability and processability in pharmaceuticals.

• Kimica Corporation (Japan): Provides specialty pharmaceutical excipients, including ultramicrocrystalline cellulose with controlled particle size and moisture content.

3. Source Selection Factors

Suppliers with ISO, GMP, and Pharmacopeial compliance are preferred. Certifications such as ISO 9001/14001, and adherence to USP, EP, and JP monographs, ensure quality. Compatibility with downstream processes and specific product requirements (e.g., particle size, flowability) should guide supplier choice.

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Geographic and Regulatory Considerations

• Asia-Pacific Region: Dominant manufacturing centers, particularly China and India, for APIs like griseofulvin; Lower production costs but necessitate rigorous quality verification.

• Europe and North America: Suppliers such as FMC, JRS, and Rettenmaier are known for compliance with stringent regulatory standards and high-quality excipient manufacturing.

• Regulatory Compliance: Global sourcing necessitates compliance with local and international pharmacopeias. Suppliers with FDA, EMA, or PMDA approvals provide greater assurance for international markets.

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Supply Chain and Business Strategy Recommendations

• Vendor Qualification: Perform rigorous audits and quality assessments of potential suppliers, emphasizing GMP compliance, quality control protocols, and stability data.

• Multi-source Strategy: Establish relationships with multiple qualified suppliers to mitigate risks associated with supply disruptions.

• Regulatory Documentation: Confirm the availability of Material Safety Data Sheets (MSDS), Certificates of Analysis (CoA), and regulatory compliance certificates.

• Long-term Contracts: Negotiate agreements ensuring consistent supply at negotiated price points, with clear terms on quality and delivery schedules.

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Key Takeaways

• Diversify supplier base for both griseofulvin and ultramicrocrystalline cellulose to mitigate supply chain risks.

• Prioritize GMP-compliant suppliers with robust quality assurance programs, especially from reputable regions like Europe and North America.

• Leverage existing regulatory approvals and certifications to streamline validation processes in target markets.

• Conduct thorough supplier audits and validate manufacturing capabilities before establishing or expanding partnerships.

• Align sourcing decisions with project-specific requirements such as purity standards, particle size, and process compatibility.

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FAQs

1. What are the main factors to consider when sourcing griseofulvin APIs?
Regulatory compliance (GMP standards), purity profiles, impurity limits, batch-to-batch consistency, and supplier certifications are critical considerations.

2. How does ultramicrocrystalline cellulose differ from standard microcrystalline cellulose?
UMC has a finer particle size (typically below 10 micrometers), offering improved flowability, compressibility, and bioavailability, suitable for sensitive formulations.

3. Are there regional differences in API quality standards?
Yes. Europe and North America enforce stringent standards through EMA and FDA respectively, whereas Asian manufacturers often follow WHO-GMP guidelines, necessitating verification for regulatory acceptance.

4. What risks are associated with sourcing from emerging markets?
Potential quality variability, regulatory non-compliance, and supply chain disruptions. Due diligence and supplier audits are essential to mitigate these risks.

5. Can ultramicrocrystalline cellulose be imported into most countries?
Yes, provided it complies with local regulations and import requirements. Validation of supplier certifications facilitates smoother regulatory clearance.

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Sources

1. [1] USP Monograph on Griseofulvin: https://www.uspnf.com
2. [2] European Pharmacopoeia (EP): https://www.edqm.eu/en/european-pharmacopoeia
3. [3] JRS Pharma Product Datasheet on UMC: https://www.jrspharma.com
4. [4] FMC Corporation Product Information: https://www.fmc.com
5. [5] Asian and Indian API Market Reports (industry publications).