Bulk Pharmaceutical API Sources for griseofulvin, microsize

Bulk Pharmaceutical API Sources for griseofulvin, microsize

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
ABI Chem		AC1L9AMF

Bulk Active Pharmaceutical Ingredient (API) Sources for: GRISEOFULVIN, MICROSIZE

Last updated: July 28, 2025

Introduction

The pharmaceutical industry's reliance on high-quality Active Pharmaceutical Ingredients (APIs) is critical to ensuring drug efficacy, safety, and manufacturing scalability. Gri­seofulvin, a well-established antifungal agent, particularly in its microsize form, exemplifies a complex API with specific sourcing criteria. This article explores global suppliers for microsize Gri­seofulvin, analyzing their manufacturing capabilities, regulatory compliance, and supply chain robustness to inform procurement strategies for pharmaceutical companies.

Overview of GRISEOFULVIN, MICROSIZE

Gri­seofulvin is an antifungal compound primarily prescribed for treating dermatophyte infections. Its microsize formulation enhances bioavailability and therapeutic efficacy, necessitating precise manufacturing controls. The microsize form typically features particle sizes of less than 10 micrometers, demanding specialized production techniques such as controlled crystallization and milling processes.

Global API Suppliers for Microsize GRISEOFULVIN

1. Major Manufacturers and Regional Distribution

The primary sources for microsize Gri­seofulvin are situated across key regions, including China, India, Europe, and North America. China's dominance in bulk API production reflects cost advantages and extensive manufacturing infrastructure. Indian manufacturers also occupy a significant position, focusing on high-quality, pharmacopeia-compliant APIs.

2. Leading Suppliers and Their Capabilities

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Known for comprehensive pharmaceutical ingredients, including antifungals, Zhejiang Hisun emphasizes GMP-compliant production lines for particle-controlled APIs. Their capacity for microsizing Gri­seofulvin involves advanced milling and crystallization processes aligned with international standards.

• Hangzhou Guobiao Pharmaceutical Co., Ltd. (China): Specializing in steriles and APIs, this firm offers microsized Gri­seofulvin with customized particle size distribution suitable for oral dosage forms. Their facilities are certified by GMP and adhere to global pharmacopeia standards.

• Spragma Pharma (India): A recognized Indian API manufacturer with validated facilities capable of producing high-purity microsized Gri­seofulvin. They focus on scalability and consistent particle size distribution, complying with USFDA and EMA regulations.

• Pharmacia & Upjohn (Europe): Although a historic name now part of global conglomerates like Pfizer, legacy manufacturing in Europe included licensed Gri­seofulvin APIs, often produced under rigorous quality standards, with dedicated micronization units.

• MikroChem (North America): Specializing in micronized active ingredients, MikroChem offers custom Gri­seofulvin in microsize forms tailored for specialized pharmaceutical formulations. Their expertise involves advanced jet milling and spray-drying techniques.

3. Manufacturing Technologies and Quality Assurance

Producers employ technologies such as jet milling, ball milling, and spray-drying, ensuring particle size uniformity and high purity levels. Strict adherence to GMP, validated processes, and comprehensive quality control, including LOQ/LOD assessments, residual solvent analyses, and polymorphic form verification, are standard.

Regulatory Compliance & Certification

Most reputable suppliers maintain certifications such as GMP, ISO 9001, and DEA registration where applicable. Regulatory compliance facilitates seamless integration into global supply chains, especially for markets with stringent standards like the US, EU, and Japan.

Supply Chain Considerations

• Capacity and Scalability: Leading suppliers have scalable manufacturing capacities capable of fulfilling both pilot and commercial productions. Long-term supply agreements mitigate risks of shortages.
• Raw Material Sourcing: Suppliers with vertically integrated processes or reliable raw material sources ensure consistent API quality.
• Logistics & Lead Times: Efficient logistics and inventory management are vital, especially given the perishability and specialized handling requirements of microsize APIs.

Emerging Trends in API Sourcing for Microsize Gri­seofulvin

• Manufacturing Innovation: Advances in micronization and crystallization techniques improve particle control, enabling more consistent bioavailability.
• Quality by Design (QbD): Suppliers integrating QbD principles improve API robustness and batch-to-batch consistency.
• Regulatory Alignment: Increasing harmonization efforts guide suppliers to comply with evolving international standards, facilitating market access.

Risk Management & Supplier Evaluation

Pharmaceutical firms must evaluate suppliers based on quality track record, capacity, technological prowess, regulatory adherence, and geopolitical stability. Multiple sourcing reduces dependency on single suppliers, safeguarding against disruptions.

Conclusion

Sourcing high-quality microsize Gri­seofulvin APIs involves navigating a landscape of regional manufacturers with varying technological capabilities and regulatory frameworks. Leading Chinese and Indian manufacturers, backed by advanced micronization processes and strict quality controls, currently dominate the market. European and North American suppliers, characterized by high regulatory standards and specialized expertise, serve niche demands. Strategic engagement with suppliers emphasizing compliance, capacity, and innovation ensures a reliable supply chain for pharmaceutical developers and manufacturers.

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Key Takeaways

• The global market for microsize Gri­seofulvin APIs is dominated by Chinese and Indian producers, offering cost-effective, compliant options.
• Advanced micronization technologies such as jet milling and spray drying are crucial for producing consistent particle sizes.
• Rigorous regulatory certification and quality assurance processes are non-negotiable when selecting suppliers.
• Supply chain resilience depends on capacity, raw material sourcing, and logistics efficiency.
• Continuous innovation and adherence to international standards position suppliers favorably in an evolving pharmaceutical landscape.

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FAQs

Q1: What are the main quality parameters to evaluate when sourcing microsize Gri­seofulvin APIs?
A1: Key parameters include particle size distribution, polymorphic form, purity levels, residual solvent content, and compliance with pharmacopeial standards such as USP, EP, or JP.

Q2: How do micronization techniques impact API performance?
A2: Micronization enhances dissolution rate, bioavailability, and uniformity, which are critical for therapeutic efficacy and formulation stability.

Q3: Are there regional differences in API regulatory standards?
A3: Yes. While GMP compliance is universal, specific documentation, testing requirements, and certifications may vary across regions such as the US (FDA), Europe (EMA), and Japan (PMDA).

Q4: Can I source microsize Gri­seofulvin from multiple suppliers to mitigate risks?
A4: Absolutely. Multi-sourcing ensures supply continuity, risk diversification, and competitive pricing, especially important during supply chain disruptions.

Q5: What future advancements could influence API sourcing for microsize Gri­seofulvin?
A5: Innovations in particle engineering, continuous manufacturing processes, and digital supply chain tracking could streamline sourcing, improve quality, and reduce costs.

References

[1] U.S. Pharmacopeia. USP Monographs on Gri­seofulvin. U.S. Pharmacopeial Convention, 2022.
[2] European Pharmacopoeia. Gri­seofulvin Monograph. European Directorate for the Quality of Medicines & HealthCare, 2022.
[3] Industry reports on API manufacturing trends by IQVIA and Frost & Sullivan, 2022.
[4] Regulatory documentation from the FDA, EMA, and WHO, 2023.