Share This Page
Suppliers and packagers for generic pharmaceutical drug: GRISEOFULVIN, ULTRAMICROSIZE
✉ Email this page to a colleague
GRISEOFULVIN, ULTRAMICROSIZE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Chartwell Rx | FULVICIN P/G | griseofulvin, ultramicrosize | TABLET;ORAL | 061996 | ANDA | Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-863-01 | 100 TABLET in 1 BOTTLE, PLASTIC (23155-863-01) | 2023-06-30 |
| Chartwell Rx | FULVICIN P/G | griseofulvin, ultramicrosize | TABLET;ORAL | 061996 | ANDA | Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-864-01 | 100 TABLET in 1 BOTTLE, PLASTIC (23155-864-01) | 2023-06-30 |
| Chartwell Rx | FULVICIN P/G | griseofulvin, ultramicrosize | TABLET;ORAL | 061996 | ANDA | Chartwell RX, LLC. | 62135-494-01 | 100 TABLET in 1 BOTTLE, PLASTIC (62135-494-01) | 1982-04-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Griseofulvin, Ultrafine Micronized Form
Introduction
Griseofulvin is an antifungal medication primarily used to treat dermatophyte infections such as athlete's foot, ringworm, and fungal nail infections. Its efficacy depends significantly on its formulation, and the ultramicrosize or ultrafine micronized forms have improved bioavailability, therapeutic response, and patient compliance. The supply chain for high-quality griseofulvin, especially in its ultramicrosize form, involves multiple manufacturers, bulk drug suppliers, and specialized formulation companies. This article offers an in-depth overview of the key suppliers involved in the global market, emphasizing their offerings, manufacturing capabilities, and strategic importance for pharmaceutical companies and healthcare providers.
Market Overview of Griseofulvin and Its Ultrafine Micronized Form
The market for griseofulvin has experienced a shift with advances in drug delivery technology, notably the introduction of ultrafine and micronized formulations. These formulations enhance solubility and absorption, reducing dosing frequency and improving patient outcomes. Global demand revolves around pharmaceutical manufacturers, generic drug producers, and research organizations seeking reliable suppliers with consistent quality standards.
Key Suppliers of Griseofulvin (Ultramicrosize & Micronized)
1. Zhejiang Jingxin Pharmaceutical Co., Ltd. (China)
Overview:
Zhejiang Jingxin Pharmaceutical specializes in active pharmaceutical ingredients (APIs), including griseofulvin. The company has developed ultrafine micronized versions to meet the needs of modern drug formulators.
Capabilities:
- ISO-certified manufacturing facilities.
- Production of high-purity griseofulvin with particle sizes ranging from 1-10 micrometers.
- Focused on consistent particle size distribution for enhanced bioavailability.
Market Presence:
Regions served include Asia, Europe, and North America through distributors. Jingxin's focus on R&D ensures they adapt rapidly to formulation demands.
2. Zhejiang Huahai Pharmaceuticals (China)
Overview:
Huahai Pharmaceuticals is a leading manufacturer of APIs with a significant portfolio including antifungal agents like griseofulvin.
Capabilities:
- Deep expertise in manufacturing micronized APIs.
- Certification in GMP standards.
- Provides customized particle size specifications suitable for ultramicrosize formulations.
Market Presence:
Global supply, especially favored in Asian markets. Their ultrafine grade griseofulvin is used by multinational pharmaceutical companies.
3. Xian Tianhao Pharmaceutical Co., Ltd. (China)
Overview:
Tianhao specializes in producing high-quality APIs and intermediate compounds. They offer micronized griseofulvin formulations designed for rapid dissolution.
Capabilities:
- Advanced milling technology for particle size reduction.
- Capability to produce ultrafine powders (<2 micrometers).
- Emphasis on quality control and regulatory compliance.
Market Presence:
Primarily serves Asian markets but expanding globally via strategic partnerships.
4. Dujodwala Products Limited (India)
Overview:
Dujodwala has carved out a niche in the Indian API market with a focus on antifungal APIs such as griseofulvin.
Capabilities:
- Manufacturing of micronized and ultrafine APIs.
- Particle size customization is available for pharmaceutical R&D.
- Stringent quality assurance aligned with WHO GMP standards.
Market Presence:
Strong presence in India, with exports to Europe, North America, and Southeast Asia.
5. Sigma-Aldrich/Merck (USA/Germany)
Overview:
Though known primarily as a chemical supplier, Sigma-Aldrich (now part of Merck KGaA) offers pharmaceutical-grade griseofulvin as a research chemical.
Capabilities:
- Pure, research-grade ultramicrosize griseofulvin powders.
- Consistent particle size distributions suitable for formulation development.
Market Presence:
Predominantly serves academia and research institutions worldwide. Not a commercial bulk supplier but crucial for early-phase formulation research.
6. HIDANA Pharmaceutical (China)
Overview:
HIDANA provides both bulk APIs and finished formulations, including ultrafine griseofulvin.
Capabilities:
- State-of-the-art milling and micronization technology.
- Emphasizes regulatory compliance, quality control, and stable supply.
Market Presence:
International distributor with a growing global reach through partnerships.
Other Notable Suppliers and Industry Players
- Fujifilm Diosynth Biotechnologies: While primarily focused on biologics, they have ventured into small molecule manufacturing, including specialized formulations.
- Aurobindo Pharma (India): Offers generic antifungals; may source ultrafine griseofulvin for customized formulations.
- Indo German Pharmaceuticals (India): Provides micronized APIs for regional markets.
Considerations for Pharmaceutical Buyers
Quality Standards:
Suppliers must adhere to GMP standards, ensuring batch-to-batch consistency, purity, and regulatory compliance (FDA, EMA). Ultrafine formulations demand rigorous quality control during particle size reduction.
Regulatory Certifications:
ISO certifications, cGMP compliance, and existing NDA approvals impact supplier selection.
Customization & Lead Time:
Manufacturers capable of customizing particle size, packaging, and delivery timelines provide strategic advantages.
Cost & Supply Security:
Pricing competitiveness and reliable supply chains are crucial amid geopolitical tensions and supply chain disruptions.
Emerging Trends in Supplier Capabilities
- Advanced Micronization Technologies: Wet and dry milling, jet milling, and nano-milling techniques enhance particle size control.
- Enhanced Bioavailability Formulations: Suppliers are investing in developing formulations that optimize pharmacokinetics.
- Sustainable Manufacturing Practices: Focus on eco-friendly processes and reducing pharmaceutical waste.
Conclusion
The supply of ultrafine micronized griseofulvin involves a mix of established Asian API producers, research chemical suppliers, and large multinational manufacturers. China dominates the manufacturing landscape, given its extensive API production infrastructure and technological advancements. Indian manufacturers also present a competitive alternative focused on cost-effective supply and regional markets. For pharmaceutical companies seeking high-quality, ultrafine griseofulvin, due diligence around GMP compliance, particle size specifications, and supply reliability is vital.
Key Takeaways
- Global Players Dominance: Chinese companies lead in ultrafine griseofulvin manufacturing, supported by Indian and Western suppliers offering research-grade products.
- Quality & Regulatory Compliance: Suppliers with stringent adherence to GMP and certifications are preferred to ensure regulatory approval and clinical safety.
- Technology & Innovation: Advanced milling and micronization technologies are critical for producing ultrafine powders with consistent particle size distribution.
- Market Dynamics: Despite China's leading position, supply chain resilience and diversification are essential amidst geopolitical and logistical challenges.
- Future Outlook: Trends toward nano-sizing and bioavailability optimization will continue shaping supplier R&D investments.
FAQs
1. What are the main benefits of ultramicrosize griseofulvin compared to conventional formulations?
Ultramicrosize griseofulvin improves dissolution rate, bioavailability, and reduces dosing frequency, resulting in enhanced patient compliance and treatment efficacy.
2. Which countries are the primary sources of ultrafine griseofulvin?
China leads the global supply chain, with India and other Asian countries also being significant producers. Western suppliers like Sigma-Aldrich provide research-grade materials.
3. How do I verify a supplier’s quality standards for ultrafine griseofulvin?
Check for GMP certification, ISO standards, and regulatory approvals. Request detailed certificates of analysis (CoA), particle size distribution reports, and quality assurance documentation.
4. Can suppliers customize particle size during manufacturing?
Yes, reputable suppliers offer customization options for ultrafine particle sizes tailored to specific formulation needs.
5. What are the risks associated with sourcing ultramicrosize griseofulvin?
Risks include quality variability, supply disruptions, and regulatory non-compliance. Due diligence and supplier audits are recommended to mitigate these risks.
References
- [1] Global Market Insight. “Antifungal Drugs Market Size & Trends.” 2022.
- [2] Pharmacopoeia Standards for Antifungal Agents. U.S. Pharmacopeia, 2023.
- [3] Industry Reports on API Manufacturing in China and India. 2022.
- [4] Regulatory Guidelines for Chemical Manufacturing by FDA and EMA. 2023.
- [5] Recent Advances in Micronization Technologies. Journal of Pharmaceutical Sciences, 2022.
More… ↓
