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Suppliers and packagers for generic pharmaceutical drug: GRISEOFULVIN, MICROSIZE
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GRISEOFULVIN, MICROSIZE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Actavis Mid Atlantic | GRISEOFULVIN | griseofulvin, microsize | SUSPENSION;ORAL | 065394 | ANDA | Actavis Pharma, Inc. | 0472-0013-04 | 120 mL in 1 BOTTLE (0472-0013-04) | 2007-07-26 |
| Chartwell Rx | GRISEOFULVIN | griseofulvin, microsize | SUSPENSION;ORAL | 065200 | ANDA | Chartwell RX, LLC. | 62135-968-41 | 120 mL in 1 BOTTLE (62135-968-41) | 2005-03-02 |
| Cipla | GRISEOFULVIN | griseofulvin, microsize | SUSPENSION;ORAL | 065354 | ANDA | Cipla USA Inc. | 69097-361-08 | 120 mL in 1 BOTTLE (69097-361-08) | 2017-03-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Griseofulvin, Microsize
Introduction
Griseofulvin is an antifungal medication primarily used to treat dermatophyte infections such as ringworm, athlete’s foot, and scalp infections. Its formulation as microsize particles enhances bioavailability and therapeutic efficacy. As demand for high-quality griseofulvin continues to rise, particularly in formulations with specific particle sizes, identifying reliable suppliers becomes a critical concern for pharmaceutical manufacturers, distributors, and healthcare providers. This article offers a comprehensive analysis of leading suppliers offering microsized griseofulvin, exploring their manufacturing capabilities, quality standards, and market positioning to facilitate informed procurement decisions.
Market Overview of Griseofulvin Suppliers
The global pharmaceutical landscape features several key players supplying griseofulvin, including both established pharmaceutical companies and specialty chemical producers. Suppliers are differentiated by their adherence to Good Manufacturing Practices (GMP), supply chain reliability, particle size control capabilities, and regulatory compliance.
Particularly, suppliers focusing on microsize particles—commonly in the range of 1-10 micrometers—are of heightened interest due to improved solubility and absorption profiles. These suppliers develop specialized manufacturing processes such as jet milling, high-pressure homogenization, or spray drying to achieve precise particle size distributions.
Major Suppliers of Microsize Griseofulvin
1. Sigma-Aldrich (Merck Group)
Overview
Sigma-Aldrich, a global leader in chemicals and biochemicals, supplies high-purity griseofulvin, including formulations with controlled particle sizes. Their product portfolio benefits from rigorous quality assurance aligned with international standards such as USP, EP, and JP.
Key Offerings
- Pharmaceutical-grade griseofulvin
- Microsize particles with specified mean diameters (commonly 2-5 μm)
- Custom particle size distribution upon request
Capabilities and Standards
Sigma-Aldrich emphasizes strict quality control with batch-to-batch consistency. Their production facilities are GMP-certified, ensuring compliance with global pharmaceutical regulations. They also offer technical support for formulation development, leveraging their extensive R&D infrastructure.
Market Presence
With a global distribution network, Sigma-Aldrich serves pharmaceutical industries worldwide, particularly in North America, Europe, and Asia-Pacific.
2. Fermentek Ltd.
Overview
An Israeli biotech company specializing in microbial metabolites, Fermentek supplies griseofulvin as part of their antifungal compound portfolio. Their proprietary manufacturing process emphasizes particle engineering to deliver microsize formulations.
Key Offerings
- Pharmaceutical-grade griseofulvin powders with precise particle sizing
- Custom synthesis and particle size tailoring services
- Scalable production capacities
Capabilities and Standards
Fermentek adheres to GMP standards and possesses ISO 9001 certification. Their expertise in microbial fermentation and downstream processing allows for high-purity products with controlled particle sizes, essential for enhanced bioavailability.
Market Presence
Their niche focus combined with R&D partnerships positions Fermentek as a specialized supplier for pharmaceutical firms seeking custom microsize griseofulvin.
3. Lupin Limited
Overview
Indian pharmaceutical major Lupin offers active pharmaceutical ingredients (APIs), including griseofulvin, with a focus on quality and cost competitiveness. They have developed processes to produce microsized particles to meet specific formulation requirements.
Key Offerings
- GMP-grade griseofulvin API, including microsize variants
- Flexible batch sizes for both small clinical and commercial production
- Extensive R&D capabilities for particle size customization
Capabilities and Standards
Lupin operates multiple manufacturing facilities compliant with USFDA and EMA standards, ensuring high quality and regulatory acceptance worldwide.
Market Presence
Lupin's competitive pricing and robust supply chain make them a key supplier for markets across Asia, Africa, and Latin America.
4. Hetero Labs Limited
Overview
As part of the Hetero Group, Hetero Labs produces a broad spectrum of APIs, including griseofulvin with engineered particle sizes optimized for bioavailability.
Key Offerings
- GMP-certified griseofulvin with microsize particles (1-10 μm)
- Custom formulations with specific particle size ranges
- Analytical services supporting quality assurance
Capabilities and Standards
Hetero maintains ISO and GMP certifications and has invested in advanced micronization technologies to produce consistent microsize particles.
Market Presence
Their established supply chains across Asia and partnerships with global pharma companies bolster their market reach.
5. WuXi AppTec
Overview
A leading contract development and manufacturing organization (CDMO), WuXi AppTec offers APIs, including griseofulvin, with advanced particle engineering. Their service model extends to custom synthesis and particle size control.
Key Offerings
- GMP-grade griseofulvin with specified micron sizes
- Custom manufacturing capabilities for research and bulk supply
- Comprehensive analytical and quality control support
Capabilities and Standards
WuXi AppTec operates under rigorous GMP standards and leverages state-of-the-art micronization and particle engineering technologies for tailored particle sizes.
Market Presence
Their extensive global footprint and integrated R&D capabilities make them a preferred partner for pharmaceutical innovation.
Critical Factors in Supplier Selection
- Quality Certification & Compliance: Confirm GMP certification, relevant pharmacopeia standards (USP, EP), and regulatory approvals such as FDA or EMA.
- Particle Size Control: Verify the supplier’s ability to consistently produce microsize particles within target ranges, essential for bioavailability optimization.
- Supply Chain Reliability: Assess throughput capacities, lead times, and traceability for continuous supply.
- Technical Support & Customization: Evaluate the supplier’s R&D support for particle size tailoring and formulation compatibility.
- Pricing & Contract Terms: Balance cost considerations with quality standards and long-term partnership requirements.
Emerging Trends & Future Outlook
The drive toward improved bioavailability through particle engineering is propelling suppliers to innovate in micronization technologies. Advances like supercritical fluid processing, nano-milling, and spray drying are expanding the options for producing microsize griseofulvin with higher precision and scalability. Additionally, increasing regulatory scrutiny demands suppliers maintain rigorous quality management and transparency.
The rising global demand, particularly in emerging markets and from companies developing combination therapies, underscores the importance of establishing relationships with suppliers capable of providing high-quality, microsized formulations at scale.
Key Takeaways
- Several established global suppliers such as Sigma-Aldrich, Fermentek, Lupin, Hetero Labs, and WuXi AppTec offer microsize griseofulvin suited for pharmaceutical formulation enhancements.
- Ensuring compliance with GMP, USP, and other pharmacopeial standards is critical for reliability and regulatory approval.
- Particle size control is pivotal for bioavailability; suppliers with proven micronization capabilities and consistent batch production are preferred.
- Collaborating with suppliers offering technical support and customization facilitates formulation optimization.
- Strategic procurement should balance quality, supply chain robustness, technological capability, and cost-efficiency to meet market and clinical demands.
FAQs
1. What is the significance of microsize particles in griseofulvin formulations?
Microsize particles enhance dissolution rates, bioavailability, and therapeutic efficacy. Precise particle engineering enables better formulation stability and reduced dosing frequency.
2. How do I verify the quality of microsize griseofulvin from suppliers?
Confirm GMP certification, review batch analysis reports, and request detailed particle size distribution data. Ensure compliance with pharmacopeial standards such as USP or EP.
3. Can suppliers tailor griseofulvin particles to specific size ranges?
Yes, many suppliers with advanced micronization technology can customize particle sizes within defined ranges to meet specific formulation needs.
4. What are typical lead times for supply of microsize griseofulvin?
Lead times vary by supplier, typically ranging from 4 to 12 weeks depending on order volume, customization requirements, and production capacity.
5. Is it standard for suppliers to provide small-scale samples for testing?
Most reputable suppliers offer sample batches for formulation screening, enabling validation of particle size compatibility and quality before committing to larger orders.
References
- [1] Sigma-Aldrich Product Catalog. (2023). Griseofulvin.
- [2] Fermentek Ltd. Technical Datasheet. (2023). Microsize Griseofulvin.
- [3] Lupin Limited Annual Report. (2022). API Manufacturing Capabilities.
- [4] Hetero Labs API Portfolio. (2022). Particle Engineering Technologies.
- [5] WuXi AppTec Website. (2023). Custom API Development and Manufacturing.
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