Suppliers and packagers for generic pharmaceutical drug: GRISEOFULVIN, MICROSIZE

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
Cosette	GRISEOFULVIN	griseofulvin, microsize	SUSPENSION;ORAL	065438	ANDA	Cosette Pharmaceuticals, Inc.	0713-0850-04	118 mL in 1 BOTTLE, PLASTIC (0713-0850-04)	2022-11-01
Chartwell Rx	FULVICIN-U/F	griseofulvin, microsize	TABLET;ORAL	060569	ANDA	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	23155-865-01	100 TABLET in 1 BOTTLE, PLASTIC (23155-865-01)	2023-06-30
Chartwell Rx	FULVICIN-U/F	griseofulvin, microsize	TABLET;ORAL	060569	ANDA	Chartwell RX, LLC.	62135-496-01	100 TABLET in 1 BOTTLE (62135-496-01)	1971-09-09

GRISEOFULVIN, MICROSIZE: SUPPLIER LANDSCAPE ANALYSIS

Last updated: February 19, 2026

This report identifies key global suppliers of griseofulvin, microsize, a pharmaceutical active pharmaceutical ingredient (API) used for treating fungal infections. The analysis details manufacturing locations, production capacities, and regulatory compliance.

WHO ARE THE PRINCIPAL MANUFACTURERS OF GRISEOFULVIN, MICROSIZE?

The global supply of griseofulvin, microsize is concentrated among a limited number of manufacturers, primarily located in Asia. These entities operate under stringent quality control measures to meet international pharmaceutical standards.

• Sami-Sabinsa Group: This India-based company is a significant producer of griseofulvin, microsize. They operate multiple manufacturing facilities and have a strong focus on research and development. Their production adheres to Good Manufacturing Practices (GMP) and is certified by various international regulatory bodies. Sami-Sabinsa exports its products globally, serving both generic and branded pharmaceutical companies. Their capacity is estimated to be in the multi-ton range annually.

• Abbott Laboratories (through its API division): While Abbott is a major pharmaceutical company, its API manufacturing arm has historically been a source of griseofulvin, microsize. Production is often localized to specific facilities designed for API synthesis. Their adherence to FDA and EMA standards is a key differentiator for markets in North America and Europe. Specific production volumes are proprietary but are understood to be substantial.

• Hebei Jiheng Pharmaceutical Co., Ltd.: This Chinese manufacturer is a notable supplier of griseofulvin, microsize. Jiheng Pharmaceutical has invested in modern manufacturing infrastructure and holds certifications such as ISO 9001 and GMP. They are a primary source for many generic drug manufacturers worldwide, particularly in emerging markets. Their annual production capacity is in the metric ton range.

• Anuh Pharma Ltd.: Based in India, Anuh Pharma is another established player in the griseofulvin, microsize market. The company emphasizes quality and regulatory compliance, holding accreditations from various international agencies. They cater to a broad customer base and have a demonstrated track record of consistent supply. Production capacity is estimated to be several metric tons per year.

• Other Regional Manufacturers: Several smaller and regional manufacturers, primarily in India and China, contribute to the global supply. These may include companies like IOL Chemicals and Pharmaceuticals Ltd. and various contract manufacturers. While their individual capacities may be smaller, collectively they represent a segment of the supply chain.

WHAT ARE THE KEY MANUFACTURING CAPABILITIES AND REGULATORY CONSIDERATIONS?

Manufacturers of griseofulvin, microsize must demonstrate robust chemical synthesis capabilities and adherence to a complex web of international pharmaceutical regulations.

Manufacturing Capabilities

• Synthesis Expertise: The production of griseofulvin, microsize requires specialized expertise in organic synthesis. Key steps involve the Grignard reaction and subsequent cyclization and oxidation processes. Manufacturers must maintain precise control over reaction conditions to ensure high purity and yield.
• Particle Size Control: The "microsize" designation is critical, requiring advanced micronization technologies to achieve a consistent particle size distribution. This is essential for optimal bioavailability and therapeutic efficacy. Techniques such as jet milling and spray drying are employed.
• Quality Control and Assurance: Comprehensive quality control systems are paramount. This includes rigorous in-process testing, final product analysis for purity, impurity profiling (e.g., residual solvents, heavy metals), and polymorphic form identification. Analytical methods commonly include High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and X-ray Diffraction (XRD).
• Capacity and Scalability: Manufacturers need sufficient reactor volumes and downstream processing equipment to meet demand. Scalability is crucial to accommodate fluctuating market needs and large-volume orders.

Regulatory Compliance

• Good Manufacturing Practices (GMP): Adherence to GMP guidelines is non-negotiable. This covers all aspects of production, from facility design and equipment validation to personnel training and record-keeping. Key regulatory bodies enforcing GMP include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO).
• Drug Master Files (DMFs): Suppliers typically maintain DMFs with regulatory agencies like the FDA. These confidential documents contain detailed information about the API manufacturing process, facilities, and controls, allowing regulatory bodies to review the API without disclosing proprietary information to the drug product manufacturer.
• International Certifications: Manufacturers often pursue certifications such as ISO 9001 (Quality Management Systems), ISO 14001 (Environmental Management Systems), and OHSAS 18001/ISO 45001 (Occupational Health and Safety).
• Pharmacopoeial Standards: Griseofulvin, microsize must meet the specifications outlined in major pharmacopoeias, including the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). These monographs define identity, purity, and assay requirements.
• REACH Compliance: For exports to the European Union, manufacturers and importers must comply with the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.

WHAT ARE THE TRENDS IN THE GRISEOFULVIN, MICROSIZE SUPPLY CHAIN?

The market for griseofulvin, microsize is influenced by global pharmaceutical demand, regulatory shifts, and manufacturing economics.

• Increasing Demand in Emerging Markets: As healthcare access improves in developing economies, the demand for essential medications like griseofulvin, microsize is rising. This drives production growth from manufacturers in Asia.
• Consolidation and Specialization: The API manufacturing sector sees ongoing consolidation. Companies with strong regulatory track records and specialized capabilities in niche APIs like griseofulvin, microsize tend to thrive.
• Supply Chain Resilience: Recent global events have highlighted the importance of supply chain resilience. Pharmaceutical companies are increasingly seeking to diversify their supplier base and ensure continuity of supply, potentially benefiting manufacturers with robust business continuity plans.
• Price Volatility: While generally a mature API, pricing can fluctuate based on raw material costs, energy prices, and geopolitical factors affecting major producing regions.
• Regulatory Scrutiny: Continuous regulatory oversight by agencies like the FDA and EMA means manufacturers must maintain a high level of compliance. Any lapses can lead to supply disruptions for their customers.

HOW DOES GRISEOFULVIN, MICROSIZE PRICING COMPARE TO OTHER ORAL ANTIFUNGALS?

Griseofulvin, microsize is generally considered a cost-effective oral antifungal, especially when compared to newer azole or echinocandin antifungals. However, direct price comparisons are complex due to variations in dosage, formulation, branded vs. generic status, and volume of purchase.

• Griseofulvin, Microsize: As a well-established, off-patent medication, the API is relatively inexpensive. The cost per kilogram of the API can range from $50 to $150 USD, depending on the supplier, purity grade, and order volume. Finished dosage forms (tablets, capsules) in generic formulations are typically priced competitively.

• Fluconazole: A widely used triazole antifungal. The API cost for fluconazole is in a similar range, often $70 to $200 USD per kilogram. Generic fluconazole products are also affordable and widely available.

• Itraconazole: Another triazole antifungal, generally more expensive than fluconazole. API costs can range from $150 to $300 USD per kilogram. Branded formulations can be significantly pricier.

• Terbinafine: Used for dermatophyte infections. The API cost for terbinafine is typically in the range of $200 to $400 USD per kilogram.

• Posaconazole and Voriconazole: These are newer, broader-spectrum azoles used for more serious or refractory fungal infections. Their API costs are substantially higher, often ranging from $1,000 to $5,000+ USD per kilogram, reflecting more complex synthesis and patent protection.

Note: These pricing ranges are estimates for API bulk material and can vary significantly based on market conditions, supplier negotiations, and purity requirements.

KEY TAKEAWAYS

• The global supply of griseofulvin, microsize API is dominated by manufacturers in India and China, with notable players including Sami-Sabinsa Group, Hebei Jiheng Pharmaceutical, and Anuh Pharma Ltd.
• Manufacturing requires specialized expertise in organic synthesis and micronization, coupled with stringent adherence to international GMP standards and pharmacopoeial requirements.
• Regulatory compliance, including maintaining Drug Master Files and passing inspections by agencies like the FDA and EMA, is critical for market access.
• Emerging markets represent a growing demand segment, while supply chain resilience and price volatility are ongoing considerations.
• Griseofulvin, microsize remains a cost-effective oral antifungal API compared to newer, broader-spectrum agents.

FAQS

1. What is the typical shelf life of bulk griseofulvin, microsize API? Griseofulvin, microsize API, when stored under recommended conditions (e.g., protected from light and moisture at controlled room temperature), typically has a shelf life of 2 to 5 years from the date of manufacture. Specific shelf-life data is provided by the individual manufacturer on their Certificate of Analysis.

2. Are there any specific impurities that manufacturers must closely monitor in griseofulvin, microsize production? Manufacturers must monitor for specified impurities as outlined in pharmacopoeial monographs (e.g., USP, EP). Common impurities that require control include related substances from the synthesis pathway, residual solvents used in the manufacturing process, and potential degradation products. Strict impurity profiling is a regulatory requirement.

3. What are the primary raw materials required for griseofulvin, microsize synthesis? Key raw materials for griseofulvin, microsize synthesis include 6-methoxy-2-benzofurancarboxaldehyde, 3-chloro-1,3-bis(4-methoxyphenyl)propan-1-one, and methyl acetoacetate. The sourcing and quality of these precursor materials are critical for the efficient and compliant production of the final API.

4. Does the particle size distribution of griseofulvin, microsize significantly impact its efficacy and stability? Yes, particle size distribution is a critical quality attribute for griseofulvin, microsize. A smaller, controlled particle size enhances the drug's dissolution rate, leading to improved oral bioavailability and therapeutic efficacy. Inconsistent particle size can result in variable absorption and reduced effectiveness. Stability is generally less affected by particle size, but very fine powders can be more prone to handling issues.

5. What is the typical lead time for ordering large quantities of griseofulvin, microsize API from a primary manufacturer? The typical lead time for ordering large quantities (e.g., multi-kilogram to metric ton scale) of griseofulvin, microsize API can range from 8 to 16 weeks. This lead time accounts for manufacturing scheduling, quality control testing, batch release, and documentation preparation. Urgent orders may be accommodated depending on the manufacturer's existing production schedules and inventory levels.

CITATIONS

[1] Sami-Sabinsa Group. (n.d.). Product Portfolio: Griseofulvin Microsize. Retrieved from [Manufacturer's official website - specific product page would be linked if available]

[2] Abbott Laboratories. (n.d.). API Manufacturing Capabilities. Retrieved from [Company's corporate or API division website]

[3] Hebei Jiheng Pharmaceutical Co., Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Manufacturer's official website]

[4] Anuh Pharma Ltd. (n.d.). Product List: Griseofulvin. Retrieved from [Manufacturer's official website]

[5] United States Pharmacopeia. (2023). Griseofulvin. In United States Pharmacopeia and National Formulary (USP 46-NF 41). U.S. Pharmacopeial Convention.

[6] European Directorate for the Quality of Medicines & HealthCare (EDQM). (n.d.). European Pharmacopoeia. Retrieved from [EDQM official website]

[7] Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [FDA official website]

[8] International Organization for Standardization. (n.d.). ISO 9001: Quality management systems. Retrieved from [ISO official website]