Suppliers and packagers for generic pharmaceutical drug: CLOTRIMAZOLE

CLOTRIMAZOLE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fougera Pharms	CLOTRIMAZOLE	clotrimazole	CREAM;TOPICAL	078338	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0133-15	15 g in 1 TUBE (0168-0133-15)	2008-09-02
Fougera Pharms	CLOTRIMAZOLE	clotrimazole	CREAM;TOPICAL	078338	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0133-30	30 g in 1 TUBE (0168-0133-30)	2008-09-02
Fougera Pharms	CLOTRIMAZOLE	clotrimazole	CREAM;TOPICAL	078338	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0133-46	45 g in 1 TUBE (0168-0133-46)	2008-09-02
Glenmark Pharms	CLOTRIMAZOLE	clotrimazole	CREAM;TOPICAL	090219	ANDA	A-S Medication Solutions	50090-7343-0	30 g in 1 TUBE (50090-7343-0)	2010-08-04
Glenmark Pharms	CLOTRIMAZOLE	clotrimazole	CREAM;TOPICAL	090219	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-181-17	15 g in 1 TUBE (68462-181-17)	2010-08-04
Glenmark Pharms	CLOTRIMAZOLE	clotrimazole	CREAM;TOPICAL	090219	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-181-35	30 g in 1 TUBE (68462-181-35)	2010-08-04

Clotrimazole Pharmaceutical Drug Supply Chain Analysis

Last updated: February 19, 2026

Clotrimazole, a widely used antifungal medication, relies on a global network of active pharmaceutical ingredient (API) manufacturers and formulation specialists. Key suppliers for Clotrimazole are concentrated in China and India, with some production also occurring in Europe. The market is characterized by established players producing generic versions of the drug, driven by demand for treatments of common fungal infections. Pricing is competitive, influenced by raw material costs and manufacturing efficiency. Regulatory compliance, particularly Good Manufacturing Practices (GMP), is a critical factor for all suppliers.

Who are the primary manufacturers of Clotrimazole API?

The primary manufacturers of Clotrimazole Active Pharmaceutical Ingredient (API) are located predominantly in China and India, two countries that dominate global API production due to cost efficiencies and established chemical manufacturing infrastructure.

Leading Clotrimazole API Producers

• China:
  • Hubei Biocause Pharmaceutical Co., Ltd. is a significant producer of various APIs, including antifungal agents. Their production capacity and adherence to international quality standards are key factors in their market position.
  • Zhejiang NHU Co., Ltd. is another major player in the Chinese API sector. The company is known for its vertically integrated manufacturing processes, which can contribute to cost competitiveness for products like Clotrimazole.
  • Anhui Dejia-Biotech Co., Ltd. supplies a range of pharmaceutical intermediates and APIs. Their focus on quality control and process optimization supports their role in the Clotrimazole supply chain.
• India:
  • Lupin Limited is a large Indian pharmaceutical company with a substantial API manufacturing division. They are involved in the production of a broad spectrum of APIs, including those for antifungal treatments.
  • Aurobindo Pharma Limited is a significant global supplier of APIs and finished dosage forms. Their extensive manufacturing capabilities and regulatory expertise position them as a key source for Clotrimazole API.
  • Divi's Laboratories Limited is a prominent API manufacturer in India, recognized for its large-scale production and strong export focus. They produce APIs for various therapeutic classes, including antifungals.

European and Other Manufacturers

While China and India lead in volume, some European manufacturers also produce Clotrimazole API, often catering to specific regional markets or higher-value formulations. Companies in countries like Germany and Italy may engage in this production, often with a strong emphasis on highly regulated markets.

What are the key raw materials required for Clotrimazole synthesis?

The synthesis of Clotrimazole involves several key chemical intermediates. The availability and cost of these raw materials directly impact the final API price and supply stability.

Essential Precursor Chemicals

The synthesis typically begins with imidazole and a substituted benzophenone derivative. The primary raw materials include:

• Imidazole: A basic heterocyclic organic compound, serving as the core structure for Clotrimazole.
• 4-Chlorobenzoyl chloride: A key intermediate for introducing the chlorinated phenyl ring.
• Dichlorophenylmethane: Another precursor that undergoes specific reactions to form the final molecule.

The production of these intermediates requires access to fundamental chemicals such as benzene, chlorine, and various reagents used in acylation and alkylation reactions. Fluctuations in the prices of these basic petrochemicals can affect the cost of the specialized intermediates and, consequently, Clotrimazole API.

Which companies specialize in Clotrimazole finished dosage forms?

Finished dosage form manufacturers reformulate Clotrimazole API into various delivery systems for patient use. These include creams, lotions, vaginal tablets, and oral solutions. The market for finished forms is diverse, with both large multinational pharmaceutical companies and smaller generic manufacturers.

Major Finished Dosage Form Suppliers

• Global Pharmaceutical Companies:
  • Bayer AG: The originator of Clotrimazole (under the brand Canesten), Bayer continues to be a significant global player with its branded and generic offerings.
  • GlaxoSmithKline (GSK): While not the originator, GSK manufactures and markets Clotrimazole in various regions under different brand names and as part of its dermatology portfolio.
  • Johnson & Johnson: Through its consumer health division, J&J offers Clotrimazole-based products for topical antifungal treatments.
• Generic Manufacturers:
  • Perrigo Company plc: A leading global provider of affordable self-care products, Perrigo manufactures and markets a wide range of generic topical medications, including Clotrimazole.
  • Te Internal Medicine AB (part of Teva Pharmaceutical Industries Ltd.): Teva is one of the world's largest generic drug manufacturers and supplies Clotrimazole in various formulations.
  • Sun Pharmaceutical Industries Ltd.: An Indian multinational pharmaceutical company, Sun Pharma is a major supplier of generic drugs globally, including Clotrimazole products.

These companies source API from the manufacturers listed previously and then undertake formulation, packaging, and distribution.

What is the regulatory landscape governing Clotrimazole production?

The production of Clotrimazole API and finished dosage forms is subject to stringent regulations by health authorities worldwide to ensure safety, efficacy, and quality.

Key Regulatory Bodies and Requirements

• U.S. Food and Drug Administration (FDA): Mandates compliance with Current Good Manufacturing Practices (cGMP) for both API and finished product manufacturing. Facilities are subject to inspection, and drug products must be approved through Abbreviated New Drug Applications (ANDAs) for generics.
• European Medicines Agency (EMA): Oversees pharmaceutical regulation in the European Union. Manufacturers must adhere to EU GMP guidelines, and products require marketing authorization. The EMA also coordinates inspections of manufacturing sites.
• Pharmaceuticals and Medical Devices Agency (PMDA) in Japan: Sets rigorous standards for drug manufacturing and quality control in Japan.
• Central Drugs Standard Control Organisation (CDSCO) in India: Regulates drug manufacturing and quality within India, with requirements aligned with international standards.
• National Medical Products Administration (NMPA) in China: Governs drug production in China, increasingly aligning with global GMP standards.

Suppliers must demonstrate robust quality management systems, impurity profiling, and stability testing for their Clotrimazole products.

How do supply chain disruptions impact Clotrimazole availability?

Clotrimazole supply chains, like those for many pharmaceuticals, are vulnerable to disruptions. These can arise from geopolitical events, natural disasters, raw material shortages, or manufacturing issues.

Potential Sources of Disruption

• Geopolitical Instability: Tensions or trade disputes involving major API manufacturing regions (e.g., China, India) can lead to export restrictions or increased logistical costs.
• Raw Material Scarcity: Shortages of precursor chemicals, often tied to broader chemical industry trends or environmental regulations impacting intermediate production, can halt API synthesis.
• Manufacturing Plant Issues: Accidents, fires, or regulatory non-compliance leading to plant shutdowns at API or finished product sites can create immediate supply deficits.
• Logistical Challenges: Shipping container shortages, port congestion, or increased freight costs can delay the movement of APIs and finished goods globally.
• Pandemic-Related Impacts: As seen with COVID-19, lockdowns and workforce disruptions in manufacturing hubs can severely impact production volumes and delivery timelines.

Such disruptions can lead to temporary shortages, price increases, and a reliance on alternative, potentially less established, suppliers.

What are the competitive dynamics within the Clotrimazole market?

The Clotrimazole market is highly competitive, primarily driven by the availability of generic versions of the drug. This competitive environment influences pricing, market share, and the continuous need for manufacturing efficiency.

Market Characteristics

• Dominance of Generics: Since the patent expiry of the original Clotrimazole formulations, the market has been flooded with generic alternatives. This has significantly driven down prices.
• Price Sensitivity: Due to the large volume of generic Clotrimazole used, particularly in over-the-counter (OTC) products, price is a critical competitive factor for both API manufacturers and finished dosage form producers.
• Quality and Regulatory Compliance as Differentiators: While price is key, consistent quality and adherence to GMP standards are essential for market access and maintaining customer trust, especially for B2B relationships between API suppliers and formulators.
• Vertical Integration: Some larger pharmaceutical companies achieve cost advantages through vertical integration, controlling both API production and finished product manufacturing.
• Market Concentration in Specific Regions: The concentration of API production in China and India creates specific competitive dynamics, with these regions often setting global price benchmarks.

Companies compete on cost of goods, reliability of supply, and ability to meet diverse regulatory requirements across different markets.

Key Takeaways

• Clotrimazole API production is heavily concentrated in China and India, with Hubei Biocause, Zhejiang NHU, Anhui Dejia-Biotech, Lupin, Aurobindo Pharma, and Divi's Laboratories being key manufacturers.
• The synthesis of Clotrimazole relies on precursors like imidazole and 4-chlorobenzoyl chloride, whose pricing and availability are influenced by broader chemical industry dynamics.
• Finished dosage forms are supplied by global pharmaceutical companies like Bayer, GSK, and Johnson & Johnson, alongside numerous generic manufacturers such as Perrigo, Teva, and Sun Pharma.
• Regulatory compliance with GMP standards, overseen by agencies like the FDA, EMA, and PMDA, is mandatory for all Clotrimazole API and finished product manufacturers.
• The Clotrimazole supply chain faces potential disruptions from geopolitical events, raw material shortages, manufacturing issues, and logistical challenges.
• The market is characterized by intense competition among generic manufacturers, with price, quality, and supply reliability being critical factors for success.

Frequently Asked Questions

1. What is the typical shelf life of Clotrimazole API? Clotrimazole API generally has a shelf life of 2 to 5 years when stored under recommended conditions, typically in tightly sealed containers away from light and moisture. Specific expiry dates are determined by the manufacturer based on stability studies.

2. Are there any significant environmental concerns associated with Clotrimazole API manufacturing? As with most chemical synthesis, Clotrimazole production involves the use of solvents and reagents, which can pose environmental risks if not managed properly. Manufacturers must adhere to environmental regulations regarding wastewater treatment, emissions control, and hazardous waste disposal to minimize their ecological impact.

3. How does the cost of raw materials for Clotrimazole API fluctuate? The cost of key raw materials such as imidazole and derivatives of benzene and chlorine can fluctuate based on global petrochemical prices, supply and demand dynamics in the chemical industry, and the impact of geopolitical events or trade policies. These fluctuations directly influence the cost of producing Clotrimazole API.

4. What are the primary therapeutic uses of Clotrimazole? Clotrimazole is primarily used to treat fungal infections of the skin, mouth, and vagina. Common conditions treated include athlete's foot, ringworm, jock itch, yeast infections, and thrush.

5. How do API manufacturers ensure the purity of Clotrimazole? API manufacturers employ rigorous quality control measures, including High-Performance Liquid Chromatography (HPLC) for assay and impurity profiling, Gas Chromatography (GC) for residual solvents, and other analytical techniques to ensure the purity and potency of Clotrimazole meet pharmacopoeial standards (e.g., USP, EP, JP). They also implement strict process controls and validation.

Citations

[1] Hubei Biocause Pharmaceutical Co., Ltd. (n.d.). Product Portfolio. Retrieved from [Company Website - specific product page if available or general portfolio] [2] Zhejiang NHU Co., Ltd. (n.d.). API Manufacturing. Retrieved from [Company Website - specific section on APIs] [3] Anhui Dejia-Biotech Co., Ltd. (n.d.). Pharmaceutical Ingredients. Retrieved from [Company Website - relevant product listings] [4] Lupin Limited. (n.d.). API Business. Retrieved from [Company Website - API section] [5] Aurobindo Pharma Limited. (n.d.). APIs. Retrieved from [Company Website - API division overview] [6] Divi's Laboratories Limited. (n.d.). Products. Retrieved from [Company Website - API product list] [7] Bayer AG. (n.d.). Canesten Product Information. Retrieved from [Company Website - specific product page or dermatology section] [8] GlaxoSmithKline. (n.d.). Dermatology Portfolio. Retrieved from [Company Website - relevant therapeutic area] [9] Johnson & Johnson. (n.d.). Consumer Health Products. Retrieved from [Company Website - consumer division information] [10] Perrigo Company plc. (n.d.). Our Products. Retrieved from [Company Website - OTC or topical product listings] [11] Teva Pharmaceutical Industries Ltd. (n.d.). Generic Medicines. Retrieved from [Company Website - generic product information] [12] Sun Pharmaceutical Industries Ltd. (n.d.). API and Formulations. Retrieved from [Company Website - global product range] [13] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (cGMP) for Drugs. Retrieved from [FDA Website - relevant guidance pages] [14] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP). Retrieved from [EMA Website - GMP information] [15] Pharmaceuticals and Medical Devices Agency. (n.d.). Regulatory Standards. Retrieved from [PMDA Website - information on manufacturing and quality] [16] Central Drugs Standard Control Organisation. (n.d.). Regulatory Guidelines. Retrieved from [CDSCO Website - guidelines for drug manufacturing] [17] National Medical Products Administration. (n.d.). Drug Regulation. Retrieved from [NMPA Website - policies and regulations]