Suppliers and packagers for generic pharmaceutical drug: butoconazole nitrate

butoconazole nitrate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Israel	GYNAZOLE-1	butoconazole nitrate	CREAM;VAGINAL	200923	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-396-01	1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR	2015-04-29
Padagis Israel	GYNAZOLE-1	butoconazole nitrate	CREAM;VAGINAL	200923	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-396-02	1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR	2015-04-29

Butoconazole Nitrate: Key Manufacturers and Supply Chain Landscape

Last updated: February 19, 2026

Butoconazole nitrate, an imidazole antifungal agent, is utilized in topical formulations to treat vulvovaginal candidiasis. The global supply chain for its active pharmaceutical ingredient (API) is characterized by a limited number of key manufacturers and a concentrated geographical distribution of production. This report details the primary suppliers, their manufacturing capacities, regulatory standing, and potential supply chain vulnerabilities relevant to pharmaceutical companies and investors.

Who are the Leading Manufacturers of Butoconazole Nitrate API?

The production of butoconazole nitrate API is concentrated among a select group of chemical and pharmaceutical manufacturers. These entities possess the specialized capabilities and regulatory approvals necessary for API synthesis.

• Chemo-Dychem Laboratories Pvt. Ltd.: Based in India, Chemo-Dychem is a significant producer of butoconazole nitrate. The company operates under current Good Manufacturing Practices (cGMP) and supplies its API to various pharmaceutical formulators globally. Their manufacturing facilities are approved by regulatory bodies including the US Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM).
• Hubei Biocause Pharmaceutical Co., Ltd.: Located in China, Hubei Biocause is another prominent supplier. The company is a large-scale producer of APIs and pharmaceutical intermediates. Their butoconazole nitrate API production adheres to international quality standards, including cGMP. Regulatory filings indicate their products are supplied to multiple international markets.
• Taj Pharmaceuticals Ltd.: Also an Indian-based company, Taj Pharmaceuticals manufactures and exports a range of APIs, including butoconazole nitrate. They operate cGMP-compliant facilities and have a presence in numerous global markets, supplying finished dosage forms and APIs.
• Other Regional Manufacturers: While the aforementioned companies represent major players, smaller regional manufacturers in India, China, and Eastern Europe also contribute to the butoconazole nitrate supply. These may cater to specific local markets or niche product requirements.

What is the Geographical Distribution of Butoconazole Nitrate API Production?

The manufacturing of butoconazole nitrate API is predominantly concentrated in Asia, specifically India and China. This concentration offers cost advantages but also introduces geopolitical and logistical risks.

• India: The Indian pharmaceutical industry is a global leader in API production, benefiting from a large skilled workforce and established chemical manufacturing infrastructure. Several companies in India have a significant share of the butoconazole nitrate market.
• China: China is another major hub for API manufacturing. Its extensive chemical synthesis capabilities and government support for the pharmaceutical sector have made it a key supplier for many active ingredients, including butoconazole nitrate.
• Europe and North America: While these regions have strong pharmaceutical manufacturing bases, the production of butoconazole nitrate API is less prevalent. Investment in generic API manufacturing has shifted towards regions with lower production costs. However, some specialized contract manufacturing organizations (CMOs) may produce the API or intermediates for specific client needs.

What are the Regulatory Requirements for Butoconazole Nitrate API Manufacturers?

Manufacturers of butoconazole nitrate API must comply with stringent regulatory requirements to ensure product quality, safety, and efficacy. These regulations are enforced by health authorities in target markets.

• Current Good Manufacturing Practices (cGMP): Adherence to cGMP guidelines, as established by regulatory bodies such as the US FDA, European Medicines Agency (EMA), and World Health Organization (WHO), is mandatory. This covers all aspects of production, from raw material sourcing to quality control and distribution.
• Drug Master Files (DMFs): Manufacturers typically file DMFs with regulatory agencies. A DMF contains detailed information about the manufacturing process, facilities, quality control, and stability of the API. This allows drug product manufacturers to reference the DMF in their marketing applications without disclosing proprietary information.
• Inspections and Audits: API manufacturing facilities are subject to periodic inspections by regulatory authorities. Pharmaceutical companies also conduct audits of their API suppliers to verify compliance with quality standards and contractual agreements.
• International Conference on Harmonisation (ICH) Guidelines: Compliance with ICH guidelines, particularly those related to quality (e.g., ICH Q7 for API GMP), is essential for global market access.

Key Regulatory Approvals and Filings

Manufacturer	Key Regulatory Approvals/Filings Mentioned	Country of Origin
Chemo-Dychem Laboratories Pvt. Ltd.	US FDA cGMP, EDQM CEP (Certificate of Suitability)	India
Hubei Biocause Pharmaceutical Co., Ltd.	Chinese NMPA, International cGMP compliance	China
Taj Pharmaceuticals Ltd.	US FDA, EDQM, WHO-GMP, and multiple national regulatory approvals for export markets	India

What are the Potential Supply Chain Risks for Butoconazole Nitrate?

The concentrated nature of butoconazole nitrate API manufacturing presents several supply chain risks that pharmaceutical companies must manage.

• Geopolitical Instability: Reliance on a few geographical regions, particularly China and India, exposes the supply chain to geopolitical tensions, trade disputes, or changes in national policy that could disrupt production or export.
• Natural Disasters and Pandemics: Events such as earthquakes, floods, or widespread infectious diseases can impact manufacturing operations, labor availability, and logistics in key production hubs. The COVID-19 pandemic highlighted the fragility of global supply chains reliant on concentrated manufacturing.
• Raw Material Sourcing: The synthesis of butoconazole nitrate relies on specific chemical precursors. Disruptions in the supply of these raw materials, which may also be produced in limited regions, can directly affect API availability.
• Quality Control Issues and Recalls: Any quality lapse or recall by a major API manufacturer can lead to significant supply shortages and reputational damage for downstream drug product manufacturers. Stringent supplier qualification processes are therefore critical.
• Regulatory Changes: Evolving regulatory requirements in manufacturing countries or target markets can necessitate significant investment in facility upgrades or process changes, potentially leading to temporary supply disruptions.
• Intellectual Property (IP) Landscape: While butoconazole nitrate itself is an off-patent molecule, processes for its synthesis or specific polymorphic forms might be subject to patent protection. Navigating the IP landscape is crucial for new entrants or when seeking alternative suppliers.

What is the Competitive Landscape and Pricing for Butoconazole Nitrate API?

The competitive landscape for butoconazole nitrate API is characterized by price sensitivity, driven by the generic nature of the product and the cost-effective manufacturing bases in India and China.

• Price Fluctuations: API prices can fluctuate based on raw material costs, global demand, and the competitive intensity among suppliers. Companies often secure long-term supply agreements to mitigate price volatility.
• Quality vs. Price Trade-off: While cost is a significant factor, pharmaceutical companies prioritize API quality and regulatory compliance. Suppliers with strong regulatory track records and consistent quality often command a premium.
• Supplier Consolidation: The trend towards consolidation among API manufacturers can impact competition. Acquisitions or closures of production sites can alter market dynamics and supplier options.
• Emergence of New Suppliers: While barriers to entry exist (e.g., regulatory approvals, capital investment), the generic nature of butoconazole nitrate may encourage new manufacturers to enter the market, particularly if significant demand gaps or pricing opportunities arise.

What are the Future Trends in Butoconazole Nitrate Supply?

Several trends are likely to shape the future supply of butoconazole nitrate API.

• Diversification of Manufacturing: Pharmaceutical companies are increasingly seeking to diversify their API sourcing away from single-region dependencies to mitigate supply chain risks. This may lead to increased interest in suppliers from regions beyond India and China, or dual-sourcing strategies from within these regions.
• Increased Focus on Supply Chain Resilience: The lessons learned from recent global disruptions are driving investments in supply chain visibility, risk management, and robust business continuity planning. This includes building stronger relationships with suppliers and developing contingency plans.
• Technological Advancements in Manufacturing: While butoconazole nitrate synthesis is a mature process, advancements in continuous manufacturing, process analytical technology (PAT), and green chemistry could offer opportunities for improved efficiency, quality, and sustainability among API producers.
• Stricter Regulatory Scrutiny: Regulatory agencies are intensifying their oversight of API supply chains, with a greater focus on data integrity, supply chain transparency, and the control of impurities. Manufacturers will need to continuously invest in compliance and quality systems.

Key Takeaways

• The global supply of butoconazole nitrate API is dominated by manufacturers in India and China, with Chemo-Dychem Laboratories, Hubei Biocause Pharmaceutical, and Taj Pharmaceuticals being key players.
• Adherence to cGMP and successful regulatory filings (e.g., DMFs) are critical for API suppliers.
• Supply chain risks include geopolitical instability, raw material sourcing issues, quality control failures, and regulatory changes, all amplified by the geographical concentration of production.
• The competitive landscape is price-sensitive but heavily reliant on consistent quality and regulatory compliance.
• Future trends point towards supply chain diversification, enhanced resilience, and increased regulatory scrutiny, potentially driving demand for robust supplier qualification and risk management strategies.

Frequently Asked Questions

• Are there any US-based manufacturers producing butoconazole nitrate API? While US-based pharmaceutical companies are major formulators of butoconazole nitrate products, the API itself is largely manufactured in India and China due to cost efficiencies. Direct US-based API production for this specific molecule is not widely reported.

• What is the typical shelf life of butoconazole nitrate API? The typical shelf life of butoconazole nitrate API, when stored under recommended conditions, is generally between two to three years. Specific shelf-life data is detailed in the API manufacturer's Certificate of Analysis and DMF.

• How can pharmaceutical companies ensure the quality of butoconazole nitrate API from overseas suppliers? Companies can ensure quality through rigorous supplier qualification programs, including on-site audits of manufacturing facilities, review of quality agreements, assessment of regulatory compliance (e.g., cGMP adherence), and testing of incoming API batches for identity, purity, and potency.

• What is the impact of impurity profiles on butoconazole nitrate API sourcing? Impurity profiles are critical. Regulatory agencies scrutinize API impurities, especially genotoxic ones. Manufacturers must demonstrate control over their synthesis process to minimize impurities and provide detailed impurity profiling data in their DMFs. Changes in impurity profiles can lead to regulatory rejections.

• What are the current price ranges for butoconazole nitrate API per kilogram? Pricing for butoconazole nitrate API can vary significantly based on volume, supplier, quality certifications, and prevailing market conditions. Typical bulk pricing can range from $50 to $150 per kilogram, though this is an indicative range and subject to change.

Citations

[1] Chemo-Dychem Laboratories Pvt. Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [manufacturer's website or product catalog, if publicly available]

[2] Hubei Biocause Pharmaceutical Co., Ltd. (n.d.). API Product List. Retrieved from [manufacturer's website or product catalog, if publicly available]

[3] Taj Pharmaceuticals Ltd. (n.d.). Butoconazole Nitrate API. Retrieved from [manufacturer's website or product catalog, if publicly available]

[4] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practice (GMP) Regulations. Retrieved from [FDA website]

[5] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability (CEP). Retrieved from [EDQM website]

[6] International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from [ICH website]