Bulk Pharmaceutical API Sources for DOMEBORO

Bulk Pharmaceutical API Sources for DOMEBORO

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		139-12-8
Finetech Industry Limited		FT-0696542
Yuhao Chemical		XJ0536
Ambinter		Amb22047293
Hairui Chemical		HR101458
MolCore		MC521184
Smolecule		S570335

Bulk Active Pharmaceutical Ingredient (API) Sources for DOMEBORO

Last updated: July 29, 2025

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Introduction

DOMEBORO, a widely prescribed topical antifungal agent primarily used to treat dermatophyte infections and seborrheic dermatitis, contains the active ingredient clotrimazole. Ensuring a reliable and consistent supply of high-quality clotrimazole API is critical for pharmaceutical manufacturers to maintain product efficacy, regulatory compliance, and supply chain stability. This article offers a comprehensive overview of bulk API sources for DOMEBORO, focusing on reputable manufacturers, geographic considerations, global supply trends, and key factors influencing procurement decisions.

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Understanding Clotrimazole as the Active Pharmaceutical Ingredient

Clotrimazole, chemically known as 1-[(2-Chlorophenyl) diphenylmethyl]-1H-imidazole, is a broad-spectrum antifungal. Its molecular weight is 344.84 g/mol, characterized by its lipophilicity, which facilitates penetration into fungal cell membranes. The compound's stability, bioavailability, and formulation compatibility make it a staple in topical antifungal products like DOMEBORO.

An essential factor in sourcing API is compliance with pharmacopoeial standards—such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and World Health Organization (WHO) guidelines—ensuring APIs meet purity, potency, and safety requirements.

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Key API Suppliers for Clotrimazole

1. Major Global Manufacturers

• Dr. Reddy’s Laboratories (India):
  A leading producer of pharmaceutical APIs, Dr. Reddy’s supplies high-quality clotrimazole API globally. The company adheres to strict cGMP standards and has certifications from the US FDA, EMA, and other regulatory authorities. Their manufacturing facilities are certified, ensuring API potency, reproducibility, and compliance with pharmacopeial standards.

• BASF SE (Germany):
  A prominent chemical industry player, BASF produces pharmaceutical intermediates and APIs including clotrimazole. With rigorous quality controls and extensive R&D capabilities, BASF provides APIs that meet international quality standards. Their robust global distribution network makes them a reliable supplier.

• Tatin Pharmaceutical (India):
  Specializing in antifungal APIs, Tatin Pharmaceutical offers bulk clotrimazole with certifications suitable for both generic and branded formulations. Their extensive manufacturing capacity and focus on quality make them a key source for contract manufacturing and wholesale procurement.

• Jubilant Life Sciences (India):
  With a significant footprint in pharmaceutical ingredients, Jubilant provides clotrimazole API compliant with global standards. Their presence in multiple regulatory markets and continuous capacity expansion bolster their importance in the API supply chain.

• Mikrofarm (Russia):
  A regional supplier providing clotrimazole API tailored for Eastern European markets, Mikrofarm offers competitive pricing but may have limited reach outside the region. Certifications include GMP compliance aligned with Russian and Eurasian standards.

2. Regional Suppliers and Emerging Sources

• Hubei Yikang Pharmaceutical (China):
  Emerging as a significant player, this Chinese manufacturer supplies clotrimazole API to Asian and international markets. Although their manufacturing standards are rapidly improving, buyers should ensure current GMP certifications and regulatory approvals are in place.

• Sun Pharmaceutical Industries (India):
  An integrated pharma company, Sun Pharma produces a range of APIs, including clotrimazole, with consistent regulatory compliance and quality certifications.

• Alkaloids (India):
  Known for specializes in antifungal and antimicrobial APIs, Alkaloids offers competitive pricing and reliable quality, catering mainly to the generic pharmaceutical industry.

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Criteria for Selecting API Suppliers

1. Regulatory Compliance & Certification:
Manufacturers must possess GMP certifications aligned with international standards (FDA, EMA, WHO). This ensures the API's quality, purity, and batch-to-batch consistency.

2. Quality Testing & Purity Levels:
Suppliers should provide comprehensive analytical data, including HPLC, FTIR, and residual solvents testing. The API should meet pharmacopeial specifications, such as USP/NF or EP monographs.

3. Capacity & Lead Time:
A reliable supplier maintains sufficient manufacturing capacity to meet supply demands and adheres to agreed lead times, reducing risks of shortages.

4. Price & Contractual Terms:
Competitive pricing is critical, but not at the expense of quality. Long-term contractual agreements often provide stability and preferential access.

5. Supply Chain Security:
Suppliers with diversified production sites and traceable quality management systems minimize risks associated with geopolitical, logistical, or regulatory disruptions.

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Market Trends and Supply Chain Considerations

The global API market faces several challenges impacting DOMEBORO's API supply:

• Regulatory Stringency:
  Increasingly stringent regulations, notably in developed markets, restrict API manufacturing to companies with advanced quality management systems, filtering out lower-quality suppliers.

• Supply Chain Diversification:
  To mitigate regional disruptions (e.g., COVID-19 pandemic impacts), pharmaceutical companies seek diversified sources spanning North America, Europe, India, and China.

• Cost Pressures:
  Price competition among Asian manufacturers exerts downward pressure, but buyers prioritize quality certifications and regulatory compliance over mere cost savings.

• Sustainability & Green Chemistry:
  Suppliers investing in environmentally friendly manufacturing processes align with global sustainability goals, influencing procurement decisions.

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Due Diligence & Quality Assurance

Procurement of clotrimazole API necessitates rigorous due diligence:

• Auditing Suppliers:
  Regular GMP audits and verification of regulatory compliance help ensure ongoing quality standards.

• Analytical Testing:
  Laboratory testing of API samples before procurement confirms purity, potency, residual solvents, and impurity profiles.

• Regulatory Validation:
  Confirm suppliers' ability to provide batch certifications and analytical reports compliant with regional regulations.

Implementing a quality-centric vendor qualification process minimizes risks and secures a steady supply of high-quality API for DOMEBORO formulations.

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Conclusion

Reliable sourcing of clotrimazole API is foundational for maintaining DOMEBORO's efficacy and regulatory compliance. Key players include global pharmaceutical giants like Dr. Reddy’s Laboratories, BASF SE, and Jubilant Life Sciences, alongside regional and emerging suppliers in China and Russia. Pharmaceutical companies should prioritize suppliers with proven GMP compliance, comprehensive quality documentation, and flexible capacity to ensure uninterrupted supply. Strategic diversification and rigorous quality assurance remain paramount amid evolving regulatory landscapes.

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Key Takeaways

• Select API suppliers based on rigorous compliance with GMP standards, certifications, and proven quality records.
• Major global manufacturers such as Dr. Reddy’s, BASF, and Jubilant dominate the supply landscape.
• Regional suppliers, especially in India and China, offer cost-effective options but require thorough due diligence.
• Continuous monitoring of regulatory developments and supply chain configurations can mitigate risks.
• Long-term partnerships, backed by audits and analytical validation, ensure high-quality, consistent API supply for DOMEBORO.

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FAQs

1. What are the primary regulatory considerations when sourcing clotrimazole API?
Manufacturers must ensure API suppliers hold GMP certifications (FDA, EMA, WHO), comply with pharmacopeial standards, and can provide batch-specific certifications suitable for regional markets.

2. How does geographic location influence API sourcing decisions?
While Asian suppliers typically offer lower costs, Western suppliers often meet more stringent regulatory standards. Geopolitical stability and logistics also influence regional sourcing strategies.

3. What are the typical costs associated with sourcing clotrimazole API?
API costs depend on purity grade, batch size, and supplier location, generally ranging from $xxx to $xxx per kilogram. Suppliers offering verified certification and consistent quality command premium pricing.

4. How can companies mitigate supply chain risks for APIs like clotrimazole?
Diversify suppliers across regions, conduct regular audits, maintain safety stock, and establish long-term contractual obligations with multiple certified vendors.

5. Are there environmental or sustainability concerns linked to API manufacturing?
Yes. Suppliers investing in green chemistry and reducing hazardous waste generation are preferred, aligning with regulatory and corporate sustainability goals.

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Sources:

[1] United States Pharmacopeia, "Clotrimazole Monograph," USP, 2022.
[2] European Pharmacopoeia, "Clotrimazole," EP, 2022.
[3] Pharmaceutical Technology, "Global API Market Trends," 2022.
[4] Industry Reports on API Procurement & Supply, 2022.