Bulk Pharmaceutical API Sources for LOTRIMIN ULTRA

Bulk Pharmaceutical API Sources for LOTRIMIN ULTRA

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		2484
NovoSeek		443867
ISpharm		I06-0093
ISpharm		I06-0721
MolPort		MolPort-002-885-811

Bulk Active Pharmaceutical Ingredient (API) Sources for LOTRIMIN ULTRA

Last updated: August 2, 2025

Introduction

LOTRIMIN ULTRA is an over-the-counter antifungal treatment primarily composed of terbinafine hydrochloride, aimed at combating dermatophyte infections such as athlete’s foot, jock itch, and ringworm. As a topical formulation, its effectiveness hinges on the quality, purity, and reliability of its active pharmaceutical ingredient (API). Ensuring a consistent supply of high-grade terbinafine hydrochloride is vital for manufacturers, regulatory compliance, and patient safety.

This analysis outlines the key sources for bulk terbinafine hydrochloride, evaluates their credibility, and offers insights into procurement considerations for pharmaceutical companies seeking to produce LOTRIMIN ULTRA.

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Understanding Terbinafine Hydrochloride: The Core API

Chemical Profile:
Terbinafine hydrochloride (C21H27ClN2) is a synthetic allylamine antifungal agent inhibiting squalene epoxidase, disrupting ergosterol synthesis essential for fungal cell membrane integrity. Its oral and topical formulations depend on high purity APIs, generally ≥98%, with strict quality specifications for pharmaceutical use.

Regulatory Standing:
API suppliers must meet Food and Drug Administration (FDA), European Medicines Agency (EMA), and pharmacopeia standards such as the USP, EP, or JP. Good Manufacturing Practice (GMP) certification and comprehensive analytical data underpin supplier credibility.

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Leading Global Suppliers of Terbinafine Hydrochloride

1. Suzhou Eashine Pharmaceutical Co., Ltd.

Overview:
Eashine is a prominent Chinese API manufacturer specializing in antifungals, including terbinafine hydrochloride. The company emphasizes GMP compliance, ISO certifications, and robust R&D capabilities.

Strengths:

• Consistent supply with high purity standards (>99%)
• Proven track record with global clients, including North America and Europe
• Dedicated quality assurance and regulatory support

Considerations:

• Regulatory acceptance varies by country; multinational clients require thorough validation processes

2. Shanghai Weileen Pharmaceutical Co., Ltd.

Overview:
A Chinese-based API producer with extensive experience in antifungal APIs. The company has ISO 9001 and GMP certifications, supporting export to regulated markets.

Strengths:

• Competitive pricing reflecting China's manufacturing costs
• Compliance with pharmacopeial standards, including USP and EP

Considerations:

• Due diligence needed for batch-to-batch consistency and documentation quality

3. Zhejiang Hisun Pharmaceuticals Co., Ltd.

Overview:
A large-scale Chinese API and finished drug product manufacturer with integrated R&D, manufacturing, and quality systems.

Strengths:

• Substantial capacity for large-volume orders
• Extensive quality control procedures aligned with global standards

Considerations:

• Potential variability given complex supply chain; requires supplier audits

4. Hubei Wudao New Materials Co., Ltd.

Overview:
Specializes in both active pharmaceutical ingredients and intermediates, including terbinafine derivatives.

Strengths:

• Innovative manufacturing processes
• Focus on quality and compliance with international standards

Considerations:

• Less established globally; verify certifications before engagement

5. European and American API Suppliers

While Chinese API manufacturers dominate the terbinafine hydrochloride market due to cost advantages and capacity, some European and U.S. firms also supply high-quality APIs suitable for regulated markets.

• G&W Laboratories, Inc. (USA):
  Known for high-quality APIs, GMP-certified, with a reputation for rigorous testing. Supplier of terbinafine hydrochloride for certain commercial applications.

• BASF SE (Germany):
  Leading global chemical supplier; although primarily a chemical distributor, BASF sometimes offers pharmaceutical-grade intermediates and APIs.

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Procurement Considerations

Regulatory Compliance & Certification
Manufacturers of APIs intended for OTC products like LOTRIMIN ULTRA must prioritize suppliers with GMP certification, good manufacturing practices, and detailed analytical and stability data compliant with pharmacopeial standards.

Quality Assurance & Testing
Conduct comprehensive audits or request detailed Certificates of Analysis (CoA). Ensure testing for microbiological contamination, residual solvents, heavy metals, and other residual impurities.

Supply Chain Resilience
Diversify sources to mitigate risks of shortages, geopolitical disruptions, or logistical delays. Long-term procurement agreements or multiple approved vendors are advisable.

Cost vs. Quality Balance
While Chinese suppliers offer competitive prices, US/EU suppliers may provide higher assurance of regulatory compliance for markets with stringent requirements, such as the U.S. or Europe.

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Emerging Trends and Considerations

The pharmaceutical industry is witnessing increased emphasis on APIs sourced from manufacturers with validated supply chains, particularly in response to global disruptions exemplified during the COVID-19 pandemic. This has led to a focus on:

• Nearshoring and local manufacturing in North America and Europe to ensure supply security.
• Advanced analytical technologies for rigorous purity testing.
• Sustainable manufacturing processes aligning with global environmental standards.

Given these trends, pharmaceutical firms producing LOTRIMIN ULTRA should prioritize suppliers capable of maintaining high-quality standards while providing reliable, scalable supply chains.

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Conclusion

Securing a stable supply of high-quality terbinafine hydrochloride remains a critical consideration for LOTRIMIN ULTRA manufacturers. Chinese API suppliers like Suzhou Eashine Pharmaceutical and Shanghai Weileen Pharmaceutical stand out for their capacity, quality, and cost; however, pharmaceutical companies targeting regulated markets must perform meticulous supplier evaluations. High-tier European and American suppliers, though more expensive, offer assurances aligned with strict regulatory environments.

Strategic sourcing, balanced with rigorous quality assurance, enables consistent product quality, regulatory compliance, and supply resilience critical for maintaining OTC antifungal formulations’ efficacy and consumer trust.

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Key Takeaways

• Supplier qualification is paramount: Prioritize GMP-certified suppliers with robust quality control systems for terbinafine hydrochloride.
• Diversify sources: Reduce supply chain risks by engaging multiple high-quality suppliers.
• Regulatory compliance matters: Ensure APIs meet pharmacopeial standards (USP, EP) and have detailed analytical data.
• Cost-quality balance: Chinese suppliers offer cost-effective APIs, but European and U.S. suppliers provide higher regulatory assurance.
• Stay informed of trends: Evolving manufacturing practices and geopolitical factors influence API sourcing strategies.

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FAQs

Q1: What are the main criteria for selecting an API supplier for LOTRIMIN ULTRA?
A1: Key criteria include GMP certification, consistent high purity (>98%), compliance with pharmacopeial standards, reliable supply, and comprehensive documentation supporting quality and regulatory approval.

Q2: Are Chinese API suppliers suitable for regulated markets like the U.S. and Europe?
A2: Yes, many Chinese suppliers have achieved GMP certification and adhere to international standards, but thorough qualification and audit processes are necessary to meet stringent regulatory requirements.

Q3: How can quality assurance be validated when sourcing terbinafine hydrochloride?
A3: Conduct onsite audits, review Certificates of Analysis, analyze batch consistency, and validate analytical testing methods for residual solvents, heavy metals, and microbial contamination.

Q4: What are the risks in sourcing APIs from multiple suppliers?
A4: Risks include variability in quality, differences in purity profiles, or supply disruptions. Proper qualification procedures and continuous quality monitoring mitigate these risks.

Q5: How will global supply chain disruptions affect API sourcing for LOTRIMIN ULTRA?
A5: Disruptions could cause shortages or delays. Diversifying suppliers across regions, maintaining safety stock, and establishing long-term contracts help ensure steady supply.

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References:

1. U.S. Pharmacopeia (USP). Monographs on Terbinafine Hydrochloride.
2. European Directorate for the Quality of Medicines & HealthCare (EDQM). European Pharmacopoeia standards.
3. Market analysis reports, including Pharma Intelligence and IQVIA data on API markets.
4. Company websites and certifications of Chinese API suppliers such as Suzhou Eashine and Shanghai Weileen.