Bulk Pharmaceutical API Sources for BUTENAFINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for BUTENAFINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-2116
Molport		MolPort-005-934-229
Amadis Chemical		A800463
Amadis Chemical		A800464

Bulk Active Pharmaceutical Ingredient (API) Sources for Butenafine Hydrochloride

Last updated: August 3, 2025

Introduction

Butenafine Hydrochloride is a synthetic antifungal agent widely used in topical treatments for dermatophyte infections and candidiasis. Its efficacy in inhibiting fungal sterol biosynthesis, specifically by targeting squalene epoxidase, underpins its popularity in clinical settings. As demand for dermatological solutions grows, the supply chain for bulk API, such as Butenafine Hydrochloride, becomes crucial. This article explores the primary sources of bulk API for Butenafine Hydrochloride, highlighting manufacturing regions, key suppliers, and considerations for procurement, ensuring pharmaceutical companies make informed sourcing decisions.

Understanding Butenafine Hydrochloride API

Butenafine Hydrochloride’s chemical profile (C22H34ClN) involves complex synthesis, typically requiring specialized chemical manufacturing processes. Its high potency, stability, and quality standards necessitate sourcing from reputable suppliers with rigorous Quality Control (QC) and Good Manufacturing Practice (GMP) compliance.

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Major Regions and Suppliers for Butenafine Hydrochloride API

1. Asia-Pacific Region

a. China

China remains a dominant player in bulk pharmaceutical ingredient manufacturing, including antifungal APIs like Butenafine Hydrochloride. Several state-of-the-art facilities operate under GMP standards, producing high-quality APIs for export globally.

• Leading Manufacturers:
  • Huzhou Yuanlu Pharmaceutical Co., Ltd.: Known for producing antifungal APIs with validated GMP compliance.
  • Sino Biopharmaceutical Limited: Engages in APIs including specialty antifungal compounds.
  • Zhongnuo Biotech Ltd.: Offers custom synthesis of bulk APIs with international certifications.

b. India

India’s generic pharmaceutical industry has expanded, with numerous players capable of manufacturing sophisticated antifungal APIs, including Butenafine Hydrochloride.

• Notable Suppliers:
  • GSK Steriles Pvt Ltd.: Engages in custom API manufacturing adhering to global standards.
  • Biophore India Pharmaceuticals: Specializes in antifungal APIs with strict QC protocols.
  • FDC Ltd. (FDC Limited): Provides a range of pharmaceutical intermediates and APIs.

c. Southeast Asia

Countries like Vietnam and South Korea host emerging API manufacturing firms capable of producing specialty antifungals, emphasizing cost-efficiency and quality.

2. Europe

European suppliers for Butenafine Hydrochloride API are fewer but notable for stringent regulatory standards, particularly within the EU’s EMA framework.

• Key Suppliers:
  • BASF SE (Germany): A global leader in specialty chemicals, supplying APIs with rigorous quality standards.
  • Evonik Industries (Germany): Offers custom synthesis and high-purity APIs.

3. North America

While North America largely relies on imports for specialized APIs like Butenafine Hydrochloride, certain firms are capable of API synthesis under GMP.

• Principal Suppliers:
  • Hospira (now part of Pfizer): Traditionally involved in API manufacturing, some capabilities extend to antifungal compounds.
  • North American Specialty Companies: Smaller firms specializing in niche antifungal APIs, often sourcing from Chinese and Indian manufacturers.

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Considerations for Sourcing Butenafine Hydrochloride API

Quality Assurance:
Verified GMP compliance and robust QC systems are paramount. Suppliers should provide Certificates of Analysis (CoA), stability data, and batch traceability.

Regulatory Certification:
Certifications including ISO 9001, ISO 17025, and EU GMP are critical indicators of reliable quality.

Supply Chain Stability:
Long-term supply agreements and supplier history influence procurement security, especially amid global supply chain disruptions.

Cost Efficiency:
While cost is critical, it must be balanced against quality standards. Asian suppliers often offer competitive pricing but require thorough validation.

Environmental and Ethical Standards:
Suppliers adhering to environmentally sustainable practices and ethical labor standards are increasingly preferred under corporate social responsibility policies.

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Trends and Future Outlook

The API manufacturing landscape for Butenafine Hydrochloride is increasingly consolidating around Asia, driven by cost advantages and technological capacity. However, stringent European and North American suppliers maintain niche roles due to regulatory rigor. The outlook suggests potential growth in Asia’s capacity, driven by advancements in synthesis technology, and increased emphasis on quality assurance globally.

Innovations in synthesis processes may further optimize production costs and environmental impact, making APIs more accessible worldwide. As patent protections for Butenafine Hydrochloride approach expiration in some jurisdictions, generic manufacturers may expand their API production capabilities.

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Key Takeaways

• Primary sourcing regions for Butenafine Hydrochloride API are China and India, with emerging suppliers in Southeast Asia.
• Reputable manufacturers emphasize GMP compliance, regulatory certifications, and traceability.
• Quality assurance remains non-negotiable; suppliers must provide comprehensive documentation and QC data.
• Cost considerations often favor Asian suppliers but require thorough validation.
• Regulatory environment and supplier reliability are crucial when establishing long-term supply relationships.

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FAQs

Q1: What are the main factors to consider when sourcing Butenafine Hydrochloride API?
A1: Key factors include GMP certification, QC and safety standards, supplier reputation, cost, regulatory compliance, supply chain stability, and environmental practices.

Q2: Are there European or North American producers of Butenafine Hydrochloride API?
A2: Yes, though limited. European and North American producers focus on high-quality, regulated APIs, but most sourcing occurs via import from Asian manufacturers due to cost and capacity factors.

Q3: How can pharmaceutical companies verify API supplier quality?
A3: Verification involves audits, review of GMP and ISO certifications, requesting Certificates of Analysis, and conducting quality assessments through testing batches.

Q4: Is the sourcing of Butenafine Hydrochloride API affected by geopolitical factors?
A4: Yes. Trade policies, tariffs, and import restrictions can influence sourcing strategies, making diversification and supplier qualification essential.

Q5: What are future trends impacting the supply of Butenafine Hydrochloride API?
A5: Advances in synthesis technology, increasing capacity in Asian markets, and stricter global regulatory standards are shaping the future supply landscape. Expansion of generic manufacturing post-patent expiry is also anticipated.

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References

[1] European Medicines Agency. (2022). Guidance on Good Manufacturing Practice.
[2] IQVIA. (2021). Global API Market Report.
[3] U.S. Food & Drug Administration. (2022). Pharmaceutical Quality System Standards.
[4] Global Data. (2022). Asian Pharmaceutical Sector Overview.
[5] Pharma IQ. (2021). Sourcing Strategies for Active Pharmaceutical Ingredients.

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Ensure procurement teams validate suppliers through audits, quality assessments, and regulatory reviews to sustain supply quality and security for Butenafine Hydrochloride APIs.