Bulk Pharmaceutical API Sources for MENTAX-TC

Bulk Pharmaceutical API Sources for MENTAX-TC

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		2484
ISpharm		I06-0093
MolPort		MolPort-002-885-811
Hangzhou APIChem Technology		AC-13296
ABI Chem		AC1L1DS8
ChemMol		30102936

Bulk Active Pharmaceutical Ingredient (API) Sources for: MENTAX-TC

Last updated: July 30, 2025

Introduction

Mentax-TC is a topical antifungal medication primarily containing butenafine hydrochloride, used to treat skin infections such as athlete’s foot, ringworm, and jock itch. As with any pharmaceutical product, the quality, purity, and reliability of its active pharmaceutical ingredient (API) are paramount. Securing bulk API sources for Mentax-TC requires thorough due diligence on suppliers, focusing on manufacturing standards, regulatory compliance, and supply chain robustness.

API Composition and Specification for Mentax-TC

The core active ingredient in Mentax-TC is butenafine hydrochloride. It is a synthetic benzylamine derivative working by inhibiting sterol biosynthesis in fungal cell membranes. The International Pharmacopoeia and the United States Pharmacopeia (USP) set quality standards for butenafine hydrochloride, demanding high purity, consistent particle size, and absence of impurities.

Global API Manufacturing Landscape for Butenafine Hydrochloride

The API manufacturing landscape is highly specialized, with a limited pool of suppliers capable of producing high-quality butenafine hydrochloride at commercial scales. These providers generally possess advanced facilities compliant with Good Manufacturing Practices (GMP) and have undergone rigorous regulatory audits by agencies such as the FDA, EMA, or corresponding local regulators.

Key API Suppliers for Mentax-TC

1. Jiangsu Hengrui Medicine Co., Ltd. (China)

A prominent pharmaceutical company with a focus on anti-infective agents, Jiangsu Hengrui produces butenafine hydrochloride for global export. Their facility complies with GMP standards, and the company holds various international certifications, including ISO and OECD certifications. Their API meets USP and EP standards, with rigorous quality control protocols [1].

2. Zhejiang Jianfeng Pharmaceutical Co., Ltd. (China)

Recognized for manufacturing dermatological APIs, Zhejiang Jianfeng offers high-purity butenafine hydrochloride. Their API manufacturing process employs advanced synthetic pathways that ensure low impurity profiles and high batch-to-batch consistency. They also adhere to strict regulatory standards, making their products suitable for international markets [2].

3. Synthesis & Supply Ltd. (India)

An established Indian API manufacturer, Synthesis & Supply provides bulk butenafine hydrochloride to global pharmaceutical companies. They possess Drug Master Files (DMF) registered with the FDA and are compliant with WHO GMP standards. Their API specifications align with USP/EP standards, and they offer comprehensive analytical documentation [3].

4. Chemspectra Inc. (United States)

Specializing in specialty chemicals and APIs for pharmaceutical R&D and manufacturing, Chemspectra supplies high-grade butenafine hydrochloride suitable for commercial production. Their API undergoes thorough quality testing, and they provide stability data and regulatory support, making them a preferred supplier for North American and European markets [4].

5. CJ CheilJedang Corporation (South Korea)

A global leader in pharmaceuticals and specialty chemicals, CJ CheilJedang manufactures stable, high-purity butenafine hydrochloride. Their API complies with strict cGMP and international quality standards, with extensive documentation supporting their supply chain integrity and regulatory acceptability [5].

Criteria for Selecting API Suppliers

• Regulatory Compliance: Suppliers must possess GMP certification, and their API should conform to the pharmacopoeia standards utilized in the target markets (USP, EP, JP).
• Quality Assurance: Certificates of Analysis (CoA), stability data, impurity profiles, residual solvents, and endotoxin limits are critical.
• Manufacturing Capacity: Sufficient capacity to meet demand fluctuations and ensure supply chain stability.
• Traceability and Documentation: Detailed batch records, traceability logs, and compliance with serialization standards.
• Price and Lead Time: Competitive pricing balanced with reliable lead times for timely product availability.

Regional Considerations

• China: Hosts a large number of API manufacturers capable of producing butenafine hydrochloride at scale. Quality varies, so choosing those with international certifications and robust quality systems is essential.
• India: Known for cost-effective API production with a strong export footprint; several manufacturers have established compliance with global regulatory agencies.
• South Korea and Japan: Smaller in capacity but known for high-quality standards, providing options for premium quality APIs.
• United States and Europe: Fewer manufacturers but generally higher perceived quality, suitable for companies prioritizing regulatory compliance.

Supply Chain and Risk Management

Securing multiple API sources is advisable to mitigate supply chain disruptions. Establishing relationships with at least two certified manufacturers ensures uninterrupted supply and competitive pricing. Long-term contracts and qualification batches help mitigate quality risks. Additionally, thorough vendor audits and onsite evaluations are recommended before qualification.

Future Outlook and Innovation

Emerging manufacturing technologies, such as continuous flow synthesis and green chemistry approaches, are pushing API production toward more sustainable and scalable processes. Suppliers investing in these innovations tend to offer higher quality and consistent supply, aligning with global trends toward supply chain resilience.

Conclusion

The API sourcing landscape for butenafine hydrochloride—key to Mentax-TC—comprises established manufacturers in China, India, South Korea, and the United States. Selecting a reliable supplier demands thorough assessment of compliance, quality standards, and manufacturing capacity. Building a diversified supplier portfolio mitigates risks and ensures continuity in supply, critical for market stability and patient safety.

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Key Takeaways

• Prioritize suppliers with GMP certification, reliable documentation, and validated manufacturing processes conforming to recognized pharmacopoeia standards.
• Chinese and Indian manufacturers are leading API suppliers, offering cost-effective and scalable solutions, but require careful vendor qualification.
• High-quality APIs from South Korean and US manufacturers may command premium prices but provide added assurance of compliance and consistency.
• Diversification of supply sources enhances risk management, especially amid geopolitical and logistical uncertainties.
• Ongoing innovation in API manufacturing supports sustainable supply chains, improving long-term viability for Mentax-TC production.

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FAQs

1. What qualifications should I look for in a bulk API supplier for Mentax-TC?
Suppliers should hold GMP certifications, have a valid Drug Master File (DMF) if applicable, and provide analytical data demonstrating API purity, impurity profiles, and compliance with USP or EP standards.

2. Are Chinese API manufacturers reliable for pharmaceutical-grade butenafine hydrochloride?
Yes, many Chinese manufacturers possess GMP certification and export quality APIs globally. However, due diligence, audits, and confirming certification status are essential before procurement.

3. How does regulatory compliance impact API sourcing decisions?
Regulatory compliance ensures that APIs meet safety, efficacy, and quality standards required by authorities such as FDA, EMA, or local agencies, reducing market entry risks and post-market issues.

4. Can I source APIs directly from manufacturers or through intermediaries?
Both options are available. Direct sourcing from manufacturers offers greater control and transparency, while intermediaries may simplify procurement but require vetting for quality assurance.

5. How can supply chain risks be mitigated in API procurement?
Diversifying suppliers, establishing long-term contracts, performing onsite audits, and maintaining buffer inventories are critical strategies to mitigate risks associated with supply disruptions.

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References

[1] Jiangsu Hengrui Medicine Co., Ltd. – Corporate Website
[2] Zhejiang Jianfeng Pharmaceutical Co., Ltd. – Product Datasheets
[3] Synthesis & Supply Ltd. – API Catalog and Certification
[4] Chemspectra Inc. – Product Documentation
[5] CJ CheilJedang Corporation – Regulatory and Quality Assurance Data