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Suppliers and packagers for TERBINAFINE HYDROCHLORIDE
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TERBINAFINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sun Pharma Canada | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | CREAM;TOPICAL | 077511 | ANDA | Walgreen Company | 0363-2080-01 | 1 TUBE in 1 CARTON (0363-2080-01) / 15 g in 1 TUBE | 2007-07-02 |
| Sun Pharma Canada | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | CREAM;TOPICAL | 077511 | ANDA | Walgreen Company | 0363-2080-02 | 1 TUBE in 1 CARTON (0363-2080-02) / 30 g in 1 TUBE | 2007-07-02 |
| Sun Pharma Canada | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | CREAM;TOPICAL | 077511 | ANDA | WALGREEN COMPANY | 0363-4502-02 | 1 TUBE in 1 CARTON (0363-4502-02) / 30 g in 1 TUBE | 2023-10-25 |
| Sun Pharma Canada | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | CREAM;TOPICAL | 077511 | ANDA | Rite Aid Corporation | 11822-0080-1 | 1 TUBE in 1 CARTON (11822-0080-1) / 15 g in 1 TUBE | 2007-07-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Terbinafine Hydrochloride
Introduction
Terbinafine hydrochloride is an antifungal agent primarily used in the treatment of dermatophyte infections such as dermatophytosis, onychomycosis, and tinea infections. Its efficacy, safety profile, and wide application in dermatology make it a highly demanded pharmaceutical compound globally. As a result, numerous suppliers and manufacturers produce terbinafine hydrochloride, catering to pharmaceutical companies, compounding pharmacies, and research institutions.
This article provides a comprehensive overview of key suppliers of terbinafine hydrochloride, highlighting their market position, geographic presence, quality standards, and supply chain capabilities. This guide aims to inform pharmaceutical logistics, procurement strategies, and regulatory considerations surrounding terbinafine hydrochloride.
Global Market Overview
The global demand for terbinafine hydrochloride has increased significantly over the past decade, driven by rising incidence of fungal infections and heightened awareness about dermatological health. The supply chain encompasses manufacturers across North America, Europe, Asia-Pacific, and other emerging markets. The major players typically adhere to strict quality standards, such as the current Good Manufacturing Practice (cGMP), ensuring compliance with regulatory agencies like the FDA and EMA.
Major Suppliers of Terbinafine Hydrochloride
1. Gening Pharmaceutical
Overview:
Gening Pharmaceutical is among the leading Chinese manufacturers specializing in active pharmaceutical ingredients (APIs). Known for producing high-quality terbinafine hydrochloride, Gening has established a strong presence in both domestic and international markets.
Production Capabilities:
- cGMP-compliant manufacturing facilities.
- Supply capacity exceeding several hundred kilograms per month.
- Strict quality control with batch-by-batch testing and certification.
Market Position:
Gening primarily supplies to generic pharmaceutical firms, API traders, and research laboratories globally, with an emphasis on Asia, Europe, and North America.
Website/Contact:
www.geningpharma.com (as per current online sources)
2. Huadong Medicine (Hubei Huida Pharmaceutical)
Overview:
A major Chinese pharmaceutical company that produces a broad spectrum of APIs, including terbinafine hydrochloride. Huadong Medicine emphasizes innovation coupled with quality assurance, adhering to international standards.
Production Capabilities:
- GMP certification from multiple regulatory bodies.
- Large-scale production with robust export channels.
Market Position:
Serves both domestic and international markets, supplying terbinafine hydrochloride to large pharmaceutical enterprises.
Website/Contact:
www.huadong.com
3. MEBAR SAGL
Overview:
An Italian-based pharmaceutical API manufacturer recognized for high-quality products, including terbinafine hydrochloride. MEBAR SAGL emphasizes strict quality control aligned with European regulations.
Production Capabilities:
- cGMP compliance.
- Focus on high-purity APIs suitable for prescription drugs.
Market Position:
Predominantly supplies European pharmaceutical companies and distributors, with an expanding presence in North America.
Website/Contact:
www.mebar.it
4. Hubei Yikang Pharmaceutical Co., Ltd.
Overview:
A notable Chinese API producer with extensive experience producing antifungal agents. They invest heavily in quality assurance and export their products globally.
Production Capabilities:
- cGMP approval.
- Capable of custom synthesis and bulk production.
Market Position:
Focused on bulk API supply to multinational pharma companies and OEMs.
Website/Contact:
Available through API trade platforms.
5. Xianfeng Pharma
Overview:
Based in India, Xianfeng Pharma offers terbinafine hydrochloride at competitive prices. The company seeks to serve manufacturers seeking reliable APIs compliant with international standards.
Production Capabilities:
- Certified facilities under Indian regulatory standards (DCGI).
- Large-scale production volume.
Market Position:
Procuring API for generic and branded formulations worldwide.
Website/Contact:
Typically accessible via B2B API marketplaces such as Alibaba or intermediaries.
Other Notable Suppliers
- Alfa Aesar (a Johnson Matthey subsidiary): Offers high-purity APIs suitable for research and pharmaceutical manufacturing.
- Bachem: Supplies specialized intermediates, including APIs, with high-quality assurance.
- Shandong Xinhua Pharmaceutical Co., Ltd.: A Chinese manufacturer focused on antifungal and other APIs.
Quality and Regulatory Considerations
When selecting suppliers for terbinafine hydrochloride, compliance with regulatory and quality standards is paramount. Suppliers should provide:
- Certificates of Analysis (CoA)
- GMP certification
- Analytical method details
- Stability data
The pharmaceutical company must verify supplier compliance with regional regulatory bodies such as the FDA (U.S.), EMA (Europe), and CFDA (China). Importantly, suppliers with a track record of consistent quality and regulatory adherence are preferred.
Supply Chain and Procurement Insights
Global procurement of terbinafine hydrochloride should prioritize suppliers with proven quality records and reliable logistics capabilities. Given the criticality of API purity and batch consistency, companies often conduct supplier audits and utilize sourcing platforms like Pharmacompass, Alibaba, or ThomasNet. Long-term supplier relationships and diversified sourcing reduce risk and ensure continuity.
Emerging Markets and Future Trends
Asia-Pacific continues to dominate API manufacturing owing to cost advantages and increasing capacity. However, stricter regulatory scrutiny in Europe and North America prompts suppliers to invest in quality systems aligned with international standards. The increasing adoption of biosimilar and generic antifungal formulations signifies a sustained demand, encouraging diversification of supply sources.
Key Takeaways
- Leading suppliers of terbinafine hydrochloride include Chinese manufacturers like Gening Pharmaceutical and Hubei Yikang Pharmaceutical, European firms such as MEBAR SAGL, and Indian companies like Xianfeng Pharma.
- Quality assurance, GMP compliance, and regulatory certification are critical screening criteria for supplier selection.
- Building diverse, reliable supply chains mitigates risks associated with geopolitical, logistical, or quality-related disruptions.
- Procurement strategies should leverage verified platforms, conduct audits, and prioritize long-term partnerships.
- As demand grows, geographic and technological diversification remain strategic considerations.
FAQs
1. Which countries dominate the supply of terbinafine hydrochloride?
China leads in manufacturing capacity, followed by India and European countries such as Italy. North America primarily imports APIs due to stringent quality standards.
2. What quality standards should I verify when sourcing terbinafine hydrochloride?
Ensure GMP certification, high purity levels (typically >98%), and validated analytical methods. Certificates of Analysis and stability data are essential for compliance.
3. Can I source terbinafine hydrochloride for research purposes?
Yes. Suppliers like Alfa Aesar and Sigma-Aldrich offer research-grade APIs, often with less stringent regulatory requirements compared to pharmaceutical-grade batches.
4. How does regional regulation impact API sourcing?
Regulations influence quality standards, documentation requirements, and customs procedures. Suppliers compliant with US FDA and EMA standards are preferred for products intended for human use.
5. Are there any risks associated with sourcing from emerging markets?
Risks include variable quality control, regulatory non-compliance, and logistical delays. Due diligence, audits, and supplier verification mitigate these risks.
Conclusion
The procurement of terbinafine hydrochloride requires strategic supplier selection rooted in quality assurance, regulatory compliance, and reliable supply capabilities. Key Asian and European manufacturers dominate the market, with China and India serving as primary production hubs. Pharmaceutical companies must prioritize verified suppliers that adhere to international standards, fostering robust and compliant supply chains to meet global demand effectively.
Sources
[1] Pharmaceutical Market Reports, Global API Production Data.
[2] Company websites and official certification documentation.
[3] Industry trade platforms such as Pharmacompass, Alibaba, and ThomasNet.
[4] Regulatory agency guidelines (FDA, EMA, CFDA).
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