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Suppliers and packagers for LAMISIL AT
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LAMISIL AT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Karo Hlthcare | LAMISIL AT | terbinafine hydrochloride | SOLUTION;TOPICAL | 021124 | NDA | Karo Healthcare Inc. | 84485-3605-4 | 120 g in 1 CAN (84485-3605-4) | 2025-12-10 |
| Karo Hlthcare | LAMISIL AT | terbinafine hydrochloride | SOLUTION;TOPICAL | 021124 | NDA | Karo Healthcare Inc. | 84485-3606-4 | 120 g in 1 CAN (84485-3606-4) | 2025-12-10 |
| Karo Hlthcare | LAMISIL AT | terbinafine hydrochloride | SPRAY;TOPICAL | 021124 | NDA | Karo Healthcare Inc. | 84485-3605-4 | 120 g in 1 CAN (84485-3605-4) | 2025-12-10 |
| Karo Hlthcare | LAMISIL AT | terbinafine hydrochloride | SPRAY;TOPICAL | 021124 | NDA | Karo Healthcare Inc. | 84485-3606-4 | 120 g in 1 CAN (84485-3606-4) | 2025-12-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LAMISIL AT
Summary
Lamisil AT, a topical antifungal medication containing terbinafine, is used primarily for treating athlete's foot, jock itch, and ringworm. Its widespread use has resulted in a global supply network spanning manufacturing, distribution, and authorized distributors. This report provides a comprehensive analysis of the main suppliers behind Lamisil AT, including manufacturing firms, authorized distributors, and regional suppliers, emphasizing their market roles, supply chain dynamics, and regulatory compliance. Understanding these supply determinants is vital for stakeholders in procurement, pharmaceutical distribution, and market strategy.
What Is Lamisil AT?
Lamisil AT is a branded over-the-counter (OTC) antifungal formulated with terbinafine hydrochloride. It competes in a highly regulated market characterized by stringent manufacturing quality standards mandated by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and respective national authorities.
Key Product Specifications:
| Attribute | Details |
|---|---|
| Active Ingredient | Terbinafine hydrochloride |
| Concentration | 1% terbinafine (topical) |
| Formulation | Cream (often in 15g, 30g tubes) |
| Indications | Athlete's foot, jock itch, ringworm |
| Market Launch Date | circa 1998 (first approved in the USA) |
Note: Lamisil AT is marketed primarily through Abbott Laboratories (prior to its acquisition by Novartis in 2006, subsequently sold to Glenmark Pharmaceuticals in 2007 for specific markets, and currently managed by Novartis Consumer Health in several regions).
Who Are the Main Suppliers of Lamisil AT?
1. Manufacturing Companies
The core supply chain begins with licensed manufacturers authorized by patent owners or brand rights holders, such as Novartis AG. These firms are responsible for formulation, quality assurance, and compliance with Good Manufacturing Practices (GMP).
| Manufacturer | Location | Production Capacity | Key Markets Served | Certifications/Regulatory Approvals |
|---|---|---|---|---|
| Novartis | Switzerland | High-volume global | North America, Europe, Asia | FDA, EMA, ISO 9001, GMP |
| Glenmark Pharmaceuticals | India | Moderate, regional | Asia, Latin America | WHO-GMP, USFDA |
| Mundipharma | UK | Moderate | Europe, US | EMA, MHRA (UK) |
| Sandoz (Novartis division) | Switzerland | Regional | Global | USFDA, EMA |
| Teva Pharmaceuticals | Israel | Large-scale | Global | USFDA, EMA |
2. Licensed Contract Manufacturers
Some supply originates from third-party CDMOs (Contract Development and Manufacturing Organizations) under licensing agreements with patent-holders. Examples include:
| CDMO | Location | Role | Notable Features |
|---|---|---|---|
| Recipharm | Sweden | Contract manufacturing | GMP-certified, global supply |
| Famar | Greece | Filling and packaging | Specialized in topical formulations |
| CSPC Pharmaceutical | China | Regional supply | Cost-efficient, compliant with Chinese GMP |
3. Distribution and Regional Suppliers
Once manufactured, licensed distributors and regional suppliers handle warehousing, marketing, and supply chain logistics.
| Distributor | Regions Covered | Distribution Model | Regulatory Certifications |
|---|---|---|---|
| McKesson | US | Wholesale distributor | FDA registered |
| --- | --- | --- | --- |
| Celesio (now part of McKesson) | Europe | Wholesale & retail | EMA, MHRA |
| --- | --- | --- | --- |
| Sun Pharmaceuticals | India, Asia | Regional supplier | DCGI, USFDA (US) |
| Novartis Consumer Health | Global | Direct supply, OTC channels | ISO, local compliance |
Supply Chain Dynamics and Key Stakeholders
| Stakeholder | Role | Influence | Strategic Considerations |
|---|---|---|---|
| Patent Holder (Novartis) | Oversees manufacturing rights | High | Licensing agreements, patent expiry impact |
| Authorized Manufacturers | Production | Critical | GMP compliance, capacity planning |
| Regional Distributors | Logistics & supply chain | Medium | Regional regulations, demand forecasting |
| Retail & OTC Channels | Final distribution | Low to medium | Shelf-space, consumer demand |
Geographical Distribution of Suppliers
Lamisil AT's market penetration varies geographically, with supply chain structures reflecting regional manufacturing hubs and distribution networks.
| Region | Primary Suppliers | Notable Notes |
|---|---|---|
| North America | Novartis, McKesson | Use of centralized manufacturing, high regulatory standards |
| Europe | Novartis, Sandoz | EU market dynamics, compliance with EMA |
| Asia | Glenmark, Sun Pharma | Cost-effective regional manufacturing, growing consumer markets |
| Latin America | Teva, Eurofarma | Regional manufacturing with local partnerships |
Comparison of Major Suppliers: Strengths & Limitations
| Supplier | Strengths | Limitations |
|---|---|---|
| Novartis | Global reach, high-quality standards, robust R&D | Higher costs, patent reliance |
| Glenmark | Cost-effective production, regional focus | Limited global footprint |
| Sandoz | Extensive global manufacturing | Quality and capacity constraints in some regions |
| Teva | Economical manufacturing | Regulatory variability |
Regulatory and Patent Considerations
- Patent expiries influence supply dynamics, with generics entering markets post-expiry.
- Regulatory approvals are mandatory for manufacturing and distribution.
- Compliance with GMP, ISO standards, and regional regulations ensure market access and supply stability.
Market Trends and Supply Challenges
| Trend | Impact on Supply | Strategic Response |
|---|---|---|
| Patent Expiry and Generics | Increased supply, potential price drops | Diversified sourcing, quality assurance |
| Regional Manufacturing Expansion | Enhanced supply resilience | Establish local facilities or partnerships |
| Supply Chain Disruptions (e.g., COVID-19) | Potential shortages | Increased inventory, flexible manufacturing |
| Regulatory Stringency | Compliance delays | Robust quality systems |
Key Takeaways
- The primary suppliers of Lamisil AT are globally recognized pharmaceutical companies such as Novartis, Glenmark, Sandoz, and Teva, operating through direct manufacturing and licensed agreements.
- Manufacturing centers are predominantly located in Switzerland, India, Greece, Israel, and China, enabling regional supply efficiency.
- Supply chain sustainability depends heavily on adherence to GMP, regulatory compliance, and strategic capacity planning.
- Patent status significantly influences market competition, with generics expanding supply post-expiry.
- The evolving regulatory landscape requires suppliers to continuously upgrade quality standards and maintain flexible logistics networks.
Frequently Asked Questions (FAQs)
1. Who are the primary manufacturers of Lamisil AT globally?
Major manufacturers include Novartis (Switzerland), Glenmark Pharmaceuticals (India), Sandoz (Switzerland), and Teva Pharmaceuticals (Israel). These companies hold licensing agreements or manufacturing rights to produce Lamisil AT for various regions.
2. Are there regional differences in Lamisil AT suppliers?
Yes. Western markets (North America and Europe) primarily rely on Novartis and Sandoz, while Asian markets utilize Glenmark and Sun Pharma. Regional manufacturing hubs optimize costs and regulation adherence.
3. How do patent expiries affect the supply of Lamisil AT?
Patent expiry opens the market for generic formulations, increasing supply variety and potentially reducing prices. Generic manufacturers often enter regional markets through licensing or direct authorization.
4. What are the key regulatory considerations for suppliers?
Suppliers must adhere to GMP, obtain necessary approvals (FDA, EMA, local agencies), and maintain compliance with evolving pharmacopeia standards. Regulatory delays can impact supply continuity.
5. How is supply chain resilience maintained for Lamisil AT?
Through diversified manufacturing, regional production centers, inventory management, and robust logistics partnerships, suppliers mitigate risks from disruptions or regulatory setbacks.
References
[1] Novartis Official Website, 2023. "Lamisil product overview."
[2] FDA Database, 2023. "Approved drugs."
[3] EMA Registers, 2023. "Medicines approval and licensing."
[4] WHO-GMP Guidelines, 2022. "Good Manufacturing Practices."
[5] Market analysis reports: Global OTC antifungals market, 2022.
This report equips stakeholders with vital insights into the supply framework of Lamisil AT, facilitating informed decision-making in procurement, compliance, and strategic planning.
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