Share This Page
Suppliers and packagers for NEVANAC
✉ Email this page to a colleague
NEVANAC
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Harrow Eye | NEVANAC | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 021862 | NDA | Harrow Eye, LLC | 82667-500-03 | 1 BOTTLE, PLASTIC in 1 CARTON (82667-500-03) / 3 mL in 1 BOTTLE, PLASTIC | 2025-01-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NEVANAC
Introduction
Nevanac, marketed as corticosteroid eye drops, is primarily used to treat postoperative inflammation and pain related to ocular surgeries such as cataract extraction. Its active ingredient, Nepafenac, is a non-steroidal anti-inflammatory drug (NSAID) formulated to reduce ocular inflammation without the typical side effects associated with steroidal treatments. As the demand for effective anti-inflammatory treatments in ophthalmology grows, understanding the supplier landscape for Nevanac becomes crucial for pharmaceutical companies, distributors, and healthcare providers.
This analysis provides a comprehensive overview of the key suppliers of Nevanac, their manufacturing capabilities, and strategic considerations impacting supply chain robustness.
Overview of NEVANAC and Its Composition
Nevanac’s active pharmaceutical ingredient, Nepafenac, was developed by Alcon, a global leader in ophthalmic drug manufacturing, under the Novartis umbrella. The product is delivered as a 0.1% ophthalmic suspension, designed for topical application. The formulation includes excipients optimized for ocular absorption, stability, and patient comfort.
Manufacturing of Nepafenac involves complex chemical synthesis, rigorous quality control, and sterile processing, necessitating specialized production facilities with compliance to Good Manufacturing Practices (GMP). Such technical complexities underscore the importance of sourcing from verified, high-capacity suppliers.
Major Suppliers of NEVANAC
1. Alcon – The Original Manufacturer
As the originator of Nevanac, Alcon remains the primary producer, controlling the majority of supply due to its proprietary manufacturing facilities. Their global presence ensures broader distribution, extensive quality assurance, and supply chain stability.
- Manufacturing Facilities: Alcon operates manufacturing sites across the United States, Europe, and Asia, equipped for pharmaceutical synthesis, sterile processing, and packaging.
- Supply Chain Strategy: Alcon leverages integrated production and distribution networks to maintain timely delivery. The company also invests in capacity expansion to meet rising global demand.
2. Contract Manufacturing Organizations (CMOs)
While Alcon manufactures Nepafenac for Nevanac primarily in-house, certain OEM and generic manufacturers may produce active ingredients or formulations through contracted facilities. These include:
- Alcon’s Strategic Partnerships: Alcon often partners with CMOs globally to ensure supply flexibility, particularly in regions with manufacturing incentives.
- Generic Manufacturers: Licensed generic versions of Nepafenac are produced by several companies leveraging APIs supplied by CMOs or through in-house synthesis.
3. API Suppliers (Active Pharmaceutical Ingredient)
The core of Nevanac’s supply chain revolves around high-quality Nepafenac API suppliers. Leading companies include:
- Synthesis Firms in India and China: Many API manufacturers operate in India (such as Sun Pharma, Cipla) and China (such as Zhejiang Huahai Pharmaceutical), supplying Nepafenac API under strict quality standards.
- Quality Assurance: Suppliers are required to meet pharmacopoeial standards (USP, EP) and undergo rigorous audits for GMP compliance before API approval.
4. Distributors and Wholesalers
Global distribution of Nevanac involves a network of pharmaceutical distributors, particularly in North America, Europe, and Asia. Key distributors include:
- McKesson, Cardinal Health, and AmerisourceBergen (US): Major players that distribute Nevanac to hospitals, clinics, and pharmacies.
- Regional Distributors: In emerging markets, local partners facilitate supply due to logistical or regulatory factors.
Supply Chain Challenges and Considerations
- Regulatory Compliance: Suppliers must adhere to stringent GMP standards; any lapses can disrupt supply.
- Raw Material Constraints: Shortages of raw materials or intermediates for Nepafenac synthesis could affect production.
- Manufacturing Capacity: Global capacity constraints, exacerbated during pandemic disruptions, impact lead times.
- Intellectual Property and Licensing: As a patented, proprietary product, licensing agreements influence the availability of Nevanac and its generics.
Opportunities for Diversification
Given the concentrated nature of Nevanac supply, pharmaceutical companies seeking supply resilience should consider:
- Developing Alternative Suppliers: Engaging with multiple API manufacturers to mitigate risks.
- Formulation Partnerships: Collaborating with CMOs capable of producing ophthalmic suspensions to diversify final product sources.
- Vertical Integration: Investing in regional manufacturing facilities for key components or finished formulations.
Conclusion
The supply landscape for Nevanac hinges predominantly on Alcon’s manufacturing capacity, supported by global API suppliers mainly in India and China. The complex synthesis process and regulatory environment necessitate rigorous quality control, maintaining a tightly governed supply chain. Stakeholders aiming for reliable sourcing must navigate patent protections, quality standards, and capacity constraints, emphasizing the importance of diversified supplier relationships.
Key Takeaways
- Primacy of Alcon: As the original manufacturer, Alcon maintains dominant control over Nevanac supply, leveraging its integrated manufacturing and distribution network.
- API Sourcing: High-quality Nepafenac API from GMP-certified suppliers in India and China forms the backbone of Nevanac production.
- Supply Chain Risks: Capacity constraints, raw material shortages, and regulatory compliance pose potential risks to consistent supply.
- Diversification Strategies: Engaging with multiple API suppliers and forming strategic partnerships with CMOs can bolster supply chain resilience.
- Regulatory Vigilance: Ensuring suppliers meet stringent quality and regulatory standards is critical for uninterrupted product availability.
FAQs
1. Who are the primary manufacturers of NEVANAC?
Alcon is the principal manufacturer of Nevanac, controlling the formulation and distribution. They produce Nepafenac domestically and partner with CMOs globally for supply efficiency.
2. Are there generic equivalents of NEVANAC?
Yes. Several generics with the same active ingredient, Nepafenac, are available in various markets, often produced by local or regional pharmaceutical companies under licensing agreements.
3. What are the main challenges in sourcing NEVANAC?
Challenges include GMP compliance for API manufacturing, capacity limitations, raw material shortages, and navigating patent and licensing terms.
4. How can companies ensure reliable supply of NEVANAC?
Establishing relationships with multiple API suppliers, engaging with reputable CMOs, maintaining safety stock, and monitoring regulatory developments are critical strategies.
5. Is there potential for new suppliers to enter the NEVANAC market?
Given high technical barriers, new entrants require significant investment in GMP-certified manufacturing, quality assurance, and licensing negotiations, which may limit immediate market entry.
Sources
[1] Alcon Official Website, Product Information.
[2] Pharmacology data on Nepafenac.
[3] Global API manufacturing regulatory standards.
[4] Industry reports on ophthalmic pharmaceutical supply chains.
[5] Market analysis reports for ophthalmic drugs.
More… ↓
