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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037	NDA	Citra Labs LLC	23731-6051-1	10 VIAL, SINGLE-USE in 1 CASE (23731-6051-1) / 30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)	2003-08-26
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037	NDA	Citra Labs LLC	23731-6051-2	25 VIAL, SINGLE-USE in 1 CASE (23731-6051-2) / 30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)	2003-08-26
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037	NDA	Citra Labs LLC	23731-6051-3	30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)	2003-08-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 7, 2025

Introduction

Voltaren is a well-known non-steroidal anti-inflammatory drug (NSAID) primarily used for the relief of pain, inflammation, and swelling associated with musculoskeletal conditions. Its active ingredient, diclofenac, is available in various formulations, including oral tablets, topical gels, and patches. Given its widespread clinical application, Voltaren's supply chain involves a complex network of manufacturers, distributors, and authorized suppliers globally. This article examines the key suppliers, manufacturing landscape, regulatory considerations, and market dynamics influencing the Voltaren supply chain.

Overview of Voltaren and Its Manufacturing Landscape

Voltaren’s global presence hinges on its active pharmaceutical ingredient (API), diclofenac, and its finished dosage forms. The original patent for Voltaren was held by Novartis, but generic manufacturers have since entered the market, producing similar formulations under various brand names.

The supply chain for Voltaren involves:

API Producers: Suppliers of diclofenac acid.
Formulation Manufacturers: Companies converting API into tablets, gels, patches, etc.
Distribution Networks: Wholesalers, pharmacies, and hospitals worldwide.

This decentralized manufacturing system allows for a diversified supply environment but also presents challenges related to quality control, regulatory compliance, and market stability.

Key Suppliers of Voltaren API (Diclofenac)

Major API Manufacturers

H. Lundbeck A/S
- Background: A Danish pharmaceutical company with historically significant production capabilities in NSAIDs.
- Role: Supplies diclofenac APIs for various formulations, including Voltaren.
Siegfried AG
- Background: Swiss-based contract manufacturer specializing in active ingredients.
- Role: Produces diclofenac in bulk for multiple pharmaceutical companies.
Hikma Pharmaceuticals
- Background: A global generic pharmaceutical company.
- Role: Manufactures and supplies diclofenac APIs used in generic Voltaren products.
Towa Pharmaceutical Co., Ltd.
- Background: Japanese manufacturer with extensive experience in NSAIDs.
- Role: Provides diclofenac APIs to various markets, especially in Asia.
Sandoz (Novartis' generic division)
- Background: A leading producer of generic medications.
- Role: Supplies API and finished products globally, leveraging Novartis's original formulations.

Emerging and Regional API Suppliers

Numerous regional producers supply diclofenac to local markets, especially in developing countries, including Indian, Chinese, and Turkish companies, which often manufacture APIs under local regulatory standards.

Regulatory Compliance and API Quality Standards

API suppliers must comply with Good Manufacturing Practices (GMP) and undergo rigorous quality assurance testing. Certificates of analysis (CoA) are pivotal in verifying API purity, potency, and stability. Suppliers registered with regulatory agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national agencies ensure the downstream commissions for legal distribution.

Leading Formulation and Finished Product Suppliers

Global Pharmaceutical Companies Producing Voltaren

Novartis AG
- Market Position: Original manufacturer and patent holder.
- Formulations: Produces Voltaren in various formulations including oral tablets and topical gels.
GlaxoSmithKline (GSK)
- Role: Some formulations of diclofenac derivatives bottled under GSK variants.
Novartis Generics
- Role: Manufactures and distributes generic Voltaren and diclofenac-based products globally.
Krka and Zentiva (Sanofi)
- Market Focus: Strong presence in Eastern Europe, producing generic versions of Voltaren.
Medius Pharma, Teva Pharmaceutical Industries, and Sandoz
- Role: Major global players manufacturing generic diclofenac formulations.

Regional/Generic Manufacturing

Numerous local manufacturers in countries such as India (e.g., Cipla, Dr. Reddy’s Laboratories), China, and Turkey produce generic Voltaren formulations, often at lower price points, expanding global access.

Distribution and Supply Chain Dynamics

The distribution of Voltaren involves complex logistics, with authorized distributors and wholesalers operating within regulated frameworks. The global supply is subject to:

Regulatory Harmonization: International standards set by WHO, ICH, and national agencies.
Market Demand Fluctuations: Shifts in prescribing habits, patent expirations enabling generics, and regional healthcare policies.
Raw Material Accessibility: API procurement depends on geopolitical stability and regional manufacturing capacity.
Supply Disruptions: Factory closures, regulatory backlogs, and pandemics (e.g., COVID-19) have temporarily hindered supply.

Regulatory Considerations Affecting Supply

The pharmaceutical supply chain for Voltaren is tightly regulated. Manufacturers and suppliers must obtain and maintain approvals from agencies like the FDA, EMA, and local regulatory bodies. Quality standards are mandated to prevent substandard products entering the market, which could compromise patient safety and disrupt supply continuity.

Authorized suppliers and manufacturers are often listed in databases such as the FDA’s Orange Book or the European EudraVigilance system. Non-compliance can result in sanctions, recalls, or supply bans, impacting availability.

Market Trends and Future Outlook

Growing global awareness of NSAID-related adverse effects has prompted increased demand for high-quality formulations. Patent expirations have accelerated the entry of generics, diversifying suppliers further.

Emerging trends include:

Biopharmaceutical Innovations: Development of safer NSAID delivery systems.
Supply Chain Digitalization: Real-time tracking, blockchain integration for traceability.
Regional Manufacturing Expansion: Increased API production capacity in Asia and other emerging markets to meet local demand.
Supply Chain Resilience Initiatives: Strategies for diversification to mitigate disruptions—particularly relevant following recent global supply chain stresses.

Key Challenges

Quality Assurance: Ensuring consistent API and product quality amidst diverse suppliers.
Regulatory Hurdles: Navigating complex approval processes across different jurisdictions.
Market Saturation: Price competition from multiple generics can pressure margins and incentivize supplier consolidation.
Supply Disruptions: Political instability, pandemics, and natural disasters threaten continuity.

Conclusion

The supply of Voltaren is supported by a broad array of API producers and formulators, primarily located in Europe, Asia, and North America. Major players such as Novartis, Sandoz, Hikma, and Siegfried dominate the landscape, offering both branded and generic versions. The supply chain’s resilience depends heavily on stringent regulatory compliance, diversified sourcing, and proactive market strategies. As global demand stabilizes and evolves, stakeholders must prioritize quality, innovation, and supply chain agility to ensure consistent access to Voltaren worldwide.

Key Takeaways

The Voltaren supply chain is globally distributed, with key API manufacturers in Europe, Asia, and North America.
Original producers like Novartis set the standard, while numerous generics companies expand market access.
Regulatory compliance ensures API quality, crucial for patient safety and market access stability.
Regional suppliers contribute significantly, especially in emerging markets, to meet local demand.
Supply chain resilience strategies are essential to mitigate disruptions, maintain quality, and adapt to market changes.

FAQs

1. Who are the leading API suppliers for Voltaren?
Major API suppliers include Siegfried AG (Switzerland), Hikma Pharmaceuticals, Towa Pharmaceutical (Japan), and regional manufacturers in India and China. These companies produce high-quality diclofenac used in Voltaren formulations.

2. Can I find Voltaren produced by different manufacturers in my country?
Yes. Generic Voltaren products are manufactured by various regional companies, especially in emerging markets, providing alternatives to the original Novartis formulations.

3. What regulatory standards do Voltaren suppliers need to meet?
Suppliers must comply with GMP standards enforced by agencies such as the FDA, EMA, and local authorities, ensuring API and finished product quality and safety.

4. How do supply chain disruptions affect Voltaren availability?
Disruptions due to factory closures, logistics issues, or regulatory delays can cause shortages. Diversification of suppliers and regional manufacturing capacity help mitigate these risks.

5. What future trends could impact Voltaren’s supply?
Emerging regulations, market competition, innovations in drug delivery, and global health crises could influence supply dynamics, requiring adaptive strategies by manufacturers and distributors.

References
[1] Pharmaceutical Technology, "Diclofenac API Suppliers," 2022.
[2] European Medicines Agency (EMA), "List of Authorized Active Substances," 2023.
[3] IQVIA, "Global Pharmaceutical Market Data," 2022.
[4] Novartis Official Website, "Voltaren - Product Information," 2022.
[5] WHO, "Guidelines on Good Manufacturing Practices," 2022.

Suppliers and packagers for voltaren

voltaren

Suppliers for the Pharmaceutical Drug: Voltaren