Bulk Pharmaceutical API Sources for VOLTAREN-XR

Bulk Pharmaceutical API Sources for VOLTAREN-XR

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jbe`cBBQRBHEDYtD}f\bbbRfabRLCIN}AAPAAL@@@
Calbiochem		287840
NIH Clinical Collection		SAM001247057
HDH Pharma		IN1491

Bulk Active Pharmaceutical Ingredient (API) Sources for VOLTAREN-XR

Last updated: July 29, 2025

Introduction

VOLTAREN-XR, a trade name for diclofenac sodium extended-release formulations, is widely used as an anti-inflammatory and analgesic agent. As a non-steroidal anti-inflammatory drug (NSAID), its efficacy hinges on the quality, purity, and consistent supply of its active pharmaceutical ingredient (API) — diclofenac sodium. Ensuring reliable sources of high-grade API is vital for manufacturers, regulatory compliance, and patient safety.

This article provides a comprehensive overview of key bulk API suppliers for diclofenac sodium, focusing on their manufacturing capabilities, regulatory status, and market positioning, enabling pharmaceutical companies to make informed sourcing decisions.

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Overview of Diclofenac Sodium as an API

Diclofenac sodium, chemically known as sodium 2-[(2,6-dichlorophenyl)amino]phenylacetate, is synthesized via multi-step chemical processes that demand precise control to achieve the required purity (>99%). Its stability, bioavailability, and batch-to-batch consistency are critical factors in formulation development, especially for extended-release products like VOLTAREN-XR.

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Global API Manufacturing Landscape for Diclofenac Sodium

The API manufacturing ecosystem for diclofenac sodium comprises several regions, with prominent manufacturers operating in India, China, Europe, and North America. These suppliers differ in capacity, regulatory approvals, and quality certifications, affecting their suitability for different market needs.

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Major API Suppliers for Diclofenac Sodium

1. Cadila Pharmaceuticals (India)

As a leading Indian API manufacturer, Cadila Pharmaceuticals offers high-grade diclofenac sodium API, compliant with international standards such as USP, EP, and JP. The company has rigorous quality control processes aligned with WHO GMP guidelines and supplies to global markets.

• Strengths: Well-established export network, robust quality systems, competitive pricing.
• Regulatory Status: Approved by the US FDA, MHRA, and other regulatory agencies.
• Capacity: Large-scale production capable of fulfilling both small and bulk orders.

2. Mylan (Global/India)

Mylan is a major global pharmaceutical company with facilities producing diclofenac sodium API in India and Europe.

• Strengths: ISO-certified manufacturing, proven quality, and global supply network.
• Regulatory Status: Holds approvals from FDA, EMA, and other regulatory bodies.
• Capacity: Significant production capacity to meet high-volume demands.

3. Jaishree Pharma (India)

Specialized in the production of NSAID APIs, Jaishree Pharma supplies diclofenac sodium API primarily to domestic and export markets.

• Strengths: Competitive pricing and high purity products.
• Regulatory Status: GMP-certified manufacturing, with approvals from local authorities.
• Capacity: Moderate scale, suitable for various production needs.

4. Hunan Lianzhong Pharmaceutical Co., Ltd. (China)

A prominent Chinese API manufacturer, Hunan Lianzhong produces diclofenac sodium with compliance to Chinese GMP and international standards.

• Strengths: Cost-effective production, extensive export experience.
• Regulatory Status: CE, ISO certifications, and growing approvals in Western markets.
• Capacity: High-volume manufacturing capacity.

5. Hubei Biocause Pharmaceutical Co., Ltd. (China)

With an established track record in NSAID APIs, Hubei Biocause provides diclofenac sodium API to global clients.

• Strengths: Vertical integration, quality certification, aggressive R&D.
• Regulatory Status: GMP certification, pursuing approvals in regulated markets.
• Capacity: Large-scale production.

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Regulatory Considerations and Certifications

For manufacturers seeking to incorporate API into VOLTAREN-XR, sourcing from suppliers with validated GMP compliance, ISO certifications, and regulatory approvals (FDA, EMA, PMDA) is critical. These certifications assure API quality, batch-to-batch consistency, and compliance with pharmacopoeial standards.

International regulatory agencies often require detailed documentation including stability data, impurity profiles, and validation reports before approval of the finished product. Therefore, selecting suppliers with established quality management systems mitigates regulatory risks.

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Emerging API Suppliers and Alternatives

Emerging suppliers in India and China are expanding capacity and improving quality standards, driven by increasing global demand and regulatory tightening. Notably, some new entrants are focusing on sustainable manufacturing practices and innovative process improvements, potentially offering higher purity grades at competitive prices.

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Sourcing Strategies for Diclofenac Sodium API

• Direct procurement from established manufacturers: Ensures supply continuity and regulatory assurance.
• Engaging with authorized distributors: Useful for small volume needs or rapid market entry, provided distributors verify manufacturer credentials.
• Partnering with Contract Manufacturing Organizations (CMOs): For integrated solutions, especially to meet bulk demands and regulatory compliance.

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Quality Assurance and Due Diligence

Prior to procurement, rigorous quality assessments, including audits and review of batch records, are vital. Ensuring GMP compliance, validated analytical methods, and transparent supply chain practices safeguards against counterfeit or substandard API, which could compromise VOLTAREN-XR quality.

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Market Trends and Future Outlook

The API supply chain landscape is dynamic, influenced by geopolitical factors, regulatory reforms, and technological innovations. Vertical integration by large pharmaceutical firms and advances in green manufacturing processes are likely to influence quality and pricing structures. Additionally, capacity expansions in India and China aim to meet increasing global demand for diclofenac sodium.

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Key Takeaways

• Reliable API sourcing for VOLTAREN-XR hinges on selecting suppliers with GMP compliance, robust quality management, and regulatory approvals such as FDA and EMA.
• India and China remain dominant in the diclofenac sodium API market, with multiple manufacturers offering high-quality products at competitive prices.
• Diversifying suppliers reduces risks associated with supply disruptions, regulatory hurdles, and quality issues.
• Implementing stringent due diligence, including audits and documentation review, ensures API integrity and regulatory compliance.
• The evolving API landscape emphasizes sustainability, technological innovation, and capacity expansion as key factors shaping future supply chains.

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FAQs

1. What are the key quality standards for sourcing diclofenac sodium API?
API suppliers should adhere to GMP, possess certifications like ISO, and have approval from major regulatory agencies such as the FDA or EMA. Analytical testing should demonstrate purity (>99%), low impurity levels, and stability.

2. How does regional manufacturing influence API quality for VOLTAREN-XR?
Manufacturers in regions with stringent regulatory frameworks (e.g., Europe, North America) typically maintain higher quality standards. However, large Indian and Chinese producers with comprehensive compliance programs also meet global standards, offering cost-effective options.

3. What should companies consider when choosing between Chinese and Indian API suppliers?
Consider regulatory compliance, certification status, production capacity, lead times, and historical quality performance. Indian suppliers often have extensive export experience and regulatory approvals, while Chinese manufacturers may offer cost advantages and higher volume capacity.

4. Are there risks associated with sourcing API from emerging producers?
Yes. Emerging suppliers may lack extensive regulatory track records, or there may be variability in quality or supply stability. Conducting thorough due diligence and quality audits mitigates these risks.

5. What future trends might impact diclofenac sodium API supply chains?
Increased regulatory scrutiny, technological advances in green manufacturing, capacity expansions in India and China, and supply chain digitization will influence sourcing decisions and market stability.

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References

[1] U.S. Pharmacopeia (USP). Diclofenac Sodium Monograph. 2022.
[2] European Pharmacopoeia (EP). Diclofenac Sodium Reference Standards. 2021.
[3] Global API Market Report, IQVIA, 2022.
[4] Regulatory Approvals Database, U.S. FDA, 2023.
[5] Industry Analysis: Chinese and Indian Pharmaceutical API Manufacturers, PharmaIQ, 2022.