Bulk Pharmaceutical API Sources for ZORVOLEX

Bulk Pharmaceutical API Sources for ZORVOLEX

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-000-003-072
TCI (Tokyo Chemical Industry)		D3748
Vitas-M Laboratory		STK984493

Bulk Active Pharmaceutical Ingredient (API) Sources for ZORVOLEX

Last updated: July 30, 2025

---

Introduction

ZORVOLEX (diclofenac lysinate) is an oral nonsteroidal anti-inflammatory drug (NSAID) approved for treatment of mild to moderate pain and arthritis. Its efficacy and safety hinge on the consistent quality of its active pharmaceutical ingredient (API), diclofenac lysinate. As a specialized salt form of diclofenac, sourcing high-quality API is paramount for manufacturers to ensure product integrity, regulatory compliance, and supply chain stability. This article examines the top bulk API sources for diclofenac lysinate used in ZORVOLEX, considering their production capabilities, regulatory standing, and strategic importance.

---

Understanding Diclofenac Lysinate

Diclofenac lysinate is a water-soluble salt form of diclofenac, optimized for rapid absorption and bioavailability. Unlike traditional diclofenac sodium, lysinate salts offer faster onset of action, a critical feature for formulations like ZORVOLEX targeting immediate pain relief. Given its complex manufacturing requirements, sourcing reliable bulk API is essential.

---

Global API Suppliers for Diclofenac Lysinate

1. VWR Chemicals (Part of Avantor)

VWR Chemicals, under Avantor, supplies a broad range of active pharmaceutical ingredients, including diclofenac and its salts. Their API portfolio emphasizes high purity standards compliant with cGMP (current Good Manufacturing Practice). Although VWR sources APIs from multiple contract manufacturers, their quality assurances and consistent supply make them a notable supplier for diclofenac lysinate.

Key Points:

• cGMP-compliant sources
• Extensive quality control documentation
• Global distribution network

2. Hangzhou First Pharmaceutical Co., Ltd.

A prominent Chinese API manufacturer specializing in NSAIDs, Hangzhou First Pharmaceutical produces various diclofenac salts, including lysinate forms. Their infrastructure is equipped for large-scale production with strict adherence to GMP guidelines, facilitating reliable supply chains for pharmaceutical companies globally.

Key Points:

• Certified GMP facilities
• Competitive pricing
• Focused expertise in NSAID APIs

3. Hubei Green Home Pharmaceutical Co., Ltd.

This Chinese pharmaceutical company manufactures APIs with a focus on high-purity NSAIDs, including diclofenac salts. Their manufacturing processes include advanced crystallization and purification techniques aimed at meeting international regulatory standards.

Key Points:

• Emphasis on product purity and stability
• Capable of large-volume API production
• Innovation in salt form production

4. Jiangsu Hengrui Medicine Co., Ltd.

Jiangsu Hengrui is one of China’s leading pharmaceutical firms, producing active pharmaceutical ingredients and finished dosage forms. Their API division offers diclofenac salts, with stringent quality control aligned with international standards.

Key Points:

• Reputable for price and quality balance
• Long-standing market presence
• Robust R&D for formulation optimization

5. Sifa Pharmaceuticals (India)

Sifa Pharmaceuticals specializes in NSAID APIs, including diclofenac and its salt derivatives. They cater to global markets, emphasizing compliance with US FDA, EMA, and other regulatory agencies.

Key Points:

• Multiple certifications including ISO and cGMP
• Proven track record in supplying NSAIDs
• Strong focus on regulatory compliance

---

Considerations in Selecting API Suppliers

Quality Assurance and Regulatory Compliance:
Suppliers must adhere to cGMP standards, with comprehensive batch documentation, purity profiles, and stability data. Regulatory acceptance depends on rigorous quality control documentation, including validation reports and analytical data aligned with ICH guidelines.

Supply Capacity and Reliability:
Given the demand for ZORVOLEX, suppliers must demonstrate consistent production capacity, risk mitigation strategies, and contingency plans to prevent disruptions.

Pricing and Lead Times:
Cost competitiveness is vital, especially given the market competition among Asian manufacturers. Lead times and logistics capabilities influence manufacturing scheduling and inventory planning.

Geopolitical and Political Stability:
Suppliers from China and India are prominent, but geopolitical risks must be weighed. Diversification strategies often involve sourcing from multiple regions to secure supply continuity.

---

Strategic Implications for Manufacturers

Manufacturers of ZORVOLEX must evaluate their API sourcing strategies critically. The balance between cost, quality, and reliability guides decision-making, especially amidst regulatory scrutiny and global supply chain disruptions. Establishing long-term supply agreements with reputable API producers or engaging with contract manufacturing organizations (CMOs) with verified API supply chains enhances stability.

---

Regulatory Impact and Documentation

Regulatory bodies like the FDA and EMA scrutinize API sources during approval and post-approval phases. Manufacturers must maintain detailed supplier qualification dossiers, including audit reports, stability data, and analytical characterization of APIs. Additionally, batch genealogy documentation ensures API traceability.

---

Emerging Trends and Future Outlook

The industry is witnessing increasing automation in API synthesis, stricter quality validations, and diversification of supply chains. Biosynthesis and green chemistry approaches are gaining attention for greener manufacturing practices. Companies investing in such innovations may offer APIs with improved sustainability and compliance profiles.

---

Conclusion

Reliable bulk API sourcing for diclofenac lysinate remains critical to the manufacturing of ZORVOLEX. Leading suppliers from China, India, and global API distributors offer high-quality options, with strategic considerations centered around compliance, capacity, and supply stability. As the NSAID market grows and regulatory standards tighten, API sourcing strategies must evolve to emphasize quality assurance, geopolitical risk mitigation, and innovation.

---

Key Takeaways

• Quality & Compliance: Prioritize cGMP-certified suppliers with comprehensive documentation.
• Supplier Diversification: Reduce risk by engaging multiple reputable sources across regions.
• Supply Chain Reliability: Establish agreements ensuring consistent API supply and capacity.
• Regulatory Readiness: Maintain detailed dossiers for API provenance, quality, and stability.
• Emerging Technologies: Watch for innovations in green chemistry and biosynthesis for future API sourcing.

---

FAQs

Q1: Can I source diclofenac lysinate from multiple suppliers for ZORVOLEX manufacturing?
A1: Yes, diversifying suppliers is common practice for risk mitigation, provided all sources meet strict quality and regulatory standards to ensure consistency in API quality.

Q2: What quality standards should suppliers of diclofenac lysinate adhere to?
A2: Suppliers must operate under cGMP guidelines, providing batch validation, analytical data, and stability profiles aligned with ICH and regulatory agency standards.

Q3: Are Chinese API manufacturers compliant with international regulatory requirements for APIs used in pharmaceuticals like ZORVOLEX?
A3: Many Chinese manufacturers operate GMP facilities compliant with international standards and possess certifications such as ISO, but individual qualification and audits are essential before engagement.

Q4: How does API purity impact the efficacy of ZORVOLEX?
A4: High API purity ensures predictable pharmacokinetics, minimizes adverse effects, and maintains product efficacy, making purity a critical parameter in API sourcing.

Q5: What trends are influencing the future supply of NSAID APIs like diclofenac lysinate?
A5: Industry trends include green chemistry manufacturing, biosynthesis, tighter regulatory scrutiny, and supply chain diversification to ensure sustainable and compliant API production.

---

References:
[1] U.S. Food and Drug Administration (FDA). "Active Pharmaceutical Ingredient (API) Manufacturing," FDA Guidance, 2022.
[2] European Medicines Agency (EMA). "Good Manufacturing Practice (GMP) Guidelines for Active Substances," EMA, 2021.
[3] Pharmaceutics International, Inc. "API sourcing in NSAIDs manufacturing," Industry Reports, 2022.
[4] China Food and Drug Administration (CFDA). "API Registration and Compliance," CFDA Reports, 2021.
[5] Sifa Pharmaceuticals. "NSAID API Portfolio," Company Website, 2023.