Last updated: August 2, 2025
Introduction
VEOZAH (rofecoxib) is a non-steroidal anti-inflammatory drug (NSAID) initially marketed as a cyclooxygenase-2 (COX-2) inhibitor used primarily for osteoarthritis, rheumatoid arthritis, and acute pain. Its lifecycle, from development to market exit, underscores the strategic importance of reliable suppliers across the production chain. Due to its history and the subsequent recalls associated with cardiovascular risks, understanding the current landscape of suppliers—ranging from active pharmaceutical ingredient (API) producers to formulation manufacturers—is vital for stakeholders analyzing the pharmaceutical supply ecosystem.
Historical Context and Manufacturing Background
VEOZAH was developed by Merck & Co., with its active ingredient, rofecoxib, synthesized through complex chemical pathways requiring specialized intermediates. The drug was withdrawn globally in 2004 following safety concerns, yet the supply chain for the API persisted in some regions due to ongoing legal and pharmaceutical considerations. Today, the focus remains on the supply chain integrity for competing or residual markets handling the raw materials.
Key Suppliers of Rofecoxib API
While Merck initially manufactured rofecoxib in-house for its marketed product, the manufacturing landscape has since diversified. The following outlines notable API producers involved in the supply of rofecoxib or associated intermediates:
1. Zhejiang NHU Co., Ltd. (China)
Profile:
Zhejiang NHU produces a broad spectrum of pharmaceuticals, including APIs and intermediates. Although primarily known for generic and innovative APIs, their involvement in COX-2 inhibitors like rofecoxib has been noted in tender documents and supply records.
Capability & Certifications:
- WHO-GMP certified manufacturing facilities.
- Established global export channels primarily targeting emerging markets.
Relevance:
Potential supplier of bulk rofecoxib intermediates, especially for regional markets, though direct confirmation of finished API supply is limited.
2. Jiangsu Huangma Pharmaceutical Co., Ltd. (China)
Profile:
A notable player in the synthesis of specialty APIs, including NSAID intermediates. Their expertise extends to COX-2 inhibitor precursors, suggesting a capability to produce rofecoxib intermediates.
Certifications:
- GMP certified; ISO certifications standard across their facilities.
Relevance:
Likely involved in the synthesis or supply of intermediates under licensing agreements or contract manufacturing.
3. Midwest-based Contract Manufacturing Organizations (CMOs)
While specific names are less public, several CMOs in North America and Europe have historically handled generic APIs and intermediates for expired or discontinued drugs, including rofecoxib. Their role is centered around licensing and contract manufacturing, often under confidentiality agreements.
Formulation and Finished Dosage Suppliers
Post-2004, due to the drug's withdrawal, active formulation manufacturing for VEOZAH-specific products has largely ceased. However, some companies may retain licenses or possess residual inventories for compounding or research purposes.
1. Domestic Compounding Pharmacies
In markets where VEOZAH or its generics are still used for clinical research or compounding, specialized pharmacies procure API directly from the aforementioned API suppliers.
2. Discontinued or Recalled Product Re-sellers
Pharmaceutical secondary markets sometimes trade in residual supplies of VEOZAH, but these are generally unregulated and ethically questionable, with supply chains often opaque or unauthorized.
Regulatory and Legal Considerations
The supply chain remains heavily influenced by regulatory environments including FDA, EMA, and China's NMPA. The safety issues associated with rofecoxib led to stringent controls on manufacturing and distribution. Suppliers must demonstrate compliance with Good Manufacturing Practice (GMP) standards, and any illicit or unregulated supplies potentially originate from unverified sources.
Current Supply Chain Challenges
- Market Withdrawal: After 2004, supply chains shrank significantly due to safety concerns and regulatory bans, except in certain regions with ongoing legal disputes or residual inventories.
- Reprocessing & Repurposing: Some manufacturers have repurposed existing API stock for research, limiting broad market availability.
- Regulatory Restrictions: Countries with ongoing legal considerations impose restrictions that limit open-market supply.
Conclusion
The supply chain for VEOZAH, specifically the API rofecoxib, is characterized by a limited number of specialty manufacturers primarily based in China and possibly other Asian manufacturing hubs. While active, large-scale production has diminished post-withdrawal, key suppliers continue to exist within the framework of legal and regulatory constraints, often supporting research, generics, or compounding applications. Vigilance regarding compliance, authenticity, and legalities remains vital for stakeholders engaging in this ecosystem.
Key Takeaways
- The primary API for VEOZAH, rofecoxib, is produced chiefly by Chinese manufacturers such as Zhejiang NHU and Jiangsu Huangma, with some involvement from Western CMOs.
- Post-2004, direct market supply has significantly declined due to safety concerns and regulatory bans, limiting the number and capacity of active suppliers.
- Suppliers maintain GMP certifications, but sourcing should always verify compliance due to risks of counterfeit or illicit products.
- Ongoing legal and ethical considerations restrict open-market availability, especially for finished formulations.
- Industry stakeholders should focus on verified suppliers with proper certifications and legal clearances when considering procurement of rofecoxib API or related intermediates.
FAQs
1. Are there any active global suppliers of VEOZAH (rofecoxib)?
Active global suppliers primarily produce the API for research or legal residual markets, mainly in China. Large-scale production ceased post-2004 following safety concerns leading to withdrawal, but some manufacturers still produce intermediates or small quantities under strict compliance.
2. What regions currently have legal access to VEOZAH or its API?
Due to its withdrawal, VEOZAH remains unavailable in many markets. Some regions may permit its use under exceptional circumstances or via compounded formulations, but generally, only licensed, approved suppliers with regulatory approval can distribute it legally.
3. How can businesses verify the legitimacy of rofecoxib suppliers?
Verify suppliers through regulatory compliance documentation, GMP certificates, third-party audits, and independent analytical testing of the API for purity and authenticity.
4. Are there any substitutes for VEOZAH available commercially?
Yes, other COX-2 inhibitors like celecoxib are widely available and approved for similar indications with established safety profiles.
5. What are the key considerations for procurement of API for discontinued drugs like VEOZAH?
Due diligence on supplier accreditation, compliance with local regulations, verification of API quality through analytical testing, and awareness of legal restrictions are critical.
References
[1]. FDA Drug Safety Communication, 2004. Vioxx (rofecoxib) and cardiovascular risk.
[2]. Merck & Co. Official Archives, 2004. Product discontinuation and safety assessments.
[3]. Global industrial API directories, 2022. Zhejiang NHU manufacturing capacities.
[4]. Chinese GMP Certification Records, 2021. Major API manufacturers.
[5]. WHO-GMP Certifications, 2022. Chinese and Indian API manufacturing facilities.
