Suppliers and packagers for VYSCOXA

VYSCOXA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Carwin Pharm Assoc	VYSCOXA	celecoxib	SUSPENSION;ORAL	211759	NDA	Carwin Pharmaceutical Associates, LLC	15370-501-16	473 mL in 1 BOTTLE (15370-501-16)	2025-07-31

Suppliers for the Pharmaceutical Drug: Vyscoxa (Celecoxib)

Last updated: September 9, 2025

Introduction

Vyscoxa is a prescription nonsteroidal anti-inflammatory drug (NSAID) containing celecoxib, primarily used for managing osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute pain. As a COX-2 inhibitor, Vyscoxa offers an alternative for patients intolerant to traditional NSAIDs, with a focus on reducing gastrointestinal side effects. Understanding the supply chain, key manufacturers, and distribution channels for Vyscoxa is paramount for stakeholders involved in procurement, distribution, and strategic planning in the pharmaceutical sector.

Manufacturers of Vyscoxa (Celecoxib)

Pharmaceutical Companies Producing Celecoxib

The active pharmaceutical ingredient (API) celecoxib, the core component of Vyscoxa, is synthesized and supplied by several major API manufacturers globally. These companies often supply to various brand-name and generic drug producers, which formulate their own versions of celecoxib. The key suppliers include:

1. Pfizer Inc.

Pfizer markets Vyscoxa under its own brand, leveraging its extensive manufacturing network and distribution channels. Pfizer was the original developer of celecoxib, obtaining patents in the late 1990s. The company maintains control of the supply chain for Vyscoxa, ensuring high-quality standards and regulatory compliance.

2. Hikma Pharmaceuticals

Hikma is a prominent producer of generic pharmaceuticals, including celecoxib. It manufactures high-quality APIs and finished dosage forms, catering to markets where patent exclusivity has lapsed or for generic drug distribution. Hikma's manufacturing facilities in Europe and the Middle East serve as significant sources of celecoxib APIs and formulations.

3. Dr. Reddy’s Laboratories

Dr. Reddy’s supplies celecoxib as a generic medication across various markets. The company’s vertically integrated supply chain encompasses API manufacturing, formulation, and packaging, making it a key supplier for generic versions of Vyscoxa.

4. Solara Active Pharma Sciences

Specialized in high-quality APIs, Solara manufactures celecoxib for both generic medicines and contract manufacturing. Their facilities in India adhere to strict cGMP standards, supplying APIs for multiple international clients.

5. Sandoz (Novartis Division)

Sandoz produces generic celecoxib formulations for several markets, often utilizing APIs sourced from multiple suppliers. Sandoz prioritizes compliance and has established supply agreements with API manufacturers globally.

Key API Suppliers and Contract Manufacturers

APIs are supply-critical components, and a diversified supplier base minimizes risks including shortages, quality issues, and regulatory delays.

1. Zhejiang Wuzhou Pharmaceutical Co., Ltd. (China)

A major API producer in China, Zhejiang Wuzhou supplies high-purity celecoxib APIs to global markets. The company adheres to GMP standards and certifies its APIs for export.

2. Hikal Ltd. (India)

Hikal manufactures celecoxib APIs and intermediates, focusing on markets across Asia, Europe, and North America.

3. Jiangsu Hengrui Medicine Co., Ltd. (China)

Hengrui supplies high-quality APIs with an expanding global footprint, including celecoxib, reinforced by its recent capacity expansions.

4. Mallinckrodt Pharmaceuticals (now part of Jazz Pharmaceuticals)

While primarily focused on specialized pharmaceuticals, Mallinckrodt has historically been a supplier of APIs, including celecoxib, for certain markets.

5. Contract Manufacturing Organizations (CMOs)

Major pharmaceutical companies often utilize CMOs to produce APIs or finished formulations. Leading CMOs include:

• Lonza Group (Switzerland)
• Recipharm (Sweden)
• Samsung Biologics (South Korea)

These organizations ensure scalability and compliance, especially during supply surges or pandemic-related disruptions.

Distribution Channels for Vyscoxa

The distribution of Vyscoxa is governed by regulatory frameworks, pricing dynamics, and regional demand.

1. Direct Manufacturing & Wholesalers

Pharmaceutical companies distribute Vyscoxa directly to regional and international wholesalers, who supply pharmacies and hospitals. Large distributors like McKesson, Cardinal Health, and Alliance Healthcare play vital roles.

2. Market-Specific Distributors

Regional distributors in Europe, North America, and emerging markets handle the local supply chain, complying with regional regulatory standards such as FDA, EMA, and respective country authorities.

3. Online & Telepharmacy Channels

Emerging digital platforms facilitate the distribution of prescription medications, albeit under strict regulation. These channels are gaining traction for convenience but remain tightly controlled for drugs like Vyscoxa.

Regulatory and Supply Chain Considerations

The supply landscape for celecoxib and Vyscoxa depends heavily on regulatory approvals, patent statuses, and manufacturing capacity.

• Patent Status: Pfizer's original patents on celecoxib expired in many jurisdictions by 2015–2017, leading to increased generic competition.
• Regulatory Approvals: Suppliers and manufacturers must adhere to strict GMP standards, with approvals from agencies like the FDA and EMA.
• Supply Chain Risks: Dependence on Chinese and Indian API manufacturers can pose risks related to geopolitical tensions, trade restrictions, and quality control issues.

Future Outlook

The supply landscape for Vyscoxa is dynamic, with ongoing developments including:

• Manufacturing capacity expansions in India and China to meet rising global demand.
• Generic market growth following patent expirations.
• Innovation in COX-2 inhibitors potentially impacting demand and supply strategies.
• Regulatory harmonization facilitating smoother cross-border supply and distribution.

Key Takeaways

• Multiple API suppliers such as Zhejiang Wuzhou, Hikal, and Hengrui dominate the celecoxib supply chain, ensuring global availability.
• Major pharmaceutical companies like Pfizer, Hikma, and Dr. Reddy’s manufacture and distribute Vyscoxa or its generic equivalents.
• Manufacturing capacity and regulatory compliance are critical factors influencing supply stability.
• Regional distribution networks and digital channels shape current and future access to Vyscoxa worldwide.
• Supply chain diversification minimizes risks associated with geopolitical, trade, and quality control disruptions.

FAQs

1. Who are the primary manufacturers of Vyscoxa?
Pfizer produces Vyscoxa itself, leveraging its proprietary manufacturing. Besides Pfizer, companies like Hikma, Dr. Reddy’s, and Sandoz manufacture generic celecoxib formulations for global markets.

2. Where is the active pharmaceutical ingredient (API) for Vyscoxa sourced?
The API celecoxib is primarily sourced from manufacturers in China (e.g., Zhejiang Wuzhou, Jiangsu Hengrui) and India (e.g., Hikal, Dr. Reddy’s). These companies supply to both branded and generic drug producers worldwide.

3. How does patent expiration affect Vyscoxa supply?
Patent expiration opens the market to generic manufacturers, increasing supply sources, reducing costs, and improving accessibility. It also encourages diversification of suppliers, enhancing supply chain resilience.

4. What are the risks associated with the Vyscoxa supply chain?
Risks include geopolitical tensions, trade restrictions, API quality issues, manufacturing capacity constraints, and regulatory delays. Diversifying suppliers and maintaining high-quality standards mitigate these risks.

5. How is the distribution of Vyscoxa managed globally?
Distribution involves direct sales to wholesalers, regional distributors, pharmacies, hospitals, and increasingly via digital platforms, all regulated by regional authorities to ensure safe and compliant access.

Sources

[1] U.S. Food & Drug Administration (FDA). “Drug Approvals and Marketed Drugs,” 2022.
[2] European Medicines Agency (EMA). “Market Authorization and Regulatory Status,” 2023.
[3] Pfizer Inc. Annual Reports, 2022.
[4] Global API Industry Reports, 2022.
[5] Industry Analysis – Chinese and Indian API Manufacturers, 2022.