OXAPROZIN: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms Co	OXAPROZIN	oxaprozin	TABLET;ORAL	208633	ANDA	Amneal Pharmaceuticals NY LLC	69238-1120-1	100 TABLET in 1 BOTTLE (69238-1120-1)	2017-05-04
Amneal Pharms Co	OXAPROZIN	oxaprozin	TABLET;ORAL	208633	ANDA	Amneal Pharmaceuticals NY LLC	69238-1120-5	500 TABLET in 1 BOTTLE (69238-1120-5)	2017-05-04
Amneal Pharms Co	OXAPROZIN	oxaprozin	TABLET;ORAL	208633	ANDA	Bryant Ranch Prepack	71335-0617-1	30 TABLET in 1 BOTTLE (71335-0617-1)	2017-05-04
Amneal Pharms Co	OXAPROZIN	oxaprozin	TABLET;ORAL	208633	ANDA	Bryant Ranch Prepack	71335-0617-2	20 TABLET in 1 BOTTLE (71335-0617-2)	2017-05-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Oxaprozin is a non-steroidal anti-inflammatory drug (NSAID) primarily prescribed for the relief of pain and inflammation associated with conditions such as arthritis and gout. Known for its long half-life, oxaprozin allows once-daily dosing, enhancing patient compliance. As the demand for effective anti-inflammatory therapies persists, understanding the supplier landscape for oxaprozin is crucial for pharmaceutical stakeholders, including healthcare providers, distributors, and manufacturers aiming to secure quality supply chains.

Overview of Oxaprozin as a Pharmaceutical Product

Oxaprozin (Chemical formula: C₁₇H₁₅NO₃) is marketed under various brand names globally, including Daypro (by Pfizer), alongside generic variants. Its molecular stability, efficacy, and safety profile have established it as a preferred NSAID within its class. The global market for oxaprozin and similar NSAIDs is driven by the prevalence of chronic inflammatory conditions.

The production of oxaprozin involves complex chemical synthesis processes that meet strict regulatory standards (e.g., FDA, EMA). As a result, suppliers must adhere to Good Manufacturing Practices (GMP), ensuring drug quality, safety, and efficacy to meet international standards.

Key Global Suppliers of Oxaprozin

The supply chain for oxaprozin is characterized by a blend of large multinational pharmaceutical companies, contract manufacturing organizations (CMOs), and regional generic drug manufacturers. Each plays a vital role in maintaining a steady supply flow, which is particularly vital amidst high demand or supply chain disruptions.

1. Patent Holders and Original Developers

Pfizer Inc.

Original innovator of Daypro, Pfizer holds the patent rights and supplies the proprietary form of oxaprozin. Pfizer's global distribution network ensures availability across multiple regions, primarily in North America and Europe.
Pfizer’s strict GMP compliance and established distribution channels position it as a primary supplier of branded oxaprozin.

2. Global Generic Manufacturers

Many regional generic companies manufacture oxaprozin due to the expiration of patents, offering lower-cost alternatives aligned with local regulatory frameworks.

a. Sun Pharmaceutical Industries Ltd. (India)

A leading global generic manufacturer, Sun Pharma produces oxaprozin and distributes it across Asia, Africa, and Latin America. The company maintains rigorous GMP standards and has a robust export footprint.

b. IPCA Laboratories (India)

Known for cost-efficient manufacturing, IPCA supplies oxaprozin to various international markets under various brand names or generic labels.

c. Aurobindo Pharma (India)

A significant player in the NSAID market, Aurobindo manufactures oxaprozin in compliance with international quality standards, targeting markets in Asia, Latin America, and emerging regions.

d. Mylan N.V. (now part of Viatris)

Mylan’s extensive portfolio includes generic NSAIDs such as oxaprozin, with supplies to North America, Europe, and other markets.

e. Zhejiang Zhongyi Pharmaceutical (China)

Focused on Chinese and Asian markets, Zhongyi produces oxaprozin in GMP-certified facilities, catering to regional demand.

3. Contract Manufacturing Organizations (CMOs)

Some pharmaceutical companies rely on CMOs for large-scale production of oxaprozin. These organizations often operate under strict OEM (Original Equipment Manufacturing) agreements:

Catalent Inc.
Evonik Industries
BASF

These CMOs manufacture active pharmaceutical ingredients (APIs) on behalf of brand-name and generic manufacturers, providing scalable, compliant production.

Regional Supply Variations and Regulatory Considerations

Manufacturing standards, licensing, and approvals significantly influence supplier availability in different regions.

North America & Europe: Suppliers such as Pfizer and Mylan dominate, with stringent regulatory oversight governing production and distribution.
Asia-Pacific: India and China are major hubs, with numerous manufacturers like Sun Pharma, Aurobindo, and Zhejiang Zhongyi providing cost-effective oxaprozin formulations.
Emerging Markets: Local manufacturers often cater to regional demand, sometimes operating with limited regulatory oversight but conforming to local GMP standards.

Importantly, market authorization and compliance with agencies such as the FDA (U.S.), EMA (Europe), and the Central Drugs Standard Control Organization (India) are prerequisites for legal distribution in respective regions.

Quality Assurance and Supplier Vetting

Given the critical role of oxaprozin in therapeutic regimens, procurement decisions should emphasize supplier quality assurance:

GMP Certification: Ensures manufacturing processes meet international standards.
Certificate of Analysis (CoA): Verifies API purity, potency, and absence of contaminants.
Regulatory Approvals: Confirm product registration and approval in target markets.
Supply Chain Transparency: Assures traceability and consistent supply.

Challenges and Considerations in Sourcing Oxaprozin

Regulatory Discrepancies: Variability in approval status among countries can influence supplier choice.
Supply Chain Disruptions: Political, logistical, or quality-related issues can lead to shortages.
Cost vs. Quality: While regional generics are cost-effective, consistent quality assurance remains paramount.
Patent and Exclusivity Periods: Patents may limit generic competition; however, patent expirations create opportunities for diverse suppliers.

Emerging Trends and Future Outlook

The global focus on biosimilars and generic drug sustainability is expected to influence oxaprozin sourcing strategies. Increased manufacturing capacity, adoption of continuous manufacturing technologies, and digital quality systems will enhance supplier reliability and regulatory compliance.

Additionally, regional development initiatives aim to bolster local pharmaceutical production, reducing dependency on imports and fostering competitive markets.

Key Takeaways

Diverse Supplier Base: The oxaprozin market encompasses original patent-holders like Pfizer and numerous regional generic manufacturers, especially from India, China, and other Asian markets.
Regulatory Compliance: Ensuring suppliers adhere to GMP and possess requisite approvals is critical for product safety and legality.
Quality Assurance is Paramount: Procurement should prioritize suppliers with transparent quality certifications and traceable supply chains.
Supply Chain Risks: Political, economic, and logistical factors can impact availability; diversified sourcing mitigates risks.
Market Trends: Evolving manufacturing technologies and regional capacities promise more reliable, cost-effective, and high-quality oxaprozin supplies.

FAQs

1. Who are the main global manufacturers of oxaprozin?
The primary producers include Pfizer (original patent holder), Sun Pharmaceutical, IPCA Laboratories, Aurobindo Pharma, Mylan (Viatris), and regional Chinese manufacturers like Zhejiang Zhongyi Pharmaceutical.

2. How do I ensure the quality of oxaprozin suppliers?
Verify GMP certification, review Certificates of Analysis, confirm regulatory approvals in your country, and establish audit protocols to assess manufacturing facilities.

3. Are generic oxaprozin products as effective as branded versions?
Yes. As long as generic products meet regulatory standards and have proper quality certifications, their efficacy and safety are comparable to branded counterparts.

4. What regions are the main sources of oxaprozin?
North America and Europe primarily source from Pfizer and Mylan, whereas India and China are major regional suppliers of generic formulations.

5. What factors might disrupt the supply of oxaprozin?
Regulatory changes, manufacturing disruptions, geopolitical issues, patent expirations, or quality concerns can all impact the supply chain.

References

[1] U.S. Food & Drug Administration (FDA). Drug Approvals and Regulatory Information.
[2] European Medicines Agency (EMA). Medicines and Regulatory Affairs.
[3] MarketsandMarkets. NSAID Market Overview.
[4] Pfizer Inc. Official Website. Product Portfolio.
[5] Indian Pharmaceutical Industry Reports. Manufacturing and Export Data.

Suppliers and packagers for OXAPROZIN

OXAPROZIN

Suppliers for the Pharmaceutical Drug: OXAPROZIN