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Last Updated: March 26, 2026

Suppliers and packagers for generic pharmaceutical drug: NAPROXEN SODIUM


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NAPROXEN SODIUM

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bionpharma NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920 NDA Bayer HealthCare LLC. 0280-6080-01 1 BOTTLE in 1 CARTON (0280-6080-01) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE 2007-02-20
Bionpharma NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920 NDA Bayer HealthCare LLC. 0280-6080-02 2 BOTTLE in 1 PACKAGE, COMBINATION (0280-6080-02) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE 2007-02-20
Bionpharma NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920 NDA Bayer HealthCare LLC. 0280-6080-04 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-04) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2007-02-20
Bionpharma NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920 NDA Bayer HealthCare LLC. 0280-6080-16 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-6080-16) 2007-02-20
Bionpharma NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920 NDA Bayer HealthCare LLC. 0280-6080-20 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2007-02-20
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Naproxen Sodium

Last updated: February 19, 2026

Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) used mainly to treat pain, inflammation, and arthritis. The global supply chain involves several major pharmaceutical manufacturers, generic drug producers, and contract manufacturing organizations (CMOs).

Major Suppliers and Manufacturers

Branded Products

  1. Eli Lilly & Company

    • Product: Aleve (marketed as Naprosyn in some regions)
    • Market Presence: Leading in North America and Europe
    • Manufacturing: Owns some production facilities, contracts with third-party suppliers
  2. Bayer AG

    • Product: Bayer's Naproxen formulations
    • Market Presence: Significant in Germany and EU countries
    • Manufacturing: Produces active pharmaceutical ingredients (APIs) and finished dosage forms

Generic Manufacturers

Several companies produce generic naproxen sodium, often utilizing shared or independently developed APIs and formulations.

Company Market Regions API Production Manufacturing Capacity Notes
Teva Pharmaceutical Industries Global Yes Large-scale facilities Major generic supplier
Mylan (part of Viatris) Global Yes Extensive Broad portfolio of NSAIDs
Sun Pharmaceutical Industries Global Yes Significant Widely distributed generics
Hikma Pharmaceuticals Middle East, Europe Yes Moderate Growing presence
Aurobindo Pharma India, US, EU Yes High API and finished product production

API Suppliers

The active pharmaceutical ingredient (API) for naproxen sodium is sourced from various suppliers, often regional manufacturers or large API producers.

  • Kaken Pharmaceutical Co. Ltd. (Japan)
  • Hainan Jiafeng Pharmaceutical Co. Ltd. (China)
  • Coryn Pharma (India)
  • Hovione (Portugal) — API synthesis and supply

Contract Manufacturers (CMOs)

CMOs play a crucial role in scaling production, especially in meeting global demand.

  • Samsung Biologics
  • Lonza Group
  • Catalent
  • Recipharm

Supply Chain Considerations

  • API Source Concentration: China and India dominate API manufacturing, accounting for over 60% of global API production as of 2021 (U.S. International Trade Commission).
  • Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP) from agencies such as the FDA, EMA, and PMDA.
  • Supply Chain Risks: Dependence on Asian API producers exposes the supply chain to geopolitical, regulatory, and pandemic-related disruptions.
  • Pricing Dynamics: API costs generally range from $70 to $150 per kilogram, influenced by purity, batch size, and geographic source.

Market Outlook

  • The global naproxen sodium market was valued at approximately USD 400 million in 2021.
  • Growth is driven by increasing prevalence of arthritis and chronic pain conditions.
  • Generic competition has driven down prices, affecting supplier profit margins.

Regulatory and Policy Factors

  • FDA: Approved API manufacturing facilities undergo regular inspections.
  • EMA: Similar GMP standards for European suppliers.
  • International Trade: Tariffs and trade policies affect API import and export costs.

Summary

Major pharmaceutical companies, including Eli Lilly, Bayer, Teva, Mylan (Viatris), Sun Pharma, and Hikma, supply naproxen sodium in various formulations. Most APIs are sourced from Chinese and Indian manufacturers, with a significant presence of contract manufacturing organizations supporting production scale. Supply chain resilience is impacted by regional dependencies and regulatory standards.


Key Takeaways

  • Branded and generic manufacturers dominate the naproxen sodium supply.
  • API sourcing is concentrated in China and India, with risks related to geopolitical and regulatory factors.
  • Supply chain reliance on Asian API producers continues to influence pricing and availability.
  • Contract manufacturers are vital for scaling and meeting global demand.
  • Regulatory compliance remains a critical factor in maintaining supply continuity.

FAQs

1. Who are the leading API suppliers for naproxen sodium?
Chinese companies like Hainan Jiafeng Pharmaceutical and Indian firms such as Coryn Pharma dominate API production, with additional supply from Japanese and Portuguese firms.

2. What companies manufacture generic naproxen sodium?
Teva, Mylan (Viatris), Sun Pharma, Hikma, and Aurobindo produce and distribute generic formulations globally.

3. How does supply chain dependency affect naproxen sodium availability?
Dependency on Asian API producers exposes the supply to geopolitical, tariff, and pandemic disruptions, potentially leading to shortages.

4. Are there quality standards that suppliers must meet?
Yes. Suppliers must comply with GMP standards set by entities like the FDA, EMA, and local authorities to ensure safety and efficacy.

5. What is the market outlook for naproxen sodium?
The market is growing at a compound annual growth rate (CAGR) of approximately 3%, driven by increasing demand for pain and arthritis medications, with prices decreasing due to generic competition.


References

  1. U.S. International Trade Commission. (2021). API supply chain and trade analysis.
  2. IQVIA. (2022). Global NSAID market report.
  3. FDA. (2022). GMP regulations and approvals for API manufacturing.
  4. European Medicines Agency. (2022). Regulatory standards for pharmaceuticals.
  5. MarketWatch. (2023). Global naproxen sodium market size and forecast.

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