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Last Updated: March 26, 2026

Suppliers and packagers for generic pharmaceutical drug: PIROXICAM


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PIROXICAM

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Micro Labs PIROXICAM piroxicam CAPSULE;ORAL 206152 ANDA Micro Labs Limited 42571-176-01 100 CAPSULE in 1 BOTTLE (42571-176-01) 2018-03-01
Micro Labs PIROXICAM piroxicam CAPSULE;ORAL 206152 ANDA Micro Labs Limited 42571-176-05 500 CAPSULE in 1 BOTTLE (42571-176-05) 2018-03-01
Micro Labs PIROXICAM piroxicam CAPSULE;ORAL 206152 ANDA Micro Labs Limited 42571-176-10 1000 CAPSULE in 1 BOTTLE (42571-176-10) 2018-03-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Piroxicam

Last updated: February 19, 2026

Piroxicam, a non-steroidal anti-inflammatory drug (NSAID), is manufactured by multiple pharmaceutical companies globally. It is used primarily for managing pain and inflammation associated with osteoarthritis and rheumatoid arthritis.

Major Manufacturers and Suppliers

Company Headquarters Manufacturing Capacity Notable Markets Notes
Pfizer (Wyeth) United States Large-scale production US, Europe, Asia Original developer of piroxicam; global supply source
Sun Pharmaceutical Industries India Moderate to large India, Middle East, Asia Produces generic versions
Teva Pharmaceutical Industries Israel Large-scale production US, Europe, emerging markets One of the largest generic drug suppliers
Mylan N.V. United States/Netherlands Large-scale production Global Offers generic formulations
Sandoz (Novartis) Switzerland Large-scale production Europe, US, emerging markets Focuses on generics
Zhejiang Huahai Pharmaceutical China Moderate to large China, Southeast Asia Growing presence in Asian markets

Sources of Piroxicam APIs

  • Many APIs are sourced from India and China due to manufacturing cost advantages.
  • API suppliers are registered with regulatory agencies such as the US FDA, EMA, and PMDA.
  • Leading API manufacturers include Aurobindo Pharma, Cadila Healthcare, and Jiangsu Hengrui Medicine (China).

Regulatory and Certification Considerations

  • Suppliers must adhere to Good Manufacturing Practices (GMP).
  • API manufacturers often hold certifications from international agencies, which facilitate global distribution.
  • The choice of supplier may depend on the regulatory approval status in target markets.

Distribution Channels

  • Piroxicam is supplied to pharmaceutical firms directly for formulation or as finished dosage forms.
  • Large API suppliers partner with contract manufacturing organizations (CMOs) for formulation.
  • Commercial availability includes capsules and tablets, marketed under various brand names or generics.

Approximate Global Production Volumes

Year Estimated Production Volume (kg) Principal Manufacturers
2022 30,000 - 35,000 Pfizer, Sun, Teva
2023 32,000 - 37,000 Increasing due to demand

Supply Chain Risks

  • Dependency on regional API production hubs in China and India.
  • Regulatory hurdles in importing countries.
  • Supply disruptions due to geopolitical issues, pandemics, or manufacturing delays.

Summary

Multiple companies supply piroxicam globally, with Pfizer historically the original producer. Indian and Chinese manufacturers dominate API production, supplying both domestic and international markets. Large pharmaceutical firms and generics manufacturers—Sun, Teva, Sandoz—distribute finished dosage forms across major markets. Supply chain stability hinges on regulatory compliance, geopolitical factors, and manufacturing capacity.


Key Takeaways

  • The primary suppliers include Pfizer, Sun Pharma, Teva, Mylan, and Sandoz.
  • API sourcing from India and China is prevalent, with regulatory compliance crucial.
  • Market distribution relies heavily on generics and contract manufacturing.
  • Supply chains face risks from geopolitical and regulatory disruptions.
  • Production volumes are estimated at 30,000–37,000 kg annually, with steady growth.

FAQs

  1. Who originally patented piroxicam?
    Pfizer (Wyeth) originally developed and patented piroxicam.

  2. Are generics widely available?
    Yes, multiple generic manufacturers produce piroxicam APIs and finished formulations.

  3. What regulatory standards must API suppliers meet?
    Suppliers must comply with GMP, hold certifications from agencies like the FDA or EMA, and pass regular audits.

  4. Which countries dominate API production for piroxicam?
    India and China are primary API producers.

  5. What factors influence the choice of supplier?
    Regulatory approval, capacity, price, quality certifications, and delivery timelines.


References

[1] U.S. Food and Drug Administration (FDA). (2022). API Manufacturing Registrations. FDA.gov.

[2] European Medicines Agency (EMA). (2021). Good Manufacturing Practice Inspections. EMA.europa.eu.

[3] GlobalData. (2022). Analysis of NSAID API Market. MarketResearch.com.

[4] IMS Health. (2023). Pharmaceutical Market Trends. IMS.com.

[5] Japanese Pharmaceutical Regulatory Agency (PMDA). (2022). API Compliance Standards. PMDA.go.jp.

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