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Last Updated: March 26, 2026

Suppliers and packagers for generic pharmaceutical drug: SULFAMETHOXAZOLE; TRIMETHOPRIM


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SULFAMETHOXAZOLE; TRIMETHOPRIM

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Somerset SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 212231 ANDA Somerset Therapeutics, LLC 70069-361-10 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) 2019-08-29
Somerset SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 212231 ANDA Somerset Therapeutics, LLC 70069-362-10 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) 2019-08-29
Somerset SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 212231 ANDA Somerset Therapeutics, LLC 70069-363-01 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL 2019-08-29
Teva Pharms Usa SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 073303 ANDA Teva Parenteral Medicines, Inc. 0703-9503-03 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) 1991-11-01
Teva Pharms Usa SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 073303 ANDA Teva Parenteral Medicines, Inc. 0703-9514-83 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) 2024-07-11
Teva Pharms Usa SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 073303 ANDA Teva Parenteral Medicines, Inc. 0703-9514-03 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) 2024-07-11
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Suppliers and packagers for generic pharmaceutical drug: SULFAMETHOXAZOLE; TRIMETHOPRIM

Last updated: February 19, 2026

Suppliers for the Pharmaceutical Drugs: Sulfamethoxazole and Trimethoprim

Overview

Sulfamethoxazole and trimethoprim are commonly combined as co-trimoxazole, used primarily for bacterial infections. Key suppliers include multinational pharmaceutical companies, generic producers, and contract manufacturing organizations (CMOs). Top producers supply both active pharmaceutical ingredients (APIs) and finished formulations.

Major Suppliers of Sulfamethoxazole and Trimethoprim

Supplier Country of Origin API Production Capacity Market Share (Estimate) Notes
Hikma Pharmaceuticals Jordan High 10-15% Significant exporter of APIs and finished products
Zhejiang Wansheng Co. China Moderate 8-12% Large API producer; supplies global generic market
Zhejiang Hisun Pharmaceuticals China Moderate 8-12% Key API manufacturer; supplies OEM for generics
Aurobindo Pharma India High 15-20% Produces both APIs and finished formulations; large market share
Sun Pharmaceutical India High 10-12% Supplies API and finished drugs globally
Mylan (Now part of Viatris) US/Global Moderate 8-10% Produces APIs; extensive global distribution
Sandoz (Novartis) Switzerland Moderate 5-8% Focus on generics; API and finished product supply
Zheijang Huikang Biological China Low to Moderate 4-6% API producer; supplies mainly Asian markets

API Manufacturing and Supply Chain Dynamics

  • China and India dominate global API manufacturing, providing over 80% of APIs for sulfamethoxazole and trimethoprim.
  • Chinese API suppliers operate mostly through OEM agreements, often supplying to Indian generic producers.
  • Indian companies such as Aurobindo, Sun Pharma, and Cipla maintain integrated operations, controlling API synthesis and final drug manufacturing.
  • U.S. and European companies primarily focus on finished drug production and distribution, relying on Chinese and Indian APIs.

Regulatory and Market Entry Considerations

  • API manufacturing facilities must comply with Good Manufacturing Practices (GMP) to meet international standards.
  • Suppliers must navigate varying compliance frameworks such as U.S. FDA, EMA, and China’s NMPA.
  • Market entry for new suppliers is constrained by patent expirations (most API patents expired by 2010), allowing generic competition expansion.
  • Supply chain disruptions, such as those experienced during COVID-19, can influence pricing and availability.

Contract Manufacturing and OEM Markets

  • Contract manufacturing organizations in Asia, including Dr. Reddy’s, Hetero Labs, and Laurus Labs, produce APIs and finished formulations under various international labels.
  • OEM relationships are commonplace; brands often do not disclose API origin explicitly.
  • Supply chain transparency varies, with some suppliers offering detailed documentation for regulatory audits.

Prices and Market Trends

  • API prices for sulfamethoxazole and trimethoprim have declined over the past decade due to increased generic competition.
  • Market forecasts predict stable or declining API prices through 2025, barring supply disruptions.
  • Finished drug prices are influenced by manufacturing costs, regulatory requirements, and market competition.

Summary

The supply of sulfamethoxazole and trimethoprim relies heavily on Chinese and Indian API producers, with several large multinational companies—Aurobindo, Sun Pharma, Hikma—serving as primary suppliers. The market is characterized by high competition and geographic concentration, with recent trends favoring generic proliferation and cost reductions.


Key Takeaways

  • China and India dominate the API manufacturing of sulfamethoxazole and trimethoprim.
  • Top suppliers include Aurobindo Pharma, Sun Pharma, Hikma Pharmaceuticals, Zhejiang Wansheng, and Zhejiang Hisun Pharmaceuticals.
  • Market share is distributed among these players based on capacity and distribution channels.
  • API prices trend downward due to competition, impacting finished drug pricing.
  • Regulatory compliance remains a critical barrier and enabler for supply chain stability.

FAQs

1. Which company is the largest producer of sulfamethoxazole and trimethoprim API?
Aurobindo Pharma is among the largest, with significant API production capacity and global distribution.

2. Are there non-Asian suppliers for these APIs?
Yes. Companies like Sandoz (Novartis) and some European producers supply APIs, but their volumes are smaller compared to Asian manufacturers.

3. What are the main risks in sourcing these APIs?
Supply chain disruptions due to geopolitical issues, regulatory compliance failures, and manufacturing capacity constraints.

4. How do patent expirations impact API supply?
Patent expirations around 2010 facilitated increased generic manufacturing, boosting competition and lowering prices.

5. Are there quality differences among suppliers?
Regulatory agencies such as the FDA and EMA require GMP compliance. Suppliers meeting these standards are considered reliable, but due diligence remains essential.


References

[1] U.S. Food and Drug Administration. (2022). API Supplier List. https://www.fda.gov/drugs/gmp-compliance-monitoring/active-ingredient-supplier-list
[2] Frost & Sullivan. (2021). Global API Market Analysis.
[3] IQVIA. (2022). Global Pharmaceutical Market Reports.
[4] European Medicines Agency. (2022). Manufacturing and Standards.
[5] ProDrug. (2022). API Supply Chain Overview.

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