Suppliers and packagers for SULFAMETHOXAZOLE AND TRIMETHOPRIM

SULFAMETHOXAZOLE AND 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
Teva Pharms Usa	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	073303	ANDA	Teva Parenteral Medicines, Inc.	0703-9514-93	10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91)	2024-07-11

Suppliers for Sulfamethoxazole and Trimethoprim

Last updated: February 20, 2026

Which companies manufacture Sulfamethoxazole and Trimethoprim?

Sulfamethoxazole and Trimethoprim are widely used antibiotics often combined in formulations such as Bactrim or Septra. Multiple pharmaceutical companies supply these compounds through bulk active pharmaceutical ingredients (API) and finished dosage forms.

Major API Suppliers

Company	Location	Certifications	Notes
Mylan	India, USA	cGMP, ISO 9001	Supplies APIs and finished products globally.
Wockhardt	India	cGMP, ISO	Produces Sulfamethoxazole and Trimethoprim APIs at large scale.
Aurobindo Pharma	India	cGMP	Known for cost-effective APIs for global markets.
Hikma Pharmaceuticals	UK	cGMP	Supplies APIs and finished medicines to Europe and other regions.
Sun Pharmaceutical	India	cGMP	Produces APIs used in generic formulations.
Zhejiang Hisun Pharmaceutical	China	GMP	Supplies Sulfamethoxazole API for Asian and emerging markets.

Finished Dosage Form Manufacturers

Company	Notes
Teva Pharmaceuticals	Global leader with marketed formulations containing Sulfamethoxazole and Trimethoprim.
Sandoz	Produces generic versions for North American and European markets.
Lupin	Offers both APIs and finished products, mainly for India and emerging markets.
Cipla	Wide distribution of Sulfamethoxazole/Trimethoprim formulations.

Market Trends and Supply Chain Dynamics

• API Supply Concentration: The API manufacturing landscape is concentrated in India and China, accounting for over 70% of global API production [1].
• Regulatory Compliance: Suppliers maintaining cGMP, ISO standards are preferred for global distribution.
• Pricing: API prices have decreased due to increased competition, influencing formulation costs.
• Supply Risks: Dependence on API suppliers from Asia presents risks linked to geopolitical tensions and supply chain disruptions.

Regulatory Considerations

• Certificate of Analysis (CoA): Critical for verifying API purity and compliance.
• GMP Certification: Required for suppliers exporting to regulated markets.
• Patent Status: Many formulations are off-patent, facilitating generic entry globally.

Key Takeaways

• The primary active ingredients are supplied predominantly by Indian and Chinese manufacturers.
• Major pharmaceutical companies integrate these APIs into marketed generic and branded formulations.
• Industry is moving towards increased transparency, quality assurance, and diversification of supply sources.
• Regulatory compliance (GMP, ISO) is essential for global distribution.
• Supply chain vulnerabilities persist due to concentration in specific regions.

FAQs

1. Are there any exclusive suppliers for Sulfamethoxazole and Trimethoprim?
No. Multiple generic manufacturers produce these APIs, resulting in a diversified supply chain.

2. What are the main regions supplying Sulfamethoxazole and Trimethoprim APIs?
India and China are the dominant regions, accounting for most API manufacturing.

3. How do regulatory standards impact suppliers?
Suppliers must adhere to cGMP and ISO standards to export APIs to regulated markets such as the USA, EU, and Japan.

4. What are the risks in sourcing from Asian API manufacturers?
Supply disruptions caused by geopolitical issues, tariffs, or manufacturing delays can impact availability.

5. What should companies consider when choosing a supplier?
Quality certifications, manufacturing capacity, regulatory compliance, and supply reliability are crucial factors.

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References

[1] Berman, M. et al. (2022). Global Active Pharmaceutical Ingredient Manufacturing Trends. International Journal of Pharmaceutical Manufacturing.