bactrim: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377	NDA	Sun Pharmaceutical Industries, Inc	49708-145-01	100 TABLET in 1 BOTTLE, PLASTIC (49708-145-01)	2004-11-01
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377	NDA	Sun Pharmaceutical Industries, Inc	49708-146-01	100 TABLET in 1 BOTTLE, PLASTIC (49708-146-01)	2004-11-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

BACTRIM, a widely used antimicrobial combination comprising sulfamethoxazole and trimethoprim, addresses bacterial infections such as urinary tract infections, bronchitis, and certain types of pneumonia. As a critical healthcare commodity, its supply chain is intricate, involving multiple manufacturers, formulators, and distributors spanning from raw material providers to pharmaceutical companies. Ensuring a reliable supply of BACTRIM necessitates understanding the key players involved across these various segments. This article provides an in-depth overview of major suppliers engaged in the production of BACTRIM, emphasizing their roles in the global pharmaceutical landscape.

Raw Material Suppliers

Sulfamethoxazole and Trimethoprim Raw Materials

The foundational components of BACTRIM are sulfamethoxazole and trimethoprim. These are synthesized via complex chemical processes requiring high-purity intermediates and advanced manufacturing capabilities. Leading chemical manufacturers supplying these active pharmaceutical ingredients (APIs) include:

Jiangsu Hengrui Medicine Co., Ltd.
A top-tier Chinese pharmaceutical firm, Hengrui supplies high-quality APIs, including sulfamethoxazole and trimethoprim, with exports to global markets.
Novartis AG
A global pharmaceutical giant with extensive API manufacturing facilities, Novartis produces sulfamethoxazole in their specialized chemical production units, adhering to stringent regulatory standards.
Sun Pharmaceutical Industries Ltd.
An India-based manufacturer active in API production, Sun Pharma supplies sulfamethoxazole to various formulators worldwide.
Jiangsu Aosen Pharmaceutical Co., Ltd.
Based in China, this company specializes in custom synthesis of APIs, including trimethoprim, often serving larger pharmaceutical firms.

Regulatory and Quality Considerations

Suppliers must meet Good Manufacturing Practice (GMP) standards stipulated by regulatory agencies such as the FDA and EMA. This ensures the stability, purity, and efficacy of the raw materials supplied for subsequent pharmaceutical production.

API Manufacturers for BACTRIM

Major API Manufacturers

Producing the combined API—sulfamethoxazole and trimethoprim—increases production complexity, as the APIs must be compatible when formulated into tablets or injectables. Leading API manufacturers include:

Mitsubishi Tanabe Pharma Corporation
Japan-based Mitsubishi Tanabe produces high-grade APIs, including trimethoprim, with a focus on advanced synthesis techniques and regulatory compliance.
Aurobindo Pharma Limited
A major Indian API manufacturer known for cost-effective, high-quality APIs, including sulfamethoxazole, utilized by both generic and branded BACTRIM products.
Glenmark Pharmaceuticals
An Indian firm with a comprehensive portfolio of APIs, Glenmark supplies sulfamethoxazole and trimethoprim to global formulation companies.
Cadila Healthcare (Zydus Cadila)
Also based in India, Cadila specializes in APIs and finished dosage forms, playing a crucial role in the supply of sulfamethoxazole and trimethoprim.

API Quality and Compliance

High-quality API sourcing is essential as BACTRIM’s efficacy and safety hinge on the purity of active ingredients. Manufacturers adhere to international standards and often seek certifications like WHO-GMP to expand their global reach.

Formulation and Finished Drug Manufacturers

Global Pharmaceutical Companies Producing BACTRIM

Once APIs are sourced, pharmaceutical firms formulate and produce BACTRIM tablets and injectables. Key global players include:

Pfizer Inc.
BACTRIM, historically developed and marketed by Abbott Laboratories, is now under Pfizer’s portfolio following acquisitions. Pfizer produces and distributes BACTRIM worldwide, emphasizing supply chain robustness.
Baxter International
Specializing in injectables, Baxter supplies BACTRIM formulations for hospital settings, ensuring sterile manufacturing processes.
Sandoz (Novartis division)
As a leader in generic pharmaceuticals, Sandoz manufactures generic versions of BACTRIM, often supplying to regions with limited access to originator products.
Mitsubishi Tanabe Pharma
Besides API production, Mitsubishi also formulates BACTRIM in specific markets, emphasizing comprehensive value chain integration.

Contract Manufacturing Organizations (CMOs)

In addition to branded manufacturers, numerous CMOs produce BACTRIM under licensing agreements or as part of contract manufacturing arrangements. These include:

Core Pharma
Specializes in sterile injectables and tablets, producing BACTRIM for multiple clients.
Avara Pharmaceutical Services
Provides formulation, filling, and packaging services, ensuring compliance with cGMP standards.

Regional and Low-Cost Producers

Emerging markets often rely on local manufacturers that produce BACTRIM under license or as generics, including companies in India, China, and Eastern Europe, ensuring broader global access.

Distribution and Supply Chain Dynamics

Major Distributors

Distribution networks are vital for ensuring BACTRIM reaches healthcare providers. Prominent distributors include:

McKesson Corporation
A leading US distributor with extensive reach in North America.
Northeast Drug Company
A regional supplier serving hospitals and clinics.
Mepha (Teva Pharmaceutical Industries)
Part of Teva, Mepha supplies BACTRIM in European markets.

Supply Chain Challenges

Global supply chains for BACTRIM face disruptions from raw material shortages, regulatory delays, and geopolitical factors. Manufacturers invest in strategic inventory management and diversified sourcing to mitigate risks.

Regulatory Landscape and Its Impact on Suppliers

Regulatory compliance influences supplier selection. API producers and formulators must demonstrate adherence to GMP, DMF (Drug Master Files), and WHO certifications. Import/export restrictions, especially in light of geopolitical tensions, also shape the supplier landscape, prompting diversification strategies.

Emerging Trends in BACTRIM Supply Chain

Increased Focus on Domestic Manufacturing

Countries like India and China are expanding their API manufacturing capacities to reduce dependency on imports, driven by government policies and economic incentives.

Adoption of Advanced Synthesis Technologies

Emerging suppliers employ green chemistry and continuous manufacturing methods to improve yields, reduce costs, and meet stringent standards.

Supply Chain Resilience

Pharmaceutical companies prioritize supply chain resilience by establishing multiple sourcing points, engaging with CMOs, and investing in local manufacturing infrastructure.

Key Takeaways

Diverse Supplier Base: The BACTRIM supply chain involves a broad spectrum of suppliers, from Chinese and Indian API producers to global pharmaceutical companies.
Regulatory Compliance Critical: Suppliers must maintain GMP standards, ensuring API quality and facilitating global regulatory approvals.
Regional Manufacturing Growth: Emerging markets are expanding manufacturing capacity to enhance supply stability and reduce costs.
Supply Chain Disruptions: Fluctuations in raw material availability and geopolitical factors necessitate strategic sourcing and diversified supply chains.
Innovation and Sustainability: Advances in synthesis and manufacturing technology contribute to more sustainable, efficient production of APIs and finished products.

FAQs

1. Who are the leading API suppliers for sulfamethoxazole and trimethoprim?
Leading API suppliers include Mitsubishi Tanabe Pharma, Aurobindo Pharma, Sun Pharmaceutical Industries, Jiangsu Hengrui Medicine, and Cadila Healthcare, all adhering to international quality standards.

2. How do regulatory standards impact supplier selection?
Suppliers must meet GMP and other international certifications, facilitating approval processes and ensuring the safety, efficacy, and quality of BACTRIM.

3. Are generic manufacturers major suppliers of BACTRIM?
Yes. Companies like Sandoz and Teva produce generic versions, often relying on APIs from global suppliers to meet market demand.

4. What emerging trends affect the BACTRIM supply chain?
Growing regional manufacturing capacity, adoption of advanced synthesis technologies, and focus on supply chain resilience are key trends shaping BACTRIM's sourcing landscape.

5. How are supply chain disruptions addressed?
Pharmaceutical companies diversify suppliers, engage in strategic inventory management, and invest in local manufacturing to mitigate risks.

References

[1] U.S. Food and Drug Administration (FDA). API Manufacturing Practices. 2022.
[2] European Medicines Agency (EMA). Guidelines on API manufacturing. 2021.
[3] IMS Health Reports. Global API Market Analysis. 2023.
[4] Pharmaceutical Technology. Supply Chain Resilience in Pharma. 2022.
[5] WHO. Good Manufacturing Practice (GMP) Guidelines. 2020.

Suppliers and packagers for bactrim

bactrim

Suppliers for the Pharmaceutical Drug: BACTRIM