TRIMETHOPRIM: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dr Reddys Labs Sa	TRIMETHOPRIM	trimethoprim	TABLET;ORAL	018679	NDA	Mayne Pharma	51862-486-01	100 TABLET in 1 BOTTLE (51862-486-01)	2016-07-18
Dr Reddys Labs Sa	TRIMETHOPRIM	trimethoprim	TABLET;ORAL	018679	NDA	Dr. Reddy's Labratories Inc.	75907-043-01	100 TABLET in 1 BOTTLE (75907-043-01)	2024-01-30
Novel Labs Inc	TRIMETHOPRIM	trimethoprim	TABLET;ORAL	091437	ANDA	Novel Laboratories, Inc.	40032-330-24	100 TABLET in 1 BOTTLE (40032-330-24)	2014-03-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Trimethoprim, an antibiotic primarily used to treat urinary tract infections and certain bacterial infections, remains a critical component in global healthcare. As a selective dihydrofolate reductase inhibitor, it impedes bacterial DNA synthesis, thereby exerting its antimicrobial effect. Ensuring a diversified, reliable supply chain is vital for healthcare providers, pharmaceutical companies, and governments to maintain uninterrupted access to this essential medicine. This article delineates the leading suppliers of trimethoprim, evaluates their market roles, and discusses strategic considerations relevant to stakeholders.

Global Market Overview for Trimethoprim Suppliers

The market for trimethoprim is characterized by a mix of large-scale pharmaceutical manufacturers, API (Active Pharmaceutical Ingredient) producers, and generic drug manufacturers. The supply dynamics are influenced by stringent regulatory frameworks, manufacturing capacities, raw material availability, and patent statuses. Notably, the APIs are often produced in regions with significant pharmaceutical manufacturing hubs, including India, China, and parts of Europe, which serve as primary sources for global distribution.

Major API Manufacturers and Suppliers

1. Indian and Chinese Manufacturers

India and China dominate the global API manufacturing landscape for trimethoprim, supported by robust chemical industries and cost-competitive production environments.

Lupin Limited (India): As a leading Indian pharmaceutical company, Lupin manufactures trimethoprim APIs and finished formulations for domestic and international markets. Its API manufacturing facilities are ISO-certified, ensuring compliance with cGMP standards. Lupin focuses on quality and operational scalability to meet global demand.
Sun Pharmaceutical Industries Ltd. (India): Sun Pharma produces both APIs and finished dosage forms. Their API segment includes trimethoprim, with manufacturing plants adhering to international quality standards, and regional distribution hubs enhancing supply chains.
North China Pharmaceutical Group Corporation (NCPC) (China): A significant Chinese supplier, NCPC offers bulk API production for global export. Its facilities are GMP-certified, and the company provides a range of antibiotics, including trimethoprim.
Shanghai Sine Pharmaceutical Co., Ltd (China): Specializes in antibiotic APIs with production plants certified by Chinese and international authorities. Their focus on quality and volume supports global supply chains.

2. European and North American Suppliers

While the API volume from European and North American manufacturers tends to be lower compared to Asian counterparts, some established firms maintain high-quality production facilities catering to markets with stringent regulatory requirements.

Evonik Industries (Germany): Known for specialty chemicals, Evonik produces certain intermediates relevant to trimethoprim synthesis. Although not a primary API manufacturer, their role in supply chain intermediates supports European formulations.
Pfizer Inc. (USA): The multinational pharmaceutical giant has historically produced trimethoprim as part of combination therapies, such as co-trimoxazole (trimethoprim-sulfamethoxazole). While primarily focused on finished drugs, Pfizer's global manufacturing footprint influences API sourcing options.

Key Contract Manufacturing Organizations (CMOs)

Contract manufacturers play an increasingly significant role in supply chain flexibility and capacity expansion.

Granules India (India): A prominent CMO specializing in antibiotics, including trimethoprim APIs; focuses on high-volume production to meet international demand.
Hikma Pharmaceuticals (UK): Operates manufacturing facilities producing antibiotics, sometimes sourcing APIs from Asian manufacturers but also developing in-house capabilities.

Supply Chain Challenges and Considerations

Regulatory Compliance: Suppliers must meet stringent cGMP standards imposed by agencies like the FDA, EMA, and PMDA. Non-compliance can disrupt supply continuity.
Raw Material Availability: Most raw materials are derived from petrochemicals or specialized chemical precursors produced predominantly in Asia, making the supply chain vulnerable to regional disruptions.
Intellectual Property and Patent Status: Although trimethoprim’s patent has expired in many jurisdictions, manufacturing rights and regulatory approvals can pose barriers for new entrants.
Quality Assurance: Variability in API purity, stability, and batch consistency between suppliers influences manufacturing decisions for pharmaceutical companies.

Emerging Trends and Future Outlook

Shift Toward Diversification: Companies are increasingly seeking to diversify suppliers and manufacturing locations to mitigate geopolitical and supply chain risks.
Conversion to Biosimilar and Generic Production: The expiration of patent protections for trimethoprim APIs has led to increased generic manufacturing, expanding the supplier landscape.
Technological Advancements: Innovations in chemical synthesis and process optimization promise to reduce costs and improve quality controls, potentially altering the supply dynamics.

Strategic Implications for Stakeholders

Pharmaceutical Companies: Must evaluate supplier reliability, regulatory compliance, and cost factors when securing trimethoprim APIs. Developing long-term partnerships with Asian manufacturers and maintaining quality oversight are critical.
Healthcare Providers: Should monitor geopolitical shifts affecting supply chains and advocate for stockpiling or alternative formulations in case of shortages.
Governments and Regulators: Need to encourage local manufacturing capabilities and establish strategic reserves to buffer against supply interruptions.

Key Takeaways

The primary sources of trimethoprim APIs are India and China, offering cost-effective and high-volume options.
Ensuring regulatory compliance and quality assurance remains paramount in supplier selection.
Supply chain diversification and strategic partnerships are vital for mitigating risks associated with regional disruptions.
Technological advancements and patent expirations are broadening the landscape, fostering increased generic production.
Stakeholders should continuously monitor geopolitical and economic trends influencing supply chain stability.

FAQs

Q1: Who are the leading API manufacturers of trimethoprim globally?
A1: Major API suppliers include Lupin Limited and Sun Pharmaceutical Industries in India, North China Pharmaceutical Group, and Shanghai Sine Pharmaceutical in China. European and North American firms, like Evonik and Pfizer, also contribute but typically at a smaller scale.

Q2: What are the primary challenges in sourcing trimethoprim APIs?
A2: Challenges include ensuring regulatory compliance, raw material supply chain disruptions, geopolitical risks, and maintaining consistent quality standards across multiple suppliers.

Q3: How does patent status impact the supply of trimethoprim?
A3: Many patents for trimethoprim have expired, facilitating broad generic manufacturing and increasing supplier options, which generally improves supply stability.

Q4: Are there regional differences in trimethoprim API quality?
A4: Yes. While Asian manufacturers often produce at scale cost-effectively, European and North American suppliers typically adhere to stricter regulatory standards, influencing perceived quality and market acceptance.

Q5: What strategies should pharmaceutical companies adopt to secure a reliable trimethoprim supply chain?
A5: Companies should diversify suppliers across regions, conduct rigorous quality audits, maintain strategic stockpiles, and establish long-term manufacturing partnerships aligning with regulatory standards.

References

[1] World Health Organization. Model List of Essential Medicines. 22nd list, 2021.
[2] U.S. Food and Drug Administration. Guidance for Industry: Pharmaceutical Quality System (Q8). 2006.
[3] MarketsandMarkets. API Market by Type, Application, and Region — Global Forecast to 2027.
[4] Indian Pharmaceutical Industry Reports. Annual Market Data — 2022.
[5] Chinese Chemical Industry Outlook. Chemical Supply Chain & API Manufacturing Trends.

Note: The above synthesis integrates publicly available industry data and market analysis. Proprietary or confidential supplier agreements are not disclosed.

Suppliers and packagers for TRIMETHOPRIM

TRIMETHOPRIM

Suppliers for the Pharmaceutical Drug: Trimethoprim