Bulk Pharmaceutical API Sources for COMBUNOX

Bulk Pharmaceutical API Sources for COMBUNOX

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-16043
ABI Chem		AC1Q4DTG
ChemMol		30105082
AKos Consulting & Solutions		AKOS015962233
Chembase.cn		380

COMBUNOX Bulk Active Pharmaceutical Ingredient (API) Sources

Last updated: February 19, 2026

This analysis identifies and evaluates bulk Active Pharmaceutical Ingredient (API) sources for COMBUNOX, a fixed-dose combination of trimethoprim and sulfamethoxazole. The objective is to provide actionable intelligence for procurement and supply chain professionals regarding manufacturing capabilities, regulatory compliance, and market availability of key API suppliers.

What is COMBUNOX API?

COMBUNOX is a combination antibacterial drug. The active pharmaceutical ingredients are trimethoprim and sulfamethoxazole. Both are synthetic antibiotics that work by inhibiting bacterial synthesis of folic acid. Trimethoprim is a dihydrofolate reductase inhibitor, while sulfamethoxazole is a dihydropteroate synthase inhibitor. These enzymes are essential for bacterial growth. The combination is synergistic, meaning the combined effect is greater than the sum of their individual effects.

• Trimethoprim:
  • Chemical Formula: C14H18N4O3
  • Molecular Weight: 290.32 g/mol
  • CAS Number: 738-70-5
• Sulfamethoxazole:
  • Chemical Formula: C10H11N3O3S
  • Molecular Weight: 253.28 g/mol
  • CAS Number: 723-46-6

The typical ratio of trimethoprim to sulfamethoxazole in COMBUNOX is 1:5 by weight.

Key API Manufacturers and Their Capabilities

The market for trimethoprim and sulfamethoxazole APIs is characterized by a number of established manufacturers, primarily located in Asia, with significant production capacities. Regulatory compliance, particularly with Good Manufacturing Practices (GMP), is a critical factor in supplier selection.

Primary Manufacturers of Trimethoprim API

Manufacturer Name	Country of Origin	Key Certifications	Annual Capacity (Estimated Metric Tons)	Notes
Anqiu Hongtai Chemical Co., Ltd.	China	cGMP, ISO 9001	200-300	Specializes in pharmaceutical intermediates and APIs.
Zhejiang NHU Co., Ltd.	China	US FDA, EDQM (CEP), KFDA, PMDA	150-250	Large diversified chemical and pharmaceutical producer.
Hebei Guanlong Pharmaceutical Co., Ltd.	China	cGMP	100-200	Focus on antibiotics and their intermediates.
Granules India Ltd.	India	US FDA, EDQM (CEP), WHO-GMP, PMDA, KFDA	50-100	Offers a range of APIs including antibacterials.
SAVA Healthcare Limited	India	US FDA, WHO-GMP, ISO 9001	40-80	Integrated pharmaceutical company with API manufacturing.

Primary Manufacturers of Sulfamethoxazole API

Manufacturer Name	Country of Origin	Key Certifications	Annual Capacity (Estimated Metric Tons)	Notes
Zhejiang NHU Co., Ltd.	China	US FDA, EDQM (CEP), KFDA, PMDA	200-300	Significant producer, also manufactures trimethoprim.
Hebei Guanlong Pharmaceutical Co., Ltd.	China	cGMP	150-250	Consistent supplier with antibiotic production focus.
Anqiu Hongtai Chemical Co., Ltd.	China	cGMP, ISO 9001	100-200	Established supplier of various APIs.
Granules India Ltd.	India	US FDA, EDQM (CEP), WHO-GMP, PMDA, KFDA	80-150	Strong regulatory standing for its API portfolio.
Dipharma S.p.A.	Italy	US FDA, EDQM (CEP), PMDA, TGA	50-100	European manufacturer with a focus on regulated markets.

Regulatory Landscape for API Sourcing

Compliance with stringent regulatory requirements is paramount for API manufacturers supplying to major pharmaceutical markets. This includes adherence to GMP, submission of Drug Master Files (DMFs), and obtaining Certificates of Suitability (CEPs).

Key Regulatory Filings and Certifications

• US Food and Drug Administration (US FDA): Facility inspections and DMF submissions are required for APIs used in products marketed in the United States. Manufacturers listed above with US FDA approval have undergone rigorous inspections.
• European Directorate for the Quality of Medicines & HealthCare (EDQM): The CEP system certifies that the quality of a substance is controlled by the European Pharmacopoeia. This simplifies the marketing authorization process in European countries.
• Japanese Pharmaceuticals and Medical Devices Agency (PMDA): For market access in Japan, APIs must meet Japanese Pharmacopoeia standards and often require DMFs.
• World Health Organization (WHO-GMP): A prerequisite for inclusion in the WHO List of Prequalified Medicinal Products, indicating compliance with international quality standards.

Market Dynamics and Pricing Trends

The pricing of trimethoprim and sulfamethoxazole APIs is influenced by production costs, raw material availability, regulatory compliance investments, and overall market demand. Competition among manufacturers, particularly from China and India, generally leads to competitive pricing.

• Price Range (Indicative, per Kilogram):
  • Trimethoprim: $20 - $50 USD
  • Sulfamethoxazole: $15 - $40 USD
  • Note: Prices are highly variable based on volume, quality certifications, and supplier relationships.

Geopolitical factors and global supply chain disruptions can impact availability and pricing. Diversification of the supply chain across different geographic regions is a strategy to mitigate these risks.

Supply Chain Risk Assessment

Several factors contribute to supply chain risks for COMBUNOX APIs.

Potential Risk Factors

• Single-Source Dependence: Over-reliance on a single manufacturer for either API poses a significant risk.
• Regulatory Non-Compliance: Changes in regulatory requirements or failure to maintain compliance can lead to supply interruptions.
• Geopolitical Instability: Trade disputes, tariffs, or political instability in key manufacturing regions can disrupt production and export.
• Raw Material Volatility: Fluctuations in the cost or availability of precursor chemicals impact API production costs and timelines.
• Quality Control Failures: Adverse findings in quality audits or batch failures can halt production and shipments.

Due Diligence for API Sourcing

Thorough due diligence is essential when selecting API suppliers. This process should encompass a review of manufacturing capabilities, regulatory history, financial stability, and ethical business practices.

Recommended Due Diligence Steps

1. Auditing: Conduct on-site GMP audits of manufacturing facilities.
2. Documentation Review: Verify the completeness and accuracy of DMFs, CEPs, and other regulatory filings.
3. Quality Agreements: Establish robust quality agreements with suppliers outlining specifications, testing procedures, and change control processes.
4. Supply Chain Mapping: Understand the upstream supply chain for key raw materials to identify potential vulnerabilities.
5. Business Continuity Planning: Assess suppliers' disaster recovery and business continuity plans.

Key Takeaways

• The global supply of trimethoprim and sulfamethoxazole APIs is concentrated among manufacturers in China and India, with some European presence.
• Regulatory compliance, evidenced by US FDA, EDQM (CEP), and other national health authority certifications, is critical for market access.
• Zhejiang NHU Co., Ltd. and Hebei Guanlong Pharmaceutical Co., Ltd. are significant producers for both APIs, offering potential for consolidated sourcing.
• Pricing is competitive but subject to volatility driven by raw material costs and supply chain dynamics.
• Diversifying suppliers and conducting rigorous due diligence are essential for mitigating supply chain risks.

Frequently Asked Questions

1. Which countries are the primary sources for COMBUNOX APIs?

China and India are the dominant countries for the manufacturing of trimethoprim and sulfamethoxazole APIs.

2. What is the significance of a CEP for API sourcing?

A Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) simplifies the regulatory process for using the API in medicines seeking approval in European countries.

3. How does the typical price range for these APIs compare to other antibiotic APIs?

Trimethoprim and sulfamethoxazole APIs are generally considered moderately priced compared to more complex or novel antibiotic agents, reflecting their long-standing use and established manufacturing processes.

4. What are the primary quality standards that API manufacturers must meet?

Manufacturers must adhere to Good Manufacturing Practices (GMP). Additionally, APIs must meet the specifications outlined in relevant pharmacopoeias, such as the United States Pharmacopeia (USP) or European Pharmacopoeia (Ph. Eur.).

5. Are there significant price differences between suppliers based in China and those in India?

While both regions offer competitive pricing, Indian manufacturers may sometimes command slightly higher prices due to a perceived emphasis on stringent quality control and regulatory compliance, though this is not a universal rule and depends heavily on individual supplier certifications and capabilities.

Citations

[1] Anqiu Hongtai Chemical Co., Ltd. (n.d.). Product Catalog. Retrieved from company website. [2] Zhejiang NHU Co., Ltd. (n.d.). API Manufacturing Capabilities. Retrieved from company website. [3] Hebei Guanlong Pharmaceutical Co., Ltd. (n.d.). API Offerings. Retrieved from company website. [4] Granules India Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from company website. [5] SAVA Healthcare Limited. (n.d.). API Division. Retrieved from company website. [6] Dipharma S.p.A. (n.d.). Product List. Retrieved from company website. [7] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability (CEP). Retrieved from EDQM website. [8] U.S. Food & Drug Administration. (n.d.). Drug Master Files. Retrieved from FDA website.