Bulk Pharmaceutical API Sources for FLAGYL ER

Bulk Pharmaceutical API Sources for FLAGYL ER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M1547_SIGMA
Vitas-M Laboratory		STK177359
TCI (Tokyo Chemical Industry)		M0924

Flagyl ER API Sourcing Landscape

Last updated: February 19, 2026

This report analyzes the current landscape of bulk Active Pharmaceutical Ingredient (API) sources for Flagyl ER (extended-release metronidazole). It identifies key manufacturers, their geographic distribution, and the implications for supply chain security and cost.

What is Flagyl ER and its API?

Flagyl ER is an extended-release formulation of metronidazole, an antibiotic and antiprotozoal medication used to treat a variety of bacterial and parasitic infections. The active pharmaceutical ingredient is metronidazole. The chemical name for metronidazole is 2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethanol. Its CAS number is 443-48-1. The extended-release formulation is designed to provide a sustained release of the drug over a prolonged period, reducing dosing frequency.

Who Manufactures Metronidazole API?

The global manufacturing base for metronidazole API is concentrated in Asia, primarily in India and China, with a smaller but significant presence in Europe. These regions benefit from established chemical manufacturing infrastructure, skilled labor, and cost advantages.

Major Metronidazole API Manufacturers

The following companies are identified as significant manufacturers of metronidazole API. This list is not exhaustive but represents key players based on market presence and regulatory filings.

• India:

  • Aarti Drugs Ltd.
  • Granules India Ltd.
  • IOL Chemicals and Pharmaceuticals Ltd.
  • Divi's Laboratories Ltd.
  • Solara Active Pharma Sciences Ltd.

• China:

  • Hubei Xingfa Chemicals Group Co., Ltd.
  • Shandong Xinhua Pharmaceutical Co., Ltd.
  • Jiangsu Xinyi Pharmaceutical Co., Ltd.
  • Zhejiang NHU Co., Ltd.

• Europe:

  • Sanofi S.A. (France) - While Sanofi is a primary marketer of Flagyl ER, their internal API production for metronidazole may be limited or focused on specific therapeutic areas. They rely on external API suppliers for broad market supply.
  • Chemi-Pharma S.p.A. (Italy)

Geographic Distribution of API Production

The majority of metronidazole API production is located in:

• India: Consistently a top producer due to its strong pharmaceutical manufacturing capabilities and cost-competitiveness. Indian manufacturers hold significant market share for APIs supplied to regulated markets like the US and Europe.
• China: A major global supplier of APIs, including metronidazole. Chinese manufacturers are competitive on price and volume. Regulatory scrutiny and quality control have been areas of increasing focus.
• Europe: European manufacturers often focus on higher-value APIs or niche markets, and may offer greater assurance of stringent quality and regulatory compliance, albeit at a potentially higher cost.

Regulatory Status and Quality Standards

API manufacturers supplying to regulated pharmaceutical markets must adhere to strict quality standards, including Good Manufacturing Practices (GMP). Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) conduct inspections of manufacturing facilities.

Key Regulatory Filings

• Drug Master Files (DMFs): API manufacturers file DMFs with regulatory authorities. These confidential documents contain detailed information about the manufacturing process, quality controls, and specifications of the API. Pharmaceutical companies reference these DMFs in their drug product applications.
• Certificates of Suitability to the European Pharmacopoeia (CEP): A CEP demonstrates that an API complies with the European Pharmacopoeia monograph and is manufactured according to European GMP standards.
• U.S. FDA Inspections: Facilities supplying to the U.S. market are subject to FDA inspections. A history of successful FDA inspections is a critical factor for API suppliers.

Quality Considerations for Metronidazole API

• Purity Profile: Ensuring minimal impurities and degradation products is crucial for patient safety and product efficacy.
• Particle Size Distribution: For extended-release formulations, the physical characteristics of the API, such as particle size, can significantly impact drug release profiles and manufacturing processability.
• Stability: The API must remain stable under various storage conditions to maintain its quality throughout its shelf life.

Supply Chain Dynamics and Risk Factors

The global API market for metronidazole is subject to various dynamics that influence availability, pricing, and supply chain security.

Supply Chain Risks

• Geopolitical Instability: Tensions or trade disputes involving major API manufacturing regions can disrupt supply.
• Regulatory Changes: Evolving GMP requirements or new environmental regulations in manufacturing countries can impact production costs and availability.
• Natural Disasters and Pandemics: Events like the COVID-19 pandemic highlighted the vulnerability of global supply chains to unforeseen disruptions.
• Raw Material Sourcing: The availability and cost of key raw materials used in metronidazole synthesis can affect API pricing and production capacity.
• Quality Issues: Any non-compliance with GMP or critical quality failures at an API manufacturing site can lead to immediate supply cessation and necessitate a rapid supplier change.

Sourcing Strategies

Pharmaceutical companies seeking to secure their supply of metronidazole API for Flagyl ER typically employ a multi-pronged approach:

• Dual Sourcing: Engaging with at least two qualified API manufacturers from different geographic regions to mitigate supply risks.
• Long-Term Contracts: Establishing long-term supply agreements to ensure consistent volume and price stability.
• Supplier Audits: Conducting rigorous audits of potential and existing API suppliers to verify compliance with quality and regulatory standards.
• Inventory Management: Maintaining adequate safety stock of the API to buffer against short-term supply disruptions.

Pricing and Market Trends

The pricing of metronidazole API is influenced by production costs, global demand, competitive landscape, and regulatory compliance overhead.

Factors Affecting Price

• Raw Material Costs: Fluctuations in the prices of precursor chemicals directly impact API manufacturing costs.
• Manufacturing Location: APIs produced in regions with lower labor and operating costs are generally more competitive.
• Regulatory Compliance: Investments required for GMP compliance, quality control, and dossier preparation add to the overall cost.
• Volume Commitments: Larger volume purchase orders typically secure more favorable pricing.
• Supply and Demand: Imbalances between global supply capacity and demand for metronidazole can lead to price volatility.

Market Trends

• Consolidation: In some API segments, manufacturing capacity has consolidated, potentially reducing competition.
• Increased Regulatory Scrutiny: Global regulatory bodies are increasing their oversight of API manufacturing, leading to higher compliance costs but also improved product quality and patient safety.
• Focus on Supply Chain Resilience: The industry is increasingly prioritizing supply chain resilience, leading to diversification of sourcing strategies and greater emphasis on risk management.
• Technological Advancements: Innovations in chemical synthesis and process optimization can lead to more efficient and cost-effective API production.

Conclusion

The sourcing of metronidazole API for Flagyl ER is primarily reliant on manufacturers in India and China, with European suppliers offering alternative, albeit potentially higher-cost, options. Pharmaceutical companies must navigate a complex landscape of regulatory requirements, quality standards, and supply chain risks. A robust sourcing strategy that emphasizes dual sourcing, rigorous supplier qualification, and proactive risk management is essential for ensuring a stable and compliant supply of this critical medication.

Key Takeaways

• Metronidazole API manufacturing is predominantly based in India and China, with European production also present.
• Key Indian manufacturers include Aarti Drugs Ltd., Granules India Ltd., and IOL Chemicals and Pharmaceuticals Ltd.
• Major Chinese manufacturers include Hubei Xingfa Chemicals Group and Shandong Xinhua Pharmaceutical.
• Supply chain resilience is paramount, necessitating strategies such as dual sourcing and long-term contracts.
• Adherence to GMP and successful regulatory inspections (FDA, EMA) are critical for API supplier qualification.

Frequently Asked Questions

What is the typical lead time for ordering metronidazole API from a new supplier?

Typical lead times for metronidazole API from a new supplier can range from 3 to 6 months, depending on the manufacturer's existing production schedules, the quantity ordered, and any required pre-shipment audits or qualification steps.

How does the extended-release formulation impact API sourcing requirements?

The extended-release formulation of Flagyl ER necessitates specific API characteristics, such as controlled particle size distribution and consistent polymorphic form, which may require specialized manufacturing processes and stringent quality control from the API supplier compared to immediate-release metronidazole.

Are there any specific environmental regulations that significantly impact metronidazole API production in key manufacturing regions?

Both India and China have been implementing stricter environmental regulations, particularly concerning wastewater treatment and emissions from chemical manufacturing. These regulations can lead to increased operational costs and potential production downtime for API facilities that do not meet compliance standards.

What is the average price range for metronidazole API on the global market?

The average price for metronidazole API can fluctuate significantly based on volume, quality certifications, and market conditions. As of recent market analyses, prices typically range from \$15 to \$40 per kilogram, with bulk purchases and long-term contracts potentially securing lower rates.

How can pharmaceutical companies ensure the authenticity and quality of metronidazole API from overseas manufacturers?

Ensuring authenticity and quality involves comprehensive supplier qualification, including site audits for GMP compliance, verification of regulatory filings (DMF, CEP), independent third-party testing of API batches, and establishing clear quality agreements with suppliers.

Citations

[1] Aarti Drugs Ltd. (n.d.). Metronidazole. Retrieved from https://www.aartidrugs.com/product/metronidazole.html [2] Granules India Ltd. (n.d.). Metronidazole. Retrieved from https://www.granulesindia.com/products/api [3] IOL Chemicals and Pharmaceuticals Ltd. (n.d.). Metronidazole. Retrieved from https://www.iolcp.com/product/metronidazole [4] Divi's Laboratories Ltd. (n.d.). API Product List. Retrieved from https://www.divis.com/product/api-list [5] Solara Active Pharma Sciences Ltd. (n.d.). Metronidazole. Retrieved from https://www.solara.com/product-profile/metronidazole/ [6] Hubei Xingfa Chemicals Group Co., Ltd. (n.d.). Metronidazole. Retrieved from https://www.xingfa.com.cn/en/products/pharmaceutical/metronidazole.html [7] Shandong Xinhua Pharmaceutical Co., Ltd. (n.d.). Product Catalogue. Retrieved from https://www.xhpharm.com/en/products.html [8] Jiangsu Xinyi Pharmaceutical Co., Ltd. (n.d.). Metronidazole. (Company website specific product information not readily available in English for direct citation, relying on industry databases and trade publications for confirmation of manufacturing). [9] Zhejiang NHU Co., Ltd. (n.d.). Metronidazole. Retrieved from https://en.nhu.com/products/API/Metronidazole [10] Chemi-Pharma S.p.A. (n.d.). Metronidazole. (Company website specific product information not readily available in English for direct citation, relying on industry databases and trade publications for confirmation of manufacturing). [11] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files [12] European Medicines Agency. (n.d.). Certificate of suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from https://www.ema.europa.eu/en/documents/other/certificate-suitability-monographs-european-pharmacopoeia-cep-guideline-application-procedure_en.pdf