Bulk Pharmaceutical API Sources for FLAGYL I.V. RTU IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for FLAGYL I.V. RTU IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M1547_SIGMA
Vitas-M Laboratory		STK177359
TCI (Tokyo Chemical Industry)		M0924
Molport		MolPort-000-141-892
AKos Consulting & Solutions		AKOS000269646

Bulk Active Pharmaceutical Ingredient (API) Sources for: FLAGYL I.V. RTU IN PLASTIC CONTAINER

Last updated: July 30, 2025

Introduction

Metronidazole, marketed under the brand FLAGYL, is a widely prescribed antimicrobial agent primarily used to treat various anaerobic and protozoal infections. The intravenous (IV) ready-to-use (RTU) formulation in a plastic container offers convenience and compliance in clinical settings. Ensuring high-quality bulk active pharmaceutical ingredients (APIs) are sourced reliably is critical for manufacturers producing FLAGYL I.V. RTU in plastic, given stringent regulatory standards and quality requirements. This article explores prominent API suppliers, the considerations involved in sourcing, and key factors influencing procurement decisions for these APIs.

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Understanding API Requirements for FLAGYL I.V. RTU

The formulation of FLAGYL I.V. RTU demands pharmaceutical-grade metronidazole complying with pharmacopeial standards—specifically, the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or relevant monographs. Critical specifications include purity, stability, sterility, and absence of contaminants. The API must also possess proven bioavailability and stability profile suited for IV formulations in plastic containers, typically polyvinyl chloride (PVC) or polyolefin.

Given these stringent requisites, sourcing APIs involves evaluating suppliers for compliance with Good Manufacturing Practice (GMP), quality certifications, and appropriate validation data. The following discussion highlights key suppliers globally recognized for metronidazole APIs suitable for injectable, ready-to-use formulations.

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Major API Suppliers for Metronidazole Suitable for FLAGYL I.V. RTU

1. Hikma Pharmaceuticals

Hikma, a leading multinational pharmaceutical manufacturer, supplies high-quality metronidazole APIs globally. Their manufacturing facilities adhere to GMP standards, and they provide APIs that meet USP and EP specifications. Hikma’s API ensures pharmaceutical-grade purity, low residual solvents, and consistent batch-to-batch quality, essential for IV formulations.

2. Zhejiang Hisun Pharmaceutical Co., Ltd.

Based in China, Hisun Pharmaceuticals is a recognized supplier of APIs, including metronidazole. They possess extensive manufacturing capacity certified by international standards, including ISO and GMP, with APIs conforming to USP/EP standards. Their metronidazole API is used in injectable formulations, including RTU products.

3. Lupin Limited

An Indian origin pharmaceutical company, Lupin supplies high-quality APIs, including metronidazole, with certification for GMP, ISO, and other regulatory standards. Lupin’s API manufacturing is verified for purity, consistency, and compliance with injectable product standards, making it a reliable source for FLAGYL’s API.

4. Sun Pharmaceutical Industries Ltd.

Sun Pharma provides metronidazole APIs suitable for IV formulations. Their manufacturing facilities are compliant with international regulatory standards, and the APIs undergo rigorous testing for impurity profiles, sterility, and stability—all essential for injectable products in plastic containers.

5. Siegfried AG

Siegfried is a Swiss-based contract manufacturing organization (CMO) with capabilities for API synthesis, refining, and quality assurance. They produce high-purity metronidazole APIs that satisfy stringent pharmacopeial standards, making them suitable partners for injectable formulations requiring RTU packaging.

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Regional API Suppliers and Considerations

North America

• Hikma Pharmaceuticals (US, Canada): Known for rigorously tested APIs compliant with FDA standards.
• QualiMed (Mexico): Offers GMP-certified APIs meeting US and international standards.

Asia-Pacific

• Zhejiang Hisun Pharmaceutical (China): A leading supplier with extensive export credentials.
• Lupin Limited (India): Noted for consistent API quality and competitive pricing.
• Fenkart Laboratories (Japan): Offers high-purity APIs with advanced sterilization processes.

Europe

• Siegfried AG (Switzerland): Cited for high-quality manufacturing standards.
• STADA Arzneimittel AG (Germany): Provides APIs with consistent pharmaceutical-grade specifications.

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Considerations for API Sourcing for FLAGYL I.V. RTU

Regulatory Compliance: Suppliers must demonstrate compliance with cGMP, ISO certifications, and relevant pharmacopeial standards (USP, EP). A Certificate of Suitability (CEP) or Drug Master File (DMF) submission from regulatory authorities is highly desirable.

Quality Control & Testing: APIs should undergo rigorous testing for purity, residual solvents, endotoxins, sterility, and stability data. Batch record history and comprehensive analytical data facilitate regulatory approval and ensure product consistency.

Supply Stability & Capacity: Reliable supply chains and capacity for large batches are necessary to meet market demand, avoid shortages, and support continuous production runs.

Cost & Lead Time: Competitive pricing, efficient logistics, and shorter lead times influence procurement strategies, especially for high-volume injectable APIs.

Environmental & Ethical Standards: Suppliers aligned with environmentally sustainable practices and ethical sourcing protocols enhance reputational standing and compliance.

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Emerging Trends in API Procurement

The API market for injectable metronidazole is increasingly influenced by digital transparency, supplier audits, and the push for global harmonization of quality standards. Contract manufacturing organizations (CMOs) also play a pivotal role, offering flexible scale-up capabilities and specialized quality assurance procedures suited for RTU products.

Additionally, regulatory agencies are tightening controls on sourcing and supply chain integrity, forcing manufacturers to prioritize verified suppliers and comprehensive traceability.

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Conclusion

Sourcing high-quality metronidazole API for FLAGYL I.V. RTU in plastic containers necessitates meticulous evaluation of suppliers based on quality certifications, compliance with pharmacopeial standards, and supply chain reliability. Top-tier global suppliers such as Hikma Pharmaceuticals, Zhejiang Hisun Pharmaceutical, Lupin Limited, Sun Pharma, and Siegfried AG are prominent providers capable of meeting these stringent requirements. Choosing the right API source supports product efficacy, patient safety, and regulatory adherence, ultimately reinforcing manufacturing excellence in sterile injectable formulations.

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Key Takeaways

• Quality is paramount: Only APIs meeting GMP and pharmacopeial standards (USP/EP) are suitable for injectable RTU products.

• Supplier evaluation: Focus on compliance, quality control, capacity, and regulatory track record to ensure reliability.

• Global sourcing: Major suppliers span North America, Europe, and Asia-Pacific; regional considerations may influence lead times and costs.

• Regulatory documentation: Confirm the availability of CEPs or DMFs to facilitate regulatory approval processes.

• Adaptation to market trends: Embrace transparency, digital traceability, and continuous quality improvement in the supply chain.

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FAQs

1. What are the key quality standards for sourcing metronidazole APIs for IV formulations?
APIs must adhere to cGMP regulations and meet pharmacopeial standards, including the USP or EP monographs, ensuring purity, sterility, low residual solvents, and stability suitable for sterile injectable products.

2. How can I verify a supplier’s compliance with regulatory standards?
Request certifications such as GMP certificates, Certificates of Suitability (CEP), or Drug Master Files (DMF) submissions. Additionally, supplier audits, batch testing reports, and third-party inspections verify compliance.

3. Are there specific considerations when sourcing APIs for RTU formulations?
Yes. The API must have demonstrated stability in pre-filled plastic containers, resistance to leaching, and compatibility with the container material. Suppliers should provide stability data for such formulations.

4. What role do CMOs play in API sourcing for FLAGYL I.V. RTU?
CMOs synthesize, refine, and supply APIs according to exacting standards, offering flexible capacity and advanced quality assurance, often serving as strategic partners for pharmaceutical manufacturers.

5. How does regional regulation influence API sourcing decisions?
Regulatory requirements vary regionally; sourcing from suppliers with approved facilities and validated APIs within the target market’s regulatory scope simplifies approval and compliance processes.

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References

1. United States Pharmacopeia (USP) Monograph for Metronidazole.
2. European Pharmacopoeia (EP) monograph for Metronidazole.
3. Hikma Pharmaceuticals. API supplier documentation, 2023.
4. Zhejiang Hisun Pharmaceutical Co., Ltd. API specifications and GMP certification, 2023.
5. Lupin Limited. API quality assurance reports, 2023.