Bulk Pharmaceutical API Sources for FLAGYL I.V.

Bulk Pharmaceutical API Sources for FLAGYL I.V.

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		68592
AAA Chemistry		AR-1C6870
ABI Chem		AC1L2A27
ABI Chem		AC1Q38LL
ChemTik		CTK5C9220
Alsachim		1864
ChemMol		99131018

Bulk Active Pharmaceutical Ingredient (API) Sources for FLAGYL I.V.

Last updated: August 3, 2025

Introduction

Flagyl I.V., the intravenous formulation of metronidazole, is a widely used antimicrobial agent primarily indicated for anaerobic bacterial and protozoal infections. Its efficacy hinges on both the active pharmaceutical ingredient (API) quality and sourcing reliability. This article explores the landscape of bulk API suppliers for metronidazole, emphasizing considerations relevant to pharmaceutical manufacturers, regulatory agencies, and procurement professionals. Ensuring a secure, compliant, and cost-effective API supply chain is critical to maintaining uninterrupted, high-quality Flagyl I.V. production.

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Overview of Metronidazole API

Metronidazole is a nitroimidazole derivative exhibiting bactericidal activity against anaerobic bacteria and protozoa. Its synthesis involves specific routes that influence API purity, stability, and batch-to-batch consistency. The API quality directly impacts the safety, efficacy, and regulatory approval of the final injectable product.

The global demand for metronidazole API, particularly for injectable use, has increased driven by the need in hospital settings, surgical prophylaxis, and infections resistant to other treatments. Consequently, robust sourcing options are vital.

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Major API Suppliers for FLAGYL I.V.

1. European and US-Based API Manufacturers

a. Novartis (Sandoz division)
Sandoz, a division of Novartis, is renowned for manufacturing high-quality APIs, including metronidazole. Their facilities are GMP-compliant, with rigorous quality control frameworks ensuring product consistency. They supply APIs across North America, Europe, and other regions.

b. TEVA Pharmaceuticals
With extensive manufacturing facilities across the globe, TEVA offers metronidazole API compliant with international standards. Their supply chain guarantees reliable access to bulk API for injectable formulations.

c. Pfizer
Pfizer manufactures APIs for various antimicrobial agents, including metronidazole. Their global distribution network and strict quality protocols make them a preferred source for large-volume procurement.

d. Archimedes Pharma & Others
Some European specialty API manufacturers cater to niche markets with high-quality metronidazole API, complying with European Pharmacopoeia standards.

2. Indian API Manufacturers

Indiais a prominent global hub for pharmaceutical ingredient manufacturing, offering a broad spectrum of APIs, including metronidazole.

a. Hetero Labs Ltd.
One of the leading Indian API producers, Hetero offers metronidazole API meeting international standards like USP and BP, with export capabilities to regulated markets.

b. Laurus Labs
Laurus Labs has a robust manufacturing process for metronidazole API, emphasizing compliance with cGMP and regulatory certifications like USFDA, EMA, and WHO GMP.

c. Aurobindo Pharma
Known for cost-effective manufacturing, Aurobindo supplies metronidazole API globally, with adherence to stringent quality parameters.

d. Surya Pharma
Specializes in antimicrobial APIs, including metronidazole, with an established export footprint.

3. Chinese API Manufacturers

China remains a significant source of cost-effective APIs, including metronidazole, although buyers should perform due diligence regarding regulatory compliance.

a. Zhejiang Hisun Pharmaceutical Co., Ltd.
They produce metronidazole API in compliance with ISO, WHO GMP standards, with export activities to multiple regions.

b. Zhejiang Huaqun Pharmaceutical
Offers metronidazole API with competitive pricing, emphasizing quality standards aligned with international requirements.

c. Jiangsu Hengrui Medicine Co., Ltd.
A major Chinese API producer with a growing reputation for quality and consistent supply.

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Quality and Regulatory Considerations

When sourcing API for injectable formulations like FLAGYL I.V., compliance with pharmacopoeial standards is paramount. Suppliers should provide documentation including:

• Certificates of Analysis (CoA)
• Certificates of Suitability (CEPs)
• Batch records and stability data
• Compliance with ICH guidelines
• Good Manufacturing Practice (GMP) certification

Regulatory approvals or clearances from agencies like the USFDA, EMA, or the WHO are critical indicators of API quality and facilitate easier registration and market access.

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Supply Chain and Risk Management

Securing an uninterrupted API supply involves assessing supplier stability, capacity, and geopolitical factors. The COVID-19 pandemic exposed vulnerabilities in global supply chains, underscoring the importance of diversified sourcing.

Multisourcing from reputable, certified manufacturers ensures risk mitigation against supply disruptions. Establishing long-term contracts, performing regular audits, and maintaining quality oversight further enhance supply security.

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Emerging Trends and Future Outlook

The API manufacturing landscape for metronidazole is evolving with technological advances like continuous manufacturing, better process controls, and quality-by-design (QbD) approaches. Additionally, rising regulatory scrutiny underscores the importance of transparent quality systems and compliance.

The shift toward bioequivalent generic APIs from emerging markets offers cost advantages but necessitates rigorous quality assurance. Importantly, validating supplier compliance with international standards remains a priority for pharmaceutical companies aiming to produce high-quality Flagyl I.V.

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Conclusion

The sourcing of bulk APIs for FLAGYL I.V. — primarily metronidazole — involves a diversified landscape spanning North America, Europe, India, and China. Leading manufacturers with GMP certification, regulatory approvals, and proven quality systems are preferred to ensure product safety, efficacy, and regulatory compliance.

Procurers should conduct thorough due diligence, including quality audits and supplier validation, to secure a reliable, compliant supply chain. Strategic diversification of sources, coupled with regulatory vigilance, is key to mitigating supply chain risks and maintaining consistent production of Flagyl I.V.

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Key Takeaways

• Leading API providers for metronidazole include Novartis/Sandoz, TEVA, Pfizer, and Indian manufacturers like Hetero Labs and Laurus Labs.
• Ensure supplier compliance with GMP, USP-BP standards, and regulatory certifications such as CEPs and USFDA approvals.
• Diversify sourcing strategies to mitigate risks associated with geopolitical issues and supply chain disruptions.
• Regularly audit and validate supplier quality to uphold the integrity of injectable formulations.
• Stay abreast of technological advances and regulatory trends impacting API manufacturing and procurement.

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FAQs

Q1: What are the critical quality attributes to consider when sourcing metronidazole API?
A1: Purity, impurity profile, physical characteristics, particle size, stability, and compliance with pharmacopeial standards (USP, BP, EP).

Q2: How does regulatory compliance influence API sourcing decisions?
A2: Regulatory compliance ensures the API meets safety and efficacy standards, facilitating registration in target markets and reducing regulatory risks.

Q3: Are there specific risks associated with sourcing APIs from Chinese manufacturers?
A3: Potential risks include variability in quality, regulatory recognition, and intellectual property concerns, mandating thorough due diligence and supplier validation.

Q4: How can pharmaceutical companies ensure supply chain resilience for API procurement?
A4: Through supplier diversification, long-term contracts, quality assurance programs, and maintaining strategic stockpiles.

Q5: What role does technology play in improving API manufacturing quality?
A5: Technologies like continuous manufacturing and quality-by-design (QbD) enhance process control, consistency, and product quality.

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References

[1] WHO. (2021). WHO Good Manufacturing Practices (GMP) Guidelines for APIs.
[2] USFDA. (2022). Current Good Manufacturing Practice (CGMP) for APIs.
[3] European Medicines Agency. (2022). Guidelines on the manufacture of medicinal products.
[4] MarketWatch. (2023). Global API Market Trends.
[5] PharmaIQ. (2022). API Sourcing Strategies in the Modern Pharmaceutical Industry.