Bulk Pharmaceutical API Sources for METRONIDAZOLE IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for METRONIDAZOLE 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
AKos Consulting & Solutions		AKOS005169650

Bulk Active Pharmaceutical Ingredient (API) Sources for: METRONIDAZOLE IN PLASTIC CONTAINER

Last updated: August 2, 2025

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Introduction

Metronidazole, a nitroimidazole antibiotic and antiprotozoal agent, is widely used to treat bacterial infections, protozoal diseases, and anaerobic infections. The pharmaceutical industry relies heavily on robust API sourcing to ensure product quality, supply chain stability, and cost-effectiveness. This article provides a comprehensive overview of bulk suppliers for Metronidazole API, specifically formulations intended for distribution in plastic containers. Understanding sourcing options for Metronidazole API is critical for manufacturers, distributors, and healthcare providers aiming to optimize procurement strategies in a competitive pharmaceutical landscape.

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Market Overview and Regulatory Landscape

The global demand for Metronidazole API persists due to its extensive therapeutic applications, especially in developing countries with high incidences of parasitic infections and bacterial diseases. The API's manufacturing is governed by stringent regulatory standards such as the US FDA, EMA, and WHO guidelines, emphasizing Good Manufacturing Practices (GMP). Suppliers holding certifications from these agencies are preferred for ensuring API quality, safety, and compliance.

The API market’s growth is driven by increasing prevalence of infections in emerging markets, along with expanding applications in pharmaceutical formulations, including tablets, capsules, and injectables in plastic containers. For pharmaceutical companies, sourcing from reputable API manufacturers is key to maintaining product efficacy and regulatory approval.

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Main Global Suppliers of Metronidazole API

1. Indian API Manufacturers

India remains a prominent hub for bulk API production, owing to advanced manufacturing infrastructure, cost advantages, and compliance with international quality standards.

• Benzo Pharmaceuticals
  Specializes in high-purity Metronidazole APIs, compliant with FDA and WHO GMP standards. Offers flexible bulk quantities for both domestic and export markets.

• Micro Labs Ltd.
  Provides bulk Metronidazole API with consistent quality, certified for global markets; actively exports to North America, Africa, and Southeast Asia.

• Wockhardt Ltd.
  One of India’s leading pharma manufacturers, Wockhardt supplies GMP-certified APIs, including Metronidazole, optimized for formulation compatibility in plastic container presentations.

2. Chinese API Manufacturers

China has increased its share in the global API market, with numerous GMP-certified producers capable of supplying Metronidazole at competitive prices.

• Haimen Sinobest Pharmaceutical Co., Ltd.
  Produces high-quality APIs, including Metronidazole, with DOT (Derivative of Traditional Chinese medicine) certification, suitable for export.

• Shandong Xinhua Pharmaceutical Co., Ltd.
  Offers Metronidazole API sourced from GMP-compliant facilities, serving both generic and branded pharmaceutical markets globally.

3. European and North American API Suppliers

While smaller, these suppliers emphasize pharmaceutical-grade quality and compliance with strict regulatory criteria.

• EMC Pharma (France)
  Supplies GMP-certified Metronidazole API for EU markets, with a focus on quality assurance suitable for plastic container formulations.

• Amneal Pharmaceuticals (USA)
  Provides high-quality APIs with rigorous regulatory compliance, including full batch traceability and GMP accreditation.

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Key Criteria for Selecting API Suppliers

• Quality Certifications: Ensure GMP, ISO 9001, and WHO-GMP accreditations.
• Regulatory Compliance: Suppliers should have experience supplying APIs approved for major markets such as US, EU, or PIC/S.
• Manufacturing Capacity & Lead Time: Reliable capacity and timely delivery for commercial and clinical batches.
• Pricing & Payment Terms: Competitive pricing aligned with quality standards.
• Supply Chain Transparency: Robust traceability of raw materials and manufacturing processes.
• Support Services: Technical support, documentation, and stability data.

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Formulation Considerations: Metronidazole in Plastic Containers

Metronidazole APIs formulated for plastic containers—primarily tablets, capsules, or suspensions—demand APIs with high purity and consistent quality to prevent degradation and ensure stability. Suppliers offering APIs validated for compatibility with common excipients in plastic formulations are preferential. Additionally, APIs intended for oral administration in plastic bottles (including suspensions) should undergo stability testing to confirm the package-API interface resilience.

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Emerging Trends and Innovations

• Green Manufacturing Processes: Focus on environmentally friendly synthesis routes reducing residual solvents and by-products.
• API Customization: Some suppliers offer tailored APIs, such as salt forms (e.g., Metronidazole benzoate), optimized for specific formulations or stability requirements within plastic packaging.
• Supply Chain Digitization: Blockchain and digital traceability are increasingly adopted to enhance transparency and prevent counterfeit APIs.

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Summary of Leading API Sources

Supplier Location	Certification & Standards	Key Features	Distribution Focus
India (Benzo Pharma, Micro Labs, Wockhardt)	GMP, WHO-GMP, ISO	Cost-effective, high-volume, scalable	Global, with focus on Asia/Africa
China (Haimen Sinobest, Shandong Xinhua)	GMP, Chinese standards	Competitive pricing, reliable supply	Asia, Africa, Latin America
Europe/North America (EMC Pharma, Amneal)	EU-GMP, US-FDA	Premium quality, strict compliance	Developed markets

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Key Takeaways

• India and China dominate the global API supply for Metronidazole, offering competitive pricing and extensive compliance certifications.
• Prioritize suppliers with recognized GMP and WHO certifications, particularly for formulations intended for plastic containers requiring high API purity and stability.
• Evaluate suppliers based on manufacturing capacity, delivery reliability, and support services to prevent supply disruptions.
• Consider emerging trends like green synthesis and supply chain digitization to enhance procurement resilience.
• Regulatory due diligence remains crucial; ensure supplier documentation aligns with target market requirements.

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FAQs

1. What should I verify before choosing a Metronidazole API supplier?
Verify GMP certification, batch consistency, supply capacity, and compliance with international quality standards such as WHO-GMP, US-FDA, or EMA.

2. Are APIs from China suitable for formulations in plastic containers?
Yes, provided the supplier supplies APIs with validated stability and compatibility data suitable for oral and suspension formulations in plastic packaging.

3. How does supplier accreditation impact API quality?
Accreditation ensures adherence to quality standards, regulatory compliance, and consistent manufacturing processes, reducing risks associated with low-quality or contaminated APIs.

4. What are the cost implications of sourcing from different regions?
Indian and Chinese suppliers generally offer lower prices due to manufacturing efficiencies, but costs should be balanced against quality assurance and regulatory compliance.

5. How can I mitigate supply chain disruptions for Metronidazole API?
Establish relationships with multiple certified suppliers across different regions and maintain safety stock to buffer against geopolitical or logistical delays.

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References

[1] WHO. (2021). Model List of Essential Medicines. World Health Organization.
[2] US FDA. (2022). API Drug Substance Guidance. U.S. Food & Drug Administration.
[3] European Medicines Agency. (2022). Guidelines on Good Manufacturing Practice. EMA.
[4] Global Pharmaceutical Market Reports. (2023). Industry Insights on API Manufacturing.
[5] Industry Publications. (2023). Emerging Trends in API Supply Chains.

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In conclusion, sourcing high-quality Metronidazole API—especially for formulations in plastic containers—requires diligent supplier evaluation focused on regulatory compliance, manufacturing quality, and supply reliability. Strategic partnerships with certified API manufacturers from India, China, or established markets will ensure product integrity, regulatory adherence, and supply chain continuity essential for global pharmaceutical operations.