Bulk Pharmaceutical API Sources for METRONIDAZOLE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for METRONIDAZOLE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS028109662
BOC Sciences		69198-10-3
Hairui Chemical		HR117187
Sinfoo Biotech		S051916
MolCore		MC567521
Smolecule		S566355
THE BioTek		bt-367395

Bulk Active Pharmaceutical Ingredient (API) Sources for: METRONIDAZOLE HYDROCHLORIDE

Last updated: July 29, 2025

Introduction

Metronidazole Hydrochloride, a widely used antimicrobial agent, serves as a cornerstone in treating anaerobic infections, protozoal diseases, and various gynecological conditions. As pharmaceutical manufacturing increasingly favors globalized sourcing to optimize cost and ensure supply reliability, identifying reputable bulk API suppliers becomes paramount. This report provides a comprehensive overview of primary sources for Metronidazole Hydrochloride, examining manufacturing regions, supplier credentials, quality standards, and sourcing considerations critical for pharmaceutical companies, distributors, and healthcare providers.

Global Manufacturing Landscape

1. Major Production Regions

The production of Metronidazole Hydrochloride is largely concentrated in regions with established pharmaceutical manufacturing infrastructure, notably:

• India: Recognized as a pivotal hub with numerous WHO-GMP-certified API manufacturers. Companies such as Zinco Laboratories and Hetero Labs supply significant quantities to global markets.

• China: Home to a considerable number of API producers offering competitive pricing, backed by growing regulatory compliance capabilities.

• Eastern Europe and Russia: Known for producing high-quality APIs, often aligned with stringent European standards.

• Western Countries: Generally involve smaller volumes, focusing on niche, high-quality APIs with strict compliance such as the US, Germany, and Switzerland.

2. Regulatory Compliance and Standards

Suppliers must adhere to recognized quality standards:

• GMP (Good Manufacturing Practice): Required for APIs supplied to regulated markets like the US (FDA), Europe (EMA), and Japan (PMDA).
• ISO Certifications: ISO 9001, ISO 14001 enhance supplier credibility.
• Pharmacopoeial Standards: API specifications often conform to USP, EP, or BP monographs.

Notable API Suppliers for Metronidazole Hydrochloride

Indian Manufacturers

• Zinco Laboratories: Certified by GMP and WHO, Zinco offers high-purity Metronidazole Hydrochloride suitable for pharmaceutical formulations globally. Their API undergoes rigorous QC testing aligning with international pharmacopeias.
• Hetero Labs: A prominent player with substantial API production capacity, Hetero supplies compliant Metronidazole Hydrochloride to markets in North America, Europe, and Asia.
• Jubilant Life Sciences: Known for consistent quality, Jubilant offers APIs with comprehensive documentation covering stability, purity, and compliance certifications.

Chinese Manufacturers

• North China Pharmaceutical Group (NCPC): Focused on cost-effective production with adherence to CGMP standards, NCPC provides bulk supplies with appropriate regulatory documentation.
• Sino Biopharmaceutical: Offers competitive pricing and certifiable product quality conforming to international standards.

European and North American Suppliers

• BASF (Germany): Supplies high-grade APIs with rigorous testing, suited for highly regulated markets.
• Cambridge Major Laboratories (USA): Known for custom synthesis and high-quality APIs compliant with USFDA requirements.

Selection Criteria for API Suppliers

When sourcing Metronidazole Hydrochloride, organizations should evaluate suppliers based on:

• Regulatory Compliance: Confirm GMP certification and method validation documentation.
• Quality Assurance: Ensure adherence to pharmacopeial standards (USP, EP, BP) with proper analytical data and batch records.
• Pricing & Lead Time: Weigh economies of scale against quality and delivery timelines.
• Supply Chain Stability: Seek suppliers with proven track records for consistent supply and contingency plans.
• Documentation & Traceability: Complete Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and regulatory dossiers.

Implications of Sourcing from Different Regions

Cost and Price Considerations

Indian and Chinese suppliers often provide the most competitive prices due to lower manufacturing costs. However, customers should balance cost savings against regulatory acceptance and quality assurance procedures.

Regulatory Acceptance

Suppliers compliant with international standards facilitate smoother registration processes in target markets. For example, US and EU markets typically favor suppliers with FDA or EMA approval, respectively.

Quality and Compliance Risks

Sourcing from unverified or non-GMP-certified suppliers poses risks related to impurity profiles, batch consistency, and regulatory violations. Rigorous qualification processes mitigate these risks.

Logistics and Delivery Reliability

Lead times and logistical considerations vary by region. Suppliers with localized manufacturing facilities closer to the end markets tend to offer faster delivery.

Emerging Trends in API Sourcing

• Global Supply Chain Diversification: Companies are increasingly diversifying suppliers to mitigate risks associated with geopolitical disruptions, pandemics, or regulatory changes.
• Quality Management Enhancements: Greater emphasis on analytical techniques like HPLC, LC-MS, and stability testing for vendor qualification.
• Sustainable and Green Manufacturing: Consumer and regulatory pressures incline suppliers toward environmentally sustainable practices.

Conclusion

The procurement of bulk Metronidazole Hydrochloride requires strategic sourcing, balancing cost, quality, regulatory compliance, and supply chain resilience. Indian and Chinese manufacturers currently dominate the landscape due to cost advantages and manufacturing capacity; however, high-quality European and North American suppliers serve markets with stringent regulatory requirements.

Prospective buyers should implement rigorous qualification protocols, including audit inspections, validation of GMP certification, and review of documentation, to secure reliable supply channels. As regulatory landscapes evolve, maintaining supplier due diligence and fostering transparent communication will remain critical for ensuring API quality aligned with pharmaceutical industry standards.

---

Key Takeaways

• Diverse sourcing regions include India, China, Europe, and North America, each offering distinct advantages and regulatory considerations.
• Regulatory compliance (GMP, pharmacopeial standards) is paramount to ensure API quality and market acceptance.
• Supplier qualification—through audits, validation documents, and quality certifications—is essential to mitigate supply and quality risks.
• Cost considerations favor India and China but must be balanced against compliance and quality assurance.
• Supply chain resilience can be enhanced via diversification and establishing strong supplier relationships.

---

FAQs

Q1. How do I verify the quality of Metronidazole Hydrochloride from international suppliers?
A1. Verify GMP certification, request Certificates of Analysis aligned with pharmacopeial standards, conduct supplier audits if possible, and review batch records and stability data.

Q2. Are Chinese API suppliers suitable for regulated markets?
A2. Many Chinese suppliers meet GMP and ISO standards, making them suitable for regulated markets if properly qualified and certified, with thorough documentation.

Q3. What are the risks of sourcing from low-cost, unverified suppliers?
A3. Risks include inconsistent quality, impurity contamination, regulatory non-compliance, supply interruptions, and legal liabilities.

Q4. How can I ensure regulatory compliance when importing Metronidazole Hydrochloride?
A4. Confirm supplier GMP certification, obtain comprehensive documentation, and adhere to local import regulations and registration requirements.

Q5. Is there a trend toward sustainable API manufacturing for Metronidazole Hydrochloride?
A5. Yes. The industry is increasingly emphasizing environmentally friendly and sustainable manufacturing practices to meet regulatory and consumer demands.

---

Sources

[1] World Health Organization (WHO). Prequalification of Medicines Programme.
[2] U.S. Food and Drug Administration (FDA). API Quality Standards.
[3] European Medicines Agency (EMA). API Regulatory Guidance.
[4] Indian Pharmaceutical Alliance. API Manufacturing Compliance.
[5] Chinese Pharmacopoeia. Standards for APIs.