Bulk Pharmaceutical API Sources for VAGISTAT-1

Bulk Pharmaceutical API Sources for VAGISTAT-1

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-711
Hangzhou APIChem Technology		AC-13425
Amadis Chemical		A835270
AKos Consulting & Solutions		AKOS015906500
Finetech Industry Limited		FT-0630756
Key Organics/BIONET		KS-5114
AbaChemScene		CS-2360

Bulk Active Pharmaceutical Ingredient (API) Sources for: VAGISTAT-1

Last updated: July 29, 2025

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Introduction

VAGISTAT-1, a topical antifungal and antibacterial agent, has garnered significant attention in the pharmaceutical industry due to its therapeutic efficacy in treating vulvovaginal candidiasis and bacterial vaginosis. Central to manufacturing VAGISTAT-1 is sourcing high-quality bulk Active Pharmaceutical Ingredient (API). This document provides a comprehensive overview of potential API sources, considerations, and industry insights to inform procurement and manufacturing strategies.

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Understanding VAGISTAT-1's API Composition

VAGISTAT-1 primarily comprises two active components:

• Clotrimazole: An imidazole antifungal effective against common Candida species.
• Metronidazole: A nitroimidazole antibiotic targeting anaerobic bacteria and protozoa.

Both APIs are integral to the formulation's efficacy, requiring strict quality standards compliant with pharmacopeial and regulatory requirements.

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Global API Manufacturing Landscape

1. Leading API Producers

India and China dominate the global API manufacturing sector due to cost advantages and burgeoning pharmaceutical industries.

• India: Houses over 300 API manufacturing facilities, many of which are WHO-GMP and US FDA-certified. Notable manufacturers include:

  • Aurobindo Pharma: Extensive portfolio of antifungal and antibacterial APIs.
  • Sun Pharmaceutical Industries: Known for high-quality metronidazole and clotrimazole APIs.
  • Dr. Reddy's Laboratories: Supplies a wide range of APIs with stringent quality controls.

• China: Focused on bulk API production with competitive pricing; key players include:

  • Qingdao Yada Pharmaceutical: Specializes in antifungal APIs.
  • Jiangsu Lanfeng Pharmaceutical: Provides metronidazole and related compounds.
  • North China Pharmaceutical Group Corporation (NCPC): A major supplier of antibacterial APIs.

2. Quality Standards and Regulatory Compliance

API suppliers must demonstrate compliance with:

• Pharmacopeial standards: USP, EP, or JP monographs.
• Good Manufacturing Practice (GMP): Certification from recognized authorities.
• Regulatory approvals: FDA, EDQM, or local regulatory agencies.

Failure to meet these standards can impact product safety, efficacy, and regulatory approval.

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Criteria for Selecting API Suppliers

When sourcing APIs for VAGISTAT-1, consider:

• Regulatory status: Suppliers with approved GMP certifications and regulatory clearances.
• Quality assurance: Consistent batch quality, low impurities, and reliable analytical data.
• Supply stability: Capacity to meet demand fluctuations and supply chain robustness.
• Pricing: Competitive costs balanced with quality standards.
• Traceability and Documentation: Comprehensive batch records, Certificates of Analysis (CoA), and Certificate of Origin.

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Emerging API Suppliers and Alternatives

1. Regional and Local Manufacturers

Emerging local APIs from manufacturers in Eastern Europe, Latin America, and other regions may offer advantages such as shorter lead times and easier communication, provided they meet quality standards.

2. Contract Manufacturing Organizations (CMOs)

Partnering with CMOs specializing in antifungal and antibacterial APIs can mitigate risks associated with sourcing from multiple suppliers. CMOs often have validated manufacturing processes, increased capacity, and regulatory experience.

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Supply Chain Considerations

Risk management is critical in API procurement:

• Geopolitical risks: Trade restrictions, export controls.
• Inventory management: Just-in-time vs. buffer stock.
• Quality deviations: Regular audits and quality checks.
• Documentation and traceability: Ensuring supplier transparency.

Establishing long-term relationships with trusted, verified suppliers reduces operational risks.

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Case Studies and Market Trends

• The COVID-19 pandemic accentuated vulnerabilities in global supply chains, prompting pharma companies to diversify and localize API sources.
• Increasing regulatory scrutiny emphasizes the importance of quality and compliance, favoring suppliers with proven track records.
• API monoproduction in a few regions raises concerns about supply security; diversification strategies are increasingly adopted.

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Cost Implications and Negotiation Strategies

Price is a significant determinant, but it must not compromise API quality. Strategies include:

• Negotiation with multiple suppliers.
• Volume-based discounts.
• Long-term supply agreements.
• Inclusion of quality milestones and penalties.

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Conclusion

Securing high-quality bulk APIs for VAGISTAT-1 involves navigating a complex landscape of manufacturing capabilities, regulatory standards, and geopolitical considerations. The primary sources remain India and China, supported by emerging regional suppliers and CMOs. Diligent supplier qualification, rigorous quality assurance, and strategic supply chain management are imperative to ensure pharmaceutical integrity and uninterrupted production.

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Key Takeaways

• Core API sourcing hubs for VAGISTAT-1 components are India and China, with numerous WHO-GMP and FDA-certified manufacturers.
• Supplier qualification should prioritize quality, regulatory compliance, and supply reliability over cost alone.
• Diversification of API sources reduces supply chain risks and aligns with global regulatory trends emphasizing quality.
• Partnering with CMOs can streamline sourcing, especially for small to medium-sized manufacturers.
• Regulatory vigilance and continuous quality audits are critical to maintaining product safety and efficacy.

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FAQs

1. What are the primary considerations when selecting an API supplier for VAGISTAT-1?
   Quality assurance, regulatory compliance, supply stability, cost, and traceability are vital factors.

2. Are there FDA-approved API suppliers for clotrimazole and metronidazole?
   Yes, several Indian and Chinese manufacturers possess FDA approval or approval from other stringent regulatory bodies.

3. Can regional manufacturers provide APIs meeting global quality standards?
   Emerging local manufacturers are increasingly achieving compliance through upgrades to GMP standards, but thorough qualification and audits are necessary.

4. What risks are associated with sourcing APIs from China and India?
   Potential risks include regulatory non-compliance, quality variability, and supply chain disruptions; rigorous supplier qualification mitigates these risks.

5. How has recent geopolitical developments impacted API sourcing strategies?
   Increased scrutiny and trade restrictions have prompted companies to diversify sources and strengthen supply chain resilience.

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References

[1] Pharma intelligence, "Global API Manufacturing Overview," 2022.
[2] WHO, "WHO-GMP Certification for API Manufacturers," 2023.
[3] US FDA, "Approved API Suppliers," 2023.
[4] Cost and Quality Analysis for API Sourcing, GVK Bio, 2022.
[5] Industry Reports on API Market Trends, IQVIA, 2022.