Bulk Pharmaceutical API Sources for VANDAZOLE

Bulk Pharmaceutical API Sources for VANDAZOLE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HcOL@HHPS\bfbbRKBmMUR@@
ChemBlock		ZERO/004064
ASINEX		BAS 02983617
Sigma-Aldrich		M1547_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for Vandazole

Last updated: July 27, 2025

Introduction

Vandazole, a trade name for the active pharmaceutical ingredient (API) tinidazole, is a nitroimidazole antimicrobial agent primarily used to treat protozoal infections such as Giardia lamblia, Entamoeba histolytica, and bacterial vaginosis caused by Gardnerella vaginalis. As an essential component of pharmaceutical formulations, the sourcing of bulk Vandazole API is critical for manufacturers seeking high quality, cost-efficiency, and regulatory compliance. This article provides a comprehensive overview of the primary sources for bulk Vandazole API, examining key manufacturers, geographic regions, regulatory considerations, and supply chain dynamics.

Understanding Vandazole (Tinidazole) and Its Market Dynamics

Vandazole contains tinidazole, a 5-nitroimidazole compound with potent antimicrobial activity. The global demand for tinidazole surged with the rise in parasitic and bacterial infections, especially in developing regions. Market growth projections indicate steady expansion, driven by infectious disease prevalence and expanding availability of combination therapies.

The manufacturing landscape for tinidazole is characterized by a mix of multinational pharmaceutical companies, Contract Manufacturing Organizations (CMOs), and API producers based mainly in Asia, Europe, and North America. Ensuring supply stability involves navigating patent rights (though many formulations are generic), regulatory approvals, and quality assurance standards such as Good Manufacturing Practice (GMP).

Key Global API Manufacturers for Vandazole (Tinidazole)

1. Indian API Manufacturers

India is a leading source of generic APIs, including tinidazole, owing to its robust chemical manufacturing ecosystem and cost advantages.

• Shilpa Medicare Ltd.
  A prominent Indian API manufacturer with GMP-certified facilities approved by regulatory agencies such as the US FDA and EDQM. They produce tinidazole in compliance with international standards, supplying both domestic and international markets.

• Hetero Labs Ltd.
  A major pharmaceutical company with extensive API manufacturing capabilities, Hetero offers tinidazole APIs processed according to stringent quality standards. Their global presence ensures reliable supply channels.

• Aurobindo Pharma Ltd.
  Known for its diverse portfolio of APIs, Aurobindo produces tinidazole with rigorous quality control and regulatory compliance, serving markets across North America, Europe, and Asia.

2. Chinese API Manufacturers

China remains a dominant player in API manufacturing and export, with many specialized producers offering competitive pricing.

• North China Pharmaceutical Group Corporation (CPGC)
  One of China’s leading API producers with advanced facilities and multiple certificates including GMP, ISO, and local regulatory approvals.

• Qingdao Yinqiao Pharmaceutical Co., Ltd.
  Offers tinidazole with established export channels, emphasizing quality assurance and compliance with pharmacopoeial standards.

• Nanjing Zelang Medical Technology Co., Ltd.
  Focuses on antimicrobial APIs, with tinidazole produced under validated processes to meet global market requirements.

3. European and North American API Producers

While less dominant than Asian counterparts in raw volume, European and North American manufacturers often cater to markets with strict regulatory demands.

• Lubrizol Life Sciences (USA)
  Provides high-quality APIs, including tinidazole, produced under GMP conditions, primarily targeting North American and European clients.

• Rottapharm International (Italy)
  Offers high-grade APIs with extensive regulatory files, serving clients seeking value in premium quality.

Emerging and Niche API Suppliers

Emerging players in Southeast Asia and Eastern Europe are gradually expanding their share, offering innovative manufacturing solutions, improved quality control, and localized supply responses.

Regulatory and Quality Considerations in Sourcing Vandazole API

Sourcing API for pharmaceutical production necessitates compliance with global regulatory standards such as FDA, EMA, WHO, and Pharmacopoeia standards (USP, EP, BP).

• GMP Certification: The most critical factor, ensuring APIs are manufactured in facilities adhering to stringent quality controls.
• Regulatory Approvals: Suppliers with validated APIs and comprehensive dossiers facilitate smoother registration processes.
• Traceability and Certification: Certificates of Analysis (CoA), Certificates of Suitability (CEPs), and other documentation aid compliance and quality assurance.
• Supply Chain Stability: Diversified sourcing reduces risks related to geopolitical issues, manufacturing disruptions, or regulatory changes.

Supply Chain Trends and Challenges

• Pricing Pressures: Increased competition from Chinese and Indian API suppliers drives cost advantages but also raises issues of quality variance.
• Regulatory Stringency: Global regulatory bodies intensify scrutiny, impacting sourcing strategies as companies demand higher compliance levels.
• Technological Advances: Adoption of continuous manufacturing and real-time quality monitoring enhances supply confidence.
• Geopolitical Factors: Trade policies, tariffs, and localization initiatives influence API sourcing routes and costs.

Conclusion

The sourcing landscape for Vandazole (tinidazole) bulk API is diverse, with prominent suppliers in India and China dominating global markets. Quality assurance through GMP certifications and regulatory compliance are paramount for pharmaceutical manufacturers. While Asian manufacturers typically offer cost advantages, European and North American suppliers provide high-quality options suited for stringent regulatory environments.

Business stakeholders should prioritize supplier validation, diversify procurement channels, and maintain visibility into supply chain dynamics to ensure consistent access to high-quality Vandazole API.

Key Takeaways

• India and China are the primary sources for bulk Vandazole (tinidazole) API, offering a broad range of cost-effective options.
• Quality standards such as GMP compliance and regulatory certifications are critical criteria in sourcing decisions.
• Supply chain diversification mitigates geopolitical and manufacturing risks.
• Regulatory compliance influences the choice of API suppliers, especially in markets with rigorous standards like the US and EU.
• Emerging Asian and Eastern European manufacturers are gaining prominence, emphasizing technological innovation and quality standards.

FAQs

1. Which countries are the leading producers of tinidazole API?
India and China are the dominant producers, with extensive manufacturing capacities and export networks catering to global demand.

2. What regulatory certifications should I verify when sourcing Vandazole API?
Certifications such as GMP, Certificate of Analysis (CoA), Certificate of Suitability (CEP), and approvals from agencies like the US FDA, EMA, or relevant pharmacopoeias are essential.

3. How does pricing compare between Indian, Chinese, and Western API suppliers?
Indian and Chinese suppliers generally offer lower-cost APIs due to manufacturing economies of scale, whereas Western suppliers often focus on premium quality and regulatory complexity.

4. What are the main risks in sourcing Vandazole API internationally?
Risks include quality variability, supply chain disruptions, regulatory non-compliance, and geopolitical issues. Proper qualification and diversification strategies mitigate these concerns.

5. Are there specialty or niche suppliers for high-purity or modified Vandazole APIs?
Yes, several European and North American manufacturers focus on high-purity APIs, including custom modifications, primarily serving markets with stringent regulatory requirements.

References

1. Global API Market Insights, IQVIA, 2022.
2. Indian API Industry Overview, Department of Pharmaceuticals, Government of India, 2021.
3. Chinese API Manufacturing Standards, Chinese Pharmacopoeia Commission, 2020.
4. Regulatory Guidelines for API Quality Assurance, U.S. FDA, 2022.
5. Emerging Trends in API Supply Chain, Global Pharmaceuticals, 2023.