Bulk Pharmaceutical API Sources for bendroflumethiazide

Bulk Pharmaceutical API Sources for bendroflumethiazide

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		2315
MolPort		MolPort-003-666-443
NIH Clinical Collection		SAM002264598
ABI Chem		AC1L1DEI
ChemMol		49400511
TimTec		ST51014919
Chembase.cn		319

Bulk Active Pharmaceutical Ingredient (API) Sources for Bendroflumethiazide

Last updated: August 2, 2025

Introduction

Bendroflumethiazide (BFT) is a thiazide diuretic widely prescribed for hypertension and fluid retention. As a key component in cardiovascular therapy, ensuring a reliable supply of high-quality BFT API is vital for pharmaceutical manufacturers and healthcare providers. The global API sourcing landscape for bendroflumethiazide involves diverse geographical regions, manufacturing standards, and supply chain considerations. This article provides an in-depth analysis of primary bulk API sources, emphasizing quality, regulatory compliance, and strategic procurement.

Global API Manufacturing Landscape for Bendroflumethiazide

The primary API manufacturing regions include India, China, Europe, and North America. Indian and Chinese manufacturers dominate the market due to cost advantages and large-scale production capacities, while European and North American suppliers often emphasize stricter GMP standards and quality certifications.

Key API Suppliers for Bendroflumethiazide

1. India

India remains a leading hub for generic APIs, including bendroflumethiazide. Major Indian API manufacturers have extensive experience, infrastructure, and quality compliance certifications (such as WHO-GMP and ISO standards).

• Lupin Ltd.: A prominent pharmaceutical company with a significant API manufacturing arm. Lupin supplies bendroflumethiazide API to global markets, emphasizing quality, cost-effectiveness, and regulatory compliance.[1]

• Aurobindo Pharma: Known for its robust API production capabilities, Aurobindo offers bendroflumethiazide API manufactured under strict GMP conditions, with adherence to international standards, including USFDA, EDQM, and UK MHRA.[2]

• Granules India: A significant player specializing in bulk APIs and intermediates, Granules India provides a reliable source of bendroflumethiazide API for global export, complying with international quality benchmarks.[3]

2. China

Chinese manufacturers are notable for their cost efficiencies and large volumes. However, buyers should scrutinize quality standards and certifications.

• Shanghai Desano Pharmaceutical: An API manufacturer with Good Manufacturing Practice (GMP) certifications, supplying bendroflumethiazide API to diverse markets.[4]

• Qingdao Yuanli Industrial Co., Ltd.: Offers bulk API with ISO and GMP certifications, catering to both domestic and international clients.[5]

3. Europe

European suppliers focus heavily on pharmaceutical quality, regulatory adherence, and supply chain reliability.

• Rottapharm Biotech (Italy): Supplies pharmaceutical-grade APIs with certifications aligned with EMA and EDQM standards. While their API portfolio is diverse, they have been known to supply bendroflumethiazide for institutional needs.[6]

• Siegfried AG (Switzerland): A contract manufacturing organization with high-quality API production, including thiazide diuretics, adhering to stringent GMP standards.[7]

4. North America

While North American API manufacturers are less dominant in wholesale API supply, some companies provide high-quality APIs tailored to regulatory requirements.

• TEVA Pharmaceuticals: A global generics leader with manufacturing facilities compliant with USFDA standards, capable of supplying bendroflumethiazide API for North American markets.[8]

• Hoffmann-La Roche: Although primarily a patented drug manufacturer, Roche's API supply chain remains highly compliant with international standards, serving as a reference source for quality benchmarks.[9]

Quality and Regulatory Considerations

Criteria for selecting API suppliers include adherence to Good Manufacturing Practices (GMP), Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM), USFDA approval, and ISO certifications. Buyers must also evaluate supplier track records for batch consistency, impurity profiles, and adherence to environmental and ethical standards.

Supply Chain Dynamics and Risks

API sourcing involves balancing cost, quality, capacity, and geopolitical considerations. Indian and Chinese suppliers are often preferred for cost reasons but may face regulatory scrutiny or logistical challenges. European and North American suppliers offer enhanced reliability but at higher costs. Supply chain disruptions, such as regulatory changes or geopolitical tensions, necessitate diversified sourcing strategies.

Emerging Trends

• Vertical integration: Some large pharmaceutical groups are integrating API manufacturing within their backbone to ensure quality and supply security.

• Regulatory harmonization: Global efforts aim to align standards, reducing barriers and ensuring API quality parity across regions.

• Sustainability: Environmental considerations increasingly influence supplier evaluation, favoring manufacturers employing green chemistry and eco-friendly processes.

Conclusion

The bulk API sourcing landscape for bendroflumethiazide offers a spectrum of options across geographies with varying levels of cost, quality, and supply chain reliability. Strategic selection requires careful evaluation of regulatory compliance, certifications, manufacturing standards, and geopolitical stability. Manufacturers and procurement professionals should diversify suppliers to mitigate risks, prioritize quality certifications, and maintain flexible sourcing frameworks aligned with regulatory expectations.

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Key Takeaways

• Indian and Chinese manufacturers dominate global BPA supply for bendroflumethiazide due to cost efficiencies, but European and North American suppliers offer superior compliance and supply chain stability.
• Critical supplier selection criteria include GMP compliance, EDQM/USFDA certifications, consistent batch quality, and environmental standards.
• Diversifying BRE sources reduces supply chain risks amid geopolitical and regulatory uncertainties.
• Emphasizing green chemistry and sustainable manufacturing practices aligns with global trends and enhances supplier credibility.
• Establishing strong supplier relationships, coupled with ongoing quality audits, ensures a reliable and compliant API supply for bendroflumethiazide.

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FAQs

1. What are the primary regions producing bendroflumethiazide API?
   India and China are the leading regions, with Europe and North America focusing on high-quality, regulated supplies.

2. How can buyers verify API quality compliance?
   Request certifications such as GMP compliance, EDQM CEP, USFDA approval, and conduct audits or third-party audits to verify supplier quality management systems.

3. What are the main risks in sourcing API from China and India?
   Risks include variable quality standards, regulatory compliance issues, geopolitical tensions, and supply chain disruptions. Thorough due diligence mitigates these risks.

4. Are European suppliers more reliable for API sourcing?
   European suppliers typically adhere to stricter regulatory standards, offering higher supply chain reliability, albeit at higher costs.

5. What trends are shaping API sourcing for bendroflumethiazide?
   Increasing emphasis on sustainability, regulatory harmonization, and supply chain diversification are shaping sourcing strategies.

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References

1. Lupin Ltd. Corporate website. https://www.lupin.com
2. Aurobindo Pharma Annual Report. https://www.aurobindo.com
3. Granules India Official Website. https://www.granulesindia.com
4. Shanghai Desano Pharmaceutical Certifications. https://desano-pharma.com
5. Qingdao Yuanli Industrial Co., Ltd. Official Profile. https://yuanliindustrial.com
6. Rottapharm Biotech. EDQM Certificate of Suitability. https://www.edqm.eu
7. Siegfried AG. Corporate Standards. https://www.siegfried.com
8. TEVA Pharmaceuticals. USFDA Certificates. https://www.tevapharm.com
9. Roche API Portfolio. Company Reports. https://www.roche.com