Bulk Pharmaceutical API Sources for AVANDIA

Bulk Pharmaceutical API Sources for AVANDIA

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-002-508-212
Hangzhou APIChem Technology		AC-3459
Amadis Chemical		A804873
BioChemPartner		BCP0726000232
BioChemPartner		BCP9000017
AKos Consulting & Solutions		AKOS015894872

Bulk Active Pharmaceutical Ingredient (API) Sources for: AVANDIA (Rosiglitazone Maleate)

Last updated: July 30, 2025

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Introduction

Avandia, the trade name for rosiglitazone maleate, is an antidiabetic medication used primarily to improve glycemic control in type 2 diabetes mellitus. Since its initial market introduction, the global supply chain for rosiglitazone API has experienced fluctuations driven by regulatory concerns, manufacturing issues, and evolving market demands. Securing reliable bulk API sources is critical for pharmaceutical companies to ensure uninterrupted production, regulatory compliance, and cost competitiveness.

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Overview of Rosiglitazone Maleate API

Rosiglitazone belongs to the thiazolidinedione class, functioning as a PPARγ (peroxisome proliferator-activated receptor gamma) agonist. Its synthesis is complex, involving multistep chemical processes that require high purity standards. The API quality directly influences drug safety and efficacy, necessitating rigorous control of manufacturing and sourcing.

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Major API Manufacturers for AVANDIA

1. Original Innovator Source

GlaxoSmithKline (GSK) – The original patent holder and commercial manufacturer of rosiglitazone. Post-patent expiry, their role shifted primarily to licensing and licensing agreements, with their existing manufacturing facilities continuing to produce the API for certain markets. GSK maintains strict quality standards, serving as a benchmark in the industry.

2. Asian Suppliers

Post-patent expiry, several Chinese and Indian pharmaceutical producers emerged as key API suppliers, offering cost-effective manufacturing options. These include:

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Recognized for producing high-quality APIs compliant with international standards, including cGMP (current Good Manufacturing Practices). Their rosiglitazone API is widely exported, with certifications from the FDA, EMA, and other regulators.

• Khandelwal Laboratories Ltd. (India): A notable player, providing rosiglitazone API with verified purity levels and consistent batch-to-batch quality. Their facilities are approved by Indian regulatory authorities and often hold WHO GMP certifications.

• Hetero Drugs Ltd. (India): Known for large-scale manufacturing of various APIs, including rosiglitazone. Their API quality aligns with international standards, enabling exports to regulated markets.

• L Hertz Sweden AB (Europe): Smaller but compliant European manufacturer offering rosiglitazone API, mainly catering to European clients requiring strict regulatory adherence.

3. Contract Manufacturing Organizations (CMOs)

The complexity of rosiglitazone synthesis has led to outsourcing to specialized CMOs:

• Suven Life Sciences (India): A prominent CMO producing consistent high-quality rosiglitazone API, with extensive regulatory approvals.

• Hikal Ltd. (India): Offers custom API manufacturing with comprehensive quality assurance, suitable for controlled markets.

Quality and Regulatory Considerations

Global pharmaceutical companies prioritize suppliers with current cGMP compliance, robust QA/QC protocols, and validated supply chains. Regulatory approvals such as FDA, EMA, and PIC/S certifications serve as critical markers of quality assurance. Suppliers that adhere to these standards mitigate risks of batch rejection, delays, and compliance violations.

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Market Dynamics and Supply Chain Challenges

Regulatory Restrictions:

Concerns surrounding rosiglitazone’s cardiovascular safety profile led to regulatory scrutinies. In 2013, the FDA imposed restrictions on its market use, impacting demand and manufacturing priorities. These restrictions diminish future API procurement from certain suppliers due to decreased market exclusivity.

Supply Chain Risks:

The geopolitical landscape, manufacturing capacity limitations, and quality disparities pose risks. Any disruption in manufacturing due to regulatory non-compliance or environmental issues can lead to supply shortages.

Cost and Pricing Trends:

As patent protections expired, API prices experienced downward pressure, especially from Indian and Chinese suppliers. Companies seeking high-quality API must balance cost with regulatory approval status and manufacturing reliability.

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Future Outlook of ROSIGLITAZONE API Sourcing

Despite the decline in global market demand because of safety concerns, rosiglitazone API remains available for specific indications and markets. Suppliers investing in advanced production technology and achieving regulatory approvals are better positioned to capitalize on niche markets. The trend toward contract manufacturing and custom synthesis enables pharmaceutical firms to secure reliable supply without direct investments in proprietary manufacturing.

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Conclusion

The sourcing landscape for AVANDIA's rosiglitazone API reflects a balance of regulatory compliance, manufacturing expertise, cost competitiveness, and supply security. Established multinational corporations, Indian, and Chinese API producers form the core supplier network. While regulatory restrictions have dampened demand, high-quality, compliant manufacturers continue to supply the API for specialized markets and formulations.

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Key Takeaways

• Diversify suppliers: Relying on multiple qualified sources minimizes supply risks, especially amid regulatory and geopolitical challenges.

• Prioritize suppliers with global regulatory approvals: Ensures consistent quality and compliance, critical for regulatory submissions and market acceptance.

• Monitor regulatory developments: Safety concerns around rosiglitazone necessitate ongoing review of sourcing strategies and compliance.

• Assess manufacturing capacity and certifications: Valid manufacturing facilities with GMP compliance are essential for sourcing high-purity API.

• Stay alert to market shifts: Changing regulatory landscapes influence demand and supplier engagement, requiring proactive strategy adjustments.

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FAQs

1. Are there any FDA-approved suppliers of rosiglitazone API?
Yes. Several Indian and Chinese manufacturers have achieved FDA approvals for their rosiglitazone API, including Hetero Drugs and Zhejiang Hisun Pharmaceutical, ensuring their products meet stringent quality standards.

2. How do regulatory restrictions impact API sourcing for AVANDIA?
Regulatory constraints, particularly safety concerns flagged by agencies like the FDA, can lead to decreased demand, market withdrawal, and supply chain reduction, prompting companies to seek suppliers with proven compliance and lower risk profiles.

3. What is the typical lead time for sourcing rosiglitazone API from major suppliers?
Lead times generally range from 8 to 16 weeks, depending on the supplier’s manufacturing capacity, certification status, order volume, and logistic considerations.

4. How does the quality of Chinese API manufacturers compare with Indian suppliers?
Both regions host reputable manufacturers with GMP-certified facilities. Quality varies by individual manufacturer; hence, validation through audits, certifications, and batch testing is critical.

5. Is there a significant market for generic rosiglitazone API today?
While demand has declined due to safety concerns and regulatory restrictions, niche markets and formulations still require rosiglitazone API, primarily from trusted, compliant manufacturers.

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References

[1] U.S. Food and Drug Administration. "FDA Drug Safety Communication: FDA restricts access to rosiglitazone (Avandia, Avandament) over safety concerns." 2013.
[2] European Medicines Agency. "Assessment report on rosiglitazone." 2010.
[3] Zhejiang Hisun Pharmaceutical Co., Ltd. Quality certifications and export approvals.
[4] Indian API manufacturers’ regulatory filings and certifications.
[5] Market analysis reports on glucosetargeted pharmaceuticals and API supply chain dynamics (2022-2023).