Bulk Pharmaceutical API Sources for ZERIT XR

Bulk Pharmaceutical API Sources for ZERIT XR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D1413_SIGMA
Vitas-M Laboratory		STK801888
TCI (Tokyo Chemical Industry)		D3580
Molport		MolPort-002-507-283
Hangzhou APIChem Technology		AC-5263

Bulk Active Pharmaceutical Ingredient (API) Sources for: ZERIT XR

Last updated: August 4, 2025

Introduction

Zeirt XR, known generically as Stavudine Extended Release, is an antiretroviral medication primarily used in managing HIV infections. Its efficacy hinges on the integrity and quality of its active pharmaceutical ingredient (API), Stavudine. As a critical component, API sourcing influences drug safety, regulatory compliance, cost efficiencies, and supply chain stability. Ensuring access to reliable, high-quality API sources is vital for pharmaceutical companies engaged in ZERIT XR manufacturing.

This article offers a comprehensive analysis of potential bulk API sources for Stavudine used in ZERIT XR formulations, emphasizing supplier credibility, regulatory landscape, manufacturing capabilities, and strategic considerations.

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Understanding Stavudine’s API Profile

Stavudine (2',3'-Didehydro-2',3'-dideoxythymidine) is a nucleoside analogue reverse transcriptase inhibitor (NRTI). It inhibits HIV replication, making its high-purity API essential for therapeutic efficacy and patient safety. API sourcing must adhere to stringent pharmacopoeial standards, including the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and others.

The API's production involves complex synthesis, requiring advanced facilities, strict quality control, and adherence to Good Manufacturing Practices (GMP). Notable specifications include API purity (>99%), low residual solvents, and consistent particle size distribution.

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Global API Suppliers for Stavudine in ZERIT XR

1. Domestic Suppliers (India and China)

India and China are prominent API manufacturing hubs owing to their cost advantages and established pharmaceutical industries.

• Aurobindo Pharma (India): A leading global API producer with a diversified portfolio, Aurobindo manufactures Stavudine under rigorous GMP standards. Their facilities are equipped for large-scale production, complying with both local and international regulatory standards.

• Hetero Drugs (India): Recognized for API excellence, Hetero offers Stavudine with documented quality assurance, supported by comprehensive documentation suitable for regulatory submissions.

• Dr. Reddy's Laboratories (India): with robust API manufacturing capacities, Dr. Reddy's provides high-quality Stavudine suitable for fixed-dose combinations and extended-release formulations like ZERIT XR.

• Shanghai Desano Pharmaceutical (China): Among Chinese suppliers, Desano has established GMP compliance for selected nucleoside analogues, including Stavudine, serving international clients with competitive pricing.

• North China Pharma (China): A reputable supplier with scalable manufacturing processes and certifications aligned with international standards.

Note: Due to regulatory constraints, especially in the US and EU, sourcing from Chinese API manufacturers requires rigorous compliance verification.

2. International and Multinational API Manufacturers

Some multinational pharma companies with established API manufacturing divisions tend to supply Stavudine, often integrated within their R&D and production networks.

• Mitsubishi Tanabe Pharma (Japan): Known for high-quality APIs, their Stavudine production aligns with stringent international standards, although supply terms vary.

• Viatris (formerly Mylan): Has a significant API manufacturing arm capable of producing nucleoside analogues for global markets.

3. Contract Manufacturing Organizations (CMOs) and API Brokers

When direct procurement from manufacturers proves challenging, CMOs or authorized brokers serve as intermediaries, offering verified APIs that meet regulatory specifications.

• Examples include Patheon and Eurofins-certified API brokers.

• Advantages: Enhanced quality assurance, regulatory due diligence, reduced supply chain complexity.

4. Regulatory Considerations

Given the strict regulatory landscape governing APIs, suppliers must demonstrate compliance through:

• GMP certification by recognized authorities (e.g., US FDA, EMA, PIC/S).
• Valid certification of analysis (CoA) reflecting API purity, residuals, and stability.
• Environmental and safety standards compliance, including REACH, ICH guidelines.

APIs sourced from non-certified or uncertified suppliers pose significant regulatory risks, potentially leading to product recalls, rejection, or legal penalties.

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Strategic Sourcing Considerations

• Regulatory Certifications: Prioritize suppliers with approved literature or certifications relevant to target markets.

• Supply Chain Resilience: Establish relationships with multiple suppliers across geographies to mitigate disruptions.

• Cost-effectiveness vs. Quality: Balance competitive pricing with compliance and quality assurance to ensure patient safety and regulatory approval.

• Volume Flexibility: Engage with suppliers capable of scaling production commensurate with demand fluctuations, especially for ZERIT XR, which may have variable uptake.

• Documentation and Audit Readiness: Ensure transparency and comprehensive documentation for regulatory audits and potential inspections.

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Emerging Trends and Future Outlook

The API supply landscape for drugs like Stavudine is evolving amid tightening regulatory scrutiny, pricing pressures, and manufacturing innovations. Advancements in synthetic chemistry, biopharmaceutical manufacturing, and patent policies influence API availability.

The drive toward sustainable and green manufacturing processes also influences supplier choice, especially among environmentally conscious pharmaceutical firms.

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Conclusion

Reliable API sourcing for ZERIT XR's Stavudine requires strategic partnerships with certified, quality-accredited manufacturers capable of supplying high-purity APIs at scale. Indian and Chinese suppliers dominate the landscape, but stringent due diligence, regulatory compliance, and supply chain stability remain crucial.

Implementing robust supplier qualification programs and diversifying sources enhances operational resilience, minimizes regulatory risks, and ensures consistent product quality for global markets.

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Key Takeaways

• Top API suppliers for Stavudine include Aurobindo Pharma and Hetero (India), Shanghai Desano Pharma, and North China Pharma (China).

• Regulatory compliance, especially GMP certification, is non-negotiable for API sourcing to meet international market standards.

• Diversification of API sources mitigates supply chain risks amid geopolitical and regulatory uncertainties.

• Collaborating with reputable CMOs or brokers can facilitate quality assurance and regulatory compliance.

• Ongoing market and technological developments may impact API availability and pricing; continuous vendor assessment is essential.

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FAQs

1. What are the primary considerations when sourcing Stavudine API for ZERIT XR?
Quality assurance, GMP compliance, regulatory certification, supply capacity, and price competitiveness are critical factors.

2. How does regulatory approval influence API sourcing?
Suppliers must demonstrate adherence to international standards; APIs lacking proper certifications may jeopardize regulatory approval and market access.

3. Can Chinese API manufacturers reliably supply Stavudine for global markets?
Yes, provided they possess appropriate GMP certification and documentation demonstrating product quality. Due diligence is essential.

4. Are there alternatives to traditional API suppliers for Stavudine?
Emerging biosynthetic methods and contract manufacturing can provide alternatives, but regulatory acceptance and quality must be thoroughly validated.

5. How does API supply chain stability affect ZERIT XR production?
Disruptions in API supply can delay drug manufacturing and jeopardize market commitments. Diversification and strategic partnerships are vital for resilience.

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References

[1] U.S. Pharmacopeia. USP Monographs for Stavudine.
[2] European Pharmacopoeia Commission. Ph. Eur. monograph for Stavudine.
[3] IMS Health. Global API Market Report 2022.
[4] Aurobindo Pharma Annual Report 2022.
[5] Hetero Labs Annual Compliance and Certification Data.