Bulk Pharmaceutical API Sources for RETROVIR

Bulk Pharmaceutical API Sources for RETROVIR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A2169_SIGMA
Vitas-M Laboratory		STK801891
TCI (Tokyo Chemical Industry)		A2052
Molport		MolPort-002-507-286
Amadis Chemical		A820413
Enamine		EN300-52518

Bulk Active Pharmaceutical Ingredient (API) Sources for RETROVIR

Last updated: February 20, 2026

Where is the API for RETROVIR sourced?

RETROVIR (zidovudine, AZT) API is primarily produced by large-scale manufacturing firms located in Asia, India, and China. The API is also available from several European and U.S. suppliers, typically through licensed formulations or contract manufacturing organizations (CMOs).

Major API manufacturing regions and key suppliers

Region	Notable Suppliers	Certification & Quality Standards	Lead Times (Est.)	Price Range (per kg)
India	APIIC, Hetero Labs, Mylan	WHO-GMP, USFDA, EMA approvals	3–6 months	$60–$100
China	Zhejiang Hisun, Shanghai Chem, SPS	GMP, ISO 9001, CNAS accreditations	2–4 months	$55–$95
Europe	Vebruma, Polpharma	EMA, MHRA approvals	4–8 weeks	$80–$120
United States	Teva, Amneal	USFDA approvals	4–6 weeks	$125–$150

Sourcing routes

• API Suppliers: Most APIs are supplied from approved manufacturing facilities with established supply chains for bulk orders.

• Contract Manufacturing: Some pharmaceutical companies contract manufacturing to Asian API producers due to lower costs and established complex synthesis processes.

• Replicator APIs: Several generic manufacturers produce APIs under non-exclusive licensing, often with limited certification, increasing risk but decreasing costs.

Regulatory considerations

• WHO Prequalification: Many suppliers listed are prequalified, ensuring quality for global health programs.

• GMP Certification: A standard requirement; suppliers without GMP certification are typically not used for regulated markets.

• IP Status: The patent on zidovudine expired globally in the 2000s, leading to widespread generic production.

Cost factors influencing API sourcing

• Quantity ordered: Large orders (>10 kg) attract volume discounts.

• Supplier location: Asian suppliers typically offer lower pricing but may have longer lead times and varying quality standards.

• Certification: Certified APIs generally cost 20-30% more but ensure compliance with regulatory standards.

Summary of API characteristics

Attribute	Details
Synthesis Complexity	Moderate; involves nucleoside analog synthesis
Purity Standards	>99% purity, HPLC tested
Shelf Life	Stable for 2–3 years when stored properly

Key notes

• API sourcing is sensitive to supply chain disruptions, quality standards, and regulatory compliance requirements.

• Suppliers must have validated manufacturing processes aligned with current Good Manufacturing Practices (cGMP).

• API availability is generally unaffected by patent restrictions due to expiry but is closely linked to manufacturing capacity and regulatory approvals.

Closures & risks

• Supply Disruption: Dependence on Asian suppliers can encounter delays due to geopolitical, regulatory, or logistical issues.

• Quality Variability: Variations in manufacturing standards may affect API quality, especially for non-GMP sources.

• Regulatory hurdles: Import approvals, customs clearance, and verification of certifications can prolong procurement.

Key Takeaways

• API sourcing for RETROVIR is concentrated in Asia, with India and China as primary suppliers.
• Cost is influenced by certification, quantity, and region.
• Regulatory compliance (GMP, WHO, FDA) remains a prerequisite for markets with strict standards.
• Supply chain risks necessitate diversified supplier relationships and inventory planning.

FAQs

1. Who are the leading manufacturers of zidovudine API?
Indian companies like Hetero Labs and Mylan, Chinese firms such as Zhejiang Hisun, and European companies including Polpharma supply zidovudine API.

2. What regulatory standards should API suppliers meet?
Suppliers should hold GMP certification, comply with WHO prequalification, and be approved by relevant national authorities such as the USFDA or EMA.

3. How does the patent status affect API sourcing?
Since the patent expired globally in the 2000s, multiple generics are available, reducing barriers to sourcing. However, licensing and regulatory approvals influence market access.

4. What are typical costs for zidovudine API?
Prices range from $55 to $150 per kg, depending on certification, supplier location, and volume ordered.

5. Are there risks in sourcing zidovudine API from Chinese suppliers?
Risks include potential quality variability, regulatory compliance issues, and supply chain delays, which require due diligence.

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References

1. World Health Organization. (2019). Prequalification of Medicines Programme. https://www.who.int/groups/prequalification-of-medicines-programme
2. U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). https://www.accessdata.fda.gov/scripts/cder/ob/
3. Indian Drug Manufacturers Association. (2021). Indian API Industry Report. https://www.idma.org.in
4. Chinese Pharmacopoeia Commission. (2020). Pharmacopoeia of China. https://www.chp.org.cn
5. European Medicines Agency. (2022). MHRA approved APIs. https://www.ema.europa.eu