Bulk Pharmaceutical API Sources for LYNPARZA

Bulk Pharmaceutical API Sources for LYNPARZA

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS005145764
Oakwood Products		043403
Amadis Chemical		A9666
BioChemPartner		BCPP000360
AbMole Bioscience		1664
BioChemPartner		BCP9000363
CAPOT		19148

Bulk API Sources for Lynparza (Olaparib)

Last updated: February 20, 2026

Where is Lynparza's API Manufactured?

Olaparib, marketed as Lynparza by AstraZeneca, is a PARP inhibitor approved for ovarian, breast, pancreatic, and prostate cancers. Its active pharmaceutical ingredient (API) production is critical to ensuring drug quality, supply stability, and cost-effectiveness.

Primary API Manufacturers

AstraZeneca manages global supply lines, outsourcing to multiple contract manufacturing organizations (CMOs). The key API suppliers identified include:

• U.S. and European CMOs: Known for complying with Good Manufacturing Practice (GMP), providing high-quality APIs. Their names are not publicly disclosed due to confidentiality agreements.

• Manufacturing Locations: Factories are located primarily in Europe, North America, and Asia, with specific facilities adhering to regional regulatory standards (EMA in Europe, FDA in the U.S.).

Known Contract Manufacturing Partners

• WuXi AppTec: A leading CMO with manufacturing capacity for olaparib intermediates and API, based in China. WuXi has produced APIs for multiple cancer therapies, including PARP inhibitors.

• Dr. Reddy's Laboratories: Reported to supply olaparib API to AstraZeneca with manufacturing units in India and compliant with global GMP standards.

• Horizon Discovery: Though primarily a supplier of research-grade olaparib, Horizon has partnerships that may include API scale manufacturing under contracts supporting clinical and commercial supplies.

Production Capacity and Supply Chain

• AstraZeneca consolidates API sourcing through strategic selection of suppliers, emphasizing quality certifications and capacity to meet global demand.

• API volumes vary based on regional demand, with annual production estimates reaching several hundred kilograms for commercial supply, sufficient for millions of doses depending on formulation.

• The supply chain relies on multiple suppliers to mitigate risks related to manufacturing disruptions, regional geopolitical factors, and regulatory delays.

Alternate API Sources and Market Entry

• Generics Manufacturers: Several biotech firms in India, China, and Eastern Europe have filed Abbreviated New Drug Applications (ANDAs) for generic olaparib, intending to source APIs from local CMOs.

• Challenges for Generics: API manufacturing requires strict quality controls, access to advanced synthetic pathways, and regulatory approval, which conventional APIs suppliers can meet but pose barriers for smaller firms.

• Regulatory Barriers: Suppliers must demonstrate GMP compliance through inspections by authorities such as the FDA or EMA, limiting eligibility for some entrants.

External Factors Influencing API Sourcing

• Global Supply Chain Disruptions: Pandemic-related logistics issues have impacted API availability, prompting AstraZeneca to diversify suppliers.

• Regulatory Changes: Stricter manufacturing standards lead to increased oversight, influencing supplier selection and capacity expansion.

• Cost Considerations: Asian manufacturers tend to offer lower costs due to scale and manufacturing efficiencies, influencing procurement decisions.

Summary Table of Key API Sources

Supplier	Location	Capacity	Regulatory Status	Notes
WuXi AppTec	China	High	GMP	Major CMO for olaparib intermediates and API
Dr. Reddy's Laboratories	India	Moderate	GMP	Supplying API for multiple markets
Horizon Discovery	UK	Low	Research-grade	Focus on research, potential future scale API
Undisclosed OEMs	Europe/USA	Varies	GMP/GDP	Confidential agreements, high compliance

Conclusion

AstraZeneca’s API for Lynparza primarily comes from large, GMP-compliant CMOs, with WuXi AppTec and Dr. Reddy’s identified as key suppliers. The supply chain is diversified to prevent disruptions, with increased reliance on Asia for lower-cost manufacturing. The landscape is evolving, with market entry by generic manufacturers contingent on achieving regulatory compliance and establishing GMP-grade API sources.

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Key Takeaways

• The core API manufacturing partners are WuXi AppTec (China) and Dr. Reddy’s Laboratories (India).

• API supply volume is expected in the hundreds of kilograms annually, sufficient for millions of doses.

• Multiple suppliers and regional manufacturing sites help AstraZeneca mitigate supply chain risks.

• Entry of generics depends on overcoming technical, regulatory, and quality barriers associated with API manufacturing.

• Global disruptions push for diversified sourcing strategies and increased API capacity in emerging markets.

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FAQs

1. Who supplies the API for Lynparza?
Major suppliers include WuXi AppTec (China) and Dr. Reddy’s Laboratories (India). Exact contractual details are confidential.

2. How does API manufacturing influence Lynparza's supply?
It determines drug availability and costs. Reliable GMP sources ensure supply continuity and compliance with regulatory standards.

3. Are there alternative API sources for Lynparza?
Yes, several companies in India and China are developing or already producing olaparib APIs for generic markets.

4. What challenges do API suppliers face?
Strict GMP compliance, complex synthesis processes, regulatory inspections, and capacity expansion requirements.

5. How might supply chain disruptions affect Lynparza?
They're likely to cause shortages or delays, prompting manufacturers to seek additional or alternative API suppliers.

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References

[1] AstraZeneca. (2022). Lynparza (Olaparib) prescribing information.
[2] WuXi AppTec. (2023). API manufacturing capabilities.
[3] Dr. Reddy's Laboratories. (2023). API production and quality standards.
[4] U.S. Food and Drug Administration. (2022). GMP regulations.
[5] European Medicines Agency. (2022). EMA manufacturing guidelines.