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 Active Pharmaceutical Ingredient (API) Sources for LYNPARZA (Olaparib)

Last updated: July 29, 2025

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Introduction

LYNPARZA (olaparib) is a groundbreaking oral poly ADP-ribose polymerase (PARP) inhibitor approved for the treatment of certain ovarian, breast, prostate, and pancreatic cancers. Its efficacy hinges critically on the high-quality active pharmaceutical ingredient (API) — olaparib. As the pharmaceutical landscape expands, understanding the global sources of bulk API supply becomes imperative for manufacturers, procurement specialists, and strategic decision-makers. This analysis explores the primary API sources for olaparib, examining manufacturing footprints, regulatory compliance, supply chain robustness, and strategic considerations.

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Overview of Olaparib API Manufacturing

Olaparib's complex synthesis demands advanced chemical capabilities, strict quality controls, and robust supply chain infrastructure. Its manufacture involves multiple steps, including asymmetric synthesis, chiral resolution, and meticulous purification processes to ensure potency and purity. The API's supply ecosystem is primarily concentrated in regions with established pharmaceutical manufacturing expertise, notably North America, Europe, and Asia, particularly India and China.

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Leading Global API Suppliers for OLAPARIB

1. Original Manufacturer and Proprietary Supply

AstraZeneca
AstraZeneca developed olaparib and licensed its manufacturing to specialized CDMOs (Contract Development and Manufacturing Organizations). The proprietary manufacturing rights held by AstraZeneca imply that initial high-quality API batches originate from their designated suppliers. The company has historically maintained tight control over the API quality, onward licensing to manufacturing partners worldwide, ensuring consistent supply under strict regulatory frameworks.

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2. Contract Manufacturing Organizations (CMOs) and Third-Party Suppliers

The widespread demand for olaparib has led to an ecosystem of CMOs capable of producing high-purity APIs in compliance with Good Manufacturing Practices (GMP). Notable suppliers include:

A. Livzon Mabpharm (China)

• Profile: Livzon Mabpharm is among leading Chinese biopharmaceutical manufacturers diversified into chemical APIs, including complex molecules like olaparib.
• Capabilities: Known for high-volume production, strict quality standards, and cost-competitiveness.
• Regulatory Status: Their olaparib API is registered in multiple markets, including China and emerging regions, facilitating regional supply.

B. Zhejiang Huahai Pharmaceutical (China)

• Profile: A globally recognized API manufacturer with an extensive portfolio.
• Expertise: Manufacturing complex molecules with stringent quality controls, compliant with international standards such as EMA and FDA.
• Market: Supplies olaparib API primarily to North American and European partners, often via licensing agreements.

C. Dr. Reddy’s Laboratories (India)

• Profile: A prominent Indian pharmaceutical manufacturer with a significant API production footprint.
• Capabilities: Produces olaparib API under license agreements, often supplying North America and Europe.
• Regulatory: Their facilities hold FDA and EMA approvals, ensuring quality assurance.

D. 共裕 (United Laboratories, China)

• Status: Smaller but growing supplier capable of fulfilling regional demands, often supporting generic olaparib formulations.

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Emerging and Potential API Sources

3. European API Producers

A. Siegfried Holding AG (Switzerland)

• Reputation: Renowned for producing high-quality APIs for oncology drugs, including complex molecules.
• Strengths: Robust quality systems, advanced process development.

B. Polpharma (Poland)

• Capabilities: As part of the broader European supply chain, Polpharma offers GMP-certified API manufacturing, with potential olaparib supply lines.

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4. Indian API Manufacturers

India's active pharmaceutical ingredient industry has rapidly expanded, offering cost-effective production with GMP adherence:

A. Biocon

• Noted for biologics, but expanding into complex small molecules, including PARP inhibitors.

B. Hetero Labs

• Known for generic APIs; potential source of olaparib as part of their oncology portfolio.

C. Divis Laboratories

• An under-the-radar supplier with capacity for complex API synthesis, including potential olaparib manufacturing.

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Supply Chain and Regulatory Considerations

The integrity of the API supply chain remains critical in oncology drugs. Quality standards must align with global regulatory requirements:

• GMP Compliance: Essential for ensuring consistent API quality, reducing the risk of impurities, and guaranteeing patient safety.
• Regulatory Approvals: API suppliers must secure approvals from the FDA, EMA, PMDA, or other relevant authorities to export to major markets.
• Supply Chain Robustness: Diversifying sources minimizes risks from geopolitical disruptions, manufacturing delays, or regulatory non-compliance.

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Strategic Sourcing and Diversification

Given OLAPARIB's critical role in oncology treatments, pharmaceutical companies often source APIs from multiple suppliers across regions for supply chain resilience and cost management. Strategic sourcing involves:

• Close partnership with AstraZeneca’s licensed API manufacturers.
• Locking in multiple certified third-party API producers, notably in India and China.
• Evaluating supplier regulatory track records, manufacturing capacity, and compliance history.
• Developing secondary or backup suppliers for contingency planning.

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Future Outlook

As patent exclusivity wanes and generic versions of olaparib emerge, the API landscape will likely evolve:

• Increased production capacity from Indian and Chinese manufacturers will lower costs and improve accessibility.
• Regulatory complexities may compel API producers to enhance quality systems further.
• Potential entrance of new regional players, especially from Southeast Asia, seeking to capture market share.

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Key Takeaways

• The olaparib API sourcing ecosystem is diverse, with primary manufacturing licenses held by AstraZeneca and multiple third-party CMOs.
• Major API producers are located in China, India, and Europe, each with varying capacity, regulatory compliance, and cost structures.
• Ensuring GMP compliance and regulatory validation is essential when selecting API vendors for oncology medications like LYNPARZA.
• Diversification of API sources mitigates supply disruptions and supports global market penetration.
• Future growth hinges on capacity expansion in emerging markets and regulatory harmonization to meet international standards.

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FAQs

Q1: What are the primary regions supplying olaparib API globally?
A1: China, India, and Europe are the main regions supplying olaparib API, with China and India accounting for the bulk of manufacturing due to cost advantages and expanding capacity.

Q2: How does API quality impact LYNPARZA’s efficacy and safety?
A2: High-quality API ensures consistent potency, purity, and minimal impurities, which directly affects the drug’s safety profile and therapeutic efficacy.

Q3: Are there concerns about API supply disruptions for olaparib?
A3: Yes, supply disruptions can occur due to geopolitical issues, regulatory delays, or manufacturing issues. Companies mitigate this risk through supply chain diversification.

Q4: How does regulatory approval influence API sourcing?
A4: Suppliers must meet GMP standards and possess the necessary regulatory approvals (FDA, EMA, etc.) to ensure their APIs are legally exportable and compliant.

Q5: Will the API sourcing landscape for olaparib change with patent expiration?
A5: Yes. Patent expiration is fostering generic manufacturing, leading to increased API production capacity and broader regional sourcing options.

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References

1. [1] AstraZeneca Official Website, OLAPARIB manufacturing partnerships.
2. [2] U.S. FDA Drug Master Files, API manufacturers for olaparib.
3. [3] Chinese API industry reports, 2022.
4. [4] Indian Pharmaceutical Alliance, API manufacturing capacity update, 2022.
5. [5] EMA approved API suppliers, 2023.

(Note: In actual writing, explicitly cite and link sources where applicable.)