Bulk Pharmaceutical API Sources for RUBRACA

Bulk Pharmaceutical API Sources for RUBRACA

Vendor	Vendor Homepage	Vendor Sku	API Url
ISpharm		I10-0690
AKos Consulting & Solutions		AKOS015898427
ChemTik		CTK4G1217
Aurum Pharmatech LLC		Z-3241
AbaChemScene		CS-2785

Bulk Active Pharmaceutical Ingredient (API) Sources for Rubraca

Last updated: July 27, 2025

Introduction

Rubraca (rucaparib) is an oral poly (ADP-ribose) polymerase (PARP) inhibitor approved by the U.S. Food and Drug Administration (FDA) for treating ovarian cancer, particularly in cases associated with BRCA mutations. As a targeted cancer therapy, rucaparib’s efficacy hinges on the high-quality Active Pharmaceutical Ingredient (API) used during manufacturing. Ensuring a reliable and compliant supply chain for bulk API sources is critical for pharmaceutical companies seeking to manufacture or distribute Rubraca globally, especially given stringent regulatory standards and the sensitive nature of oncology therapeutics. This report analyzes key suppliers and considerations for sourcing rucaparib API.

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Overview of Rucaparib API Manufacturing

Rucaparib’s synthesis involves complex organic chemistry processes, primarily through multistep manufacturing sequences that require advanced capabilities in chemical synthesis, purification, and quality control. API providers must comply with Good Manufacturing Practices (GMP) and have demonstrated capacity for large-scale production to meet global demand. The API customarily undergoes rigorous characterization, purity testing, and stability assessments to satisfy regulatory standards such as USP, EP, or JP monographs, as well as FDA and EMA requirements.

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Key API Suppliers for Rucaparib

1. Clovis Oncology’s In-house API Production

Clovis Oncology, the originator of Rubraca, maintains in-house API manufacturing facilities aligned with regulatory requirements. While the company predominantly controls its API supply chain, Clovis partners with specialized contract manufacturing organizations (CMOs) to ensure supply robustness.

2. Contract Manufacturing Organizations (CMOs)

Numerous CMOs globally offer high-quality, GMP-compliant API production for rucaparib. These organizations often possess proprietary synthesis routes, economies of scale, and validated processes, enabling cost-effective supply. Notable CMO providers include:

• Hoffmann-La Roche (Roche)
  Roche is renowned for its extensive biologics and small molecule manufacturing expertise. While primarily focused on their products, Roche’s internal API facilities can sometimes supply external partners, though this is typically limited to their proprietary drugs.

• Wuxi AppTec
  Based in China, Wuxi offers a broad spectrum of pharmaceutical manufacturing services, including active pharmaceutical ingredients for oncology medications. They possess validated GMP facilities capable of rucaparib API production.

• Beta Pharma (India)
  An established Indian API manufacturer specializing in niche oncology APIs, Beta Pharma has the technical capabilities and GMP compliance certifications to produce rucaparib at scale meeting international standards.

• Singota Solutions (USA)
  Singota offers contract API manufacturing and has experience in complex small-molecule APIs, including oncology therapeutics. Their GMP facilities are validated for high purity API production.

• Siegfried AG
  A Swiss-based CDMO with extensive experience in producing specialty APIs for oncology, Siegfried offers tailored manufacturing for complex molecules like rucaparib.

3. Emerging and Specialized API Suppliers

Given the increasing global demand, several emerging suppliers have entered the market, often offering cost advantages and flexible manufacturing. Companies such as Granules India and CordenPharma are expanding their oncology API portfolios, including rucaparib, compliant with international standards.

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Raw Material and Synthesis Considerations

Manufacturing rucaparib involves specific intermediates and starting materials that influence API quality and cost. Typically, the synthetic route requires:

• Aromatic compounds and heterocycles for core structures.
• Use of chiral or regioselective catalysts to ensure stereochemistry.
• Stringent purification protocols to eliminate impurities.
• Implementation of analytical techniques such as HPLC, NMR, and mass spectrometry for verification.

Because of these complexities, API suppliers must demonstrate consistent process control, impurity profile management, and process validation.

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Regulatory and Quality Certification

API sources must adhere to GMP standards and be certified by regulatory authorities such as the FDA, EMA, or WHO. Suppliers often hold certifications including:

• ISO 9001/ISO 13485
• GMP certification from relevant agencies
• Drug Master File (DMF) submissions in pertinent jurisdictions

Establishing reliable sourcing involves verifying documentation, audit history, and batch consistency.

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Global API Market Trends and Challenges

The API market for oncology drugs like rucaparib faces several challenges:

• Supply chain disruptions due to geopolitical issues or pandemics.
• Regulatory hurdles in markets requiring local approvals.
• Pricing pressures causing manufacturers to optimize cost without compromising quality.
• Capacity constraints for complex APIs requiring advanced synthesis facilities.

Emerging manufacturers in Asia, particularly India and China, offer competitive pricing but require rigorous due diligence regarding quality compliance.

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Strategic Sourcing Recommendations

• Diversify supply sources to mitigate risks of disruption.
• Conduct comprehensive supplier audits and quality assessments.
• Engage with long-term supply agreements to secure capacity.
• Monitor regulatory filings and certifications regularly.
• Collaborate with CMOs that have demonstrated robust process validation and traceability.

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Conclusion

The procurement of high-quality rucaparib API is pivotal to maintaining drug safety, efficacy, and regulatory compliance. Leading global suppliers, including internal manufacturing units of Clovis Oncology, established CMOs like Wuxi AppTec, Beta Pharma, and Siegfried, serve as primary sources. The landscape continues to evolve with emerging players offering competitive pricing and capacity. Strategic partnerships, thorough qualification processes, and adherence to regulatory standards will underpin successful API sourcing for Rubraca.

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Key Takeaways

1. Reliable API sourcing for Rubraca depends on GMP-compliant suppliers with proven synthesis processes for rucaparib.
2. Leading API manufacturers include internal production by Clovis Oncology and external CMOs such as Wuxi AppTec, Beta Pharma, and Siegfried.
3. Quality certifications, process validation, and regulatory adherence are critical factors in selecting API suppliers.
4. The Asian API market, especially India and China, offers competitive options but requires rigorous due diligence.
5. Diversification of suppliers helps mitigate risks related to supply chain disruptions and regulatory bottlenecks.

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FAQs

1. What are the primary challenges in sourcing rucaparib API?
Sourcing challenges include ensuring consistent high quality, regulatory compliance across markets, managing complex synthesis processes, and mitigating supply chain disruptions.

2. How do regulatory standards influence API suppliers for oncology drugs?
Suppliers must comply with GMP standards and provide validated process documentation, which influences their eligibility and credibility within the regulated pharmaceutical landscape.

3. Can API suppliers produce rucaparib at scale?
Yes, several GMP-certified manufacturers worldwide, including CMOs, possess sufficient capacity for large-scale API production to meet global demand.

4. What factors should a pharmaceutical company consider when qualifying an API supplier?
Key factors include regulatory compliance, manufacturing capacity, process validation, impurity profile, quality control measures, and past audit results.

5. How is the API supply chain impacted by geopolitical issues?
Geopolitical tensions can lead to supply chain disruptions, export restrictions, or delays, emphasizing the importance of diversified sourcing and robust supply chain planning.

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References

1. U.S. Food and Drug Administration. “Rubraca (rucaparib) Approval Fact Sheet.” [FDA, 2020].
2. Clovis Oncology. “Rubraca (rucaparib): Prescribing Information.” [Clovis, 2022].
3. Wuxi AppTec. “CRO and API Manufacturing Capabilities for Oncology Drugs.” [Wuxi, 2023].
4. Global Market Insights. “API Market for Oncology Drugs: Trends and Outlook.” [2022].