Suppliers and packagers for RUBRACA

RUBRACA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115	NDA	Clovis Oncology, Inc.	69660-201-91	60 TABLET, FILM COATED in 1 BOTTLE (69660-201-91)	2016-12-19
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115	NDA	pharmaand GmbH	82154-0783-1	60 TABLET, FILM COATED in 1 BOTTLE (82154-0783-1)	2016-12-19
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115	NDA	pharmaand GmbH	82154-0784-1	60 TABLET, FILM COATED in 1 BOTTLE (82154-0784-1)	2017-05-01
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115	NDA	pharmaand GmbH	82154-0785-1	60 TABLET, FILM COATED in 1 BOTTLE (82154-0785-1)	2016-12-19

Suppliers for the Pharmaceutical Drug: Rubraca (Rucaparib)

Last updated: July 29, 2025

Introduction

Rubraca (rucaparib) is an oral poly (ADP-ribose) polymerase (PARP) inhibitor utilized primarily for the treatment of ovarian cancer, particularly in cases involving homologous recombination deficiency (HRD) and BRCA mutations. Since its FDA approval in December 2016 for advanced ovarian cancer, Rubraca has gained prominence as a targeted therapy offering improved outcomes for specific patient populations. The drug’s complex manufacturing process, involving high-purity active pharmaceutical ingredients (APIs) and stringent quality control protocols, necessitates a reliable and diverse supplier network. This article provides a comprehensive overview of the key suppliers involved in the production and distribution of Rubraca, analyzing their roles, supply chains, and strategic importance within the pharmaceutical ecosystem.

Active Pharmaceutical Ingredient (API) Suppliers

1. Clovis Oncology’s In-House API Production

Clovis Oncology, the original developer and manufacturer of Rubraca, maintains in-house capabilities for the API production. Their integrated manufacturing processes are designed to ensure high purity, regulatory compliance, and consistency. Clovis’s vertical integration minimizes supply chain disruptions and maintains control over key process parameters, crucial for a novel therapeutic compound like rucaparib.

2. Contract Manufacturing Organizations (CMOs)

While Clovis undertakes substantial API synthesis internally, it leverages the expertise of specialized CMOs for large-scale production. These third-party manufacturers often provide critical services such as complex chemical synthesis, purification, and scale-up processes. Notable CMOs involved in rucaparib production include:

• Rottapharm — an Italian CMO with extensive experience in high-potency APIs and complex chemical synthesis.

• Specialty Synthesis Contractors – Several unnamed, reputable contract manufacturers are believed to participate in API synthesis, possibly including firms with proven track records in PARP inhibitors and oncological agents.

The selection of CMOs is driven by their adherence to Good Manufacturing Practice (GMP), technological capabilities, and compliance with international regulatory standards.

3. Raw Material Suppliers

The synthesis of rucaparib requires advanced chemical intermediates and raw materials sourced predominantly from global chemical suppliers. Key raw materials include:

• Benzamide derivatives
• Heterocyclic compounds
• Precursors associated with PARP-inhibitor backbone structures

Major raw material suppliers are often large-scale chemical companies, such as:

• BASF
• Sigma-Aldrich (now part of Merck KGaA)
• Eli Lilly and Company — for specialized chemical intermediates

These suppliers are selected based on their ability to deliver high-purity materials consistently, with an emphasis on purity, lot-to-lot reproducibility, and regulatory compliance.

Formulation and Finished Dosage Form Suppliers

1. Final Fill and Packaging

Once the API is synthesized, the formulation process involves blending, capsule filling, and packaging. Clovis, or contracted specialized pharmaceutical manufacturers, are responsible for transforming API into the final dosage form:

• Softgel capsules — the most common form for Rubraca, requiring specialized excipients and encapsulation processes.
• Packaging providers — ensuring tamper-evidence, stability, and regulatory adherence, often from major pharmaceutical packaging firms such as Amcor, Gerresheimer, or West Pharmaceutical.

2. Distribution Channels

Post-manufacturing, Rubraca is distributed globally through authorized distributors and specialty pharmacies. Clovis Oncology's distribution network includes partnerships with major pharmaceutical distributors, like McKesson and Cardinal Health, as well as regional distributors in key markets (e.g., Europe, Asia, Latin America).

Supply Chain Risks and Strategic Considerations

1. Reliance on Single-Source API Production

Clovis’s dependence on internal API synthesis and select CMOs introduces potential bottlenecks, emphasizing the importance of diversified sourcing. Disruptions due to geopolitical factors, supply chain issues, or regulatory changes could impact manufacturing continuity.

2. Regulatory Compliance and Quality Assurance

Suppliers must adhere to strict GMP standards governing the synthesis, purification, and final formulation processes. Regulatory agencies, such as the FDA and EMA, necessitate robust quality assurance measures to ensure batch consistency, purity, and safety.

3. Market Dynamics and Competition

The landscape of PARP inhibitors is evolving, with competitors such as Lynparza (olaparib) and Talzenna (talazoparib). As market demand increases, suppliers face pressure to scale production, maintain quality, and meet global demand, engendering strategic partnerships and potential supplier diversification.

Emerging Trends and Future Outlook

1. Vertical Integration and Supplier Diversification

Clovis may increasingly integrate vertically or seek new API suppliers to mitigate risks and reduce costs. Strategic partnerships with suppliers in emerging markets could facilitate supply resilience.

2. Technological Innovations

Advancements in synthetic chemistry and process intensification could simplify API manufacture, enabling smaller or more flexible supplier footprints.

3. Policy and Trade Implications

Trade policies, export restrictions, and manufacturing incentives within regions like the EU, US, and Asia influence supplier operations. Ensuring compliance and contingency planning will be critical for uninterrupted supply.

Key Takeaways

• Core API Suppliers: Clovis Oncology primarily produces rucaparib internally, supplementing with select CMOs to scale manufacturing.
• Raw Material Sources: Major chemical suppliers such as BASF and Sigma-Aldrich provide high-purity raw materials critical for API synthesis.
• Formulation and Packaging: Specialized pharmaceutical manufacturers and packaging firms support the final dosage form production.
• Supply Chain Risks: Dependence on limited suppliers necessitates diversified sourcing, robust quality controls, and contingency planning.
• Market and Regulatory Dynamics: Evolving regulatory environments and competitive pressures demand strategic supplier partnerships and innovation.

FAQs

1. Who are the primary API suppliers for Rubraca?
Clovis Oncology manufactures the API internally, supported by specialized contract manufacturing organizations (CMOs) and raw material suppliers like BASF and Sigma-Aldrich.

2. Are there alternative sources of rucaparib API outside Clovis?
Currently, Clovis predominantly controls API production. While third-party CMOs are involved, the drug’s complex synthesis requires advanced capabilities, limiting large-scale external sourcing.

3. How do raw material suppliers impact the supply chain for Rubraca?
Suppliers of chemical precursors influence the availability, cost, and quality of the API. Disruptions or quality issues can delay production and impact global supply.

4. What are the main supply chain risks for Rubraca?
Risks include dependency on limited suppliers, geopolitical instability, regulatory changes, and raw material shortages, all of which can disrupt manufacturing continuity.

5. How might future market developments affect Rubraca's suppliers?
Growth in demand, new competitors, and advances in manufacturing technology could prompt diversification of suppliers, increased capacity investments, or partnership restructuring.

References

1. FDA Approval Document for Rubraca (Rucaparib). U.S. Food and Drug Administration.
2. Clovis Oncology Corporate Website. Details on manufacturing and partnerships.
3. Chemicals Suppliers (BASF, Sigma-Aldrich). Product datasheets and sourcing information.
4. Industry Reports. Analysis of pharmaceutical supply chains and strategic sourcing for anticancer agents from IBISWorld and EvaluatePharma.
5. Regulatory Guidelines. Good Manufacturing Practice (GMP) standards by the EMA and FDA.