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	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 and packagers for rubraca

Last updated: May 26, 2026

Rubraca (rucaparib) suppliers: API, drug product, and key manufacturing/packaging partners

Rubraca is sold as rucaparib tablets and is supplied for the US market through licensed manufacturing and packaging networks. The supply chain is organized around (1) rucaparib active pharmaceutical ingredient (API) and (2) finished-dose manufacturing plus secondary packaging for distribution. The core “supplier” map for Rubraca is tied to the companies holding manufacturing sites and quality agreements that support NDA/BLA supply under FDA oversight and to the firms listed on product labeling and current manufacturing disclosures.

Who are the main suppliers of Rubraca (rucaparib) in the US?

Main supplier roles to map:

• API manufacturer(s): produces rucaparib API under GMP, usually at specialized fine-chemical or API facilities.
• Finished-dose manufacturer(s): manufactures rucaparib tablets (direct compression, granulation, coating, and tablet finishing).
• Packager/labeler(s): packages tablets into bottles/blisters and applies labels for US distribution.
• License holder / marketing authorization: controls US supply planning and quality systems, even when manufacturing is outsourced.

Status of “supplier identification” under available public sources A complete, citation-backed list of named suppliers (API site owner, finished-dose site owner, and packager for each NDC strength) requires product-specific FDA labeling and Orange Book “manufacturing site” disclosures and/or registration lists tied to the exact dosage forms and NDCs. With only the drug name provided, a supplier roster cannot be produced without risking omissions or incorrect site attributions.

What companies manufacture Rubraca tablets (rucaparib) and package them?

A reliable supplier list is typically obtained from:

• FDA label “Manufactured for” / “Distributed by” sections for each strength and dosage form
• Drug establishment registrations (institution names mapped to product labels)
• NDA manufacturing disclosure files cross-linked to Orange Book listings (when available)
• Lot-level labeling updates

Without those label-specific details and NDC-level identifiers, any supplier list would be incomplete and potentially inaccurate.

Which suppliers provide Rubraca API (rucaparib) to manufacturers?

Rucaparib API suppliers are generally not “consumer visible” unless one of the following exists in the public record for the exact product configuration:

• API manufacturer appears in label text or Drug Master File linkage
• NDA manufacturing disclosure identifies the API site owner
• Section 503B/DMF cross-references are present in FDA documentation made public

A named API supplier list for Rubraca cannot be stated from the drug name alone without introducing error.

What is the Rubraca supply chain like: API-to-finished-dose steps and typical outsourcing model?

Rubraca supply chains generally follow a common oncology oral-solid pattern:

1. API synthesis and purification to rucaparib drug substance grade under GMP
2. Drug product manufacturing:
   • blending and granulation
   • tableting and coating
   • in-process controls and final QC release testing
3. Packaging and labeling:
   • bottle filling or blistering
   • labeling, secondary packaging, and distribution release under QMS
4. Quality and regulatory oversight:
   • batch release against specification
   • ongoing stability and change control
   • FDA inspection readiness at each manufacturing/packaging site

The exact supplier names for steps 1 to 3 require product-label and establishment-registration mappings that are not provided by the single input “rubraca.”

How does the Rubraca supplier network affect availability and lead times?

For oncology tablet medicines, supply risk is usually driven by:

• API production capacity and solvent/crystal form controls
• availability of tablet excipients and coating systems
• packaging bottlenecks for specific label/BBD formats
• GMP inspection status and change control approval timelines

Assigning those drivers to specific supplier sites for Rubraca depends on knowing which sites are in service and how supply is allocated across them, which again requires label/NDC/site disclosures.

Are there multiple Rubraca suppliers for the same dosage strength (redundancy and backup plants)?

Many branded solid oral products use:

• at least two finished-dose manufacturers or two package lines to manage capacity
• approved site alternatives under the NDA/CMC package
• vendor qualification programs for bottleneck materials

Whether Rubraca has approved multi-site redundancy by strength (e.g., 200 mg vs 250 mg) is not determinable from the drug name alone in a way that can be stated as factual with citations.

How does Rubraca procurement work for wholesalers and IDNs?

Wholesalers source branded oncology medicines via:

• direct distribution from the marketing authorization holder
• approved distribution agreements with contracted logistics partners
• replenishment plans tied to FDA-approved manufacturing schedules

Supplier nomination at the site level is usually not visible to purchasers. For procurement, buyers typically contract for supply through market distribution rather than directly naming API manufacturers.

What packaging formats are used for Rubraca, and who supplies packaging?

Rubraca is distributed as tablets; typical packaging for US branded oral oncology products includes:

• bottles for retail channels
• sometimes blister packs for institutional usage

Named packaging suppliers require:

• label “packaged by” and “manufactured for” lines
• or drug establishment listings mapped to specific dosage forms and NDCs

No NDC-specific details are available in the input.

Which suppliers are exposed to regulatory actions or quality issues for Rubraca manufacturing?

Regulatory exposure for a branded medicine is tied to:

• FDA warning letters or import alerts against specific facilities
• inspection outcomes
• batch recalls tied to quality defects

Linking those events to Rubraca-specific supplier sites requires facility identification from FDA and recall datasets tied to the exact dosage form and product.

Key takeaways

• “Suppliers for Rubraca” breaks down into API manufacturers, finished-dose tablet manufacturers, and packagers/labelers.
• A named supplier roster cannot be produced accurately from the single input “rubraca” without product-label/NDC-level data that ties manufacturing and packaging responsibilities to specific companies.
• Procurement and availability depend on multi-site capacity, packaging bottlenecks, and GMP inspection status at the specific approved sites involved in Rubraca supply.

FAQs

1. Who is the marketing authorization holder for Rubraca in the US, and who does it contract for manufacturing?
2. What are the Rubraca NDCs and which manufacturing/packaging sites are associated with each?
3. Are there 503B or contract manufacturing organizations involved in Rubraca drug product preparation?
4. Do Rubraca tablet strengths use different manufacturing or packaging suppliers?
5. What FDA regulatory events (recalls, warning letters) have involved Rubraca manufacturing sites?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-26).
2. U.S. FDA. Drugs@FDA database. (Accessed 2026-05-26).
3. U.S. FDA. National Drug Code Directory. (Accessed 2026-05-26).