Suppliers and packagers for generic pharmaceutical drug: rucaparib camsylate

rucaparib camsylate

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

Rucaparib Camzylate Suppliers: Who Can Supply Raw Materials, Intermediates, and Drug Product for Commercial Scale

Last updated: May 25, 2026

Rucaparib camzylate is a branded, camphorsulfonate (camsylate) salt form of rucaparib (PARP1/2 inhibitor). Supplier coverage splits into (1) API and salt-manufacturing supply, (2) intermediate and synthesis supply chains, and (3) finished-dose CDMO supply. A reliable sourcing decision requires screening suppliers against the specific rucaparib camzylate salt form, the crystalline form and specifications, regulatory documentation package, and manufacturing capacity for the intended GMP market.

What companies supply rucaparib camzylate API or salt?

Direct supplier lists for rucaparib camzylate are typically disclosed via commercial catalogs, CDMO tender responses, and regulatory filings rather than in public product labels. In practice, sourcing teams identify suppliers at three levels:

Level 1: API manufacturer with salt-form capability

A smaller subset of firms can supply rucaparib camzylate itself (salt conversion plus control of the salt form and purity specs), not only freebase rucaparib.

What to confirm in supplier due diligence

• Salt conversion method to camphorsulfonate (camsylate)
• Control of polymorph/crystal habit and particle size distribution (PSD)
• Residual solvents and trace impurities profile
• Water content/solvate status if relevant to your target grade
• Batch-to-batch reproducibility for salt formation and isolation
• Ability to generate a full GMP documentation package (DMF/ASMF route where applicable)

Level 2: API supply chain that starts from rucaparib base

Some suppliers can provide rucaparib base API plus camphorsulfonic acid for salt formation, but not all can guarantee the exact camzylate grade consistent with the reference drug.

Where this matters

• If your development or commercial program is under a strict form/composition standard, base-to-salt conversion risk increases unless the supplier’s salt control strategy matches the target spec.

Level 3: CDMOs for solid oral drug product

Even if an API supplier is locked, drug product supply is usually handled by a CDMO with experience in:

• Film/tablet compression and coating
• Handling of low-dose potent compounds
• Analytical method transfer and stability support
• Packaging and distribution for oncology-grade supply

Which raw material suppliers provide camphorsulfonic acid (camsylate) for rucaparib salt formation?

Rucaparib camzylate requires camphorsulfonic acid (CSA) as the counterion source. CSA supplier coverage is broad, but the key gating items are grade and impurity control.

What CSA specs change supplier selection

• Chiral source and impurity profile
• Passivation of metal catalysts residues if used in CSA production
• Water content and physical form
• Compatibility with rucaparib salt crystallization process
• GMP status and documentation availability for intended regulator

How sourcing teams screen CSA

• CoA review for trace impurities and typical specs
• Consistency across lots tied to your crystallization yield targets
• Lot release testing cadence and method coverage
• Audit status for supply continuity

Which CDMOs can manufacture rucaparib camzylate tablets or capsules under GMP?

Finished-dose manufacturing typically comes from experienced oncology-focused CDMOs. Key capabilities to qualify:

• Potent API containment and occupational safety controls
• In-process controls for blend uniformity and content uniformity
• Method transfer for HPLC/LC-MS identity, assay, and salt-form confirmation
• Stability protocol suitability for salt form (humidity and temperature stress)

What drug product manufacturing details must be aligned

• Dosage strength target (reflects your labeling and patient regimen)
• Tablet/capsule platform and excipient compatibility
• Granulation and compression strategy that avoids salt-form conversion during processing
• End-to-end supply including packaging (serialization often needed)

How do suppliers differ on regulatory readiness for rucaparib camzylate?

Supplier “readiness” is less about whether they can make material and more about whether they can support submissions.

Documentation package benchmarks

• DMF/ASMF availability for API or drug substance process
• Drug product master files for formulation and manufacturing where applicable
• Batch history and validation packages
• Analytical procedures and reference standards for the camzylate form
• Stability data packages that match your target shelf-life conditions

Market implications

• For partnerships and regulatory submissions, suppliers that can support a rapid method transfer and provide form-specific characterization typically reduce timeline risk.

What supplier criteria predict quality problems in rucaparib camzylate manufacturing?

Salt-formulation failure modes are predictable in camphorsulfonate salts.

High-risk quality gaps to audit

• Incomplete salt conversion leading to mixed forms
• Residual freebase rucaparib or residual CSA outside tight limits
• Particle morphology drift affecting dissolution and uniformity
• Water uptake causing performance variability
• Impurity excursions in the salt isolation step

Analytics that matter for “salt-form correct” material

• Identity tests that discriminate salt vs free base
• Solid-state characterization (typical toolset includes XRPD and DSC in commercial supply qualification)
• Quantitative assay that aligns with your regulatory specification
• Controlled impurity monitoring for the full process chain

What are the most common supply chain routes for rucaparib camzylate?

Route A: Salt-manufacturing at the API stage

1. Rucaparib intermediate synthesis
2. Rucaparib freebase formation
3. Salt conversion to camzylate
4. Isolation, drying, milling/PSD adjustment
5. GMP release with form-specific analytics

Route B: Salt-manufacturing by the API buyer (conversion at buyer site)

1. Supplier provides rucaparib base API
2. Buyer performs salt conversion with CSA
3. Buyer performs solid-state characterization and release

Route C: CDMO handles conversion and drug product

1. API and salt conversion under one CDMO umbrella
2. Drug product manufacturing under the same contractor
3. Lower coordination overhead but higher dependency on one vendor

Supplier landscape for rucaparib camzylate: decision framework

A practical sourcing framework splits decisions across four workstreams:

1) Confirm the exact salt form

• Supplier must demonstrate the camsylate salt form, not generic “rucaparib salt.”

2) Match the target regulatory pathway

• For US filings, documentation quality and method transfer support are critical.
• For EU, focus on quality system readiness and batch traceability.

3) Validate performance specs

• Dissolution behavior and content uniformity are not guaranteed by salt naming alone.
• Confirm specs at both API and drug product stages.

4) Secure supply continuity

• Oncology supply contracts are sensitive to API crystallization yield and drying cycle capacity.
• Audit batch capacity for the month and quarter of expected release.

Key Takeaways

• Rucaparib camzylate sourcing hinges on salt-form control, not only rucaparib API availability.
• Shortlisting suppliers should separate API salt makers, CSA suppliers (camphorsulfonic acid), and tablet/capsule CDMOs.
• Supplier qualification should center on analytics that confirm the camzylate form, tight impurity and residual CSA/freebase limits, and documentation packages that support regulatory timelines.
• The lowest technical risk route is typically one where the same supplier controls salt conversion to camzylate under GMP, with validated solid-state characterization.

FAQs

1) Can I buy rucaparib freebase API and convert it to rucaparib camzylate myself?
Yes, but the conversion must meet your required salt-form specs and stability/dissolution performance. This is a quality-critical step that should be validated end-to-end.

2) Is camphorsulfonic acid supply continuity a bottleneck for rucaparib camzylate?
It can be. CSA lot variability can affect salt formation yield and impurity profile, so continuity planning and qualification of multiple CSA lots is standard.

3) What analytical tests confirm rucaparib camzylate identity versus freebase rucaparib?
Identity methods that discriminate salt from freebase are required, usually complemented by solid-state characterization and impurity profiling.

4) Do tablet manufacturing processes risk changing the rucaparib camzylate salt form?
Yes. Moisture and thermal stress during granulation/drying and excipient compatibility can alter solid-state behavior, so you need process controls aligned to the salt’s stability profile.

5) What is the fastest supply route for commercial scale if my drug product must launch soon?
Prioritize a supplier that can provide the camzylate salt API with full documentation support, or a CDMO that can deliver API salt and drug product under one system to reduce handoff risk.