Last updated: May 23, 2026
Niraparib tosylate is supplied through a vertically segmented model: (1) active pharmaceutical ingredient manufacturers for niraparib (free base) and/or niraparib tosylate, (2) finished-dose manufacturers for capsules/tablets, and (3) packaging and distribution partners. Supplier selection is constrained by controlled-substance style handling requirements for niche oncology APIs, stringent CGMP expectations for cytotoxic processing, and regulatory qualification tied to specific manufacturing sites listed for the finished product and drug substance in regulatory filings (e.g., FDA DMFs and ANDA/505(b)(2) submissions).
Because “suppliers” can mean either drug-substance (API) manufacturers or finished-dose (drug product) manufacturers, the correct procurement map depends on which part of the chain is being sourced. The only compliant way to deliver a complete supplier list is to anchor to authoritative public listings (FDA Orange Book for drug product/manufacturer, and FDA DMF/Patent/Reference Agent records for drug substance). No such authoritative listings were provided in the prompt, so a complete, accurate supplier inventory cannot be produced.
What companies supply niraparib tosylate drug product (capsules) for the US market?
Answer: Niraparib tosylate is sold in the US as branded oncology therapy; drug product suppliers are identified via FDA Orange Book “Applicants/Manufacturers” listings. A complete supplier roster requires Orange Book confirmation for each dosage strength and NDA holder.
Which dosage forms and strengths are typically supplied?
- Capsule strengths are the market standard for niraparib tosylate.
- Supplier qualification is strength-specific where manufacturing differences exist.
How to use FDA Orange Book to identify finished-dose suppliers
- Pull Orange Book listings for the NDA covering niraparib tosylate.
- Extract “Applicant,” “Manufacturer,” and “Dosage Form” fields.
- Map each strength to manufacturing site names and submission types.
Who manufactures niraparib API (drug substance) and/or niraparib tosylate (API form)?
Answer: API suppliers are identified via FDA Drug Master File (DMF) holders for niraparib and/or niraparib tosylate, plus global filings referenced in drug product applications. A complete API supplier list requires DMF/public filing records.
What counts as an API supplier in procurement terms?
- DMF holder for the relevant drug substance manufacturing process.
- Contract manufacturer that performs site-specific synthesis, isolation, and salt formation to tosylate.
- Any intermediate manufacturer tied to the drug substance process.
How tosylate salt formation changes the supplier map
- API supplier may sell free base while finished-dose supplier or salt-formation partner converts to tosylate.
- Some chains consolidate both steps at one site, which changes qualification scope and supply continuity risk.
How many qualified suppliers exist for niraparib tosylate across global markets?
Answer: Qualified suppliers are limited by highly specific CGMP capability for oncology cytotoxic compounds, yield and impurity controls, and validated salt-form parameters for tosylate.
Supplier count drivers
- Complexity of the synthetic route and impurity profile.
- Capacity for cytotoxic handling in dedicated lines.
- Regulatory qualification and inspection outcomes at manufacturing sites.
What are the main supply-chain risk points for niraparib tosylate sourcing?
Answer: The largest procurement risks cluster in synthesis scale-up, tosylate salt conversion/solid-state control, and validated impurity management.
Typical risk nodes
- API lot-to-lot consistency for key impurities.
- Salt form control (crystal habit, polymorph risk, moisture sensitivity).
- Dedicated containment and cleaning validation for cytotoxic oncology handling.
Does supplier switching trigger regulatory filing changes?
Answer: Yes. Changing drug substance manufacturer or drug product manufacturing site typically triggers regulatory actions, including manufacturing supplements and updated validation/CMC packages.
Where switching most often hits timelines
- Drug substance manufacturing site change requires comparability and updated stability and impurity data.
- Drug product site change requires new process validation and updated release testing methods for capsule/tablet packaging.
What generic or biosimilar suppliers affect niraparib tosylate competition and supply?
Answer: For small-molecule oncology drugs like niraparib tosylate, “biosimilar” is not the competitive analogue; the competitive set is generics and authorized generics. Supplier demand shifts when a generic product launches using specific API sourcing networks.
What to track for competition-driven supply shifts
- ANDA applicants’ referenced API sources.
- Settlement agreements that permit earlier supply before full patent expiry.
- FDA approvals and manufacturing site designations in approval letters and labels.
Key Takeaways
- Niraparib tosylate supplier mapping requires separation between drug substance (API) and finished-dose (drug product) manufacturers.
- The authoritative method to compile a complete supplier list is FDA Orange Book for finished-dose manufacturers and FDA DMF records for drug substance holders.
- Procurement risk concentrates in cytotoxic CGMP capability, tosylate salt solid-state control, and validated impurity management.
- Supplier changes commonly trigger CMC comparability and regulatory supplements, impacting launch and continuity timelines.
FAQs
- How do I identify the NDA holder and finished-dose manufacturers for niraparib tosylate in the US? Use the FDA Orange Book listing for the niraparib tosylate NDA and extract the “Applicant/Manufacturer” fields for each dosage strength.
- Where can I find the drug master file (DMF) holders linked to niraparib API? Search FDA DMF public indices for the niraparib drug substance and extract DMF holder names tied to the filing.
- Can niraparib API be supplied as free base and converted to tosylate in-house? Yes in some supply chains, but qualification depends on solid-state form control and salt-formation validation at the receiving site.
- What CMC data is typically required when switching niraparib tosylate API suppliers? Comparability (impurities, polymorph/solid state, dissolution/particle properties), process validation evidence, and updated stability/release testing alignment.
- What is the biggest manufacturing bottleneck for niraparib tosylate supply continuity? Tosylate salt formation and impurity control at scale, coupled with dedicated cytotoxic CGMP capacity.
References
No sources were provided in the prompt, and no authoritative FDA/Orange Book/DMF records were included; therefore, no citations can be generated while maintaining accuracy.
