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Suppliers and packagers for generic pharmaceutical drug: pentostatin
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pentostatin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hospira Inc | NIPENT | pentostatin | INJECTABLE;INJECTION | 020122 | NDA | Hospira, Inc. | 0409-0801-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2007-08-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Pentostatin Suppliers: Who Manufactures Pentostatin API and Finished Drug Products, and What Supply Risks Exist
Pentostatin supply in the US is typically concentrated in a small number of manufacturers for the active pharmaceutical ingredient (API) and sterile drug product. Pentostatin is also subject to tighter supply visibility than many branded oncology drugs because it is commonly used in limited indications, which reduces the incentive for multiple parallel supply sources. For business planning, the actionable view is: identify the API producers, the sterile fill-finish sites supporting the marketed product, and the regulatory status (FDA approvals and labeling) tied to each listed supplier.
Scope note (terminology). “Pentostatin suppliers” can mean (1) API manufacturers for pentostatin, (2) finished dose manufacturers and distributors of the FDA-approved drug product, and (3) contract manufacturing organizations (CMOs) or sterile fill-finish operators that produce commercial batches under NDA/BLA or drug master files (DMFs). The most decision-relevant supplier map is API plus marketed product holders.
Who supplies pentostatin API (active pharmaceutical ingredient) and how is it sourced?
Answer (featured snippet): Pentostatin API supply is concentrated among a limited set of specialty API producers that can support oncology-grade, sterile-dose requirements. Finished product supply depends on sterile manufacturing capacity and regulatory filings tied to the marketed NDA.
What API-grade specifications constrain the pentostatin supply chain?
Pentostatin used in oncology is supplied as a sterile parenteral drug product. That means API suppliers must support:
- Tight impurity and identity controls (including stereochemistry and degradation products).
- Consistent particle and solid-state characteristics needed for downstream sterile manufacturing.
- DMF or cross-referenced information that allows the finished-dose sponsor to file and maintain regulatory compliance.
Where do pentostatin API suppliers typically appear in practice?
In the US, pentostatin supply chain mapping is usually done through:
- FDA DMF references tied to the NDA/BLA sponsor and manufacturing controls.
- Labeling “Manufactured for” and “Distributed by” lines on the finished dose product packaging.
- Inspection histories and manufacturing site details linked to FDA facility registrations.
Which companies manufacture the marketed pentostatin drug product in the US?
Answer (featured snippet): The practical supplier list for pentostatin in the US is the set of companies that hold the approved NDA for pentostatin sterile drug product and the companies that perform the commercial manufacturing at the registered manufacturing sites.
What to extract from the finished-dose labeling
For supplier decisions, the relevant fields on the carton/label and FDA listing are:
- NDA holder name.
- “Manufactured for” or “Manufactured by” line (finished-dose manufacturer).
- “Distributed by” (wholesale distributor).
- Strength(s), dosage form, and presentation (vial size and reconstitution instructions).
How to separate finished-dose suppliers vs distributors
- Finished-dose manufacturer: sterile fill-finish and bulk drug product manufacturing site(s).
- Distributor: logistics and channel management. Distributors do not replace manufacturing constraints; they replace commercial routing.
What is the FDA approval status of pentostatin and how does it affect supplier options?
Answer (featured snippet): FDA status governs which sponsors and contract manufacturers can legally market pentostatin in the US and which manufacturing changes can be made without triggering major regulatory work.
How FDA approval status drives supplier count
- If only one NDA holder is active, the supplier count at the commercial level stays small.
- If the drug is marketed under limited approvals and strengths, sterile capacity and validated processes tend to stay with a narrow set of manufacturers.
Orange Book relevance for supply
For supply risk, Orange Book listings matter because patent-protected products can limit generic entrants, which in turn can restrict the number of approved sources of the finished drug.
When do pentostatin supply disruptions happen and what are the common root causes?
Answer (featured snippet): Pentostatin supply disruptions usually trace to sterile manufacturing capacity, batch failures, regulatory maintenance, or raw material availability for the API.
Supply risk drivers by step in the chain
- API step: limited qualified suppliers, batch impurity drift, supply seasonality for specialty precursors.
- Drug product step: sterile fill-finish throughput, validated lyophilization or sterile solution controls (depending on formulation), and QC release bottlenecks.
- Channel step: distributor allocation during scarcity, reorder lag, and lot-to-lot handling.
What generic or biosimilar entry risks exist for pentostatin?
Answer (featured snippet): Pentostatin is not a biologic, so the “biosimilar” framework does not apply. Generic supply depends on whether an ANDA can be filed and approved for the approved dosage form and strength, and whether there is an Orange Book-protected barrier that drives Paragraph IV and litigation dynamics.
Paragraph IV and launch timing as supply catalysts
Where Orange Book patents exist, generic entry timing affects supplier diversification. If an ANDA is approved and launched, it can expand the number of finished-dose suppliers and improve resilience.
Which pentostatin formulations and strengths affect supplier coverage?
Answer (featured snippet): Supplier coverage is often strength- and presentation-specific. A supplier may cover one vial size or strength but not another.
Why strength matters for supply
- Different strengths can require different fill volumes, container closures, and process parameters.
- Sterile release criteria can vary with concentration and reconstitution instructions.
- Hospitals sometimes treat “product form” as the purchase unit, not API equivalence.
How do licensing and manufacturing agreements influence pentostatin supplier availability?
Answer (featured snippet): Pentostatin supply is often controlled by NDA manufacturing agreements and tech transfer scope. A small number of licensed CMOs limits redundancy.
Licensing patterns that constrain supply
- If tech transfer is incomplete, alternative manufacturing sites cannot be qualified quickly.
- If the NDA relies on a single approved manufacturing route, changing route requires additional regulatory work.
What commercial leverage do large distributors have for pentostatin?
Answer (featured snippet): Distributors can manage allocations across regions and customers, but they cannot solve upstream sterile manufacturing or API batch availability constraints.
Distributor allocation signals to monitor
- “Backorder” windows by lot.
- Substitution policies (if any) and product brand/vial-level substitutions.
- Time-to-order fill after new shipment release.
What manufacturing/IP barriers can block alternative pentostatin suppliers?
Answer (featured snippet): Barriers typically come from a combination of regulatory qualification (sterile process validation), DMF cross-references, and IP constraints on the finished-dose product.
Common barrier types
- Regulatory: approved manufacturing method restrictions, validated QC systems, and facility readiness.
- Technical: lyophilized vs solution formulation constraints and reconstitution compatibility.
- IP: Orange Book patents covering composition, formulation, or method of use.
Pentostatin supplier map template (API + finished dose) for procurement and risk planning
Use the structure below to build a live supplier register from FDA product labeling and DMF references.
| Layer | What to list | Decision fields | Primary evidence |
|---|---|---|---|
| API | API manufacturer(s) | DMF holder, site address, USDMF number | FDA DMF references tied to NDA |
| Finished dose | NDA holder and sterile manufacturer | “Manufactured for/by,” site, vial size, strength | FDA label, drug listing |
| Fill-finish/CMO | Contract sterilization/fill-finish site(s) | Capacity, inspection history, tech transfer scope | FDA facility registration and inspection reports |
| Channel | Distributor/wholesaler | Allocation coverage, fulfillment lead times | Purchase orders and channel notices |
Key Takeaways
- Pentostatin supply is constrained by sterile manufacturing capacity and API qualification, which typically limits the number of qualified sources.
- “Supplier” should be treated as a chain: API producers plus the NDA-linked sterile finished-dose manufacturer(s).
- FDA approval and Orange Book status determine whether multiple finished-dose sources can exist, which directly affects supply resilience.
- Practical procurement risk is driven less by distributors and more by sterile fill-finish throughput, API batch release variability, and regulatory/tech transfer scope.
- Build supplier redundancy only at sites that can support validated sterile processes for the exact strength and presentation.
FAQs
What information on pentostatin packaging shows who the finished-dose manufacturer is?
Look for “Manufactured by” or “Manufactured for” and the firm name and address on the label and prescribing information tied to the specific NDC.
Are there multiple pentostatin API suppliers in the US market?
In practice, pentostatin API availability often comes from a small number of qualified specialty producers; verify via FDA DMF references tied to the marketed NDA.
Does pentostatin have an Orange Book listing that impacts generic competition and supply?
If pentostatin’s marketed product has Orange Book-listed patents, those listings can slow generic approvals and reduce the number of approved finished-dose sources.
What is the fastest path to de-risk pentostatin procurement?
Reduce dependency on a single lot allocation route by contracting with customers/distributors that can access alternate NDC presentations and by ensuring the sterile manufacturing source is diversified.
What typically causes pentostatin backorders?
Upstream API batch release issues and downstream sterile manufacturing capacity or QC release bottlenecks are the common causes.
References (APA)
[No sources were provided in the prompt to cite, and producing a numbered reference list would require verifiable source documents.]
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