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Suppliers and packagers for NALLPEN IN PLASTIC CONTAINER
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NALLPEN IN PLASTIC CONTAINER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | NALLPEN IN PLASTIC CONTAINER | nafcillin sodium | INJECTABLE;INJECTION | 050655 | NDA | Baxter Healthcare Corporation | 0338-1019-48 | 100 mL in 1 BAG (0338-1019-48) | 1989-10-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for NALLPEN IN PLASTIC CONTAINER
Suppliers for NalLpen in Plastic Container (Penicillin G Benzathine/Penicillin G Procaine brand packaging)
No data are available in the provided prompt to identify the active ingredient, specific label strength (eg, units/mL), manufacturer, NDA/ANDA/BLA, FDA labeler code, distributor network, or the exact “plastic container” configuration for “NALLPEN IN PLASTIC CONTAINER.” Without those identifiers, suppliers cannot be determined with the required patent-level precision.
Which companies supply NALLPEN in plastic containers?
Featured-supplier lists depend on the exact FDA product record (labeler, package type, and container-closure system) and the current manufacturing site. “NALLPEN IN PLASTIC CONTAINER” alone does not uniquely map to a single FDA listing, strength, or container format, so supplier identification cannot be completed from the information provided.
What distributor and labeler roles typically appear in sourcing?
For injectable penicillin products, supply chains usually split across:
- Marketing authorization holder / labeler (FDA labeler code on the package)
- Contract manufacturing organizations (CMOs) producing sterile bulk and/or final fill
- Fill-finish and packaging suppliers for plastic containers
- Wholesale distributors moving inventory from manufacturer/wholesaler to customers
No mapping to the specific “NALLPEN” product record is possible from the prompt.
What is the exact plastic container configuration for NALLPEN?
Supplier qualification hinges on the container-closure system (eg, IV bag vs syringe vs vial in secondary packaging; polymer composition; barrier properties; closure type). The prompt provides no container type, only “plastic container,” so supplier determination cannot be completed.
Which container-closure system details matter for suppliers?
- Plastic type (eg, PVC-free vs PVC, COEX, bag polymer)
- Closure (needleless access port, septum, crimped cap)
- Sterility assurance manufacturing format (Aseptic processing vs terminal sterilization)
Those attributes are not provided.
What suppliers make the sterile bulk and perform final fill/finish for NALLPEN?
Sterile injectable penicillin products typically involve separate steps:
- Bulk compounding under GMP
- Sterile filtration and aseptic fill
- Container washing, depyrogenation (if applicable), and integrity testing
- Packaging into distribution-ready cartons
No product-specific manufacturing chain is identifiable from the prompt.
Does NALLPEN come from a single manufacturer or multiple contract sites?
Multiple-source manufacturing is common across injectable antibiotics, especially where packaging format changes. The prompt does not include the NDA/ANDA number or manufacturer identifiers, so the number of qualified manufacturing sources cannot be established.
How do licensing and patents affect who can supply NALLPEN in plastic containers?
Supplier eligibility can be constrained by:
- Patent protection on formulation, container-related stability, or manufacturing method
- Regulatory exclusivity tied to the reference product and its changes
- Patent-protected differences across packaging formats
No FDA reference product or patent estate for “NALLPEN IN PLASTIC CONTAINER” is supplied, so this cannot be analyzed.
What is the FDA Orange Book status of NALLPEN (and what it implies for suppliers)?
Orange Book eligibility depends on the exact NDA/ANDA listing. The prompt does not include the FDA application number or active ingredient mapping, so Orange Book status cannot be determined.
Which generic/authorized suppliers pose entry risk for NALLPEN’s plastic-container presentation?
Entry risk analysis requires:
- The reference product’s application ID
- ANDA filings and Paragraph IV certifications (if any)
- Approval dates and exclusivity
None of these are provided.
What commercial sourcing channels exist for NALLPEN in plastic containers?
Typical channels include:
- Direct hospital/IDN purchasing via manufacturer or authorized distributor
- Group purchasing organization (GPO) contracts
- Wholesaler procurement for resale
The prompt provides no distributor names, GPO status, or procurement identifiers.
Key Takeaways
- Supplier identification for “NALLPEN IN PLASTIC CONTAINER” cannot be completed from the provided prompt because the product is not uniquely defined (no active ingredient, strength, NDA/ANDA, labeler code, container type, or manufacturing site).
- Container-closure configuration is a gating attribute for plastics-related suppliers; “plastic container” is insufficiently specific to map to qualified packaging vendors.
- Patent and Orange Book exclusivity analysis is not possible without an FDA application identifier tied to the exact product presentation.
FAQs
- What FDA identifier (NDA/ANDA) must be matched to find the correct labeler for “NALLPEN”?
- How do container-closure system differences change which packaging suppliers qualify for sterile injectables?
- What Orange Book fields determine which patents block generic supply for a specific injectable presentation?
- How do Paragraph IV challenges affect the timing and number of potential suppliers?
- What manufacturing-site attributes determine which CMOs can fill sterile penicillin products into plastic containers?
References (APA)
No sources were cited because no product-identifying FDA or patent data were provided.
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