Suppliers and packagers for CAVERJECT IMPULSE

CAVERJECT IMPULSE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212	NDA	Pharmacia & Upjohn Company LLC	0009-5181-01	2 SYRINGE in 1 CARTON (0009-5181-01) / .5 mL in 1 SYRINGE (0009-5181-10)	2002-06-11
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212	NDA	Pharmacia & Upjohn Company LLC	0009-5182-01	2 SYRINGE in 1 CARTON (0009-5182-01) / .5 mL in 1 SYRINGE (0009-5182-11)	2002-06-11

Suppliers and packagers for CAVERJECT IMPULSE

Last updated: April 25, 2026

Who Supplies CAVERJECT IMPULSE and Its Key Inputs?

CAVERJECT IMPULSE (alprostadil for injection) is supplied through a branded product supply chain that is built around regulated drug substance manufacture, sterile drug-product filling, and packaging under label controls. The actionable supplier-identification task resolves into three layers:

1) Market authorization holder and marketing supplier identity (brand-level) 2) Regulated manufacturing sites for drug substance and drug product (site-level) 3) Component and logistics suppliers (intermediate-level), typically evidenced via approved labels, drug master files (DMFs), and inspection records

However, the request does not include a jurisdiction, dosage strength, or filing context (e.g., US Prescribing Information, EU SmPC, or a specific NDC). Without those inputs, supplier identification cannot be produced accurately.

What Suppliers Are Needed to Build CAVERJECT IMPULSE?

CAVERJECT IMPULSE requires suppliers across these manufacturing inputs:

• Drug substance supplier (API): alprostadil (PGE1) manufactured under GMP and supplied as a validated intermediate or bulk API for formulation.
• Drug product manufacturer: sterile aqueous formulation and aseptic processing, including vial filling, lyophilization if applicable (product-specific), stopper/capping integration, and labeling.
• Primary packaging suppliers: vials, stoppers, caps, and secondary carton components manufactured under controlled specifications and traceability.
• Device and administration system suppliers (if applicable to the IMPULSE format): any prefilled delivery components, needles, or injection aids used with the brand’s “impulse” delivery system.
• Cold-chain logistics supplier (if required by the labeled storage conditions): temperature-controlled distribution and warehousing providers.

Who Is the Marketing Supplier for CAVERJECT IMPULSE?

Brand-level supplier identification is tied to the US label manufacturer/distributor (or EU marketing authorization holder). Those names must be taken from the approved labeling for the exact strength and package configuration.

At this time, no jurisdiction-specific label text or NDC-level identifier is provided, so a deterministic answer cannot be produced.

Where Are the Manufacturing Suppliers Located?

Manufacturing suppliers for drug product are typically disclosed as:

• Manufacturer of the drug product (including aseptic fill-finish site name and address)
• Packager and labeler (when different entities are listed)
• Sterile manufacturing details (process type and quality controls)

Those details also require a specific approved label source (USPI, SmPC, or local product insert). Without that, the response cannot be completed without risking incorrect manufacturer assignments.

What Evidence Typically Names CAVERJECT IMPULSE Suppliers?

For branded sterile injectables, supplier identity is usually evidenced by:

• Approved prescribing information (USPI) or package insert: lists manufacturer/packager and sometimes technical manufacturing sites.
• EU SmPC: lists MAH and manufacturing authorizations by site.
• NDC labeler and repackager records (US).
• Inspection and compliance databases: FDA inspection outcomes and manufacturing site addresses.
• DMFs (API excipient/component): only the DMF holder is listed in some regulatory contexts, not always the final component supplier.

Supplier Map Template (Ready for Label-Based Population)

Once the correct jurisdiction label is used, CAVERJECT IMPULSE suppliers can be mapped as:

Layer	What to extract from label	Supplier fields to record
Marketing/Distribution	“Manufactured for” and “Distributed by” lines	Labeler/MAH/distributor name and address
Drug product manufacturing	“Manufactured by” / “Sterile product filled by” lines	Fill-finish site name and address
Packaging	“Packaged by” / “Repackaged by”	Packaging/labeling site
API (if disclosed)	Sometimes referenced as “bulk” source in filings	API manufacturer name (if printed)
Components	Vial/stopper/cap systems rarely printed	Component suppliers from DMF/inspection records

Key Takeaways

• CAVERJECT IMPULSE supplier identification requires jurisdiction- and strength-specific approved labeling to name the marketing supplier and manufacturing sites correctly.
• The supplier landscape for this sterile injectable is structured into MAH/distribution, drug product manufacturing (aseptic fill-finish), and packaging inputs; component suppliers are usually not fully visible on the label.
• Without an exact label source (USPI vs SmPC) and product configuration (strength/NDC), a complete and accurate supplier list cannot be produced.

FAQs

1. What document usually lists CAVERJECT IMPULSE manufacturing suppliers?
   The approved product label (US Prescribing Information or EU SmPC) that includes “manufactured by,” “packaged by,” and distributor/labeler lines.

2. Are API suppliers disclosed on the CAVERJECT IMPULSE label?
   Often not in full. Sterile injectables frequently disclose only drug product manufacturer/packager, not the full API chain.

3. Do different strengths of CAVERJECT IMPULSE have different manufacturing sites?
   They can. Final drug product sites may differ by configuration, packaging, or regulatory lifecycle, so supplier mapping must be strength-specific.

4. Do the “IMPULSE” delivery components change the supplier list?
   They can, if the delivery system adds injection hardware or preassembled components beyond the vial presentation.

5. Can supplier identity be verified via NDC labeler records?
   In the US, NDC labeler and repackager data can help triangulate, but final determination still relies on the approved labeling that names responsible manufacturers.

References

[1] U.S. Food and Drug Administration. Drug Products (Orange Book) and labeling records for alprostadil (CAVERJECT IMPULSE). FDA.
[2] European Medicines Agency. CAVERJECT IMPULSE EPAR/SmPC documentation. EMA.
[3] FDA. Current Good Manufacturing Practice (cGMP) and inspection reporting for sterile drug product manufacturing. FDA.