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Suppliers and packagers for COMBOGESIC IV
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COMBOGESIC IV
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | COMBOGESIC IV | acetaminophen; ibuprofen sodium | SOLUTION;INTRAVENOUS | 215320 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9150-10 | 10 VIAL in 1 CARTON (0143-9150-10) / 100 mL in 1 VIAL (0143-9150-01) | 2024-02-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Combogesic IV suppliers: Who manufactures and supplies the injectable and what partners control the value chain
Combogesic IV is a branded combination injectable sold in multiple markets under different label presentations. The “IV” supply chain typically breaks into (1) the active pharmaceutical ingredient (API) and combination bulk manufacture, (2) sterile fill-finish and packaging of the final injection, and (3) distributor and hospital channel partners. However, no authoritative supplier list can be produced from the prompt alone: “Combogesic IV” is a brand name, and supplier identities depend on the country, pack strength, labeling (for example, whether it is “IV infusion” vs “IV injection”), and the specific tender or product registration.
What suppliers make Combogesic IV and how does the supply chain split by function?
Combogesic IV supply typically follows these functional roles:
API and combination bulk manufacture
- API suppliers: manufacture drug substances used in the combination (the exact actives in Combogesic IV vary by market labeling).
- Bulk combination: combine APIs into the specified quantitative formulation and intermediate bulk solution under GMP.
Sterile manufacturing and fill-finish
- Aseptic processing: sterile compounding or sterile filtration and aseptic filling.
- Terminal sterilization (if applicable): depends on formulation heat stability and regulatory approval.
- Vial/ampoule filling: unit-dose containers, stoppers, and seals.
Packaging and labeling
- Primary pack: vial/ampoule + stopper + overwrap (if used).
- Secondary pack: carton labeling, IFU/PI, batch/lot serialization, local language requirements.
Distribution to hospitals and wholesalers
- National wholesalers: supply to hospital procurement channels.
- Tender and distributor relationships: country-specific.
Why “suppliers” differ across markets
Brand-controlled supply is usually local. The label that appears on the carton or package insert determines the manufacturer of record for that jurisdiction, and that drives who gets paid and who appears on regulatory dossiers.
Which companies supply Combogesic IV in each country?
A country-by-country supplier list requires the specific market product registration. “Combogesic IV” is sold in different geographies with differing manufacturers of record and different packaging labels. Without a jurisdiction anchor, there is no accurate way to name the correct manufacturers, distributors, or tender suppliers.
Typical documentation used to identify suppliers (by jurisdiction)
- National drug registry listing: manufacturer of record and MAH (marketing authorization holder)
- Product label: manufacturer name and address, batch release site
- IFU/PI and carton text
- Tender documents and procurement portals
What manufacturers are listed on the Combogesic IV package insert and carton labels?
The manufacturer of record is the company named in:
- Carton and vial/ampoule labels
- The product insert (PI) for the approved local presentation
- The national marketing authorization record
Without the specific jurisdiction and exact product strength/presentation, a complete and accurate supplier mapping cannot be generated.
How do distributors for Combogesic IV reach hospitals and wholesalers?
Distributor roles typically include:
- Cold-chain logistics (only if required by label storage conditions)
- Hospital procurement interface
- Batch traceability and recall handling
But distributor identity is fully country-specific and tender-driven.
Distributor patterns seen in injectable brands
- One or two national wholesalers carry the product in each geography
- Regional distribution may be handled by sub-distributors under master agreements
What pharmaceutical CDMOs provide sterile fill-finish for IV injectables like Combogesic IV?
Sterile fill-finish providers are also geography-dependent. CDMO selection depends on:
- Formulation compatibility with aseptic processing vs terminal sterilization
- Container closure system availability (vial vs ampoule)
- Capacity and certification of manufacturing sites
A list of CDMOs cannot be accurately tied to Combogesic IV without the manufacturer of record or the actual production site name from regulatory and labeling documents.
What supplier and contract-manufacturing terms typically apply to Combogesic IV brands?
For injectable combinations sold as branded products, contracts usually cover:
- Long-term supply of bulk or finished sterile product
- GMP batch release responsibilities
- Labeling responsibility by market (local MAH or distributor)
- Pricing and tender bid commitments in public procurement markets
Again, the contractual terms depend on the specific country supplier and MAH.
Key Takeaways
- “Combogesic IV” suppliers cannot be determined from the brand name alone; suppliers vary by country, strength, and labeled presentation.
- The authoritative supplier for an injectable is the manufacturer of record shown on the carton/vial label and the local package insert, with distribution handled by jurisdiction-specific wholesalers and tender partners.
- A defensible supplier list must be anchored to the exact jurisdiction and product registration labeling.
FAQs
- How can I identify the Combogesic IV manufacturer of record? Look at the carton and vial/ampoule label and the local package insert’s “manufacturer” section.
- Do Combogesic IV suppliers change by packaging strength? Yes, manufacturer of record and labeling can change by presentation and market registration.
- Are sterile fill-finish suppliers the same as API suppliers? Usually not; injectable manufacturing commonly uses separate API and sterile fill-finish sites.
- Who typically controls distribution to hospitals for branded IV injectables? National wholesalers and hospital tender distributors in each country.
- What documents show batch release and GMP site information? The local package insert and regulatory dossier summaries tied to the product registration.
References
(No sources cited. The prompt does not provide jurisdiction, product strength, or manufacturer-of-record label information required to produce an accurate supplier list.)
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