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Suppliers and packagers for generic pharmaceutical drug: ALBUMIN HUMAN
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ALBUMIN HUMAN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ge Healthcare | OPTISON | albumin human | INJECTABLE;INJECTION | 020899 | NDA | GE Healthcare Inc. | 0407-2707-03 | 5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03) / 3 mL in 1 VIAL, SINGLE-USE | 2002-01-02 |
| Ge Healthcare | OPTISON | albumin human | INJECTABLE;INJECTION | 020899 | NDA | GE Healthcare Inc. | 0407-2707-18 | 18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18) / 3 mL in 1 VIAL, SINGLE-USE | 2002-01-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for ALBUMIN HUMAN (Human Albumin)
Which companies supply “ALBUMIN HUMAN” for pharmaceutical use?
“ALBUMIN HUMAN” is a medicinal substance used in multiple product formats (e.g., human albumin for infusion). Supplier landscapes differ by country, regulatory approvals, and whether the buyer sources licensed medicinal product versus fractionated plasma-derived albumin starting material.
The supplier set below covers companies that are publicly active in human albumin manufacturing and supply (plasma fractionation and/or commercial albumin products), and are commonly listed as sources in global tenders and regulatory dossiers.
Global supplier set (major plasma-fractionation and albumin product manufacturers)
| Supplier | Corporate footprint | Typical supply role | Product scope (human albumin) |
|---|---|---|---|
| CSL Behring | Global | Licensed products and plasma-derived albumin supply | Human albumin for infusion and related formulations |
| Grifols | Global | Plasma-derived medicinal products | Human albumin products for clinical use |
| Octapharma | Global | Plasma fractionation and albumin product supply | Human albumin products for infusion |
| Kedrion Biopharma | Italy-based, global | Plasma-derived albumin supply | Human albumin medicinal products |
| Takeda (historical albumin footprint; varies by region) | Global | Licensed products (region-dependent) | Human albumin products where marketed |
| Sanquin / plasma fractionation ecosystem (region-dependent access via distributors) | Netherlands | Fractionation and supply network | Human albumin products through local channels |
Note: In procurement, “supplier” is often the licensed product holder or national distributor, not the fractionator. The same fractionator can be supplied under different brandings across jurisdictions.
What supplier types exist for ALBUMIN HUMAN?
| Supplier type | What they provide | Where buyers see it |
|---|---|---|
| Plasma fractionators | Human albumin bulk intermediates and/or fractionated product | Raw material supply, sourcing lists, contract manufacturing |
| Licensed medicinal product manufacturers | Finished sterile albumin infusions | Tender submissions, hospital formularies, wholesaler catalogs |
| National distributors/wholesalers | Import and distribution of approved products | Purchase orders, hospital pharmacy procurement |
| Government or regional blood-plasma systems (where applicable) | Plasma-derived products via regional frameworks | Public procurement channels |
Which product variants drive different supplier selection?
Human albumin is procured in multiple clinical presentation formats. Supplier choice often tracks the presentation and regulatory status in the buyer’s country.
| Variant dimension | Common procurement impact |
|---|---|
| Concentration (e.g., 5%, 20%) | Determines target clinical indication set and dosing protocols |
| Container type (e.g., vial/bottle/bag depending on market) | Drives supply chain packaging compatibility |
| Sterility and batch release standards | Locks to finished-product GMP release capability |
| Patient safety labeling language and traceability | Requires region-specific regulatory alignment |
| Plasma origin and fractionation process claims | Impacts tender scoring and supplier qualification |
How do buyers typically qualify suppliers for ALBUMIN HUMAN?
Qualification concentrates on regulatory and quality evidence, not marketing.
| Qualification axis | Typical evidence requested |
|---|---|
| Regulatory status | Marketing authorization in the buyer’s jurisdiction; product license holder/MAH |
| GMP compliance | GMP certificates for manufacturing sites; batch release practices |
| Plasma sourcing framework | Licensed plasma collection and traceability controls (where relevant) |
| Quality system documentation | Batch records, specifications, CoA issuance cadence |
| Pharmacovigilance | PV contact and system for adverse event reporting |
| Supply continuity | Manufacturing site capacity, lead times, and back-up sourcing |
What supplier landscape looks like by category (procurement reality)?
1) Finished medicinal product supply
Finished product suppliers are commonly:
- Plasma-derived medicinal product companies (e.g., CSL Behring, Grifols, Octapharma, Kedrion) for markets where they hold marketing authorizations.
- Local national distributors where procurement is executed through approved wholesalers.
2) Bulk/fractionated starting material supply
Bulk supply is typically sourced from:
- Plasma fractionators with contractual relationships to formulation/packaging partners.
- Contract manufacturing networks for sterile filling and labeling in specific jurisdictions.
Country-by-country supply is determinative
“ALBUMIN HUMAN” is approved and marketed differently by country. Two implications for procurement planning:
- A global manufacturer may not be the direct tender respondent in a given country.
- The “supplier” on the PO is often the distributor/MAH in that jurisdiction, while the fractionation may occur elsewhere.
Key takeaways
- Major global manufacturers supplying human albumin products include CSL Behring, Grifols, Octapharma, and Kedrion Biopharma.
- Procurement lists may show licensed product distributors or marketing authorization holders, not the plasma fractionator.
- Supplier selection depends on presentation (concentration, container format), local regulatory approval, and GMP release capability, not just corporate presence.
FAQs
1) Is ALBUMIN HUMAN supplied as bulk or as a finished drug?
It is supplied both ways in practice: some buyers source finished, sterile medicinal product for direct clinical use, while others source fractionated plasma-derived albumin for downstream processing in regulated manufacturing chains.
2) What are the main global manufacturers of human albumin products?
The main globally active suppliers in human albumin include CSL Behring, Grifols, Octapharma, and Kedrion Biopharma.
3) Why do hospital and tender “suppliers” differ from fractionators?
Tenders and hospital POs often list the local distributor or marketing authorization holder responsible for the approved product in that country, while fractionation may be performed by a parent company or partner elsewhere.
4) Does albumin concentration change the supplier list?
Yes. Procurement for different strengths (commonly 5% and 20% in many markets) often maps to different packaging SKUs, regulatory dossiers, and distribution contracts.
5) What criteria most often block a new supplier for ALBUMIN HUMAN?
The most common blockers are local marketing authorization status, site GMP compliance, and the ability to provide consistent batch release documentation (CoA) aligned to the buyer’s quality requirements.
References
[1] CSL Behring. “Products.”
[2] Grifols. “Medicines and plasma-derived products.”
[3] Octapharma. “Plasma-derived products.”
[4] Kedrion Biopharma. “Products.”
[5] European Directorate for the Quality of Medicines and HealthCare (EDQM). Human albumin monograph and related quality framework references.
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