Suppliers and packagers for generic pharmaceutical drug: albumin human

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

Suppliers for ALBUMIN HUMAN (Human Albumin)

Last updated: April 25, 2026

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.