Human albumin (5% / 20% / 25%) — Indian EU-GMP supply for NHS, GCC and African ICU programmes.
Plasma-derived oncotic expander, fractionated by Cohn cold-ethanol from pooled human plasma with double viral-inactivation (pasteurisation + solvent-detergent). 5%, 20% and 25% solutions in 50ml, 100ml, 250ml and 500ml glass bottles from Indian EU-GMP-aligned fractionation partners. NHS shortage-cover available via the MHRA Specials route; GCC ICU tender + transfusion-services supply; African public-sector procurement against country-level fractionation-product tenders.
EU-GMP partner fractionation lines · 5% / 20% / 25% solutions · 50ml / 100ml / 250ml / 500ml glass bottles · CTD dossier on file · double viral-inactivation validated.
Active ingredient
Human serum albumin, fractionated by Cohn cold-ethanol fractionation method from pooled human plasma (donor source: voluntary unpaid donations per WHO recommendation, IPPF/PPTA member fractionators). Viral-inactivation pathway: pasteurisation at 60°C for 10 hours + solvent-detergent treatment. Final product is ≥96% pure albumin with regulated traces of alpha- and beta-globulin; sodium content controlled to ~145 mmol/L (isotonic with plasma); sodium octanoate stabiliser; aluminium content <200 µg/L.
Strengths stocked
5% solution (isotonic, plasma volume expander): 250ml (12.5g) and 500ml (25g) glass bottles for hypovolaemic shock + plasma-exchange replacement. 20% solution (hyperoncotic, low-volume): 50ml (10g) and 100ml (20g) for severe hypoalbuminaemia + cirrhosis paracentesis + SBP. 25% solution (hyperoncotic, low-volume): 50ml (12.5g) and 100ml (25g) for burns resuscitation + nephrotic syndrome + neonatal exchange transfusion. Glass bottle with halobutyl rubber stopper + aluminium overseal.
Indications
Hypovolaemic shock; severe hypoalbuminaemia with overload; large-volume paracentesis in cirrhosis; SBP adjunct; HRS; burns resuscitation post-24h; therapeutic plasma exchange replacement; ARDS with hypoalbuminaemia (selected); cardiopulmonary bypass priming; severe nephrotic syndrome refractory oedema. WHO EML core. Standard adult bolus 100-200ml of 20% over 30-60 min; cirrhosis paracentesis 8g per L of ascites removed.
Storage
2-25°C, do NOT freeze. Frozen albumin is denatured (precipitate visible on thaw); discard if frozen. Solution should be clear amber to faintly opalescent; discard if cloudy, with sediment, or showing colour change. Once opened, use within 4 hours (no preservative). Standard ambient-temperature dispatch lane in hot climates needs hot-tail control; cold-tail (freeze) is the catastrophic excursion.
Shelf life
36 months from manufacture; minimum 24 months at dispatch. Or we won't ship it.
Pack format
Single bottle per carton, hospital pack. Type-I clear/amber glass bottle, halobutyl rubber stopper, aluminium overseal with flip-off cap. Outer carton and leaflet in destination-regulator language. Plasma-derived viral-inactivation chain documentation + donor traceability (anonymised lot-to-donor pool reference) on the pack insert per WHO guideline. Theoretical vCJD risk warning per regulator-specific labelling (UK MHRA, EU EMA, FDA) — UK regulator-specific donor-exclusion criteria followed.
Hospital pharmacies, ICUs, transfusion services and tender desks across thirty markets.
India is our origin. We do not sell into the Indian market. Human albumin is exported only.
United Kingdom
Albumin has been on the MHRA shortage register periodically (most notably 2022-2023 global supply disruption from the US plasma-collection downturn during COVID-19). NHS hospital pharmacies and Blood Transfusion services use the MHRA Specials / named-patient import route during shortage windows — see MHRA Specials. NHS Blood and Transplant SaBTO viral-safety standards alignment documented in our pre-dispatch pack. UK-specific donor-exclusion criteria (vCJD historical context) followed by the partner fractionator.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH ICU + transfusion-services tender awards (NUPCO and Saudi MoH for KSA — King Faisal Specialist Hospital and SEHA major buyers; MoHAP, DHA and DOH Abu Dhabi for UAE; Kuwait MoH; MoPH Qatar including Hamad Medical Corporation; MoH Oman; NHRA Bahrain). Cardiopulmonary bypass priming + burns resuscitation tender lots are particularly high-volume given regional cardiac surgery and burns programmes. SFDA, MoHAP and GCC central registration supported with full CTD dossier including viral-inactivation validation report.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania
Public-sector hospital tenders (NAFDAC for Nigeria, KEMSA + MEDS for Kenya, FDA Ghana + Central Medical Stores, SAHPRA for South Africa, EFDA + EPSS for Ethiopia, TMDA + MSD for Tanzania) and teaching-hospital ICU + transfusion-services supply. Africa CDC, donor-funded liver-disease programmes and humanitarian burns-care procurement (MSF, IRC, IFRC) source through Indian fractionation partners under WHO + EU-GMP standards.
Germany, France, Brazil, Mexico, Philippines
Supply via licensed importers under §72 AMG (Germany, with QP certification on EU arrival per fractionation-product regulatory pathway), ANSM equivalent (France), ANVISA (Brazil), COFEPRIS (Mexico), FDA Philippines. EMA fractionation-product regulatory pack covers donor-source documentation, viral-inactivation validation, and batch-traceability per EMA/CHMP/BWP guidance for human plasma-derived products.
5% vs 20% vs 25% indication discipline, no freeze, slow infusion in elderly, theoretical viral-residual risk — albumin is high-yield in the right indication and dangerous in the wrong one.
5% solution is iso-oncotic plasma volume expander: hypovolaemic shock, plasma exchange. 20% / 25% are hyperoncotic, low-volume: severe hypoalbuminaemia + fluid overload, cirrhosis paracentesis (8g per L of ascites removed; replace 6-8L), SBP (1.5 g/kg day 1 + 1 g/kg day 3 reduces HRS incidence per Sort et al), burns resuscitation post-24h after capillary leak normalises (NOT in first 24h — Parkland with crystalloid only). Speed of infusion: standard 1-2 ml/min for 5%, 1 ml/min for 20%/25%; faster rates risk circulatory overload especially in elderly and renal-impaired. Cardiac failure with overload is the major adverse event: 25% albumin draws ~3-4 ml of interstitial fluid into the vasculature per ml infused; left-ventricular failure can develop within hours. Monitor JVP, oxygen saturation, urine output; have furosemide ready. Hypersensitivity reactions are rare but documented (anaphylaxis ~1 in 10,000 patients); pre-medication is not standard but vigilance is. Aluminium content: chronic high-dose albumin in renal-impaired patients can cause aluminium accumulation; spec is <200 µg/L. No mixing: do not co-administer albumin with red blood cells, hydrolysates, alcohol-containing solutions, or carbohydrate-rich preparations through the same line. Pregnancy: albumin is safe in pregnancy and breastfeeding; first-line for severe pregnancy-induced hypoalbuminaemia. Theoretical vCJD risk: pasteurisation + solvent-detergent reduces but does not eliminate prion theoretical risk; UK donor-exclusion criteria followed by partner fractionator. Cost-effectiveness debate: SAFE study (NEJM 2004) showed no mortality benefit over saline in general ICU resuscitation; ALBIOS (NEJM 2014) showed targeted hypoalbuminaemia correction is beneficial in severe sepsis. Use against indication, not as default volume expander.
The documentation pack a regulator actually asks for — fractionation-product chain is more demanding than small-molecule.
Human albumin is a plasma-derived biological. Donor source documentation, viral-inactivation validation, and batch-traceability are regulatory-critical and far beyond a small-molecule generic. Our role is manufacturer-facing — we sit between the Indian EU-GMP-aligned fractionation partner and your clinical, regulatory or procurement team.
CTD Module 3 + plasma-derived dossier annex
Full chemistry, manufacturing and controls section per ICH Q5A-Q5E and EMA fractionation-product guidelines (CHMP/BWP for plasma-derived products). Plasma master file (PMF) documenting donor source, donation centre standards, NAT and serology screening (HIV-1/2, HBV, HCV, HAV, HEV, syphilis), donor-exclusion criteria (vCJD UK-specific lookback, Zika, HEV in EU). Viral-inactivation validation report per CHMP/BWP/268/95 — pasteurisation 60°C × 10h for HIV/HBV/HCV/HAV/HEV, solvent-detergent for enveloped viruses.
CoA and MoA, per batch
Albumin assay (≥96% by cellulose acetate electrophoresis), pH, sodium content (~145 mmol/L), potassium, aluminium (<200 µg/L), pyrogenicity (rabbit + LAL), sterility, sodium octanoate stabiliser confirmation, prekallikrein activator, aggregates by SEC-HPLC, pre-albumin / alpha-globulin / beta-globulin profile by electrophoresis — signed by the manufacturer's authorised QC head.
CoPP, EU-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. EU-GMP certificate from the partner fractionation facility (PIC/S inspection report where available); plasma master file approved by the destination authority for fractionation-product registration.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards. Theoretical vCJD risk warning per UK MHRA + EU EMA + FDA fractionation-product labelling. Donor source acknowledgement (voluntary unpaid). Speed-of-infusion guidance. Indication-specific discipline (5% vs 20% vs 25%). Storage warning (do not freeze).
Temperature control
Pre-shipment validation on each shipper configuration. Glass-bottle ships at 2-25°C ambient with hot-tail control in summer dispatch; cold-tail (freeze) is catastrophic excursion mode — frozen albumin is denatured. Active-cooled containers for trans-continental summer dispatches; passive PCM coolers for shorter lanes. Excursion protocol covers both tails with explicit freeze-discard rule.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C plus the fractionation-product traceability requirement (every adverse event must reference the specific donor-pool lot for theoretical viral-residual investigation). Hypersensitivity / anaphylaxis, circulatory overload (LVF, pulmonary oedema), and any window-period viral seroconversion in recipients (theoretical residual risk despite pasteurisation + S/D) remain the PSUR priority signals.
Plasma-derived + recombinant biological cluster.
Albumin sits in the fractionation-product family alongside IVIg, anti-D immunoglobulin, factor concentrates, and the recombinant biosimilar cluster (EPO, G-CSF, mAb biosimilars).
IVIg
Intravenous immunoglobulin, fractionated. 1g, 2.5g, 5g, 10g vials. Multiple indications.
Erythropoietin biosimilars
Epoetin alfa / beta + darbepoetin biosimilars. CKD anaemia + chemotherapy-induced anaemia.
Filgrastim / pegfilgrastim
G-CSF biosimilars. Neutropenia prevention + stem-cell mobilisation.
Rituximab
Anti-CD20 mAb biosimilar. NHL / CLL / RA / ANCA vasculitis.
All haematology / biologicals →
70+ haematology + biological SKUs: fractionation, biosimilars, transfusion, factor concentrates.
Vaccines →
Public-sector vaccine supply — DPT, MMR, BCG, conjugates, donor-funded.
Strength · volume · destination. One working day to a quote.
- Send us the specifics. Concentration (5% / 20% / 25%), bottle size (50ml / 100ml / 250ml / 500ml), bottle count, destination, NHS hospital pharmacy / GCC ICU + transfusion-services tender / African public-sector / NGO supply / donor-funded liver-disease programme. Flag if plasma master file documentation, viral-inactivation validation report, or vCJD-risk warning compliance set is needed for the receiving formulary committee.
- We route to the right line. Multiple EU-GMP-aligned fractionation partner facilities on the M Care roster. Partner selection driven by destination registration status + plasma source compatibility (some destinations restrict to specific plasma origins). Registered-market preference goes to facilities already holding the destination plasma master file approval.
- Commercial and regulatory offer. FOB / CIF price (fractionation-product pricing reflects upstream donor source cost + downstream viral-inactivation), lead time (fractionation cycle is 6-9 months minimum), plasma master file status per destination, viral-inactivation validation, batch-traceability lot-to-donor reference, and the documentation pack. Inside one working day for stock-on-hand; longer for made-to-order.
- Order, produce, release, ship. QC release on the Indian fractionation side. Glass-bottle dispatch 2-25°C with hot-tail summer control + freeze-discard rule on cold-tail. In-transit temperature logging, on-arrival inspection (inspect every bottle for clarity — discard cloudy / sedimented / colour-changed product). Photo evidence of seal integrity on request.
- After delivery. Batch records, CoA, MoA, plasma master file extract for the donor-pool lot, viral-inactivation validation summary, and thermal logs archived for the full shelf life. PV contact opened on registration with fractionation-product traceability per EU EMA + FDA + MHRA requirement; hypersensitivity reactions, circulatory overload, and theoretical viral-residual events remain the PSUR priority signals.
Human albumin supply — the specific questions.
What concentrations and bottle sizes of human albumin do you supply?
5% (iso-oncotic plasma volume expander): 250ml (12.5g) and 500ml (25g) glass bottles. 20% (hyperoncotic, low-volume): 50ml (10g) and 100ml (20g). 25% (hyperoncotic, low-volume): 50ml (12.5g) and 100ml (25g). Type-I clear/amber glass bottle, halobutyl rubber stopper, aluminium overseal with flip-off cap. Single bottle per carton, hospital pack. The 20% / 25% are the highest tender-volume strengths globally for cirrhosis paracentesis + SBP + severe hypoalbuminaemia + burns resuscitation; 5% covers hypovolaemic shock + plasma exchange.
What's the viral-inactivation pathway for your albumin?
Standard double inactivation per CHMP/BWP/268/95: pasteurisation at 60°C for 10 hours (effective against HIV-1/2, HBV, HCV, HAV, HEV, parvovirus B19) plus solvent-detergent treatment (effective against enveloped viruses, complementary kinetics to pasteurisation). Donor-source screening: NAT and serology for HIV-1/2, HBV, HCV, HAV, HEV, syphilis on every donation; donor-exclusion criteria including vCJD UK-specific lookback, Zika exposure, HEV high-prevalence region. The validation report (CHMP/BWP/268/95 format) is included in the destination registration pack and shipping documentation.
Can you supply albumin against MHRA shortage cover for the UK?
Yes. Albumin has been on the MHRA shortage register periodically — most notably 2022-2023 global supply disruption from the COVID-19-related US plasma-collection downturn. NHS hospital pharmacies and Blood Transfusion services use the MHRA Specials / named-patient import route during these shortage windows. M Care prepares the manufacturer-side Special-form documentation pack (EU-GMP certificate from the fractionation partner, plasma master file extract, viral-inactivation validation, batch CoA + MoA, CoPP, pack insert with vCJD risk warning) so the importing UK pharmacy's Responsible Person can complete the import notification without paperwork delay. Air-freight from Mumbai to a UK bonded warehouse runs 4-6 days once the Special form is signed (longer than small-molecule because of additional viral-safety documentation).
Which markets can you ship human albumin into?
The UK (NHS hospital pharmacy supply, MHRA-aligned, MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — ICU + cardiopulmonary bypass + transfusion services tender channel — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania) for tender + donor-funded liver-disease programmes, Egypt and Jordan on the Levant side, Germany under §72 AMG with QP certification on plasma-derived products, France under ANSM, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). We do not supply into India. Full market coverage is at markets.
What documentation is included with a human albumin consignment?
Every consignment ships with a batch-specific Certificate of Analysis (albumin assay, pH, sodium, potassium, aluminium, pyrogenicity, sterility, sodium octanoate stabiliser, prekallikrein activator, aggregates by SEC-HPLC, electrophoresis profile), Method of Analysis, plasma master file extract for the donor-pool lot, viral-inactivation validation summary (CHMP/BWP/268/95 format), Certificate of Pharmaceutical Product (CoPP), EU-GMP certificate from the fractionation partner, manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert with vCJD-risk warning + speed-of-infusion guidance + storage warning (do-not-freeze), and temperature logs from pre-dispatch through on-arrival. Fractionation-product PV contact nominated on registration.
Do you provide CTD dossiers for human albumin registration?
Yes. Full CTD Module 3 + plasma-derived dossier annex per EMA CHMP/BWP guidance is available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. Plasma master file (PMF) documenting donor source + donation centre standards + NAT/serology screening + donor-exclusion criteria is the gating regulatory document for fractionation-product registration; the fractionation partner facility holds active PMFs across multiple destinations. Lead time on a fractionation-product dossier against a new registration is typically 12-16 weeks given complexity. See dossier preparation.
What are typical lead times for albumin orders, and what's the cold-chain requirement?
Fractionation manufacturing is a 6-9 month upstream cycle (from plasma pool aggregation through Cohn fractionation through viral inactivation through filling), so made-to-order batches require advance planning. For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (NUPCO, KEMSA, NDOH South Africa, donor-funded programmes), the lead time is set in the tender award document. For UK NHS hospital pharmacy ad-hoc shortage cover with urgency flagged, air-freight from Mumbai can be on a flight within 4-6 days of MHRA Special form signature. Glass-bottle dispatch is 2-25°C ambient with hot-tail summer control + freeze-discard rule on cold-tail. Frozen albumin is denatured and must be discarded — the cold-tail excursion protocol is the gating QA step on every consignment.
Send the specifics. You'll have a price inside one working day.
Concentration (5% / 20% / 25%), bottle size (50ml / 100ml / 250ml / 500ml), bottle volume, destination, NHS hospital pharmacy / GCC ICU tender / African public-sector / donor-funded liver-disease programme / NGO, target delivery, plasma master file documentation if required. That's the enquiry. Everything else is on us.