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Recombinant Human Albumin

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Recombinant Human Albumin

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Recombinant Human Albumin
Generic Name (API): Recombinant human serum albumin (Oryza sativa, rice-derived; OsrHSA)
Dosage Form & Strength: 10 g / 50 mL (20%)
Route: Intravenous (IV) infusion
Drug Class: Recombinant human serum albumin (plasma volume expander)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Recombinant Human Albumin Used For?

This is the first human albumin made without blood plasma. Wuhan Healthgen Biotechnology in China grows it in specially bred rice (Oryza sativa) that carries the human albumin gene, then extracts and purifies the protein. In China it is sold as 奥福民® under the official name 重组人白蛋白注射液(水稻), "recombinant human albumin injection (rice)". In research papers it is called OsrHSA.

China's National Medical Products Administration (NMPA) approved it in July 2025, after priority review, for one use:

  • Low blood albumin in liver cirrhosis (hypoalbuminaemia, serum albumin of 30 g/L or less)

It is a hospital liver medicine, given as a drip under a hepatologist or gastroenterologist.

How It Works

Albumin is the main protein in blood. It holds fluid inside the blood vessels and carries many substances around the body. In cirrhosis the liver makes too little of it, which adds to fluid build-up in the belly (ascites) and swelling. A drip of albumin raises the level in the blood. Healthgen reports that its rice-made albumin has the same crystal structure as the human protein, a purity of over 99.9999%, and, because no plasma is used, no risk of passing on blood-borne infections.

What the Trials Showed

In the phase 2 trial published in Gut in 2025, 220 people with decompensated cirrhosis and albumin of 30 g/L or less received 10 g or 20 g a day for up to two weeks. 76% of those on the rice-made albumin reached a level of 35 g/L, compared with 75.6% on plasma-derived albumin, which met the non-inferiority goal, and there were no drug-related serious side effects.

In the phase 3 trial, as summarised in China's drug review report, 326 patients received 20 g a day. 90.24% reached 35 g/L, against 95.68% with plasma-derived albumin, which was within the pre-set non-inferiority margin. Both groups took a median of 7 days to get there, and changes in ascites depth and blood osmotic pressure were similar.

Recommended Dosage

  • Given as an intravenous drip; the doctor sets the dose and speed according to how severe the illness is and how much protein is being lost
  • Drip slowly for the first 15 minutes while the patient is watched
  • In people with normal blood volume, usually no faster than 2 mL per minute
  • There are no data for giving 20 g a day for more than 14 days in a row

In the trials, patients received 10 g or 20 g once a day (one or two 50 mL bottles), until albumin reached the target or for up to two weeks.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

Allergic reactions: it must not be used by anyone allergic to the active ingredient or any other ingredient, or with a past allergy to human albumin. Vital signs, urine output and blood tests are watched closely during the drip, because allergic reactions, including anaphylactic shock, can happen.

  • Fluid overload: this is a concentrated (20%) solution that pulls fluid into the blood. Large doses or a fast drip can overload the circulation. If breathlessness or signs of fluid on the lungs appear, the drip is stopped at once.
  • Hydration and salts: the patient must be kept properly hydrated, and blood salts such as potassium are checked as needed.
  • Heart, blood pressure and anaemia: use with care in people with poorly controlled heart failure, high blood pressure or severe anaemia.
  • Kidney problems: the doctor weighs benefits and risks in kidney impairment.

Side effects in the trials: each was uncommon. They included lower platelet counts (2.7%), protein in the urine (2.7%), low potassium (2.7%), low white cell and neutrophil counts (2.4% each), anaemia (2.4%), raised bilirubin (1.8%), itching (1.8%), allergic reactions (1.8%) and a longer QT interval on the ECG (1.2%). In 676 patients in the ongoing post-approval study, allergic reactions (1.48%) and fever (1.04%) were the most common. Safety in pregnancy, breastfeeding and children is not covered in the published summary, so discuss this with your doctor.

How to Access Recombinant Human Albumin in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant, cold-chain conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation & Availability

What documents are required to import Recombinant Human Albumin to India?

The injection can be imported only in the patient's name, by the patient or a government hospital, in line with India's import regulations for unapproved medicines. You will need:

  • A valid prescription from a qualified hepatologist or gastroenterologist
  • Diagnostic reports confirming liver cirrhosis, with a recent serum albumin result
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Recombinant Human Albumin available in India?

No. This rice-derived albumin is approved only in China. It has no CDSCO approval and is not sold in Indian pharmacies. It is not approved by the US FDA or the European Medicines Agency either; the company reports that a phase 3 trial is under way in the United States.

Patients can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription. For hepatitis C, one of the common causes of cirrhosis, see our page on Alfosbuvir.

It can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.

Sourcing & Delivery

NamedPatientProgram.com (NPP) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients, doctors, and hospitals under applicable legal provisions. Each bottle holds 10 g of albumin in 50 mL (20%). The bottles must be kept at 2°C to 8°C and protected from light, so they travel under temperature-controlled shipping directly to the treating hospital. Quantities are planned from the dose your doctor prescribes. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For the current cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability Across Major Cities in India

Patients across India can access this medicine through regulated import pathways, with delivery arranged to the treating hospital on a valid specialist's prescription.

Delhi

Large liver institutes in Delhi treat cirrhosis patients from all over North India, and the short distance from our New Delhi base helps keep the cold chain tight.

Mumbai

Bottles are delivered refrigerated to the hospital pharmacy, ready for the infusion schedule set by the hepatologist.

Bangalore

Hepatologists in Bangalore can request it for a named patient, with the quote shared before anything is ordered.

Chennai

Liver units in Chennai can send us the prescription and albumin report to begin a cold-chain import.

Hyderabad

We plan the number of bottles around the daily dose so the course is not interrupted.

Kolkata

Shipments to Kolkata and eastern India are routed to stay between 2°C and 8°C all the way.

Pune

Hospitals in Pune can use the same documented import route, with updates at every stage.

Ahmedabad

Gastroenterologists in Ahmedabad can coordinate access for in-patients with cirrhosis and low albumin.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, delivering to the treating hospital.

Jaipur

Hospitals in Rajasthan can receive refrigerated supply once the patient's documents are checked.

Lucknow

We coordinate cold-chain delivery to public and private liver units across Uttar Pradesh.

Kochi

Hospitals in Kochi and across Kerala can receive the bottles in temperature-controlled packaging.

Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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