WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Heparin sodium injection is unfractionated heparin (UFH), a hospital anticoagulant given by IV infusion, intermittent IV injection or deep subcutaneous injection, supplied in several vial and ampoule strengths and kept apart from low molecular weight heparin such as enoxaparin.

M Care Exports supplies heparin sodium injection, in regulator-registered brands and Indian-made lines, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for heparin 5,000 IU/mL vials, 25,000 IU presentations or heparin lock flush, send the destination, strength, pack and quantity, and we quote per destination.

Heparin sodium injection 5,000 units per mL single-dose vial
WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Heparin exporter and bulk supplier from India.

"We need a partner for heparin sodium injection" is a routine hospital-pharmacy or ministry tender enquiry. M Care is a merchant-exporter: we offer regulator-registered brands as well as Indian-made lines, and align each offer with your destination's registration route before quoting. Heparin is not one product. The labels we read cover plain vials at 1,000 and 5,000 units per mL, preserved and preservative-free versions, and a 10 IU/mL flush ampoule. Each is a separate line, so the quote turns on strength, vial or ampoule, preservative, quantity, the registration route and Incoterms. Heparin is also not the same as enoxaparin. Full-dose unfractionated heparin is monitored by aPTT; for the low molecular weight option see our enoxaparin page.

Source

WHO-GMP-certified Indian manufacturing line, named on every quote.

Minimum order

No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.

Pricing

On request. Indicative FOB or CIF quote, formal proforma on confirmation.

Incoterms

EXW, FOB, CIF, CIP or DAP.

Payment

Letter of credit (sight or usance) and telegraphic transfer.

Documentation

WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.

Shelf-life

Minimum remaining shelf-life agreed per order and confirmed on the proforma.

Response

Availability and CoPP status within two working days; pre-alert documents before dispatch.

Request a bulk quote → Send a bulk enquiry by form How bulk supply works
At a glance

Unfractionated heparin anticoagulant, sourced and documented for export.

Heparin sodium is an anticoagulant derived from porcine intestinal mucosa, as the US label and the UK Reig Jofre SmPC state. The US label lists prophylaxis and treatment of venous thrombosis and pulmonary embolism, prevention of postoperative DVT and PE, atrial fibrillation with embolisation, consumptive coagulopathy, clotting prevention in arterial and cardiac surgery, peripheral arterial embolism, and anticoagulant use in transfusion, extracorporeal circulation and dialysis. UK SmPCs list treatment of DVT and PE, unstable angina, acute peripheral arterial occlusion, and extracorporeal circulation and haemodialysis, with some adding prophylaxis of DVT and PE and of mural thrombosis after myocardial infarction. Routes vary by label: the Wockhardt and Panpharma SmPCs include subcutaneous use, while the Reig Jofre SmPC lists IV use only. The US label's dosage-forms section covers preservative-free 2,000 units per 2 mL and 5,000 units per 0.5 mL single-dose vials, benzyl alcohol multiple-dose vials, and paraben-containing vials at 1,000, 5,000, 10,000 and 20,000 units per mL, among others. The UK 5,000 IU/mL vials in the SmPCs we read hold 25,000 IU in 5 mL. Heparin sodium has been on the WHO Model List of Essential Medicines since 1977, as the WHO EML committee record notes.

Active ingredient

Heparin sodium (unfractionated heparin, porcine intestinal mucosa). Unfractionated heparin anticoagulant.

Forms and strengths

1,000 USP units/mL multiple-dose vial (US, paraben-containing); 5,000 IU/mL, 5 mL vial (25,000 IU per vial, UK SmPCs); 5,000 units/0.5 mL preservative-free single-dose vial (US); 10 IU/mL, 5 mL ampoule (50 IU) heparin lock flush (UK).

Indications

Heparin sodium, an unfractionated heparin anticoagulant for the prophylaxis and treatment of venous thrombosis and pulmonary embolism and other hospital uses, given IV or deep subcutaneously and monitored by aPTT in full-dose use. Supplied as regulator-registered brands and Indian-made lines, stored at room temperature, with a separate low-strength lock flush.

Administration

Intravenous, Subcutaneous. Solution for injection or concentrate for infusion (vials and ampoules).

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

India is our origin. We do not sell into the Indian market.

Buyers are hospital pharmacists, ministry of health and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for heparin 5,000 IU/mL vials for a hospital tender" or "We need a partner for heparin lock flush". Each destination has its own registration route, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting. M Care supplies both regulator-registered brands and Indian-made lines. Our catalogue includes Indian-made lines such as Beparin, Celparin and Hepfav injection, offered for destinations whose registration accepts them. We do not claim these are registered in any destination.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on heparin.

Read the presentation before the strength. Heparin comes with and without preservative. The US label says to use preservative-free heparin in neonates and infants because benzyl alcohol products have been linked to fatal gasping syndrome, and the UK Panpharma SmPC states its 5,000 IU/mL vial contains 10 mg/mL benzyl alcohol and is contraindicated in neonates and children up to 3 years. Dosing is guided by aPTT, not a fixed schedule: the UK SmPCs aim for 1.5 to 2.5 times the control midpoint in full-dose treatment and the US label treats an aPTT of 1.5 to 2 times normal as adequate. Check platelets for HIT; the US label says HIT can occur up to several weeks after stopping. For overdose the labels describe protamine, about 1 mg per 100 units of heparin, given slowly, with no more than 50 mg in a single bolus in the UK SmPCs or in any 10-minute period on the US label, and the US label warns of fatal reactions resembling anaphylaxis. Do not give heparin intramuscularly. Storage is simple: the US label says 20 to 25 °C, the UK SmPCs say no special conditions or not above 25 °C, and the Reig Jofre and Panpharma SmPCs add do not freeze. This is not a cold-chain product, so no refrigerated freight line is needed.

Regulatory & quality

The documentation pack a regulator actually asks for.

Heparin is a room-temperature injectable: the US label states 20 to 25 °C and the UK SmPCs state no special storage or not above 25 °C, with the Reig Jofre and Panpharma SmPCs adding do not freeze. Unopened shelf lives differ by product, for example 4 years for the Reig Jofre 5,000 IU/mL vial, 5 years for the Panpharma vial, and 3 years for the Wockhardt 5,000 IU/mL product and the 10 IU/mL flush. Check remaining shelf life on arrival. Marketing authorisations sit with several companies. On emc, Wockhardt UK holds PL 29831/0107 for heparin sodium 5,000 IU/mL, also listed as Monoparin, and PL 29831/0112 for the 10 IU/mL flush, listed as Hepsal; Reig Jofre UK and Panpharma hold separate 5,000 IU/mL products. US labels come from several labelers, for example Cardinal Health. Because heparin is a multi-source medicine, buyers choose by manufacturer and presentation rather than by one reference brand. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it. We state each manufacturer's quality status per line before quoting, and make no claim for M Care itself beyond merchant-exporter documentation.

CoA and MoA, per batch

Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.

CoPP, WHO-GMP, MFG licence

Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.

CTD Module 3

Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.

Pack insert, labels, artwork

Destination-language patient information and labelling to the local regulator's standard, locked before shipment.

Pharmacovigilance

A named PV contact arranged in the destination market where the registration requires one.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for heparin.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Heparin supply, the specific questions.

What decides the price of heparin injection for an importer, for example in Nigeria?

We do not publish prices. The landed cost of heparin sodium injection depends on whether you want a regulator-registered brand or an Indian-made line, the strength (for example 5,000 IU/mL or 25,000 IU per vial), vial or ampoule, preserved or preservative-free, quantity, the registration route at the destination, and Incoterms. Heparin is stored at room temperature, so there is no cold-chain freight line. M Care Exports quotes per destination, including Nigeria, once you send the strength, pack, volume and country.

What is heparin sodium injection used for?

Heparin sodium injection is an anticoagulant used in hospitals. The US label lists prophylaxis and treatment of venous thrombosis and pulmonary embolism, atrial fibrillation with embolisation, consumptive coagulopathy, clotting prevention in arterial and cardiac surgery, peripheral arterial embolism, and anticoagulation in transfusion, extracorporeal circulation and dialysis. UK SmPCs also list unstable angina and acute peripheral arterial occlusion. Indications differ by label, so a buyer should match the product to the destination's registered text.

What is the usual heparin injection dose?

Dose is set by the prescriber and adjusted by laboratory monitoring, not by a fixed schedule. As examples from the US label, a continuous infusion starts with a 5,000 unit IV injection then 20,000 to 40,000 units over 24 hours, and low-dose prophylaxis is 5,000 units subcutaneously 2 hours before surgery, then every 8 to 12 hours. UK SmPCs adjust the dose to keep aPTT at 1.5 to 2.5 times the control midpoint, with daily monitoring in full-dose treatment. This is label information for buyers, not dosing advice.

What is the heparin injection route and where is it injected?

The route depends on the label. The US label gives continuous IV infusion, intermittent IV injection and deep subcutaneous injection, and says to avoid intramuscular use. The Wockhardt and Panpharma UK SmPCs list IV infusion, IV injection and subcutaneous injection, while the Reig Jofre SmPC lists IV use only and states heparin should not be given intramuscularly. A heparin lock flush is a separate low-strength product for catheter patency, not for systemic use. Buyers should match the route to the registered label.

What are the side effects and the main safety warning for heparin injection?

The main labelled risks are bleeding from excessive anticoagulation and heparin-induced thrombocytopenia (HIT). The US label says to stop heparin and evaluate for HIT if platelets fall or thrombosis recurs, that HIT can occur up to several weeks after stopping, and it contraindicates heparin after prior HIT. Protamine, about 1 mg per 100 units of heparin and no more than 50 mg at a time, is described for overdose. For the full adverse reaction list, use the current label of the product you buy.

Can heparin injection be used in pregnancy, and is it the same as enoxaparin?

The Wockhardt and Panpharma UK SmPCs state heparin does not cross the placenta or enter breast milk, and the Wockhardt text says to stop at the onset of labour. The US label says published reports show no increased risk of adverse maternal or fetal outcomes and recommends a preservative-free product. The Panpharma SmPC advises avoiding its benzyl alcohol product in pregnancy. Heparin is also not enoxaparin: heparin sodium is unfractionated and monitored by aPTT in full-dose use, while enoxaparin is a low molecular weight heparin. For that product see our enoxaparin page.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.

This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.

Heparin enquiry

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Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.

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