Calcium gluconate 10% injection, Indian WHO-GMP supply for emergency, ICU and obstetric procurement.
The preferred parenteral calcium salt for peripheral lines, less vein-irritant than calcium chloride. Frontline for acute hypocalcaemia, membrane stabilisation in hyperkalaemia, magnesium-sulfate toxicity in obstetrics, calcium-channel-blocker overdose and hydrofluoric-acid burns. A 10 ml ampoule of 10% w/v (100 mg/ml) carries 1 g calcium gluconate, about 2.2 mmol of elemental calcium. A WHO Essential Medicines List item supplied from Indian WHO-GMP-certified manufacturers, in wholesale and tender volumes. M Care is an exporter, not a manufacturer, and we say so plainly.
WHO-GMP partner lines · 10% w/v (100 mg/ml) 10 ml ampoule · CoPP and CTD dossier on file · wholesale and tender volumes · exporter, not manufacturer.
Active ingredient
Calcium gluconate, the parenteral calcium salt of choice for peripheral venous access because it is markedly less irritant than calcium chloride. Supplied as a 10% w/v aqueous solution (100 mg/ml). M Care supplies from Indian WHO-GMP-certified manufacturers and does not manufacture itself. The higher-solubility calcium glucono-galacto-gluconate and calcium lactate-gluconate salt forms are sourced on request for markets that specify them.
Strength and calcium content
10% w/v (100 mg/ml) is the universal injectable strength. A 10 ml ampoule contains 1 g of calcium gluconate, approximately 2.2 mmol (about 90 mg, 4.5 mEq) of elemental calcium. This elemental-calcium figure is the number a prescriber works from, and it is why calcium gluconate and calcium chloride are not interchangeable millilitre-for-millilitre.
Indications
Acute symptomatic hypocalcaemia (tetany, carpopedal spasm, seizures, prolonged QT); cardiac membrane stabilisation in hyperkalaemia with ECG changes; magnesium-sulfate toxicity in pre-eclampsia and eclampsia; calcium-channel-blocker and beta-blocker overdose; citrate-induced hypocalcaemia in massive transfusion and apheresis; hydrofluoric-acid burns. A core emergency, ICU, obstetric and toxicology agent.
Administration
Slow intravenous injection or dilute infusion. Preferred over calcium chloride for peripheral lines, but extravasation still risks tissue necrosis and calcinosis, so a secure line and slow rate are essential. Rapid injection causes hypotension, bradycardia and arrhythmia. Do not co-administer in a line with bicarbonate or phosphate. Caution in digitalised patients.
Storage
Store below 25-30°C; do not refrigerate or freeze, as cooling can crystallise the solution. Protect from freezing in transit. Clear, colourless solution, discard if cloudy or crystallised. Standard ambient dispatch lane, no cold-chain required, which keeps freight straightforward for high-volume tender orders.
Pack format and shelf life
Type-I clear glass ampoule, 10 ml, hospital packs of 5, 10 or 50. Destination-language carton and leaflet. Shelf life typically 24-36 months from manufacture, minimum 18 months at dispatch, or we will not ship it. Ampoule snap-ring or OPC scoring to destination standard.
Hospital pharmacies, emergency departments, ICUs, obstetric units and central medical stores.
India is our origin. We do not sell into the Indian market. Calcium gluconate is exported only.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
A high-volume emergency and ICU formulary line, procured through licensed local importers against MoH and central-store tenders (NUPCO and SFDA in Saudi Arabia; MoHAP, DHA and DoH Abu Dhabi in the UAE; Kuwait MoH Central Drug Store; MoPH Qatar; MoH Oman; NHRA Bahrain). Full CTD dossier for MoH registration and GCC central registration.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda
Public-sector and teaching-hospital procurement through the central medical stores and regulators (NAFDAC, KEMSA and MEDS, FDA Ghana and CMS, SAHPRA, EFDA and EPSS, TMDA and MSD, NDA and NMS). An essential-medicines commodity with constant emergency, maternal-health and ICU demand, and a natural fit for donor and NGO pooled procurement.
United Kingdom and Europe
Supplied through licensed importers; in the UK the MHRA Specials / named-patient route covers shortage and unlicensed-supply situations for this emergency staple. Ph.Eur.-grade product, QP certification on EU arrival, CoPP and CTD prepared for BfArM, ANSM and comparable bodies.
Latin America and ASEAN
Brazil (ANVISA), Mexico (COFEPRIS), and ASEAN markets (Philippines FDA, Vietnam DAV, Malaysia NPRA) through licensed importers, against hospital and public-health tenders. CTD dossier and CoPP prepared for destination-body recognition. M Care does not hold US FDA or TGA registration for this molecule, confirm the regulatory route on enquiry.
Elemental calcium, not millilitres; line safety; the bicarbonate and digoxin traps.
Calcium gluconate 10% delivers about 2.2 mmol of elemental calcium per 10 ml ampoule (1 g of the salt), roughly a third of the elemental calcium in the same volume of 10% calcium chloride, so the two salts are never substituted millilitre-for-millilitre. In symptomatic hypocalcaemia a typical adult dose is 10-20 ml of 10% by slow IV over about 10 minutes, repeated or followed by an infusion against serial ionised-calcium checks. In hyperkalaemia with ECG changes, calcium gluconate stabilises the myocardium within minutes but does not lower serum potassium, it buys time while insulin-dextrose, salbutamol and definitive potassium removal take effect, and the dose may be repeated if ECG changes persist. In magnesium-sulfate toxicity during eclampsia management it is the standard antidote for respiratory or cardiac depression. Calcium gluconate is preferred over calcium chloride for peripheral administration because it is far less irritant, but extravasation still causes tissue necrosis and calcinosis cutis, so use a free-flowing secure line, give slowly, and stop immediately on any pain or swelling at the site. Rapid IV injection can precipitate hypotension, bradycardia, vasodilatation and arrhythmia. Two classic incompatibility traps: do not mix calcium with sodium bicarbonate or phosphate in the same line or bag (calcium carbonate / calcium phosphate precipitation), and use extreme caution in patients on digoxin, where calcium potentiates digitalis toxicity and can trigger fatal arrhythmia, give very slowly with cardiac monitoring or avoid. For hydrofluoric-acid burns, calcium gluconate gel, infiltration or intra-arterial infusion neutralises the fluoride ion and is a recognised antidote under specialist toxicology guidance. Storage matters operationally, the solution should be kept below 25-30°C and not refrigerated, since cooling can crystallise it, so it ships and stores as an ambient line rather than a cold-chain one.
The documentation pack a regulator actually asks for.
Calcium gluconate is a WHO Essential Medicines List item supplied from Indian WHO-GMP facilities. Our role is manufacturer-facing, we sit between the WHO-GMP plant and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls section in eCTD-ready format where the importing authority accepts it, Module 2 quality overall summary included. Sterile small-volume parenteral process and container-closure integrity documented.
CoA and MoA, per batch
Assay, related substances and limit tests per Ph.Eur./USP, pH, clarity and colour of solution, particulate matter, bacterial endotoxin and sterility, signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (India) and apostilled where the destination requires it, notarised copies in the shipping pack. M Care does not hold US FDA or TGA registration for this molecule, confirm the regulatory route on enquiry.
Pack insert, labels, artwork
Destination-language leaflet and labelling to local standards, carrying the slow-IV administration instruction, the bicarbonate and phosphate incompatibility warning, the digoxin-potentiation caution and the extravasation warning. Artwork QC before print, not after.
Stability and condition control
Zone IVb stability data for hot-climate markets. Ambient dispatch with a do-not-freeze instruction, since crystallisation on cooling is the main transit risk for this product, condition logs from dispatch to arrival.
Pharmacovigilance
Named PV contact organised in the destination market against registration, PSURs to ICH E2C. Hypercalcaemia on overdose, injection-site reactions and extravasation injury, and arrhythmia in digitalised or rapidly-injected patients remain the priority signals.
The emergency and ICU electrolyte and resuscitation shelf.
Calcium gluconate rarely travels alone on a tender. Emergency and ICU buyers pair it with the rest of the electrolyte, resuscitation and antidote shelf.
Anaesthesia & ICU range →
Electrolytes, sedatives, neuromuscular blockers, vasopressors, resuscitation and antidote lines for critical-care and theatre tenders.
Cardiovascular →
Antiarrhythmics, antihypertensives, heart-failure and anticoagulation therapy, the cardiology and coronary-care shelf.
Anti-infectives →
Injectable antibiotics and antifungals for ICU and surgical-prophylaxis tenders, broad-spectrum and reserve agents.
Full portfolio →
Eighteen therapeutic categories across injectables, orals, biologicals and surgical consumables, exported to forty-nine markets.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (10% w/v), ampoule size (10 ml), pack format, quantity, destination, and channel: hospital or ICU tender, central medical store, donor or NGO programme, or importer stock. Flag if the calcium glucono-galacto-gluconate or lactate-gluconate salt form is specified.
- We route to the right line. Multiple WHO-GMP calcium gluconate lines on the M Care roster, matched to the destination's regulatory and pharmacopoeial requirement (Ph.Eur. or USP).
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier status per destination, and the documentation pack you will receive, inside one working day.
- Order, produce, release, ship. QC release on the Indian side, ambient dispatch with a do-not-freeze instruction, in-transit condition logging and on-arrival inspection.
- After delivery. Batch records, CoA and condition logs archived for the full shelf life, PV contact opened on registration.
Calcium gluconate supply, the specific questions.
What strength and pack of calcium gluconate injection do you supply?
The standard line is calcium gluconate 10% w/v (100 mg/ml) in a 10 ml ampoule, which contains 1 g of calcium gluconate, approximately 2.2 mmol (about 90 mg, 4.5 mEq) of elemental calcium. Type-I glass ampoules in hospital packs of 5, 10 or 50 are the common tender formats. The higher-solubility calcium glucono-galacto-gluconate and calcium lactate-gluconate salt forms, used in some injectable and effervescent calcium products, are sourced on request. All supplied from WHO-GMP-certified Indian manufacturers.
Is M Care a calcium gluconate manufacturer?
No. M Care is a merchant exporter. We supply calcium gluconate injection from Indian WHO-GMP-certified manufacturers and handle the export, documentation, registration support and freight. We do not operate a manufacturing plant ourselves, and we say so plainly. The benefit to a buyer is that we route each order to the right WHO-GMP line for the destination and take the regulatory and logistics paperwork off both sides.
What is calcium gluconate injection used for?
Acute symptomatic hypocalcaemia (carpopedal spasm, tetany, seizures, prolonged QT); cardiac membrane stabilisation in hyperkalaemia with ECG changes (it protects the myocardium, it does not lower potassium); magnesium-sulfate toxicity in pre-eclampsia and eclampsia; calcium-channel-blocker and beta-blocker overdose; citrate-induced hypocalcaemia during massive transfusion or apheresis; and hydrofluoric-acid burns (topical gel, infiltration or intra-arterial under specialist guidance). It is a frontline emergency, ICU, obstetric and toxicology medicine, which is why it is a high-volume hospital tender line.
Which markets can you ship calcium gluconate into?
GCC hospital and ICU tenders through licensed local importers (NUPCO and SFDA in Saudi Arabia, MoHAP/DHA/DoH in the UAE, and the Kuwait, Oman, Qatar and Bahrain MoH stores); African public-sector and teaching-hospital procurement (NAFDAC, KEMSA and MEDS, FDA Ghana, SAHPRA, EFDA and EPSS, TMDA and MSD, NDA and NMS); the UK and EU through licensed importers; and Latin America (ANVISA, COFEPRIS) and ASEAN. M Care does not hold US FDA or TGA registration for this molecule; confirm the regulatory route on enquiry. We do not supply into India. Full coverage at markets.
How must calcium gluconate be administered and stored safely?
Give by slow intravenous injection or dilute infusion; calcium gluconate is preferred over calcium chloride for peripheral lines because it is less irritant, but extravasation still risks tissue necrosis and calcinosis, so a secure line and slow rate are essential. Rapid injection can cause hypotension, bradycardia and arrhythmia. Do not mix in the same line with sodium bicarbonate or phosphate-containing solutions (precipitation), and use extreme caution in digitalised patients (calcium potentiates digoxin). Store below 25-30°C; do not refrigerate or freeze, as crystallisation can occur. The pack insert carries the full administration and incompatibility warnings.
What documentation ships with a calcium gluconate consignment?
A batch-specific Certificate of Analysis (assay, related substances and limit tests per Ph.Eur./USP, particulate matter, bacterial endotoxin, sterility, pH, clarity), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert with the administration, incompatibility and digoxin-caution warnings, and temperature/condition logs from dispatch to arrival. Full CTD Module 3 dossiers are available against an NDA for registration support, see dossier preparation.
Send the specifics. You'll have a price inside one working day.
Strength (10% w/v), ampoule and pack format, volume, destination, and channel: hospital or ICU tender, central medical store, donor or NGO programme, or importer stock. That's the enquiry. Everything else is on us.