Esomeprazole splits into two distinct purchases: oral tablets bought on wholesale terms, and IV esomeprazole bought for the post-endoscopic bleeding-ulcer infusion protocol on hospital tender terms.
Esomeprazole is not one purchasing decision, it is two. Twenty-four of M Care's stocked lines are oral tablets for routine acid-suppression therapy, bought on standard wholesale terms. The remaining two are esomeprazole sodium for injection, formulated for the specific 72-hour high-dose infusion protocol used after endoscopic treatment of a bleeding gastric or duodenal ulcer. A tender desk ordering for an emergency department is not solving the same problem as a wholesaler restocking a maintenance-therapy shelf, and the order code has to match which one is needed.
Esomeprazole exporter and bulk supplier from India.
Export documentation is form-specific. Oral tablet shipments move as standard pharma cargo with a Certificate of Pharmaceutical Product, batch Certificate of Analysis and stability data appropriate to the enteric-coated pellet fill, since the coating is what protects the acid-labile molecule between manufacture and the buyer's shelf. Esomeprazole sodium for injection ships as sterile lyophilised powder for reconstitution, requiring temperature-monitored transit, sterility and endotoxin test data, and container-closure integrity documentation alongside the standard CoPP and CoA. Both forms travel under the same CDSCO export licence and are packed to the destination market's labelling requirements. Buyers should confirm which form they need before requesting quotes, since the two dossiers do not substitute for each other.
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.
Proton pump inhibitor (PPI), S-isomer of omeprazole, sourced and documented for export.
Esomeprazole sold under one INN actually serves two separate procurement lines. Oral tablets, the bulk of M Care's 26 stocked lines, cover routine maintenance therapy for gastro-oesophageal reflux disease and peptic ulcer healing, dosed once daily at 20mg or 40mg. Esomeprazole sodium for injection is a narrower, hospital-specific product: it is indicated for reducing the risk of rebleeding after therapeutic endoscopy in acute gastric or duodenal ulcer bleeding, given as an 80mg intravenous loading dose over 30 minutes followed by a continuous 8mg-per-hour infusion for 71.5 hours, a 72-hour course in total with no oral equivalent in the catalogue. Esomeprazole is the S-isomer of omeprazole and, being acid-labile, the tablet is manufactured as compressed enteric-coated pellets rather than a conventional compressed tablet, a formulation detail that matters for storage and handling instructions on the pack.
Active ingredient
Esomeprazole (as magnesium in oral tablets, as sodium in injection). Proton pump inhibitor (PPI), S-isomer of omeprazole.
Forms and strengths
20 mg; 40 mg.
Indications
Esomeprazole is a proton pump inhibitor used to reduce gastric acid secretion in gastro-oesophageal reflux disease and peptic ulcer disease. M Care Exports supplies it as an oral enteric-coated tablet for routine maintenance therapy and as a sterile injection for short-term inpatient use, including the post-endoscopic bleeding-ulcer infusion protocol, sourced from WHO-GMP certified Indian manufacturers for export markets outside India.
Administration
Oral, Intravenous. Enteric-coated oral tablet (pelletised fill) and lyophilised powder for solution for intravenous injection.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers fall into two groups that rarely overlap. Hospital and institutional pharmacy tender desks in the Gulf, and public procurement units across Africa and Southeast Asia, source the injection specifically for emergency department and gastroenterology ward stock, usually against a documented critical-care or endoscopy-unit formulary line. Licensed wholesalers and importers across the UK, EU, Latin America and CIS states order the oral tablet in volume for retail and hospital-outpatient distribution, alongside other PPI lines. Regulatory affairs teams preparing a national dossier for either form request the same underlying documentation set. M Care does not supply the Indian domestic market; all esomeprazole shipments are export under CDSCO licence.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on esomeprazole.
A pharmacist reviewing an esomeprazole order first confirms which form and indication it is for. For the oral tablet, the enteric coating on the pelletised fill is the critical quality attribute: esomeprazole is acid-labile, so the pellets must survive gastric pH before releasing in the duodenum, and any coating defect shows up as reduced bioavailability rather than an obvious dissolution failure. For the injection, the checks are different: reconstitution volume and diluent compatibility, infusion rate for the 80mg loading dose versus the 8mg-per-hour continuous infusion used in the post-endoscopic rebleeding protocol, and confirmation that the vial is being ordered for the labelled short-term inpatient indication rather than routine maintenance therapy, since there is no long-term outpatient use case for the intravenous form. Esomeprazole is metabolised through CYP2C19, so a pharmacist also checks for interacting co-medication, particularly clopidogrel, where concurrent PPI use can reduce antiplatelet activation. Renal and hepatic dose adjustment notes should be confirmed against the current label before an order is finalised.
The documentation pack a regulator actually asks for.
Every esomeprazole shipment carries a Certificate of Pharmaceutical Product issued under CDSCO export licensing, a batch-specific Certificate of Analysis, and a stability data package. For the oral tablet, stability data must reflect the enteric-coated pellet-in-tablet format specifically, since accelerated and long-term stability of a pelletised esomeprazole tablet is not the same study as for a plain compressed tablet, and reviewers in destination markets increasingly ask for this distinction explicitly. For the injection, the dossier adds sterility assurance data, bacterial endotoxin testing, and container-closure integrity evidence appropriate to a lyophilised powder for reconstitution. M Care sources both forms from Indian manufacturers holding WHO-GMP certification directly; M Care itself does not manufacture and holds ISO 9001:2015 certification and a CDSCO export licence, not a manufacturing certification. Buyers requiring destination-specific registration support should specify the form and target market at enquiry stage, since the two esomeprazole formulations follow different regulatory pathways in most jurisdictions.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Esomeprazole sodium for injection is indicated only for short-term, in-hospital use (post-endoscopic bleeding ulcer rebleeding risk reduction, or short-term GERD when oral therapy is not possible); it is not a substitute for oral maintenance therapy.
Long-term PPI use, oral or injectable, carries labelled risk of hypomagnesemia, particularly with concomitant diuretics or digoxin; product labelling recommends periodic magnesium monitoring for extended use.
Labelling includes a risk of fracture of the hip, wrist and spine associated with high-dose or long-duration PPI therapy.
Esomeprazole inhibits CYP2C19 and can reduce the antiplatelet activation of clopidogrel; concomitant use requires clinical review.
M Care Exports is a merchant-exporter and does not hold WHO-GMP or WHO-PQ certification directly; esomeprazole is sourced from WHO-GMP certified Indian manufacturers.
M Care does not supply the Indian domestic market; all shipments are export-only under CDSCO licence to licensed importers.
Adjacent lines procurement desks order alongside esomeprazole.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for esomeprazole.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Esomeprazole supply, the specific questions.
What is the difference between the oral tablet and the injectable form of esomeprazole M Care supplies?
The oral tablet, 24 of M Care's 26 stocked esomeprazole lines, is an enteric-coated formulation for routine once-daily maintenance therapy in reflux disease and ulcer healing. The injection, sourced as sterile lyophilised powder for reconstitution, is labelled for short-term inpatient use only, most notably an 80mg loading dose plus a 71.5-hour continuous infusion (a 72-hour course in total) to reduce rebleeding after therapeutic endoscopy for a bleeding gastric or duodenal ulcer. They are not interchangeable products.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification itself. Esomeprazole is sourced from Indian manufacturers who hold WHO-GMP certification directly, with manufacturer certificates and batch documentation supplied per shipment. M Care's own credentials are ISO 9001:2015 certification and a CDSCO export licence.
Is esomeprazole safe for long-term use?
Esomeprazole labelling carries the same class warnings as other proton pump inhibitors: long-term use is associated with hypomagnesemia, particularly with concomitant diuretics or digoxin, and with an increased risk of hip, wrist and spine fracture at high doses or extended duration. Regulatory affairs teams should reference current labelling for monitoring recommendations rather than treat esomeprazole as risk-free for indefinite use.
Can the injectable form be used in place of the tablet for routine maintenance therapy?
No. Esomeprazole sodium for injection is indicated for short-term, in-hospital use, including the post-endoscopic rebleeding protocol and short-term GERD treatment when oral therapy is not possible. It is not labelled or stocked as a routine outpatient maintenance option. Buyers ordering for maintenance therapy should be sourcing the oral tablet line, not the injection.
What documentation does M Care provide with an esomeprazole shipment?
Every shipment includes a Certificate of Pharmaceutical Product under CDSCO export licensing, a batch-specific Certificate of Analysis, and stability data. For the oral tablet, stability data reflects the enteric-coated pelletised format; for the injection, the pack adds sterility assurance, endotoxin testing and container-closure integrity data appropriate to a lyophilised product for reconstitution.
Does M Care supply esomeprazole capsules or oral suspension?
No. M Care's stocked esomeprazole lines are limited to oral tablets and injection. M Care does not currently stock esomeprazole as a capsule, oral suspension, or any topical, ophthalmic, inhaled or sachet form, even though such forms exist elsewhere in the market. Buyers needing those forms should say so at enquiry stage so we can advise honestly on availability.
What strengths of esomeprazole does M Care stock?
M Care's catalogue covers esomeprazole at 20mg and 40mg, the two strengths used across both the oral tablet and the injectable lines. These match the strengths used in the labelled dosing regimens for maintenance reflux therapy, ulcer healing and the high-dose infusion protocol for bleeding ulcer rebleeding prevention.
Which markets does M Care export esomeprazole to?
M Care exports esomeprazole to licensed importers, wholesalers and hospital procurement units across the UK, EU, Gulf and GCC states, Africa, Latin America, Southeast Asia and CIS countries. India is the country of manufacture only; M Care does not supply the Indian domestic market.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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.
Send the specifics. You'll have a price inside one working day.
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.