Omeprazole, Indian WHO-GMP supply for acid-suppression therapy across dosage forms.
Omeprazole is not a molecule a procurement desk needs convincing about. It has been on the WHO Model List of Essential Medicines for decades, it is manufactured by dozens of GMP-certified Indian plants, and every hospital formulary already knows what it does. The question a buyer actually has to answer when sourcing it is duller and more important: which supplier can hold three different dosage forms in stock at once, match the exact strength and pack format a tender specifies, and produce the paperwork without a week's delay. That is the problem this page is written to address.
Omeprazole exporter and bulk supplier from India.
Omeprazole is a genuine commodity molecule, which means the sourcing risk is rarely "can this be found in India" and almost always "can this specific supplier actually deliver the specific form, strength and documentation the tender or import license requires, at the volume needed, without substituting a different manufacturer mid-order." M Care Exports works from a network of WHO-GMP certified Indian manufacturers covering the full formulation range, capsules, delayed-release tablets and IV powder for injection, so we can quote against a tender's exact specification rather than pushing buyers toward whichever single form one factory happens to run. We coordinate COA, COPP, GMP certificates and stability data per batch and per manufacturer on request; we do not publish standing prices, minimum order quantities or lead times on this page because those vary by strength, pack size and manufacturer and would be guesswork if stated generically. Enquire with your required strength, dosage form and destination country and we will return manufacturer-specific terms.
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 (substituted benzimidazole), sourced and documented for export.
Proton pump inhibitor (substituted benzimidazole class). WHO EML core list medicine. Marketed as delayed-release capsules (enteric-coated pellets, 10 mg / 20 mg / 40 mg), delayed-release tablets including MUPS formats, and as a lyophilized powder for IV injection/infusion (typically 40 mg per vial). Oral and IV routes both in wide institutional use. Not a scheduled or controlled substance in any of our export regions; regulatory attention centers on long-term-use safety labelling (hypomagnesemia, bone fracture risk, C. difficile infection, interstitial nephritis) and a well-documented CYP2C19 drug interaction with clopidogrel, not on export restriction.
Active ingredient
Omeprazole (as omeprazole or omeprazole sodium for the injectable form). Proton pump inhibitor (substituted benzimidazole).
Forms and strengths
10 mg; 20 mg; 40 mg.
Indications
Omeprazole irreversibly inhibits the gastric H+/K+-ATPase proton pump, suppressing basal and stimulated gastric acid secretion. It is a WHO Model List of Essential Medicines core-list agent used for GERD, erosive esophagitis, peptic ulcer disease, NSAID-associated ulcer prevention, H. pylori eradication regimens and hypersecretory conditions including Zollinger-Ellison syndrome, with the IV form used where oral dosing is not feasible.
Administration
Oral, Intravenous. Delayed-release capsule, delayed-release (MUPS) tablet, powder for solution for injection/infusion.
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.
M Care Exports supplies omeprazole to licensed pharmaceutical importers, hospital and government tender desks, and wholesale distributors across the Gulf, Africa, the UK and EU, South-East Asia and LATAM. We do not sell into India, which is excluded from our served markets. Buyers we work with are typically procurement teams filling a tender line item that specifies an exact dosage form and pack configuration (capsule vs. MUPS tablet vs. IV vial), not retail pharmacies looking for a single SKU.
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 omeprazole.
Omeprazole irreversibly inhibits the H+/K+-ATPase (proton pump) of gastric parietal cells and is indicated for GERD, erosive esophagitis, peptic ulcer disease (gastric and duodenal), NSAID-associated ulcer prevention, H. pylori eradication as part of triple or quadruple therapy, and pathological hypersecretory conditions including Zollinger-Ellison syndrome. The IV formulation is used where oral dosing is not feasible, including stress ulcer prophylaxis in critically ill patients and short-term bridging before oral therapy resumes.
Contraindications are narrow but not trivial: hypersensitivity to omeprazole or other substituted benzimidazoles, and co-administration with rilpivirine or nelfinavir, both of which require gastric acidity for adequate absorption and are meaningfully reduced by PPI co-therapy. The interaction procurement teams should flag to prescribers most often is clopidogrel: omeprazole (and esomeprazole) inhibit CYP2C19, the enzyme that activates clopidogrel to its active metabolite, and concomitant use can reduce the antiplatelet effect in patients relying on clopidogrel post-stent or post-MI. Regulatory guidance in most of our export markets recommends avoiding the combination or separating dosing where an alternative PPI is not practical.
Monitoring and long-term-use considerations that belong in any tender-side clinical note: hypomagnesemia with prolonged use (magnesium checks recommended before and during extended therapy, particularly with concurrent diuretics or digoxin), increased risk of Clostridioides difficile-associated diarrhea, reduced vitamin B12 absorption with multi-year use, an association between long-term high-dose PPI therapy and fracture risk that most regulators require reflected in labelling, and the general caution that PPI therapy can mask the symptoms of gastric malignancy, so it is not a substitute for endoscopic evaluation where gastric cancer is a differential. None of this makes omeprazole an unusual molecule to handle; it makes it a molecule where the paperwork trail (batch-specific COA, stability data appropriate to the destination climate zone) matters more than clinical novelty, because the clinical profile is already fully characterized and familiar to every prescriber who will use it.
The documentation pack a regulator actually asks for.
M Care Exports is a merchant-exporter, not a manufacturer, and holds ISO 9001:2015 certification for its own quality management system. We do not hold, and do not claim, WHO-GMP or WHO-Prequalification status ourselves; those are manufacturing-site credentials. Every omeprazole batch we supply is sourced from WHO-GMP certified Indian manufacturers, and we pass through the manufacturer's own COA, GMP certificate, COPP and stability documentation for the specific batch and dosage form shipped. Buyers should verify the receiving country's import registration status for the specific manufacturer and pack presentation before committing to a tender; omeprazole itself is not scheduled, controlled or restricted in any of our served export markets, so registration friction, where it exists, is administrative rather than regulatory-prohibition in nature.
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.
Clinically significant CYP2C19-mediated interaction with clopidogrel is a prescribing caution, not a supply restriction, and is disclosed on this page.
Contraindicated for co-administration with rilpivirine and nelfinavir due to acid-dependent absorption; disclosed for prescriber awareness, not a supply-side restriction.
Adjacent lines procurement desks order alongside omeprazole.
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 omeprazole.
- 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.
Omeprazole supply, the specific questions.
Do you supply omeprazole as IV injection, not just oral capsules?
Yes. Omeprazole for injection (lyophilized powder for reconstitution, commonly 40 mg per vial) is manufactured alongside the oral forms by several of the WHO-GMP certified Indian manufacturers we work with. Tender desks sourcing for hospital stress-ulcer-prophylaxis or NPO-patient use should specify the IV form explicitly when enquiring, since not every manufacturer in our network runs both oral and injectable lines.
What is the difference between the delayed-release capsule and the MUPS tablet, and does it matter for a tender?
Both are enteric-coated formulations designed to protect omeprazole from gastric acid degradation before it reaches the small intestine; the capsule holds enteric-coated pellets inside a gelatin or HPMC shell, while MUPS (Multiple Unit Pellet System) tablets compress similar pellets into a tablet that disperses after swallowing. Clinically they are considered interchangeable at equivalent strengths, but many tenders specify one or the other by name, so we quote against the exact format requested rather than substituting.
Is omeprazole a controlled or restricted substance in any of the markets you export to?
No. Omeprazole is not scheduled or controlled in the Gulf, Africa, UK/EU, South-East Asia or LATAM markets we serve. Where import friction exists it is administrative, tied to the specific manufacturer's site registration or dossier status in that country, not to any restriction on the molecule itself.
Why won't you quote a standing price or MOQ for omeprazole on this page?
Because both vary meaningfully by dosage form, strength, pack configuration and manufacturer, and a generic figure would not reflect what any given tender actually requires. We provide manufacturer-specific pricing and minimum order quantities once we know the strength, form and destination country, so the quote is accurate rather than indicative.
Can omeprazole be co-prescribed with clopidogrel, and should that affect a hospital's procurement of both?
It can be, but regulators in most of our export markets advise caution: omeprazole inhibits the CYP2C19 enzyme that activates clopidogrel, which can blunt clopidogrel's antiplatelet effect in patients who depend on it post-stent or post-cardiac-event. This is a prescribing and clinical-protocol matter for the buyer's own pharmacists, not a supply restriction, but procurement teams building a formulary sometimes ask us to flag it, so we do.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter and holds ISO 9001:2015 certification for our own quality management system. The WHO-GMP certification sits with the manufacturing sites we source from, and we pass through their site-specific GMP certificates, COAs and COPP documentation with every shipment.
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.