Pantoprazole, oral and IV: high-volume Indian PPI supply for hospital and retail formularies.
Pantoprazole is a high-volume PPI line: a 20mg gastro-resistant tablet for retail and outpatient dispensing, and a 40mg intravenous formulation for hospital acid-suppression. Fifty-eight pantoprazole product lines sit on the M Care roster, and on a line this competitive, landed cost is what buyers actually compare.
58 pantoprazole product lines · 20mg gastro-resistant tablet and 40mg IV injection · CTD dossier on file · GORD, peptic ulcer and hospital upper GI bleed support.
Active ingredient
Pantoprazole sodium sesquihydrate, the salt form used in both the tablet and the injection. A proton-pump inhibitor: it binds irreversibly to the H+/K+-ATPase enzyme on the gastric parietal cell's secretory surface, blocking the final common step of acid secretion regardless of the stimulus (histamine, gastrin or acetylcholine). Metabolised partly by non-enzymatic sulfation alongside CYP2C19, giving a comparatively lower CYP2C19-interaction burden than some other PPIs; individual interaction risk, for example with clopidogrel, still needs checking.
Strengths stocked
20mg gastro-resistant (enteric-coated) tablet, the standard oral maintenance and retail-dispensing strength. 40mg lyophilised powder for solution for injection, reconstituted for intravenous use where oral therapy is not possible, including hospital acid-suppression support. Both strengths draw on the same 58-line M Care roster, so oral and IV can usually be sourced and quoted on one enquiry.
Indications
Gastro-oesophageal reflux disease and erosive reflux oesophagitis; gastric and duodenal peptic ulcer, including H. pylori eradication regimens; prevention and treatment of NSAID-associated ulcer; Zollinger-Ellison syndrome and other hypersecretory states. The intravenous formulation covers short-term hospital use where oral dosing is not possible, including acid-suppression support in upper gastrointestinal bleeding alongside endoscopic management.
Storage
Gastro-resistant tablets store below 30°C in the original blister, protected from light and moisture. The injection is a lyophilised powder, light-sensitive, stored below 25°C before reconstitution; reconstitute and handle per the product's own instructions, and do not co-infuse with other medicines through the same line.
Shelf life
Typically 24 to 36 months from manufacture for both the tablet and the injection, depending on the manufacturer and pack; the specific product label and Certificate of Analysis carry the exact labelled figure. Minimum remaining shelf life at dispatch is confirmed on the order, not assumed.
Pack format
Tablets in Alu-Alu or Alu-PVC blister, hospital and retail pack sizes, destination-language carton and leaflet. Injection vials in single-vial cartons, with the diluent supplied separately per the manufacturer's convention, batch and expiry laser-coded on both vial and carton for tender traceability.
Hospital pharmacies, retail wholesalers and tender desks across twenty-plus export markets.
India is our origin, not our market. Pantoprazole is exported only, and on a commodity PPI line the buyers who do best are the ones comparing landed cost across manufacturers properly, not the ones who stop at the first quote.
United Kingdom
NHS hospital pharmacy and community wholesale supply, and the MHRA (Medicines and Healthcare products Regulatory Agency) Specials / named-patient route for a strength or pack not currently registered. Pantoprazole's retail generic-dispensing volume makes price discipline, not brand, the deciding factor in most UK enquiries.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through licensed local importers, against hospital formulary listing and MoH tender award. CTD dossiers prepared for SFDA (Saudi Food & Drug Authority), MOHAP (UAE Ministry of Health and Prevention) and the GCC central registration route. Tablet and injection are quoted together where a hospital tender specifies both presentations.
Nigeria, Kenya, Ghana, South Africa
Public-sector hospital tenders and wholesale distribution through NAFDAC (Nigeria), PPB (Pharmacy and Poisons Board, Kenya) and SAHPRA (South African Health Products Regulatory Authority) registration routes. Pantoprazole's deep catalogue on the M Care roster gives African tender desks several price points to compare on one enquiry.
Germany
Supply via licensed German importers under §72 AMG (Arzneimittelgesetz, the German Medicines Act), with Qualified Person certification on arrival. CTD dossier and Certificate of Pharmaceutical Product prepared for BfArM (German federal institute for drugs) recognition, German-language leaflet included.
CYP2C19 interaction burden, IV reconstitution, and the hepatic-versus-renal dose question.
Pantoprazole's CYP2C19 involvement is real but comparatively modest: alongside hepatic CYP2C19 metabolism it undergoes non-enzymatic sulfation, so its effect on co-administered CYP2C19 substrates tends to be smaller than omeprazole's, most relevantly for clopidogrel, where pantoprazole is often the PPI of choice on cardiology wards for that reason; it is not interaction-free, and the individual combination still needs checking. On reconstitution, the intravenous powder is light-sensitive: reconstitute and dilute per the product's own instructions, protect the prepared solution from direct light, and do not co-infuse it through a line carrying another medicine. Hepatic impairment, particularly severe, is the dose-review flag for pantoprazole; renal impairment alone does not typically require a dose adjustment, since elimination is predominantly hepatic. One practical point for tender planning: neither the tablet nor the injection needs cold-chain handling, ambient storage and transport suffice for both, which keeps distribution to hospital pharmacy stores and retail wholesalers simpler than for a biologic on the same order.
The documentation pack a regulator actually asks for.
Pantoprazole is a high-volume generic line, so the documentation is standard, not something either side improvises. The discipline is doing it the same way, correctly, across whichever of the 58 lines we quote.
CTD Module 3
Full chemistry, manufacturing and controls section, eCTD-ready where the importing authority accepts it, with the Module 2 quality overall summary. Separate CMC packages held for the tablet and the injection, since they are different dosage forms with different stability and impurity profiles.
CoA and MoA, per batch
HPLC assay, related substances, water content by Karl Fischer, dissolution (tablet) or reconstitution and particulate testing (injection), and microbial limits, signed by the manufacturer's authorised QC head. Salt form and manufacturing site stated explicitly on every batch CoA.
CoPP, WHO-GMP, MFG licence
Certificate of Pharmaceutical Product in WHO format, WHO-GMP certificate and manufacturing licence for the named Indian manufacturing site, issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. M Care is the exporting merchant named on the commercial documents; the manufacturing site is named on the regulatory ones.
Pack insert, labels, artwork
Destination-language patient information leaflet and carton labelling to local regulator convention, artwork QC'd before print. Tablet and injection cartons carry separate batch and expiry coding, since they are packed and released independently.
Temperature control
No cold-chain needed for either presentation. Standard ambient pharmaceutical freight applies, with pre-shipment packaging checks and an on-arrival inspection record; the injection's light-sensitivity is a packaging and handling matter, not a temperature one.
Pharmacovigilance
A named PV contact organised in the destination market on registration, Periodic Safety Update Reports compiled to ICH E2C. Hepatic function changes, rare hypersensitivity and, on long-term use, the recognised class effects of PPI therapy remain the standard PSUR watch items.
Complete the gastroenterology formulary.
Pantoprazole rarely ships alone. Hospital and retail buyers pair it with an antiemetic, a prokinetic or an antispasmodic on the same order. We carry the wider gastroenterology cluster.
Ondansetron
5-HT3 antagonist antiemetic for chemotherapy-, radiotherapy- and post-operative nausea and vomiting. 4mg / 8mg tablets, ODT, oral solution and 2mg/ml injection.
Esomeprazole
The S-isomer proton-pump inhibitor, GORD and peptic ulcer, often the direct comparator buyers price pantoprazole against. 20mg / 40mg tablets and IV injection.
Domperidone
Peripheral dopamine antagonist and prokinetic, used for GORD-associated and functional dyspepsia symptoms per destination-country labelling. 10mg tablets.
Mebeverine
Musculotropic antispasmodic for irritable bowel syndrome and gastrointestinal spasm. 135mg tablets, a common companion line on a gastroenterology tender.
Bisacodyl
Stimulant laxative for constipation and bowel-preparation protocols. 5mg tablets and suppository, a standard line on a hospital gastroenterology formulary.
All gastroenterology →
511+ gastroenterology SKUs: proton-pump inhibitors, antiemetics, antispasmodics, laxatives and the wider GI formulary.
Molecule · form · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form (20mg tablet, 40mg injection, or both), pack size, destination market, buyer type (hospital tender, wholesaler, retail chain) and target volume. Tell us if the enquiry is price-led, since that changes which of the 58 lines we quote first.
- We route to the right line. Pantoprazole has one of the deepest rosters we carry. We shortlist two or three manufacturer lines against your price point, registration status in the destination market and current stock position, and confirm availability before quoting.
- Commercial and regulatory offer. FOB or CIF price, lead time, CoPP and CTD dossier status for the destination, and the documentation pack included. Inside one working day, tablet and injection quoted on the same sheet where both are needed.
- Order, produce, release, ship. QC release on the Indian side. Ambient freight for both presentations, with the injection packed to protect against light. In-transit tracking and an on-arrival inspection record on request.
- After delivery. Batch records, CoA and shipment documentation archived for the consignment's full shelf life. Pharmacovigilance contact opened on registration; re-order lead time confirmed ahead of your next tender cycle.
Pantoprazole supply, the specific questions.
What strengths and forms of pantoprazole do you supply?
Two presentations, drawn from 58 pantoprazole product lines on the M Care roster: the 20mg gastro-resistant tablet for retail and outpatient dispensing, and the 40mg lyophilised powder for solution for injection for hospital intravenous use where oral therapy is not possible. Tell us the form, pack size and destination market and we shortlist the manufacturer lines that fit your price point and registration status.
Is pantoprazole a low-interaction PPI, and does that matter for a tender?
Pantoprazole is metabolised partly by non-enzymatic sulfation alongside CYP2C19, which gives it a comparatively lower propensity for clinically significant CYP2C19-mediated interactions than some other proton-pump inhibitors, most relevantly with clopidogrel. That is a genuine pharmacological difference, and one reason hospital cardiology formularies often prefer pantoprazole, but it is not interaction-free, and prescribers should still check individual combinations. It is a clinical formulary consideration, not something that changes the supply or documentation package we provide.
Why does pantoprazole have so many competing brand lines, and how do you handle that?
Pantoprazole is off-patent, high-volume and manufactured widely in India, so the M Care roster carries 58 product lines across tablet and injection, referenced in the market under brand names such as Pantocid, Pran, Panpraz or Pantin. We supply the underlying WHO-GMP-manufactured product, named on every quote; these are reference brand names for the buyer's own comparison, not M Care house brands. On a line this competitive, we quote two or three manufacturer lines side by side so you can compare landed cost directly.
Which markets and buyers do you supply pantoprazole into?
UK hospital pharmacy and wholesale distribution, GCC hospital tenders through licensed importers (Saudi Arabia via the SFDA, UAE via MOHAP, and the wider GCC via national bodies or the central registration route), African public-sector tenders (Nigeria's NAFDAC, Kenya's PPB, South Africa's SAHPRA), Germany under §72 AMG import, and importers across Latin America and South-East Asia through their national registration pathways. We do not supply into India. Full coverage is at markets.
Do you provide CTD dossiers, and is the tablet dossier the same as the injection dossier?
No, they are separate. The tablet and the injection are different dosage forms with different manufacturing processes, stability data and impurity profiles, so each carries its own CTD Module 3 chemistry, manufacturing and controls package. Full dossiers are available for registration with the MHRA, SFDA, MOHAP, NAFDAC, PPB, SAHPRA, BfArM and comparable regulators. Tell us which presentation, or both, and we assemble the matching pack.
What storage and shelf life applies to pantoprazole tablets and injection?
Gastro-resistant tablets store below 30°C in the original blister, protected from light and moisture. The injection is a light-sensitive lyophilised powder, stored below 25°C before reconstitution and reconstituted per the product's own instructions. Shelf life is typically 24 to 36 months from manufacture for both presentations, depending on the manufacturer and pack; the specific product label and Certificate of Analysis carry the exact figure. No cold-chain is required in transit for either form.
Can M Care supply both the tablet and the injection on one hospital tender?
Yes, and it is a common request. Hospital tenders often specify both an oral maintenance line and an IV formulation for inpatients who cannot take oral medication. We quote both presentations on the same commercial offer where the destination and dossier status allow it, and flag separately if one presentation has a materially different lead time than the other.
Send the specifics. You'll have a price inside one working day.
Form (tablet or injection), strength, pack, volume, destination and buyer type. On a line with 58 competing product lines, the fastest way to a good landed-cost quote is telling us where price matters most.