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Vantin (US) and Orelox (France/UK), the originator brands of cefpodoxime, an oral third-generation cephalosporin, are now largely legacy names, and FDA and MHRA-approved generic cefpodoxime proxetil tablets and paediatric suspension are the standard commercial form buyers specify.

M Care Exports supplies cefpodoxime proxetil, the oral prodrug ester of the third-generation cephalosporin cefpodoxime, first brought to market as Vantin in the United States and Orelox in France and the UK. The FDA Orange Book records Vantin as discontinued in the US, and no current Orelox listing appears on the UK's own medicines register, so FDA and MHRA-approved generic cefpodoxime proxetil, in tablet and paediatric suspension form, is now the product buyers actually specify. M Care is a merchant exporter: we source generic and, where a tender names the legacy brand, originator-channel cefpodoxime through licensed Indian distribution and manufacturing partners, and dispatch on quote, not from our own manufacturing.

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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

Cefpodoxime exporter and bulk supplier from India.

For hospital pharmacy, wholesaler and MoH tender orders, M Care quotes cefpodoxime against buyer specification: 100 mg or 200 mg film-coated tablets for adults and adolescents, or 50 mg/5 mL and 100 mg/5 mL powder for oral suspension for paediatric dosing, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because cefpodoxime absorbs better with food and the reconstituted suspension needs refrigerated storage with a 14-day discard window, we confirm the buyer's intended dosage-form split and cold-chain-at-destination capability before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.

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.

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At a glance

Third-generation cephalosporin antibacterial; oral prodrug ester hydrolysed to active cefpodoxime, sourced and documented for export.

Cefpodoxime is a third-generation cephalosporin antibacterial, dosed orally as the proxetil ester prodrug, which is hydrolysed by intestinal esterases to active cefpodoxime after absorption; oral bioavailability is roughly 50 percent and rises when the dose is taken with food, a dosing nuance that affects how consistently a patient absorbs the drug outside a supervised hospital setting. Unlike many third-generation cephalosporins, cefpodoxime has no licensed injectable form, so it is used as an oral agent in its own right or as oral step-down therapy after an injectable third-generation cephalosporin such as ceftriaxone. The FDA label's flagship adult indications are pharyngitis/tonsillitis, community-acquired pneumonia, acute bronchitis exacerbation, uncomplicated skin infections, acute maxillary sinusitis, uncomplicated urinary tract infection and uncomplicated gonorrhoea; the paediatric label covers acute otitis media in children aged two months to twelve years. It is supplied as 100 mg and 200 mg film-coated tablets and as a granule reconstituted to 50 mg/5 mL or 100 mg/5 mL oral suspension.

Active ingredient

Cefpodoxime proxetil (prodrug ester of cefpodoxime). Third-generation cephalosporin antibacterial; oral prodrug ester hydrolysed to active cefpodoxime.

Forms and strengths

100 mg film-coated tablet; 200 mg film-coated tablet; 50 mg/5mL oral suspension; 100 mg/5mL oral suspension.

Indications

Cefpodoxime, an oral third-generation cephalosporin dosed as the proxetil prodrug ester, indicated for respiratory-tract, urinary and skin infections in adults and acute otitis media in children. Supplied as licensed generic tablets and paediatric suspension, and originator-channel Vantin/Orelox where specified, from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.

Administration

Oral. Film-coated tablet and oral suspension.

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 for cefpodoxime are hospital and community pharmacists treating respiratory-tract and paediatric ear infections, MoH tender desks running general anti-infective formulary lists, licensed importers and wholesalers restocking outpatient and hospital pharmacy shelves, and NGO or foundation procurement programmes covering paediatric otitis media and respiratory-infection treatment in primary-care settings.

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 cefpodoxime.

Cefpodoxime proxetil's absorption is measurably better with food: the label's own pharmacokinetic data show AUC rising 21-33 percent over the fasted state, so dispensing counsel should specifically instruct patients to take it with a meal, not simply "as directed". The paediatric suspension needs refrigeration once reconstituted, 2-8 degrees C, and must be discarded after 14 days; shake well before each dose. The unmixed powder and the film-coated tablets are stable at controlled room temperature and need no cold-chain handling in transit. As with all cephalosporins, the label warns that cross-reactivity in patients with a documented penicillin allergy can occur in up to 10 percent of cases, so allergy history should be checked before dispensing, and Clostridioides difficile-associated diarrhoea should be considered in any patient who develops diarrhoea during or after a course. No premedication or extravasation precautions apply; this is an oral, not infused, agent.

Regulatory & quality

The documentation pack a regulator actually asks for.

Third-generation cephalosporins as a class sit in the WHO AWaRe Watch group, reserved for specific indications to protect their future usefulness, but cefpodoxime itself does not appear on the current WHO Model List of Essential Medicines, unlike stablemates cefixime and cefuroxime, which are separately EML-listed; buyers building a WHO-EML-aligned formulary should treat cefpodoxime as a formulary-specific choice rather than an EML first-line agent. It is not a controlled drug and carries no boxed warning. On the brand-versus-generic question, Vantin (Pfizer, US) and Orelox (Sanofi, France/UK) were the originator brands: the FDA Orange Book lists Vantin (NDA 050674) as discontinued, and the UK's own medicines register carries no current Orelox listing, leaving FDA-approved generic cefpodoxime proxetil, from manufacturers including Aurobindo, Sandoz and others, as the product most tenders now specify by molecule rather than brand. Buyers with a legacy brand line item should confirm with M Care whether an equivalent generic satisfies the specification. Paediatric suspension supply can be less resilient than tablet supply even for a well-established molecule, so M Care confirms current manufacturer production status for the suspension line specifically before quoting a paediatric order.

The paperwork above is the molecule-specific part; the general pathway a destination regulator expects is set out in our licensed import route guide.

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 cefpodoxime.
  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

Cefpodoxime supply, the specific questions.

Is cefpodoxime the same as Vantin or Orelox?

Yes. Vantin was the originator brand name in the United States (Pfizer) and Orelox in France and the UK (Sanofi), both for cefpodoxime proxetil. The FDA Orange Book lists Vantin as discontinued, and generic cefpodoxime proxetil tablets and suspension are now the standard commercial form; M Care can quote against either the legacy brand name or the generic INN depending on how your tender specification is written.

Does cefpodoxime come as an injection?

No. Cefpodoxime is only licensed as an oral product: film-coated tablets for adults and adolescents, and a powder for oral suspension for children. Where a formulary needs an injectable third-generation cephalosporin, that is typically ceftriaxone or cefotaxime, with cefpodoxime used as the oral step-down or first-line oral agent instead.

Why does food matter for dosing cefpodoxime?

Cefpodoxime proxetil's oral bioavailability, already only around 50 percent, is measurably higher when the dose is taken with food; the label shows AUC rising 21-33 percent over the fasted state. Dispensing counsel should tell patients specifically to take it with a meal, since taking it on an empty stomach can meaningfully reduce drug exposure without any outward sign that the dose has been under-absorbed.

What strengths and forms can M Care supply?

100 mg and 200 mg film-coated tablets for adults and adolescents, and a granule for oral suspension reconstituted to 50 mg/5 mL or 100 mg/5 mL for paediatric dosing. Tell us your indication mix and age range and we quote the strength and format split accordingly.

Is cefpodoxime on the WHO Essential Medicines List?

No. Cefpodoxime itself is not listed on the current WHO Model List of Essential Medicines, unlike cefixime and cefuroxime, which are separate third- and second-generation cephalosporins that are EML-listed. Third-generation cephalosporins as a class sit in the WHO AWaRe Watch group. Buyers building a strict WHO-EML formulary should treat cefpodoxime as a formulary-specific choice rather than an EML first-line agent.

How should the reconstituted paediatric suspension be stored?

Once mixed with water, the suspension must be refrigerated at 2-8 degrees C and used within 14 days, shaken well before each dose. The unmixed powder and the film-coated tablets need no refrigeration and are stable at controlled room temperature, so only the reconstituted liquid form requires cold-chain handling at the pharmacy or clinic level.

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 2026-09-19.

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.

Cefpodoxime enquiry

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