Faropenem sodium, an oral penem-class antibiotic licensed in Japan and supplied as generic tablets and dry syrup from India, sits in WHO's Reserve AWaRe group and carries no US, UK or EU marketing authorisation.
M Care Exports supplies faropenem sodium, an oral penem antibiotic in the same structural class as the injectable carbapenems, for urinary tract, respiratory tract and skin and soft-tissue infections. It is licensed and marketed in Japan, and in India it is manufactured and sold as a domestic generic under multiple brand names. Faropenem has no FDA, MHRA or EMA marketing authorisation. M Care is a merchant exporter: we source WHO-GMP faropenem tablets and dry syrup through licensed Indian manufacturing channels and dispatch on quote, into markets where the buyer holds or can obtain national registration.
Faropenem exporter and bulk supplier from India.
For MoH tender desks, licensed importers and NGO procurement quoting faropenem, M Care confirms two things before dispatch: the destination country's own registration or import-licensing route for the product, since faropenem is not FDA, MHRA or EMA-approved and cannot be supplied against a UK, US or EU tender, and the buyer's required dosage form, adult 200mg or 300mg film-coated tablets or paediatric 50mg/5mL dry syrup. We then align CDSCO export documentation and CTD or country-specific dossier paperwork drawn from licensed WHO-GMP manufacturer lines on the M Care roster to whatever the destination regulator asks for.
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.
Oral penem antibacterial (beta-lactam subclass related to the injectable carbapenems), sourced and documented for export.
Faropenem is an oral penem, a beta-lactam subclass structurally related to the injectable carbapenems, that inhibits bacterial cell-wall synthesis by binding penicillin-binding proteins and resists hydrolysis by many common beta-lactamases, including some ESBL enzymes, in vitro. It is licensed in Japan and marketed as a domestic generic in India for uncomplicated and complicated urinary tract infections, upper and lower respiratory tract infections, skin and soft-tissue infections, and gynaecological infections; UTI dosing in adults typically runs 200mg to 300mg three times daily depending on infection severity, and paediatric dosing is weight-based per the manufacturer's label. It carries no US, UK or EU licence: faropenem medoxomil, the ester form once pursued for US approval covering acute bacterial sinusitis, community-acquired pneumonia, chronic bronchitis exacerbation and skin infections, received an FDA non-approvable letter in October 2006 and was never resubmitted. It is an oral-only therapy needing no reconstitution for the tablet form; the paediatric dry syrup is reconstituted before dispensing. Faropenem is supplied as 200mg and 300mg film-coated tablets and a 50mg/5mL oral dry syrup for children unable to swallow tablets.
Active ingredient
Faropenem sodium. Oral penem antibacterial (beta-lactam subclass related to the injectable carbapenems).
Forms and strengths
200 mg film-coated tablet; 300 mg film-coated tablet; 50 mg/5mL oral dry syrup.
Indications
Oral penem-class antibiotic with activity against many beta-lactamase-producing organisms in vitro, licensed in Japan and marketed as a domestic generic in India for urinary tract, respiratory tract, skin and soft-tissue and gynaecological infections. No FDA, MHRA or EMA marketing authorisation exists.
Administration
oral. Film-coated tablet and oral dry syrup (reconstituted suspension).
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.
Faropenem buyers are national and regional MoH tender desks in GCC and African markets where the destination regulator can register a product independent of FDA or EMA harmonisation, licensed pharmaceutical importers and wholesalers running an oral antibiotic line for community and hospital-outpatient prescribing, and NGO or humanitarian procurement desks sourcing an ESBL-active oral option for settings without reliable access to injectable carbapenems. We do not quote faropenem against UK, US or EU tenders: the molecule has no MHRA, FDA or EMA marketing authorisation, and India, where it is most widely used, is not a market M Care serves.
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 faropenem.
Confirm the indication before dispensing: uncomplicated UTI dosing sits at the lower end, 200mg three times daily, while complicated UTI and respiratory infections typically need 300mg three times daily; paediatric dosing is weight-based per the manufacturer's label rather than a fraction of the adult tablet. The dry syrup needs reconstitution at the pharmacy before dispensing and should be shaken before each dose; tablets need no reconstitution and no cold chain, storing at controlled room temperature and protected from moisture. The stewardship point worth flagging to a tender desk: faropenem sits in WHO's AWaRe Reserve group for monitoring rather than the Essential Medicines List, and published in-vitro data show MICs rising quickly on exposure with a signal for cross-resistance to carbapenems, so formulary committees should treat it as a targeted option for confirmed susceptible organisms, not a first-line empirical UTI or respiratory choice.
The documentation pack a regulator actually asks for.
As an oral solid and oral dry-syrup dosage form, faropenem ships on standard ambient logistics, not the validated cold-chain lanes M Care runs for biologics; pack and storage guidance calls for a cool, dry place, protected from moisture, at standard controlled room temperature. What a tender desk needs instead of a harmonised FDA or EMA label is batch-level certificate of analysis, CDSCO export documentation confirming the Indian manufacturing site's WHO-GMP status, and CTD or country-specific dossier support so the buyer's own regulator can complete national registration, since faropenem has no MHRA, FDA or EMA marketing authorisation to reference. WHO's AWaRe classification places faropenem in the Reserve group for antimicrobial-stewardship monitoring; it does not appear on the WHO Model List of Essential Medicines. Buyers should confirm their national formulary or tender specification names faropenem explicitly rather than assuming EML-equivalent status.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
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.
Adjacent lines procurement desks order alongside faropenem.
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 faropenem.
- 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.
Faropenem supply, the specific questions.
Is faropenem approved by the FDA, MHRA or EMA?
No. Faropenem medoxomil, the ester prodrug once pursued for US approval covering acute bacterial sinusitis, community-acquired pneumonia, chronic bronchitis exacerbation and skin and skin-structure infections, received an FDA non-approvable letter in October 2006 requesting further clinical studies, and was never resubmitted. There is no MHRA or EMA marketing authorisation either. M Care does not quote faropenem against UK, US or EU tenders as a result; supply is to markets where the destination regulator can register the product on its own terms.
Where is faropenem actually licensed and marketed?
Japan, under its own national licensing, and India, where it is manufactured and sold as a domestic generic under multiple brand names. Neither is a market M Care serves: Japan because our export network does not cover it, India because M Care is an exporter and does not sell into the Indian market. We source the WHO-GMP Indian manufacturing base and export to destination countries that hold their own registration route.
What strengths and forms of faropenem does M Care supply?
200mg and 300mg film-coated tablets for adults, and a 50mg/5mL oral dry syrup, reconstituted at dispensing, for children who cannot swallow a tablet. Tell us your buyer mix, hospital, tender or paediatric formulary, and destination country, and we confirm which strengths that market can register before quoting.
What is faropenem used to treat?
Uncomplicated and complicated urinary tract infections, upper and lower respiratory tract infections, skin and soft-tissue infections, and gynaecological infections, per its Japanese and Indian labelling. Adult UTI dosing runs 200mg to 300mg three times daily depending on severity; paediatric dosing is weight-based per the manufacturer's label. Confirm destination-country labelling before a tender submission, since indications are not FDA or EMA-verified.
Is faropenem on the WHO Essential Medicines List, and what is its AWaRe classification?
It is not on the WHO Model List of Essential Medicines. WHO's AWaRe antibiotic classification places faropenem in the Reserve group, allocated there for antimicrobial-stewardship monitoring purposes rather than as a first-line empirical choice. Published data show faropenem MICs rising quickly under exposure in vitro, with a signal for cross-resistance to the injectable carbapenems, so tender desks should specify it for confirmed-susceptible indications rather than blanket empirical UTI or respiratory cover.
Does faropenem need cold-chain shipping?
No. Both the tablet and the dry syrup are oral solid or oral powder-for-reconstitution formats that travel on standard ambient logistics, stored in a cool, dry place, protected from moisture, at standard controlled room temperature. This is unlike the validated cold-chain lanes M Care runs for biologics and some injectable antibiotics.
What documentation does M Care provide with a faropenem shipment?
Batch-level certificate of analysis, CDSCO export documentation confirming the Indian manufacturing site's WHO-GMP status, and CTD or country-specific dossier support so the destination regulator can complete national registration, since no FDA, MHRA or EMA label exists to reference. We also confirm in writing which brand or generic product a shipment contains before dispatch.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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.
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