Faropenem Tablet
| Product/Composition:- | Faropenem Tablet |
|---|---|
| Strength:- | 200mg, 300mg |
| Form:- | Tablet |
| Production Capacity:- | 10 Million Tablets/Month |
| Packaging:- | 10 X 10 Tablets / Box |
| Therapeutic use:- | Serious bacterial infections |
| Package Insert/Leaflet:- | Available upon request |
Introduction
Faropenem is an oral penem, a beta-lactam class related to but distinct from the carbapenems, and it is manufactured in a dedicated beta-lactam block segregated from penicillin and cephalosporin operations.
It is approved in a limited number of jurisdictions, so we confirm registrability in your market before quoting rather than after.
Complete CTD dossiers, in vivo bioequivalence data, CoPP, FSC, and ICH Zone IVb stability are supplied, together with the stewardship documentation that responsible procurement in this class now expects.
Product Overview
| Field | Details |
| Product Name | Faropenem Sodium Tablets |
| INN / Generic Name | Faropenem sodium |
| Therapeutic Class | Oral penem beta-lactam antibacterial, related to but distinct from the carbapenems |
| Mechanism | Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins |
| Spectrum | Activity against many Gram-positive and Gram-negative aerobes and anaerobes, including some beta-lactamase-producing strains |
| Oral Bioavailability | Reported at approximately 70-80% |
| Indications | Upper and lower respiratory tract infections, urinary tract infections, skin and soft tissue infections, and gynaecological infections per approved local labelling |
| Regulatory Footprint | Approved in Japan since 1997 and in India. NOT approved by the US FDA a non-approvable letter was issued in 2006 and not authorised in Europe. |
| Stewardship Flag | Literature links faropenem overuse to cross-resistance with carbapenems, which are reserved as last-line agents. |
| Susceptibility Testing | CLSI and EUCAST breakpoints are not established, so routine susceptibility testing is generally not performed. |
| API Quality | Manufactured using DMF-grade Faropenem Sodium |
| Pharmacopoeial Standard | IP / JP |
| Available Strengths | 150 mg and 200 mg tablets |
| Reference Regimen | Adult dosing typically 200–300 mg three times daily per approved local labelling |
| Shelf Life | 24 Months |
| Storage | Protect from moisture |
| Manufacturing Facility | WHO-GMP certified DEDICATED beta-lactam block, segregated from penicillin and cephalosporin operations |
| Dossier Available | Yes, CTD format |
Strengths & Presentation
Faropenem Sodium Tablets 200 mg
The principal adult strength, dosed three times daily under approved labelling.
This is the presentation that carries most of the volume in the markets where the molecule is registered, and it is the one used in the ESBL-related indications for which faropenem is genuinely valued by clinicians.
Target buyers: hospital procurement and specialist distributors in markets where the molecule is registrable.
Faropenem Sodium Tablets 150 mg
The lower adult strength, providing dosing flexibility within the approved regimen. Typically tendered alongside the 200 mg strength rather than separately.
Specification & Testing
Assay, content uniformity, dissolution, and related substances against the declared monograph
Moisture control is a primary stability concern beta-lactams are moisture-sensitive, and the packing specified in Section 8 follows from this
Degradation product profile characterised, with the beta-lactam ring-opening pathway monitored across stability
Discriminatory dissolution method validated across the physiological pH range
Regulatory & Dossier Support
Dossier Availability
CTD (Common Technical Document) ICH-aligned, prepared for the jurisdictions where the molecule is registrable.
Module 3 quality documentation includes beta-lactam facility information, dedicated equipment justification, moisture control strategy, and degradation product characterisation.
Stability data includes real-time and accelerated under ICH Zone IVb (30°C / 75% RH), with particular attention to moisture uptake.
Country-specific dossier customisation and regulatory query response support for eligible jurisdictions.
Bioequivalence Position
In vivo bioequivalence (BE) data against the reference product is the standard route for registration of faropenem sodium tablets.
Reported oral bioavailability of approximately 70 to 80 percent suggests reasonable absorption, but whether a BCS-based biowaiver is available depends on solubility and permeability data recorded in your own dossier.
Comparator sourcing is a practical constraint on this molecule.
The reference product is marketed in very few countries, so obtaining comparator material for a bioequivalence study is materially harder than for an ordinary generic.
BE study data available
Comparative dissolution profiles held throughout shelf life
Drug Master File (DMF)
Drug Master File (DMF) reference for the Faropenem Sodium API is available for cross-referencing in your registration dossier.
API is sourced from a qualified vendor with full impurity, residual solvent, and degradation product characterisation.
The API supplier must itself hold beta-lactam-appropriate segregation a finished-dose manufacturer’s dedicated block does not compensate for cross-contamination upstream.
Manufacturing Compliance Dedicated Beta-Lactam Block
WHO-GMP certified manufacturing facility, audit-ready, with inspection reports shared on an NDA basis.
Dedicated beta-lactam block with self-contained air handling, dedicated equipment, pressure cascade, and separate personnel and material flows.
Segregation between beta-lactam sub-classes is critical.
Penicillins, cephalosporins and penems are handled in separate dedicated arrangements rather than campaigned through shared beta-lactam facilities.
Cross-contamination control is a patient-safety issue here, not only a compliance one beta-lactam residues at trace levels can provoke hypersensitivity reactions in sensitised patients.
Validated cleaning with swab and rinse recovery data, and analytical methods sensitive to trace beta-lactam residue dedicated effluent handling for beta-lactam waste, with deactivation before discharge.
Complete Documentation Package (Per Shipment)
| Document | Purpose |
| Certificate of Analysis (CoA) | Confirms batch quality against the agreed specification |
| Certificate of Pharmaceutical Product (CoPP / CPP) | Required for MOH registration where the molecule is registrable |
| Free Sale Certificate (FSC) | Confirms the product is freely sold in the country of manufacture |
| Method of Analysis (MOA) | Analytical methodology mandatory dossier component |
| GMP Certificate | Confirms site compliance, specifically for the dedicated beta-lactam block |
| Beta-Lactam Segregation Statement | Confirms separation from penicillin and cephalosporin operations |
| Cleaning Validation Summary | Swab and rinse recovery against trace beta-lactam residue limits |
| Stability Data | Real-time and accelerated ICH Zone IVb, with moisture uptake data |
| BE Study Report or Biowaiver Justification | States comparator used and its market of origin |
| Dissolution Profile Report | Across the physiological pH range |
| Stewardship Information Pack | Prescribing-context material for the destination |
| Excipient Declarations | For all inactive ingredients |
Clinical Information & Stewardship Assessment
Faropenem is an oral penem that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins. It has activity against many Gram-positive and Gram-negative aerobes and anaerobes, including some beta-lactamase-producing strains, with reported oral bioavailability of approximately 70 to 80 percent.
Approved indications per local labelling: upper and lower respiratory tract infections, urinary tract infections, skin and soft tissue infections, and gynaecological infections.
The genuine clinical value is oral treatment of infections, including some ESBL-related presentations, that would otherwise require intravenous therapy and hospital admission.
In markets where it is registered, clinicians value it for exactly that reason.
The Stewardship Problem Stated Plainly
Published literature raises a specific and serious concern about this molecule.
Carbapenems such as meropenem and imipenem are reserved as last-line intravenous agents for critically ill patients with multidrug-resistant organisms.
Faropenem is an oral penem in the same broad beta-lactam family; it is inexpensive, and it is convenient to prescribe in outpatient settings.
Reports indicate that faropenem resistance can be associated with cross-resistance to carbapenems, and commentators have warned that widespread outpatient use may erode the effectiveness of the agents that hospitals depend on.
A practical compounding factor: CLSI and EUCAST breakpoints are not established for faropenem, so routine susceptibility testing is generally not performed.
In Japan, use is reported to be reserved for specific situations such as ESBL-producing organisms, which is a materially different pattern from broad outpatient prescribing.
Paediatric use draws the sharpest criticism, on the grounds that the convenience of an oral penem in outpatient paediatric practice drives the overuse pattern of concern.
Commercial Positioning
Sell to the hospital and specialist channel, not to volume retail.
The molecule’s legitimate value is in situations where oral therapy substitutes for intravenous treatment.
Supply stewardship material with the product.
We provide prescribing-context information covering the reserved place of this agent, the absence of routine susceptibility testing, and the carbapenem cross-resistance concern.
Do not build a forecast on outpatient volume growth.
Regulatory attention to this molecule is increasing, and a business case that depends on unrestricted outpatient prescribing is exposed to restriction.
Decline enquiries that signal unregulated supply.
A buyer seeking bulk unbranded oral penem for undefined channels is a reputational risk that outweighs the order.
Registrability Screen
Where the Molecule Is Approved
Japan approved since 1997, with use reported to be reserved for specific situations such as ESBL-producing organisms. India approved for the indications above.
NOT approved by the US FDA a non-approvable letter was issued in 2006, and development did not proceed to approval. NOT authorised in Europe.
The Screening Sequence
Export Packaging & Supply Chain
Primary Packaging Options
| Presentation | Packaging Options |
| Faropenem Sodium Tablets 200 mg | Alu-Alu blister 10×10 and 2×10, high moisture barrier, in mono-carton with leaflet |
| Faropenem Sodium Tablets 150 mg | Alu-Alu blister 10×10 and 2×10 |
| Course packs | Configurations matching the approved course length, so a complete course is dispensed |
Alu-Alu is specified rather than offered as an option.
Beta-lactams are moisture-sensitive, the ring-opening degradation pathway is moisture-driven, and a permeable blister in a Zone IVb market is a stability failure waiting to happen.
Course-matched packs deserve particular attention: a partial course is the mechanism by which resistance develops, and pack size is among the few levers a manufacturer genuinely controls.
Labelling & Customisation
Private label manufacturing available, subject to unchanged regulatory content. Multi-lingual labelling per destination.
Mandatory artwork content: the beta-lactam hypersensitivity caution and cross-allergenicity warning, the approved indication set, the full course instruction, storage and moisture-protection statement, and country-specific registration fields.
Note: Consider whether private label is appropriate on this molecule. Placing a third-party brand reduces traceability of where the product ends up, and the channel discipline is harder to maintain through an unbranded supply chain.
Logistics & Supply
Incoterms: FOB, CIF, CFR, EXW as per buyer requirement.
No cold chain required; protect from moisture and sustained heat in transit.
Dedicated beta-lactam block capacity is campaign-scheduled and shared across the beta-lactam portfolio.
Why Source Faropenem Sodium Tablets From Us?
A Genuinely Dedicated Beta-Lactam Block Self-contained air handling, dedicated equipment, and separate flows, with segregation between penicillin, cephalosporin, and penem operations. Ask any supplier about sub-class segregation specifically.
Trace-Residue Cleaning Validation Swab and rinse recovery with methods sensitive to trace beta-lactam residue, because cross-contamination is a hypersensitivity risk to patients.
We Confirm Registrability Before We Quote Oral penems are approved in very few countries. We establish the regulatory position for your destination first.
Frequently Asked Questions
Q1. Can you supply faropenem to my market?
Only where the molecule is registered or registrable.
Oral penems are approved in very few countries principally Japan, where faropenem has been available since 1997, and India.
The US FDA issued a non-approvable letter in 2006. We confirm the regulatory position for your destination before quoting.
Q2. Is faropenem a carbapenem?
No, but the distinction matters less than the relationship. Faropenem is an oral penem a beta-lactam class related to the carbapenems.
That relationship is the source of the stewardship concern: reports indicate faropenem resistance can be associated with cross-resistance to carbapenems, which are reserved as last-line intravenous agents.
Q3. What manufacturing facility does this product require?
A dedicated beta-lactam block. Penems require segregation from penicillin and cephalosporin operations, because cross-contamination between beta-lactam sub-classes is a regulatory concern and a hypersensitivity risk to sensitised patients.
Ask suppliers about sub-class segregation specifically.
Q4. Why do you raise antimicrobial stewardship on a product page?
Because any buyer with a clinical adviser will raise it, and a page that omits it looks either uninformed or evasive.
Faropenem has genuine value for oral treatment of infections that would otherwise need intravenous therapy.
It also carries a documented concern about promoting carbapenem cross-resistance. Both are true.
Q5. Is susceptibility testing available for faropenem?
Generally not as a routine test. CLSI and EUCAST breakpoints are not established for faropenem. Prescribing therefore proceeds without the microbiological feedback that would normally guide antibiotic selection, which is a real limitation.
Q6. Do you provide a dossier?
Yes, in CTD format, prepared for jurisdictions where the molecule is registrable.
The dossier includes Module 3 quality documentation with beta-lactam facility information and dedicated equipment justification, moisture control strategy, degradation product characterisation, ICH Zone IVb stability, and the bioequivalence study report.
Q7. What is the position on comparator sourcing for bioequivalence?
It is a genuine constraint, and we raise it early.
Because the reference product is marketed in very few countries, obtaining comparator material for a bioequivalence study is materially harder than for an ordinary generic.
We will tell you what we hold and from which market of origin.
Q8. Which channels do you supply?
Hospital and specialist channels. The legitimate clinical value lies in situations where oral therapy substitutes for intravenous treatment.
We do not pursue volume retail supply, and enquiries that suggest unregulated or undefined distribution channels are declined.
Enquiring about Faropenem Sodium Tablets?
Tell us your destination market and your intended channel first.
Our regulatory team will confirm whether the molecule is registered or registrable there, address comparator availability for bioequivalence purposes, and then follow with specification, dossier scope, pack options, and pricing.
Facility documentation covering beta-lactam sub-class segregation is shared under confidentiality during technical evaluation.