Cefepime injection — supplier from India to the UK, GCC and Africa.

A fourth-generation cephalosporin for empirical febrile neutropenia, hospital-acquired pneumonia and complicated Gram-negative infection with retained Pseudomonas activity. 500mg, 1g and 2g IV vials from Indian WHO-GMP partner sites, with the CTD dossier, WHO-PQ pathway support and the neurotoxicity-warning stewardship documentation an ICU pharmacy actually reads.

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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
At a glance

Multiple WHO-GMP partner lines · 500mg, 1g and 2g IV vials · WHO-PQ pathway supported.

Active ingredient

Cefepime (dihydrochloride monohydrate salt on label). Fourth-generation cephalosporin beta-lactam. Penetrates the outer membrane of Gram-negative organisms faster than 3rd-generation agents, has lower affinity for AmpC beta-lactamases, and retains Pseudomonas aeruginosa activity. Maintained Gram-positive coverage including methicillin-susceptible S. aureus and streptococci.

Strengths stocked

500mg, 1g and 2g lyophilised vials. Reconstitute the 1g vial with 10ml water for injection or 0.9% NaCl; further dilute in 50-100ml for infusion. IV infusion over 30 minutes is standard; IM use is approved but rare in tender markets. Extended-infusion protocols (3-hour) supported for severe Pseudomonas disease.

Indications

Empirical febrile neutropenia (WHO EML core indication), hospital-acquired and ventilator-associated pneumonia, complicated urinary tract infections, complicated intra-abdominal infections (with metronidazole), moderate to severe skin and soft-tissue infections. Cefepime sits in the WHO AWaRe Watch group: stewardship-aligned procurement.

Storage

Store the lyophilised vial below 25°C. Reconstituted solution is stable for up to 24 hours refrigerated at 2-8°C in approved diluents, or 18 hours at room temperature. Slight yellow-to-amber discoloration on storage is normal and does not indicate loss of potency, but the receiving pharmacy should confirm against the diluent-specific stability table.

Shelf life

24 months from manufacture; minimum 18 months at dispatch, or we won't ship.

Pack format

Type I colourless glass vial with bromobutyl rubber stopper and aluminium flip-off seal. Single-vial cartons per strength. Five- and ten-vial outer cartons available for tender supply with batch-level traceability and outer-carton variable data printing.

Who we supply

Oncology day units, ICU pharmacies and tender desks across twenty markets.

India is our origin. We do not sell into the Indian market. Cefepime is exported only.

United Kingdom

NHS oncology and critical-care pharmacies under licensed wholesale supply, and specialist importers under the MHRA (Medicines and Healthcare products Regulatory Agency) Specials / named-patient route when licensed UK supply is constrained. Cefepime has appeared on the MHRA medicines supply notification list intermittently. Pack inserts to the SmPC standard; QP release organised on arrival in the UK.

Named-patient import, UK →

GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)

Through local licensed importers, against MoH tender awards and hospital pharmacy purchase orders for haematology-oncology day units and ICU. CTD dossiers prepared for national registration with SFDA (Saudi Food & Drug Authority), MOHAP (UAE Ministry of Health and Prevention) and the GCC central registration pathway. Arabic-language PIL with neurotoxicity warning prepared for MoH review.

MoH registration, GCC →

Nigeria, Kenya, Ghana, South Africa

Public-sector oncology and ICU tenders (NAFDAC Nigeria, KEMSA Kenya, CMS Ghana, SAHPRA South Africa), teaching-hospital supply and NGO procurement. Cefepime is on the WHO EML core list for febrile neutropenia. Global Fund, UNICEF SD and MSF buyers catered for separately with WHO-PQ-aligned documentation and antimicrobial-stewardship evidence.

Germany

Supply through licensed German importers under §72 AMG, with Qualified Person (QP) certification on arrival. CTD dossier and CoPP prepared for BfArM (Federal Institute for Drugs) recognition. German-language PIL matches the EMA reference SmPC with the renal-impairment neurotoxicity warning verbatim and the AWaRe Watch classification noted.

Pharmacist's note

What the haematology-oncology pharmacist actually checks before the first dose.

Adult dose is 1-2g IV every 8-12 hours, with the febrile-neutropenia indication using 2g q8h for the duration of neutropenia. Paediatric dose is 50 mg/kg every 8 hours up to a 2g cap. Renal dose adjustment is non-negotiable: at CrCl 30-60 ml/min reduce the dose interval to q12h or halve the dose; at CrCl <30 ml/min reduce further; on dialysis, supplementary dose post-dialysis. The risk most often missed is neurotoxicity in renal impairment: encephalopathy, non-convulsive status, myoclonus and frank seizures have been documented with inadequately renal-adjusted dosing (FDA safety communication 2012; cumulative case literature ongoing). Symptoms typically appear 1-10 days into therapy and reverse on discontinuation. Watch elderly patients, baseline CNS pathology, and any acute drop in renal function during therapy. Cross-reactivity with documented penicillin or first-gen cephalosporin allergy is approximately 1-3% — proceed with caution if the history is anaphylactic. Coombs-positive haemolytic anaemia is a recognised but uncommon signal in long courses. Procure to oncology day-unit consumption: cefepime sits in AWaRe Watch and stewardship discipline applies.

Regulatory & quality

The documentation pack a regulator and a Global Fund buyer both ask for.

Cefepime is on the WHO Essential Medicines List core list (febrile neutropenia indication) and the WHO AWaRe Watch group. Multiple Indian WHO-GMP facilities have WHO-PQ prequalification on cefepime. We sit between the partner site and your clinical, regulatory or procurement team and take the paperwork off both sides.

CTD Module 3

Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary and sterility-assurance justification included, with the stability package covering the 24-month lyophilised shelf life and the reconstituted-solution stability table across approved diluents.

CoA and MoA, per batch

HPLC assay, related substances, water content (Karl Fischer — critical for a lyophilised cephalosporin), residual solvents, sterility per USP <71>, bacterial endotoxin per USP <85>, particulate matter, pH of reconstituted solution — signed by the manufacturer's authorised QC head.

CoPP, WHO-GMP, MFG licence

Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires. WHO-PQ status confirmed against the current WHO list where the tender specifies it. Notarised copies in the shipping pack.

Pack insert, labels, artwork

Destination-language PIL to MHRA SmPC, EMA, SFDA, MOHAP, SAHPRA or BfArM style. Renal-impairment neurotoxicity warning verbatim from the reference label. AWaRe Watch classification noted where destination labelling requires. Artwork QC before print.

Temperature control

Pre-shipment thermal validation confirms the below-25°C specification holds through worst-case transit routes. Continuous in-transit logging; on-arrival inspection with a signed record. Excursion protocol defined before dispatch. Reconstituted-solution stability table shared with the receiving pharmacy.

Pharmacovigilance

Local PV partner or named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. Neurotoxicity (encephalopathy, myoclonus, seizures), Clostridioides difficile, anaphylaxis and Coombs-positive haemolytic anaemia signals tracked on the 15-day expedited reporting track.

Related anti-infectives molecules

Complete the oncology and critical-care antimicrobial roster.

Cefepime is the 4th-generation cephalosporin in the empirical febrile-neutropenia toolkit. The surrounding beta-lactams, carbapenems, glycopeptides and macrolides cover the rest of the empirical and targeted hospital roster.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Strength split (500mg / 1g / 2g vial counts), pack format (single-vial cartons or 5/10-vial outer packs), destination market, tender / hospital / Global Fund route, and target delivery window.
  2. We route to the right line. Multiple WHO-GMP partner lines sit on the M Care roster for cefepime, several with current WHO-PQ prequalification. Registered markets get facilities with in-country registration; tenders get WHO-PQ lines where the buyer specifies prequalified supply.
  3. Commercial and regulatory offer. FOB / CIF price, lead time, dossier status per destination, WHO-PQ status where relevant, and the documentation pack with the shipment. Inside one working day.
  4. Order, produce, release, ship. QC release on the Indian side with HPLC assay, water content, sterility and endotoxin on the certificate. Temperature-controlled dispatch under 25°C, continuous logging in transit, on-arrival inspection. Photo evidence of seal integrity on request.
  5. After delivery. Batch records, CoA and thermal logs archived for the shelf life of the consignment. Pharmacovigilance contact opened on registration. Neurotoxicity, C. difficile and anaphylaxis signals tracked on the 15-day expedited reporting track.
Frequently asked

Cefepime supply — the specific questions.

What strengths of cefepime do you supply?

Cefepime is supplied as 500mg, 1g and 2g lyophilised vials, the three standard hospital strengths across MHRA, EMA, SFDA, MOHAP, SAHPRA and BfArM labelling. The 1g vial reconstitutes with 10ml water for injection or 0.9% NaCl and further dilutes into 50-100ml for a 30-minute IV infusion. Single-vial cartons are standard; 5- and 10-vial hospital outer packs are available against firm tender orders with batch-level traceability on the outer.

Do you supply WHO-PQ prequalified cefepime for Global Fund and UN procurement?

Yes. Multiple Indian WHO-GMP partner lines on the M Care roster hold current WHO Prequalification (WHO-PQ) on cefepime, which is the gating requirement for Global Fund, UNICEF Supply Division, GHSC-PSM and comparable UN procurement routes. Where a tender specifies prequalified supply we route to the WHO-PQ lines; where it doesn't, the broader WHO-GMP roster applies. The PQ status is confirmed against the WHO list at point of offer and the prequalification reference appears in the CoPP pack. See NGO and donor procurement.

How serious is the cefepime neurotoxicity risk and how is it handled in the documentation?

The neurotoxicity signal is real and the failure mode is almost always inadequate renal dose adjustment. Encephalopathy, non-convulsive status epilepticus, myoclonus and frank seizures have been documented when cefepime accumulates in renal impairment; the FDA issued a formal safety communication in 2012 and case literature has continued. Our destination-language pack inserts carry the renal-dosing table and the neurotoxicity warning verbatim from the reference SmPC. Standard pharmacy guidance: calculate CrCl on day one, recalculate on any change in renal function, reduce frequency to q12h at CrCl 30-60 ml/min, halve the dose at CrCl <30 ml/min, supplementary dose post-dialysis. Symptoms typically appear 1-10 days in and reverse on discontinuation; do not rechallenge.

Which markets can you ship cefepime into?

We routinely ship cefepime into the UK (licensed wholesale and MHRA Specials / named-patient import where the UK supply is constrained), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain through licensed local importers), sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa through oncology and ICU tender supply plus Global Fund procurement where the tender specifies WHO-PQ), and Germany (§72 AMG import channels with QP certification). We do not supply into India.

What documentation is included with a cefepime consignment?

Every consignment ships with a batch-specific Certificate of Analysis (HPLC assay, related substances, water content by Karl Fischer, sterility per USP <71>, bacterial endotoxin per USP <85>, particulate matter, reconstituted-solution pH), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO-PQ confirmation where applicable, Certificate of Origin, destination-language PIL with the renal-impairment neurotoxicity warning, temperature logs, and the WHO AWaRe Watch stewardship reference insert. Full list under anti-infectives.

How should oncology procurement structure cefepime orders for febrile neutropenia cover?

Cefepime is the WHO EML core agent for empirical febrile neutropenia, so demand is driven by chemotherapy cycle volume rather than emergency-department flow. Procurement should match the haematology-oncology day-unit cycle calendar: estimate cycles per month, multiply by an average 5-7 day empirical course at 2g q8h, and order to a 3-6 month rolling consumption with one month of safety stock. AWaRe Watch classification means batch sizes should be modest and shelf-life pressure should not force consumption; we'll size the first order conservatively and step it up once draw-down is observed. Where ESBL or AmpC resistance prevalence on the local antibiogram is high, factor in carbapenem escalation rates: cefepime use may fall and meropenem use rise, and the order mix should adjust quarter on quarter.

What are typical lead times for cefepime orders?

For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. Made-to-order batches, 8-12 weeks inclusive of QC release (HPLC, water content, sterility, endotoxin) and destination-specific artwork approval; lyophilised cephalosporins need full sterility and endotoxin clearance before release. Air-freight to UK or GCC: 3-5 days; sea-freight to Africa: 18-28 days at below-25°C with continuous in-transit logging and on-arrival inspection.

Cefepime enquiry

Send the specifics. You'll have a price inside one working day.

Strength split, pack format, destination, tender or hospital pharmacy or Global Fund route, target delivery. That's the enquiry. Everything else is on us.

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