Cefotaxime is the third-generation cephalosporin neonatal and paediatric units specify by name because, unlike ceftriaxone, it carries no calcium-interaction restriction in newborns.
Cefotaxime is the third-generation cephalosporin that hospital pharmacies keep on formulary specifically because ceftriaxone cannot go near a neonate on a calcium-containing intravenous line. M Care Exports supplies cefotaxime injection lines sourced from WHO-GMP certified Indian manufacturers, spanning the 125mg to 1g range used across adult and neonatal dosing protocols. We work with regulatory affairs teams, hospital procurement desks and licensed importers across the UK, EU, Gulf, Africa, Latin America, Southeast Asia and CIS markets who need documentation that stands up to tender scrutiny.
Cefotaxime exporter and bulk supplier from India.
Cefotaxime ships as sterile powder for reconstitution, so export documentation centres on the Certificate of Analysis, Certificate of Pharmaceutical Product and stability data supporting the labelled shelf life. Cefotaxime powder for injection is stored at controlled room temperature, not refrigerated, which simplifies freight compared with biologics and removes cold-chain logistics from the shipment plan. Packing uses tamper-evident vials in cartons rated for standard pharmaceutical freight, with batch-specific documentation, packing lists and certificates of origin prepared per shipment for customs and import-licence review. M Care coordinates CDSCO export paperwork, manufacturer WHO-GMP certificates and country-specific labelling requirements ahead of shipment, and aligns documentation to the buyer's national drug regulatory authority format for tender submissions across UK/EU, Gulf, African, Latin American, Southeast Asian and CIS markets.
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.
Third-generation cephalosporin antibiotic, sourced and documented for export.
Cefotaxime is the third-generation cephalosporin many neonatal and paediatric units specify by molecule name rather than by class, because its closest same-generation comparator, ceftriaxone, is contraindicated in neonates who require calcium-containing intravenous solutions, following fatal ceftriaxone-calcium precipitation cases. Cefotaxime does not carry that restriction, which is why regulatory literature describes it as a cephalosporin of choice for hospitalised neonates. Clinically it is a broad-spectrum agent active against many Gram-negative and Gram-positive organisms, used for sepsis, meningitis, respiratory, skin and intra-abdominal infections and gonorrhoea, dosed several times daily because of its short half-life and partial hepatic conversion to an active metabolite, desacetylcefotaxime. M Care's catalogue reflects this clinical picture: injectable lines dominate, spanning 125mg to 1g presentations, sourced from WHO-GMP certified Indian manufacturers for supply into regulated and semi-regulated export markets.
Active ingredient
Cefotaxime sodium. Third-generation cephalosporin antibiotic.
Forms and strengths
125 mg; 250 mg; 500 mg; 750 mg; 1000 mg; 1 g.
Indications
Cefotaxime is a third-generation cephalosporin antibiotic active against a broad range of Gram-negative and Gram-positive organisms, used in hospital settings for sepsis, meningitis, respiratory, skin and intra-abdominal infections and gonorrhoea. It is cleared partly by hepatic conversion to an active metabolite, desacetylcefotaxime, and partly by renal excretion, and it is not contraindicated with calcium-containing intravenous solutions in neonates, distinguishing it from ceftriaxone in that specific setting.
Administration
Intravenous, Intramuscular, Oral (single suspension line; confirm destination-market registration). Powder for solution for injection or infusion (predominant, 26 of 27 stocked lines); oral suspension (1 line).
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.
Cefotaxime injection moves mainly through hospital and institutional channels rather than retail pharmacy, reflecting its use in inpatient sepsis, meningitis and neonatal protocols. M Care Exports supplies regulatory affairs teams preparing import dossiers, hospital and NICU procurement desks, tender boards at government and institutional buyers, and licensed pharmaceutical importers and distributors. Demand originates from the UK and EU markets running national import assessments, Gulf and GCC tender authorities sourcing injectable anti-infectives for public hospital systems, African ministries of health and NGO-linked procurement programmes, Latin American distributors serving hospital networks, and importers across Southeast Asia and the CIS states. India is the country of manufacture only; it 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 cefotaxime.
A pharmacist reviewing a cefotaxime dossier checks the salt form, cefotaxime sodium, and the sodium content per gram, relevant where a receiving formulary tracks sodium load in neonates or renal-impairment patients. Renal function matters: cefotaxime and its active metabolite, desacetylcefotaxime, are renally eliminated, and labelling calls for the dose to be halved once creatinine clearance falls below roughly 20 mL/min/1.73m2, a standard formulary note distinct from hepatically cleared agents in the same class. The comparison pharmacists raise most often is against ceftriaxone: cefotaxime's shorter half-life means more frequent daily dosing, but it avoids ceftriaxone's calcium-precipitation contraindication in neonates, which is why cefotaxime, not ceftriaxone, appears in most neonatal sepsis and meningitis protocols. Cross-reactivity screening for penicillin or cephalosporin allergy history is standard for any cephalosporin review. For the oral suspension line specifically, a reviewing pharmacist should confirm the product's marketing authorisation and absorption data in the destination market before listing it, since major regulatory labelling describes cefotaxime as a parenteral-only antibiotic with no oral formulation.
The documentation pack a regulator actually asks for.
M Care's documentation pack for cefotaxime lines includes the Certificate of Analysis per batch, Certificate of Pharmaceutical Product, stability data supporting shelf life under standard, non-cold-chain storage, and the manufacturer's WHO-GMP certification, since M Care itself does not hold manufacturing certification. M Care operates as a merchant-exporter under ISO 9001:2015 and a CDSCO export licence, and sources cefotaxime exclusively from WHO-GMP certified Indian manufacturing partners; it does not itself hold WHO-GMP or WHO-PQ status. Because cefotaxime is a sterile injectable, sterility assurance and endotoxin testing documentation from the manufacturer forms part of the standard pack, alongside container-closure data for the vial format. For the single oral suspension line in the catalogue, buyers should request that specific product's marketing authorisation or registration status in the destination country before including it in a tender, since major regulatory agencies list cefotaxime only as a parenteral formulation. Buyers preparing MHRA, EU, Gulf or African tender submissions receive documentation formatted to the requesting authority's dossier structure.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Cefotaxime injection is a prescription-only, hospital-administered antibiotic, not for patient self-administration or OTC sale.
M Care Exports is a merchant-exporter and does not hold WHO-GMP or WHO-PQ certification; all cefotaxime lines are sourced from WHO-GMP certified Indian manufacturers.
India is the country of manufacture only; M Care does not supply the Indian domestic market.
Buyers must confirm destination-market marketing authorisation and registration status before import, particularly for the single oral suspension line, since major regulatory agencies list cefotaxime only as a parenteral formulation.
Cefotaxime carries standard cephalosporin cross-reactivity and hypersensitivity warnings for patients with a penicillin or cephalosporin allergy history.
Renal impairment requires dose or interval adjustment per manufacturer labelling; this is a prescriber and dispensing-institution responsibility, not a dosing recommendation from M Care.
Adjacent lines procurement desks order alongside cefotaxime.
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 cefotaxime.
- 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.
Cefotaxime supply, the specific questions.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, so it does not hold WHO-GMP or WHO-PQ certification itself. Every cefotaxime line is sourced from Indian manufacturing partners who hold WHO-GMP certification, and M Care operates under ISO 9001:2015 and a CDSCO export licence for its own trading and export operations.
Why do neonatal units request cefotaxime instead of ceftriaxone?
Ceftriaxone is contraindicated in neonates who require calcium-containing intravenous solutions, following reports of fatal ceftriaxone-calcium precipitation in the lungs and kidneys. Cefotaxime does not carry that restriction, which is why regulatory and formulary literature describes it as the third-generation cephalosporin of choice for hospitalised neonates.
What dosage forms does M Care supply for cefotaxime?
M Care's cefotaxime catalogue is predominantly injectable, spanning strengths from 125mg to 1g. One oral suspension line is also stocked; buyers should confirm its registration status in their destination market before including it in a tender, since major regulatory agencies list cefotaxime only as a parenteral formulation.
Why does cefotaxime need more frequent dosing than some comparators?
Cefotaxime has a short elimination half-life and is cleared partly by hepatic conversion to an active metabolite, desacetylcefotaxime, alongside renal excretion of both parent drug and metabolite. This pharmacokinetic profile is why cefotaxime schedules run several times daily, a difference procurement teams should factor into tender volume calculations against once-daily alternatives.
Is cefotaxime supply affected by cold-chain requirements?
No. Cefotaxime powder for injection is stored at controlled room temperature, not refrigerated, so shipments do not require the cold-chain logistics that biologics need. Standard pharmaceutical freight and storage conditions apply, which simplifies export logistics into markets with limited cold-chain infrastructure.
What documentation does M Care provide for tender submissions?
Each shipment is supported by a batch-specific Certificate of Analysis, Certificate of Pharmaceutical Product, manufacturer WHO-GMP certification and stability data. M Care aligns packing lists, certificates of origin and labelling documentation to the format required by the destination country's drug regulatory authority for tender or import-licence review.
Which markets does M Care supply cefotaxime into?
M Care exports cefotaxime to buyers across the UK and EU, Gulf and GCC states, Africa, Latin America, Southeast Asia and the CIS. India is the country of manufacture only; M Care does not sell into the Indian domestic market.
Does cefotaxime require dose adjustment in renal impairment?
Cefotaxime and its active metabolite are renally eliminated, and labelling calls for the dose to be halved once creatinine clearance falls below roughly 20 mL/min/1.73m2. This is a standard formulary and labelling note that regulatory affairs teams typically carry into local product documentation during registration or tender 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 2026-08-22.
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.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.