Cefalexin, the first-generation oral cephalosporin once sold as Keflex and now supplied almost entirely as generic, is a WHO AWaRe Access-group antibiotic for respiratory, skin and urinary tract infections that M Care sources as WHO-GMP capsules and suspension for hospital and tender-desk procurement.
M Care Exports supplies cefalexin, a first-generation oral cephalosporin originated by Eli Lilly under the brand Keflex and now marketed almost exclusively as generic cephalexin capsules and suspension following the brand's discontinuation across major markets. As a merchant exporter, we source WHO-GMP generic cefalexin through licensed Indian manufacturing and distribution channels and dispatch on quote, not from our own manufacturing.
Cefalexin exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes cefalexin against buyer specification: dosage form (250 mg and 500 mg capsules, or 125 mg/5 mL and 250 mg/5 mL oral suspension), pack size and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because cefalexin's suspension requires refrigeration once reconstituted while the capsules do not, we confirm the buyer's intended dosage-form mix and in-market cold-chain handling capacity 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.
First-generation cephalosporin antibiotic; beta-lactam, WHO AWaRe Access group, sourced and documented for export.
Cefalexin is a first-generation cephalosporin antibiotic that inhibits bacterial cell-wall synthesis by binding penicillin-binding proteins, active against a narrower Gram-positive-weighted spectrum than later cephalosporin generations. It is dosed orally, not injected, and the capsule form needs no reconstitution. The FDA label's flagship indications are respiratory tract infections, otitis media, skin and skin structure infections, bone infections and genitourinary tract infections caused by susceptible organisms; the WHO Essential Medicines List separately recommends cefalexin 500 mg for COPD exacerbations and, at a different dosing frequency, for bacterial pharyngitis and mild skin and soft-tissue infections. Cefalexin sits in the WHO AWaRe Access group, the tier of narrow-spectrum, lower-resistance-risk antibiotics WHO recommends as first- or second-choice empiric therapy, which formulary committees increasingly favour on antimicrobial-stewardship grounds. It is supplied as 250 mg and 500 mg capsules and as 125 mg/5 mL and 250 mg/5 mL granules for oral suspension.
Active ingredient
Cefalexin monohydrate. First-generation cephalosporin antibiotic; beta-lactam, WHO AWaRe Access group.
Forms and strengths
250 mg capsule; 500 mg capsule; 125 mg/5 mL granules for oral suspension; 250 mg/5 mL granules for oral suspension.
Indications
Cefalexin, a first-generation oral cephalosporin originated as Keflex by Eli Lilly and now supplied almost exclusively as generic cephalexin, indicated for respiratory tract, skin and skin-structure, bone, genitourinary and ear infections caused by susceptible bacteria. Supplied as WHO-GMP generic capsules and oral suspension from Indian facilities to regulated and semi-regulated markets outside India.
Administration
Oral. Capsule and granules for 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.
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 cefalexin are mainly hospital and community pharmacy procurement teams managing routine respiratory, skin and urinary tract infection caseloads, national and regional MoH tender desks running essential-medicines and antimicrobial-stewardship formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or primary-care access programmes needing an AWaRe Access-tier oral antibiotic for high-volume paediatric and adult prescribing.
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 cefalexin.
Cefalexin dosing varies by indication and age: adults typically take 250 mg every six hours or 500 mg every twelve hours for most infections. The WHO Essential Medicines List recommends a simplified 500 mg regimen to reduce pill burden and support adherence, but the frequency differs by indication: 500 mg every 12 hours for 5 days for COPD exacerbations, versus 500 mg every 8 hours for 5 days for bacterial pharyngitis and mild skin and soft-tissue infections. Paediatric dosing is weight-based, 25 to 50 mg/kg per day in divided doses. The oral suspension is reconstituted with water at dispensing, then must be kept refrigerated at 2 to 8°C and used within 10 days, unlike the capsules, which store at controlled room temperature and travel on standard ambient logistics. Cross-hypersensitivity with penicillins occurs in up to 10% of patients with a documented penicillin allergy, so allergy history should be checked before dispensing, and pseudomembranous colitis should be considered in any patient who develops diarrhoea during or after a course. No extravasation or infusion-site risk applies, as cefalexin is oral-only.
The documentation pack a regulator actually asks for.
As an oral solid or reconstituted-suspension dosage form, cefalexin travels on standard ambient-temperature logistics for the capsules; only the reconstituted suspension needs refrigerated handling, and that step happens at the dispensing pharmacy rather than in transit. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Cefalexin sits on the WHO Model List of Essential Medicines, with a 500 mg solid oral dosage form added to the core list in 2021 specifically to reduce pill burden, and it is classified in the WHO AWaRe Access group, the tier of antibiotics WHO recommends prioritising in stewardship-driven formularies. On the brand-versus-generic question, cefalexin is not a live choice between brand and generic: the originator brand Keflex, developed by Eli Lilly and FDA-approved in 1971, has been discontinued across its major markets, so the molecule is supplied almost exclusively as generic cephalexin today, from a wide base of WHO-GMP and FDA/MHRA-inspected manufacturers. Buyers building a tender specification around cefalexin are therefore specifying a generic-standard essential antibiotic rather than choosing between an active originator and its copies.
Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route; this page sticks to what is specific to the molecule.
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 cefalexin.
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 cefalexin.
- 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.
Cefalexin supply, the specific questions.
Is Keflex still available, or is cefalexin generic-only now?
Keflex, the originator brand developed by Eli Lilly and FDA-approved in 1971, has been discontinued across its major markets including the United States. Cefalexin is now supplied almost exclusively as generic cephalexin capsules and suspension, manufactured by a wide base of WHO-GMP and FDA or MHRA-inspected generic producers, so a tender specification for this molecule is effectively a generic-standard specification.
What dosage forms and strengths does M Care supply?
250 mg and 500 mg capsules, and 125 mg/5 mL and 250 mg/5 mL granules for oral suspension. Tell us your indication mix and paediatric-versus-adult split and we quote the strength and pack format accordingly.
Is cefalexin on the WHO Essential Medicines List?
Yes. Cefalexin is on the WHO Model List of Essential Medicines, including a 500 mg core-list strength added in 2021 specifically to reduce pill burden for adult dosing. It also sits in the WHO AWaRe Access group, the narrow-spectrum, lower-resistance-risk antibiotic tier WHO recommends prioritising in stewardship-driven formularies, which makes it a natural fit for MoH essential-medicines and antimicrobial-stewardship tenders.
Does cefalexin need cold-chain handling?
No, not in transit. The capsules store at controlled room temperature and travel on standard ambient logistics. Only the oral suspension needs refrigeration, and that applies after reconstitution at the dispensing pharmacy, where it should be used within 10 days of mixing, not during M Care's shipping and warehousing.
What should we know about penicillin allergy before dispensing cefalexin?
Cross-hypersensitivity between cephalosporins and penicillins occurs in up to 10% of patients with a documented penicillin allergy, per the FDA label. Prescribers and pharmacists should confirm allergy history before dispensing, and pseudomembranous colitis should be considered in any patient who develops diarrhoea during or after a course, consistent with warnings across the beta-lactam class.
What documentation does M Care provide with a cefalexin shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration. Because cefalexin is a high-volume, multi-source generic, we also confirm current manufacturer capacity and lead time against the buyer's tender volume before quoting.
Can M Care supply cefalexin for a public-sector or NGO tender?
Yes. Cefalexin's AWaRe Access classification and WHO Essential Medicines List status make it a common line item on MoH essential-medicines tenders and NGO primary-care procurement lists. We quote against the buyer's specified strength mix, pack format and destination regulatory documentation, sourced from WHO-GMP manufacturer lines on the M Care roster.
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.
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.