Ceftriaxone injection — Indian WHO-GMP supply for sepsis, meningitis, gonorrhoea and OPAT.
The single most-prescribed parenteral antibiotic globally. Broad-spectrum third-generation cephalosporin with once-daily IV or IM dosing. 250mg, 500mg, 1g and 2g lyophilised vials from Indian WHO-GMP facilities, WHO Prequalification supported for Global Fund and Africa CDC tender qualification, AWaRe Watch antimicrobial stewardship documentation included.
Multiple WHO-GMP partner lines · 250mg / 500mg / 1g / 2g lyophilised vials · CTD dossier on file · WHO PQ pathway supported · AWaRe Watch antibiotic class.
Active ingredient
Ceftriaxone disodium hemiheptahydrate, a semi-synthetic third-generation cephalosporin. Mechanism: irreversible binding to penicillin-binding proteins (PBP-1a, PBP-1b, PBP-2, PBP-3) interrupting cell-wall transpeptidation. Beta-lactamase stability — resistant to most TEM and SHV penicillinases, but susceptible to ESBLs and AmpC enzymes (Klebsiella pneumoniae ESBL outbreaks are the major resistance signal globally).
Strengths stocked
250mg and 500mg for paediatric dosing, IM gonorrhoea single-dose protocols, and OPAT outpatient titration. 1g and 2g are the high-volume tender lines for adult CAP, meningitis empirical therapy, surgical prophylaxis and ICU sepsis. Reconstitute IV with sterile water for injection or 0.9% NaCl; IM with 1% lidocaine for less painful administration. Further dilute IV in 0.9% NaCl or 5% glucose to 10-40 mg/ml for slow infusion (≥30 min).
Indications
CAP (with macrolide for atypical cover); bacterial meningitis empirical (with vancomycin + dexamethasone); gonorrhoea (single 1g IM); Lyme neuroborreliosis; typhoid fever; surgical prophylaxis; pyelonephritis and complicated UTI; OPAT once-daily ambulatory therapy. WHO AWaRe Watch class — antimicrobial stewardship oversight. Standard adult dose 1-2g once daily IV or IM; meningitis 2g BD.
Storage
Lyophilised vials at 15-25°C, protected from light. Reconstituted product 24 hours at 2-8°C; further-diluted infusion 24 hours at 2-8°C or 6 hours at room temperature in 0.9% NaCl. Do NOT mix with calcium-containing solutions (Ringer's, Hartmann's, calcium gluconate) — ceftriaxone-calcium precipitation has caused fatalities in neonates; mandatory contraindication in hyperbilirubinaemic neonates and infants ≤2 weeks. Standard ambient-temperature dispatch lane; cold-chain at hospital end.
Shelf life
36 months from manufacture; minimum 24 months at dispatch. Or we won't ship it.
Pack format
Single vial per carton, hospital pack. Type-I clear glass vial, halobutyl rubber stopper, aluminium seal with flip-off cap. Outer carton and leaflet in destination-regulator language. AWaRe Watch antibiotic stewardship label, calcium-incompatibility neonatal warning, and gonococcal-resistance surveillance note prominently set on SmPC.
Hospital pharmacies, ICUs, OPAT clinics and tender desks across thirty markets.
India is our origin. We do not sell into the Indian market. Ceftriaxone is exported only.
United Kingdom
Ceftriaxone is core NHS hospital pharmacy and OPAT (Outpatient Parenteral Antibiotic Therapy) stock. Standard empirical for CAP, meningitis, pyelonephritis and surgical prophylaxis at every adult acute trust. Where the primary licensed supplier cannot fill, the MHRA Specials / named-patient import route is available — see MHRA Specials. NHS BSAC AMR Stewardship Programme alignment included for hospital pharmacy committee approval.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH ICU + general-ward formulary tender awards (NUPCO and Saudi MoH — King Faisal Specialist Hospital and SEHA major buyers; MoHAP, DHA and DOH Abu Dhabi for UAE; Kuwait MoH Central Drug Store; MoPH Qatar including Hamad Medical Corporation; MoH Oman; NHRA Bahrain). Surgical-prophylaxis tender lots are particularly high-volume. SFDA, MoHAP and GCC central registration supported with full CTD dossier.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda
Public-sector hospital tenders (NAFDAC for Nigeria, KEMSA + MEDS for Kenya, FDA Ghana + Central Medical Stores, SAHPRA for South Africa, EFDA + EPSS for Ethiopia, TMDA + MSD for Tanzania, NDA + NMS for Uganda) and teaching-hospital supply. Ceftriaxone is the highest-volume sepsis-treatment commodity in Global Fund pooled procurement — PEPFAR-aligned HIV-associated bacterial-infection programmes, Africa CDC AMR Stewardship initiatives. WHO Prequalification supported.
Germany, France, Brazil, Mexico, Philippines
Supply via licensed importers under §72 AMG (Germany), ANSM equivalent (France), ANVISA (Brazil), COFEPRIS (Mexico), FDA Philippines, with Qualified Person (QP) certification on EU arrival. CTD dossier and CoPP prepared for BfArM, ANSM, ANVISA, COFEPRIS and FDA Philippines recognition.
Calcium incompatibility, gonococcal-resistance trend, biliary pseudolithiasis — ceftriaxone is everyday but the safety margins matter.
Adult IV/IM dose is 1-2g once daily; meningitis 2g twice daily; uncomplicated gonorrhoea single 1g IM (raised from 500mg in CDC, BASHH and EUROGUIDELINES protocols 2020-2024 due to global gonococcal MIC creep). Paediatric dose 50-100 mg/kg/day; meningitis 100 mg/kg/day. Calcium incompatibility is the killer issue: ceftriaxone-calcium crystals precipitate in lung, kidney and biliary tract. Contraindicated absolutely in neonates ≤2 weeks (kernicterus risk from bilirubin displacement) and in hyperbilirubinaemic neonates of any age. In older patients do not co-infuse with calcium-containing solutions (Lactated Ringer's, Hartmann's, parenteral nutrition with calcium); separate the IV line by at least 48 hours of clearance time, or use a different access. Biliary pseudolithiasis (sludge formation) occurs in 10-25% of patients on prolonged courses, mostly asymptomatic but occasionally causing biliary colic; resolves on discontinuation. Gonococcal MIC monitoring: rising 2024-2025 ceftriaxone MICs in N. gonorrhoeae prompted the CDC and BASHH dose increase to 1g IM (from 500mg/250mg historical); azithromycin 1g PO co-administered in CDC protocols, dropped from BASHH 2024 protocol. C. difficile colitis risk is moderate-low (lower than the carbapenems, fluoroquinolones, clindamycin). Diluent for IV: 0.9% NaCl, 5% glucose, sterile water; for IM: 1% lidocaine without epinephrine for less painful injection (paediatric dose adjustment for lidocaine load needed).
The documentation pack a regulator actually asks for.
Ceftriaxone is a WHO EML core-list AWaRe Watch antibiotic and WHO PQ-listed. Our role is manufacturer-facing — we sit between the Indian WHO-GMP facility 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 included. Antimicrobial Stewardship Programme alignment documented for AWaRe Watch compliance.
CoA and MoA, per batch
HPLC assay (≥98%), related substances (E-isomer, 2-mercaptobenzothiazole degradation product, ceftriaxone open-form per Ph.Eur./USP), water content (Karl Fischer for the heptahydrate form), pH on reconstitution, sterility, bacterial endotoxin (≤0.10 EU/mg), particulate matter — 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 it. Notarised copies in the shipping pack. WHO-PQ certificate available for Global Fund and Africa CDC tender qualification.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards. Calcium-incompatibility neonatal warning prominently set per current EMA, MHRA and FDA labelling requirement (post-2007 fatal-precipitation deaths). Gonococcal-resistance surveillance note documented. AWaRe Watch antibiotic stewardship label included. Artwork QC before print, not after.
Temperature control
Pre-shipment validation on each shipper configuration. Lyophilised vial ships at 15-25°C ambient; integrity-critical factors are container closure (sterile lyophilised), moisture exclusion, and protection from light. Reconstituted product is cold-chain at the hospital end.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. Calcium-precipitation-related events (especially neonatal), biliary pseudolithiasis, severe hypersensitivity (penicillin cross-reactivity), and gonococcal MIC creep remain the PSUR priority signals. AMR Stewardship Programme surveillance reporting included for AWaRe Watch compliance.
Empirical sepsis, ICU escalation, AWaRe-aligned cluster.
Ceftriaxone is rarely a standalone in tertiary care — empirical sepsis pairs it with vancomycin (MRSA cover) or a macrolide (atypical CAP cover), and resistant Gram-negatives escalate to carbapenems.
Vancomycin
Glycopeptide, MRSA cover. 500mg / 1g lyophilised. AWaRe Reserve.
Meropenem
Carbapenem, ESBL/AmpC escalation post-ceftriaxone failure. 500mg / 1g vials.
Piperacillin-tazobactam
Broad-spectrum + Pseudomonas cover (which ceftriaxone lacks). 2.25g / 4.5g.
Metronidazole
Anti-anaerobe nitroimidazole. Combo with ceftriaxone for intra-abdominal sepsis.
All anti-infectives →
180+ anti-infective SKUs: cephalosporins, glycopeptides, carbapenems, fluoroquinolones, antifungals.
Antivirals →
ART backbones — HIV PrEP and ART regimens.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (250mg / 500mg / 1g / 2g), vial count, destination, NHS hospital pharmacy / GCC ICU tender / African public-sector / Global Fund sepsis-commodity grant / NGO. Flag if AMR Stewardship documentation, gonococcal-resistance surveillance compliance set, or calcium-incompatibility neonatal warning is needed for the receiving formulary.
- We route to the right line. Multiple WHO-GMP ceftriaxone lines on the M Care roster, including WHO PQ-listed manufacturers for Global Fund and Africa CDC tender qualification.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier status per destination, AWaRe Watch antibiotic stewardship documentation, and the documentation pack you'll receive. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Ambient-temperature dispatch lane, in-transit logging, on-arrival inspection. Photo evidence of seal integrity on request.
- After delivery. Batch records, CoA and thermal logs archived for the full shelf life. Pharmacovigilance contact opened on registration; calcium-precipitation events (especially neonatal), biliary pseudolithiasis, severe hypersensitivity and gonococcal MIC creep remain the PSUR priority signals. AMR Stewardship surveillance reporting included for AWaRe Watch compliance.
Ceftriaxone supply — the specific questions.
What strengths of ceftriaxone do you supply?
250mg, 500mg, 1g and 2g lyophilised vials. Reconstitute IV with sterile water for injection or 0.9% NaCl; IM with 1% lidocaine for less painful administration. Further dilute IV in 0.9% NaCl or 5% glucose to 10-40 mg/ml for slow infusion (≥30 min). 1g and 2g are the high-volume tender lines for adult CAP, meningitis empirical therapy, surgical prophylaxis and ICU sepsis. 250mg and 500mg cover paediatric dosing, IM gonorrhoea single-dose protocols, and OPAT outpatient titration. Do NOT mix with calcium-containing solutions (Ringer's, Hartmann's, calcium gluconate) — fatal precipitation risk.
Is your ceftriaxone WHO PQ-listed for Global Fund tenders?
Yes. Multiple M Care partner facilities hold WHO Prequalification for ceftriaxone. The WHO PQ certificate is included in the shipping documentation pack. Ceftriaxone is the highest-volume sepsis-treatment commodity in Global Fund pooled procurement globally, plus PEPFAR-aligned HIV-associated bacterial-infection programmes and Africa CDC AMR Stewardship initiatives. We engage on Global Fund pooled tenders, country-level public-sector tenders (KEMSA, NAFDAC, CMS Ghana, EPSS, MSD Tanzania, NMS Uganda), and NGO procurement (MSF, Direct Relief, Partners In Health) through the same manufacturing lines.
How is the calcium-incompatibility neonatal warning handled in your labelling?
Post-2007 fatal-precipitation deaths in neonates prompted EMA, MHRA, FDA and ANSM to mandate explicit calcium-incompatibility warnings on ceftriaxone labelling. Our destination-language pack inserts and SmPCs carry the contraindication for hyperbilirubinaemic neonates and infants ≤2 weeks, plus the older-patient warning to avoid co-infusion with calcium-containing solutions (Lactated Ringer's, Hartmann's, parenteral nutrition with calcium). The dispensing-side responsibility (separate IV line, 48-hour clearance) sits with the prescribing pharmacy; the manufacturer-side responsibility (clear labelling) is ours.
Which markets can you ship ceftriaxone into?
The UK (NHS hospital pharmacy supply or named-patient / MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — ICU and surgical-prophylaxis tenders are the main channels — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital supply with WHO PQ pathway support — Global Fund sepsis-commodity grants are a high-volume channel. Egypt, Jordan, Iraq on the Levant side. Germany under §72 AMG, France under ANSM-equivalent route, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). We do not supply into India. Full market coverage is at markets.
What documentation is included with a ceftriaxone consignment?
Every consignment ships with a batch-specific Certificate of Analysis (HPLC assay, related substances per Ph.Eur./USP, water content by Karl Fischer, pH on reconstitution, sterility, bacterial endotoxin, particulate matter), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where applicable, Certificate of Origin (chamber-attested), destination-language pack insert with calcium-incompatibility neonatal warning + gonococcal-resistance surveillance note + AWaRe Watch antibiotic stewardship label, Antimicrobial Stewardship Programme documentation for hospital pharmacy committee approval, plus temperature logs from pre-dispatch through on-arrival. PV contact nominated on registration.
Do you provide CTD dossiers for ceftriaxone registration?
Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, TMDA, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. Ceftriaxone has a well-established CMC template — lead time on a dossier against a new registration is typically 3-5 weeks from NDA signature. WHO PQ dossier prepared separately for Global Fund and Africa CDC qualification. AWaRe Watch antimicrobial stewardship documentation prepared as a CTD addendum. See dossier preparation.
What are typical lead times for ceftriaxone orders, and does it need cold-chain transit?
For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (Global Fund, Africa CDC, NUPCO, KEMSA, CMS Ghana), the lead time is set in the tender award document. For UK NHS hospital pharmacy ad-hoc supply with urgency flagged, air-freight out of Mumbai can be on a flight within 72 hours. Made-to-order batches run 6-10 weeks inclusive of QC release and destination artwork. Ceftriaxone lyophilised vial does not require cold-chain in transit — it ships at 15-25°C ambient. Cold-chain only kicks in at the hospital end after reconstitution: reconstituted ceftriaxone is stable for 24 hours at 2-8°C. Transit temperature is logged on every consignment for QA traceability.
Send the specifics. You'll have a price inside one working day.
Strength (250mg / 500mg / 1g / 2g), vial volume, destination, NHS hospital pharmacy / GCC ICU tender / African public-sector / Global Fund sepsis-commodity grant / NGO, target delivery, AMR stewardship documentation if required. That's the enquiry. Everything else is on us.