Vancomycin hydrochloride injection — Indian WHO-GMP supply for MRSA and the AWaRe Reserve formulary.
Glycopeptide antibiotic, the last-resort cell-wall inhibitor for MRSA, MRSE and severe Gram-positive infections. 500mg and 1g lyophilised vials from Indian WHO-GMP facilities, with WHO Prequalification supported for Global Fund and Africa CDC tender qualification. AWaRe Reserve class — supplied with antimicrobial stewardship documentation and TDM (therapeutic drug monitoring) guidance.
Multiple WHO-GMP partner lines · 500mg and 1g lyophilised vials · CTD dossier on file · WHO PQ pathway supported · AWaRe Reserve antibiotic class.
Active ingredient
Vancomycin hydrochloride, a tricyclic glycopeptide antibiotic isolated from Amycolatopsis orientalis. Mechanism: binds the D-alanyl-D-alanine terminus of cell-wall precursor pentapeptides, sterically blocking transglycosylation and transpeptidation — Gram-positive bacteria cannot complete peptidoglycan synthesis and cell wall integrity fails. Resistance mechanism (VanA, VanB) replaces D-Ala-D-Ala with D-Ala-D-Lac, dropping affinity 1000-fold.
Strengths stocked
500mg and 1g lyophilised powder for reconstitution. Reconstituted with 10ml or 20ml sterile water for injection respectively, then further diluted to ≤5 mg/ml in 0.9% sodium chloride or 5% glucose for slow IV infusion (over at least 60 minutes per gram, to avoid red-man syndrome). Both strengths are common ICU stocking; 1g is the higher-volume tender line.
Indications
MRSA and MRSE infections (bacteraemia, endocarditis, pneumonia, SSTI, prosthetic-device); penicillin-resistant pneumococcal meningitis with ceftriaxone; enterococcal endocarditis in beta-lactam allergy; surgical prophylaxis with MRSA colonisation; febrile neutropenia empirical Gram+ cover. WHO AWaRe Reserve class — antimicrobial stewardship oversight. We supply only the IV injectable; oral capsules for C.difficile colitis are a separate listing.
Storage
Vials at 15-25°C, protected from light. Reconstituted vancomycin is stable for 24 hours at 2-8°C; further-diluted infusion is stable for 24 hours at 2-8°C or 14 days at -20°C frozen storage. The lyophilised vial is ambient-temperature dispatch; cold-chain only kicks in post-reconstitution at the hospital.
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. Red-man-syndrome warning prominently set on labelling. Trough-monitoring guidance documented in the patient leaflet (target trough 15-20 mg/L for serious deep-seated infections, 10-15 mg/L for skin and soft-tissue).
Hospital pharmacies, ICUs and tender desks across thirty markets.
India is our origin. We do not sell into the Indian market. Vancomycin is exported only.
United Kingdom
Vancomycin is core NHS critical-care formulary stock — every adult ICU and major teaching trust holds it. Where the primary licensed supplier cannot fill against scheduled MRSA-cover demand, the MHRA Specials / named-patient import route is available — vancomycin has appeared on the MHRA shortage register intermittently. See MHRA Specials for the shortage-cover documentation pack we prepare manufacturer-side. Antimicrobial stewardship documentation included for hospital pharmacy committee approval.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH tender awards (NUPCO and Saudi MoH for KSA — ICU formulary tenders are a major channel; MoHAP, DHA and DOH Abu Dhabi for UAE; Kuwait MoH Central Drug Store with strong military medical service demand; MoPH Qatar including Hamad Medical Corporation; MoH Oman; NHRA Bahrain) and hospital pharmacy purchase orders. SFDA, MoHAP and GCC central registration supported with a full CTD dossier.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda
Public-sector hospital tenders (NAFDAC-registered for Nigeria, KEMSA + MEDS for Kenya, FDA Ghana + Central Medical Stores, SAHPRA-registered for South Africa, EFDA + EPSS for Ethiopia, TMDA + MSD for Tanzania, NDA + NMS for Uganda) and teaching-hospital ICU supply. WHO Prequalification supported for Global Fund (sepsis-treatment commodity grants) and Africa CDC qualification. AMR Stewardship Programme alignment is part of the standard tender documentation.
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. Named-patient (Einzelimport in Germany, ATU in France) route available.
Trough-target dosing, slow infusion to avoid red-man, and AKI surveillance — vancomycin is high-yield but unforgiving.
Adult IV vancomycin is dosed 15-20 mg/kg actual body weight every 8-12 hours, with a loading dose of 25-30 mg/kg in critically ill patients to reach therapeutic exposure faster. The current evidence-based target is AUC₂₄/MIC of 400-600 mg·h/L for serious S. aureus infections (replacing the older trough-only target), but pragmatic pharmacy practice still uses trough monitoring at 15-20 mg/L for deep-seated infections and 10-15 mg/L for skin and soft-tissue. First trough is checked before the 4th or 5th dose at steady state. Infuse slowly — minimum 60 minutes per gram to avoid red-man syndrome (histamine-mediated, NOT IgE-mediated, presents with flushing, pruritus, tachycardia, hypotension; manage by slowing the infusion and pre-medicating with diphenhydramine for the next dose). True anaphylaxis is rare. Nephrotoxicity is the dose-limiting toxicity: AKI risk rises with concurrent piperacillin-tazobactam, aminoglycosides, IV contrast, NSAIDs and ACE inhibitors. Monitor SCr at baseline, then every 2-3 days, and trough at steady state. Ototoxicity (cochlear and vestibular) is rare at therapeutic troughs but documented at sustained troughs >20 mg/L. Diluent: 0.9% NaCl or 5% glucose, final concentration ≤5 mg/ml. Do not mix in line with ceftazidime, ceftriaxone, piperacillin-tazobactam, or alkaline drugs (precipitation). The oral formulation (capsules, separate listing) is for C.difficile colitis only — oral vancomycin is not absorbed systemically and does not treat MRSA bacteraemia.
The documentation pack a regulator actually asks for.
Vancomycin is a WHO EML core-list AWaRe Reserve 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 Reserve compliance.
CoA and MoA, per batch
HPLC assay of vancomycin B (the active component, ≥85% per Ph.Eur.), related substances (CDP-I, vancomycin A, des-vancosamine vancomycin per IP/Ph.Eur./USP), water content (Karl Fischer), pH on reconstitution, sterility, bacterial endotoxin (≤0.4 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 included 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 (MHRA SmPC style for the UK, MoH style for GCC, SAHPRA for South Africa, BfArM for Germany). Red-man-syndrome warning, infusion-rate limit (≥60 minutes per gram) and trough-monitoring guidance prominently set. Artwork QC before print, not after.
Temperature control
Pre-shipment validation on each shipper configuration. Vancomycin lyophilised vial ships at 15-25°C ambient; the integrity-critical factors are container closure (sterile lyophilised product) and protection from light. Reconstituted product is cold-chain at the hospital end (24h at 2-8°C); pre-reconstitution dispatch is room-temperature.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. Acute kidney injury, red-man syndrome reactions, and sustained-trough-related ototoxicity remain the PSUR priority signals for this molecule. Antimicrobial stewardship surveillance reporting included for AWaRe Reserve compliance.
ICU-grade Gram+ and Gram- cover.
Vancomycin is rarely a standalone — empirical sepsis cover combines it with a Gram-negative agent. We carry the supporting cluster.
Meropenem
Carbapenem, broad-spectrum Gram+/Gram-/anaerobe. 500mg and 1g vials.
Metronidazole
Anti-anaerobe nitroimidazole. 500mg/100ml IV bag, 250mg/500mg tablets.
All anti-infectives →
180+ anti-infective SKUs: beta-lactams, glycopeptides, aminoglycosides, fluoroquinolones, antifungals, antivirals.
Antivirals →
Antiretroviral and antiviral cluster — HIV ART, hepatitis, CMV.
Anesthesia / ICU →
Critical-care molecules — paralytics, sedatives, antiemetics, vasopressors.
Vaccines →
Public-sector and tender vaccine supply — DPT, MMR, BCG, conjugates.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (500mg or 1g vial), vial count, destination market, whether this is NHS hospital pharmacy supply, GCC ICU tender, African public-sector procurement, Global Fund / Africa CDC sepsis-commodity grant, or NGO supply, and the target delivery window. Flag if AMR Stewardship Programme documentation is needed for the receiving hospital pharmacy committee.
- We route to the right line. Multiple WHO-GMP vancomycin lines sit on the M Care roster, including WHO PQ-listed manufacturers for Global Fund and Africa CDC tender qualification. Registered-market preference goes to facilities already holding the relevant destination registration.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier status per destination, AWaRe Reserve antibiotic stewardship documentation, and the documentation pack you'll receive with the shipment — including red-man-syndrome warning compliance set for the destination labelling. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Ambient-temperature dispatch lane (lyophilised vial is room-temperature stable; cold-chain kicks in at the hospital post-reconstitution), 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 of the consignment. Pharmacovigilance contact opened on registration; AKI, red-man reactions and sustained-trough ototoxicity remain the PSUR priority signals. Antimicrobial stewardship surveillance reporting included for AWaRe Reserve compliance.
Vancomycin supply — the specific questions.
What strengths of vancomycin do you supply?
Vancomycin hydrochloride is supplied as 500mg and 1g lyophilised powder for reconstitution. Reconstitute with 10ml or 20ml sterile water for injection respectively, giving a 50 mg/ml solution; further dilute to ≤5 mg/ml in 0.9% sodium chloride or 5% glucose for slow IV infusion (minimum 60 minutes per gram to avoid red-man syndrome). Pack size is one vial per carton in hospital pack; multi-vial consolidations available against firm orders. The 1g strength is the higher-volume ICU tender line; 500mg covers paediatric dosing, fine titration in renal impairment, and small surgical-prophylaxis units.
Is your vancomycin compliant with WHO AWaRe Reserve antibiotic classification?
Yes. Vancomycin is on the WHO AWaRe (Access, Watch, Reserve) classification as a Reserve antibiotic — last-resort, surveillance-critical, dispensed only against antimicrobial stewardship oversight. Our documentation pack includes Antimicrobial Stewardship Programme (ASP) alignment material for the receiving hospital pharmacy committee, including: dosing protocol with trough-target guidance (15-20 mg/L for serious infections, 10-15 mg/L for skin and soft-tissue), AKI surveillance schedule, red-man syndrome management protocol, and resistance-monitoring (VanA, VanB) reporting templates. WHO PQ certificate available for Global Fund and Africa CDC tender qualification where AWaRe Reserve documentation is a stewardship requirement.
What's the difference between IV vancomycin and oral vancomycin — do you supply both?
IV vancomycin (this listing) is for systemic Gram-positive infections including MRSA bacteraemia, endocarditis, pneumonia and SSTI. Oral vancomycin (capsules, a separate listing in our anti-infectives catalogue) is exclusively for Clostridioides difficile colitis — oral vancomycin is not absorbed systemically and acts locally in the colon. The two are not interchangeable: oral does not treat MRSA bacteraemia, and IV does not reach therapeutic colonic concentration for C.diff. We supply both formulations from WHO-GMP facilities; for C.diff oral capsules, the typical regimen is 125mg four times daily for 10 days, escalated to 500mg in severe disease. Enquiry volumes for the two formulations are routed separately.
Which markets can you ship vancomycin 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 formulary is the main channel — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital supply with WHO PQ pathway support, 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 vancomycin consignment?
Every consignment ships with a batch-specific Certificate of Analysis (HPLC vancomycin B assay, related substances, water content by Karl Fischer, pH on reconstitution, sterility, bacterial endotoxin, particulate matter), Method of Analysis, Certificate of Pharmaceutical Product (CoPP) where required, WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where applicable, Certificate of Origin (chamber-attested), destination-language pack insert with red-man-syndrome warning and trough-monitoring guidance, Antimicrobial Stewardship Programme documentation for hospital pharmacy committee approval, and temperature logs from pre-dispatch through on-arrival. PV contact nominated in the destination market on registration.
Do you provide CTD dossiers for vancomycin 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. Vancomycin 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 Reserve antimicrobial stewardship documentation prepared as a CTD addendum. See dossier preparation.
What are typical lead times for vancomycin orders, and does vancomycin 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. Vancomycin 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 vancomycin is stable for 24 hours at 2-8°C, or 14 days at -20°C frozen. Transit temperature is logged on every consignment for QA traceability.
Send the specifics. You'll have a price inside one working day.
Strength, vial volume, destination, NHS hospital pharmacy / GCC ICU tender / African public-sector / Global Fund / NGO, target delivery, AMR stewardship documentation if required. That's the enquiry. Everything else is on us.