Linezolid, Indian WHO-GMP supply for hospital MRSA / VRE infections and the WHO BPaL MDR-TB regimen.
A reserve oxazolidinone antibacterial with two distinct clinical lanes. In hospital practice it is the first-line oral switch for MRSA pneumonia and complicated SSTI, and the workhorse for VRE bacteraemia. In the WHO Global Drug Facility BPaL regimen it is the L of the 6-month all-oral treatment for rifampicin-resistant and multidrug-resistant tuberculosis recommended since 2022. Supplied as 600 mg film-coated tablets, 600 mg/300 mL IV infusion bags and 100 mg/5 mL paediatric oral suspension from Indian WHO-GMP-certified manufacturers, with WHO Prequalification active for the MDR-TB indication. The generic equivalent of Zyvox, off-patent globally. M Care is an exporter, not a manufacturer, and we say so plainly.
WHO-GMP partner lines · 600 mg tablet + 600 mg/300 mL IV bag + 100 mg/5 mL paediatric suspension · WHO EML core · BPaL backbone · exporter, not manufacturer.
Active ingredient
Linezolid, a synthetic oxazolidinone antibacterial that binds the 23S rRNA of the bacterial 50S ribosomal subunit at a site distinct from chloramphenicol, lincosamides and other 50S agents, preventing 70S initiation complex formation and arresting protein synthesis at the earliest possible step. Active against MRSA, VRE faecium and faecalis, penicillin-resistant pneumococcus and coagulase-negative staphylococci. Supplied from Indian WHO-GMP-certified manufacturers; M Care does not manufacture.
Strengths stocked
600 mg film-coated tablet (adult hospital MRSA/VRE/SSTI and BPaL TB backbone), 600 mg in 300 mL IV infusion bag (2 mg/mL ready-to-use, ICU and intolerant-of-oral patients), 100 mg/5 mL oral suspension (reconstituted, 150 mL bottle, paediatric body-weight dosing). 200 mg paediatric tablet available where formulary requires.
Indications
Hospital: MRSA pneumonia (community and nosocomial), complicated and uncomplicated SSTI including diabetic foot, VRE bacteraemia and complicated UTI, penicillin-resistant pneumococcal disease. TB programme: the L of BPaL (bedaquiline + pretomanid + linezolid) and BPaLM (BPaL + moxifloxacin) 6-month all-oral regimens for rifampicin-resistant and pre-XDR/XDR tuberculosis, WHO-recommended since 2022.
Monitoring
Weekly FBC after 14 days for myelosuppression. Eye exam and ankle-reflex testing on BPaL TB courses for peripheral and optic neuropathy. MAO-inhibitor interactions: avoid co-administered SSRIs / SNRIs / tricyclics / fentanyl / pethidine / tramadol / triptans where possible. Tyramine-restricted diet on prolonged outpatient use. Tightened glucose monitoring in insulin/sulfonylurea-treated diabetics.
Storage and pack
Tablets store below 30°C in original Alu-Alu blister or HDPE bottle. IV bag protected from light, room temperature; do not freeze. Suspension stable 21 days at 25°C maximum after reconstitution. Adult tablet pack 10 / 30 / 60 / 1000 tablets; IV bag 1 / 10 / 50 bags per shipper. Shelf life typically 24-36 months for tablets, 18-24 months for IV.
Access & pricing
Linezolid is off-patent globally and Indian generic supply has driven the TB-programme price down dramatically since the 2022 WHO BPaL recommendation expanded MDR-TB treatment globally. The cost gap between Indian generic and originator is the lever for both hospital antimicrobial-stewardship budgets in the UK / EU and TB programmes in LMICs. We confirm formulary inclusion per destination on every quote.
Hospital antimicrobial pharmacy, ICU MRSA/VRE, BPaL MDR-TB programmes, paediatric infection.
India is our origin. We do not sell into the Indian market. Linezolid is exported only.
WHO Global Drug Facility BPaL MDR-TB
The Stop TB Partnership Global Drug Facility (GDF) is the central procurement arm for MDR-TB regimens used by most LMIC National TB Programmes. Linezolid sits alongside bedaquiline, pretomanid and moxifloxacin in the WHO-recommended 6-month BPaL / BPaLM treatment-shortening regimen. We hold WHO PQ-listed lines for GDF tender qualification and engage GDF cycles against country NTP awards (South Africa NDOH, Nigeria NTBLCP, Indonesia, Philippines NTP, Vietnam NTP, Bangladesh NTP, Mozambique).
Hospital antimicrobial pharmacy (UK NHS, EU, GCC)
UK NHS Trusts and EU hospital pharmacies treat linezolid as a reserve antimicrobial with formulary restriction and antimicrobial-stewardship-team approval. We supply through licensed wholesalers under the antimicrobial-stewardship framework, with the named-patient route for specific access where the trust formulary is constrained. GCC procurement runs through NUPCO and SFDA, MoHAP, DHA and DoH, with hospital antimicrobial pharmacies driving the volume.
African public-sector hospital and TB programmes
NAFDAC Nigeria, SAHPRA South Africa, KEMSA Kenya, FDA Ghana, EFDA Ethiopia, TMDA Tanzania, NDA Uganda. Linezolid moves on two parallel tracks here: the hospital antimicrobial budget for MRSA/VRE/SSTI in tertiary centres, and the NTP MDR-TB programme draw under GDF or country procurement. Country-level registration and WHO PQ alignment both held. NGO procurement →
LATAM, ASEAN, paediatric
Brazil (ANVISA), Mexico (COFEPRIS), Philippines (FDA), Vietnam (DAV), Indonesia (BPOM), Bangladesh (DGDA) through licensed importers against hospital and TB-programme tenders. Paediatric oral suspension supplied for body-weight dosing across paediatric ICU and TB programmes. M Care does not hold US FDA registration for this molecule; UK supply is through MHRA-approved wholesalers only.
Two clinical lanes (hospital MRSA/VRE vs MDR-TB BPaL), five priority safety signals, MAO interactions.
Linezolid is dosed 600 mg twice daily orally or intravenously in adults regardless of indication, with oral bioavailability essentially 100 percent allowing seamless IV-to-oral switch, a frequent driver of early hospital discharge in MRSA SSTI and pneumonia. In children the dose is 10 mg/kg every 8 hours up to 600 mg, with the 100 mg/5 mL suspension allowing accurate body-weight titration. The five priority safety signals govern monitoring. Myelosuppression is the dose- and duration-limiting toxicity: thrombocytopenia appears first, typically after 14 days of treatment, with anaemia and leukopenia following on longer courses; weekly full blood count on courses beyond two weeks, and the cytopenia is reversible on discontinuation. Peripheral and optic neuropathy emerge on the prolonged 4-6 month BPaL TB regimens (rare on short hospital courses), warranting baseline and on-treatment ankle-reflex testing and ophthalmologic review at each clinic visit. Serotonin syndrome risk reflects linezolid's weak reversible non-selective MAO-inhibitor activity: the high-risk co-administrations are SSRIs, SNRIs, tricyclics, fentanyl, pethidine, tramadol, triptans and lithium, and avoidance or close monitoring is the rule; standard washout is 14 days for SSRIs / SNRIs but in practice the antimicrobial decision drives the timing. Lactic acidosis is a rare mitochondrial-toxicity event seen on prolonged courses, presenting as unexplained acidosis with elevated lactate, prompting discontinuation. Hypoglycaemia is reported in diabetic patients on insulin and sulfonylureas, warranting tightened glucose monitoring. Tyramine restriction (aged cheese, cured meats, draught beer, fermented soy) is recommended for prolonged outpatient courses given the MAO-inhibitor activity. Renal impairment does not require dose adjustment but the metabolites accumulate; hepatic impairment mild to moderate does not require adjustment. The destination-language SmPC carries the full interaction table for the receiving hospital pharmacy and antimicrobial-stewardship team.
The documentation pack a regulator actually asks for.
Linezolid is supplied from Indian WHO-GMP-certified facilities, with WHO Prequalification active for the MDR-TB indication. Our role is manufacturer-facing, we sit between the WHO-GMP plant and your procurement, hospital pharmacy or TB programme team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls in eCTD-ready format for the tablet, IV bag and oral suspension separately. Module 2 quality overall summary included. Stability under ICH Zone IVb (30°C / 75% RH for 12 months minimum). Specific photostability data for the IV bag formulation.
Bioequivalence
Comparative bioequivalence study reports against Zyvox reference product for tablet and oral suspension. IV bag is non-BE (direct administration). Photostability profile included where regulator requires it.
CoA + WHO-PQ certificate per batch
HPLC linezolid assay, related substances per Ph.Eur./USP/JP, water content, dissolution profile, content uniformity, hardness, friability for tablets. Sterility, pH, bacterial endotoxin, particulate count, container integrity for IV. WHO Prequalification certificate in the shipping pack for GDF reconciliation.
CoPP, GMP, MFG licence
Issued by CDSCO (India), apostilled where required, notarised copies in the shipping pack. M Care does not hold US FDA registration for this molecule, confirm the regulatory route on enquiry.
Stop TB Partnership alignment
WHO PQ for MDR-TB satisfies the GDF tender prequalification gate. We engage Stop TB Partnership procurement cycles directly through the WHO-PQ-listed line.
Pharmacovigilance
Named PV contact in the destination market against registration, PSURs to ICH E2C. Myelosuppression, neuropathy, serotonin syndrome, lactic acidosis and hypoglycaemia are the priority signals for ADR routing.
The reserve-antibacterial and TB-regimen shelf.
Linezolid sits inside the hospital reserve-antimicrobial shelf and the WHO BPaL TB regimen, alongside the agents that travel on the same tenders.
Vancomycin
Glycopeptide. The IV standard for MRSA bacteraemia and pneumonia. Linezolid is the oral switch and the alternative for vancomycin failure.
Meropenem
Carbapenem. Hospital Gram-negative ICU backbone; pairs with linezolid where mixed Gram +/Gram- coverage is needed for sepsis source unclear.
Piperacillin + tazobactam
Broad-spectrum beta-lactam/inhibitor. Empirical hospital sepsis cover before culture, sometimes combined with linezolid where MRSA risk is high.
All anti-infectives →
Penicillins, cephalosporins, carbapenems, glycopeptides, oxazolidinones, antimalarials, anti-TB, antifungals, 1800+ lines.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Formulation mix (600 mg tablet / 600 mg IV bag / 100 mg/5 mL suspension), volume, destination, channel (hospital antimicrobial pharmacy / GDF MDR-TB / country NTP / NGO), and target delivery window. Flag if BPaL regimen co-procurement (bedaquiline + pretomanid) is in scope.
- We confirm the route. WHO-PQ line for GDF MDR-TB, EU-GMP-capable line for NHS antimicrobial supply, local-formulary-matched line for African hospital tenders.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier and bioequivalence status, WHO PQ certificate reference (for MDR-TB), full documentation pack, inside one working day.
- Order, produce, release, ship. QC release on the Indian side, ambient dispatch (tablets, suspension), light-protected dispatch (IV bag), in-transit logging and on-arrival inspection.
- After delivery. Batch records, CoA, stability data and WHO-PQ certificate archived for the full shelf life. PV contact opened on registration, ADR routing established.
Linezolid supply, the specific questions.
What strengths and formulations of linezolid do you supply?
Three presentations covering hospital adult and paediatric use plus the WHO BPaL MDR-TB regimen. Adult 600 mg film-coated tablet (the standard hospital MRSA/VRE/SSTI tablet, also the BPaL backbone tablet for rifampicin-resistant TB), 600 mg in 300 mL intravenous infusion bag (2 mg/mL ready-to-use for ICU and intolerant-of-oral patients), and 100 mg/5 mL oral suspension (reconstituted, 150 mL bottle, for paediatric patients per body-weight dosing). All from Indian WHO-GMP-certified facilities. The 200 mg paediatric tablet is also available where the destination formulary requires it.
Is your linezolid WHO Prequalified for the Global Drug Facility BPaL MDR-TB tender?
Yes. Multiple M Care partner facilities hold active WHO Prequalification for linezolid 600 mg for the MDR-TB indication, the gating regulatory ticket for the WHO Global Drug Facility (GDF) BPaL and BPaLM regimen procurement. The Stop TB Partnership / GDF currently sources linezolid alongside bedaquiline, pretomanid and moxifloxacin for the 6-month BPaL / BPaLM MDR/XDR-TB treatment shortening regimen recommended by WHO since 2022. We engage GDF tender cycles and the country-level NTPs that draw on the same pool.
Is M Care a linezolid manufacturer?
No. M Care is a merchant exporter. We supply linezolid from Indian WHO-GMP-certified manufacturers and handle export, documentation, registration support, freight and pharmacovigilance routing. We do not run a manufacturing plant ourselves. For a buyer, that means we route each order to the right WHO-GMP line for the destination (the WHO-PQ-listed line for GDF MDR-TB procurement, the EU-GMP-capable line for NHS antimicrobial supply, the local-formulary-matched line for African country tenders) and carry the regulatory and logistics paperwork.
What is linezolid used for clinically?
Two distinct clinical lanes. In hospital practice, linezolid is a reserve oxazolidinone antibacterial for serious infections caused by resistant Gram-positive organisms: MRSA pneumonia and SSTI (the IDSA / ESCMID first-line oral switch for community-onset MRSA), VRE faecium bacteraemia and complicated UTI, penicillin-resistant pneumococcal disease, and diabetic foot infection. In the TB programme, linezolid is the L of the WHO-endorsed BPaL (bedaquiline + pretomanid + linezolid) and BPaLM (BPaL + moxifloxacin) all-oral 6-month regimens for rifampicin-resistant and pre-XDR / XDR tuberculosis, recommended by WHO since 2022.
What are the key safety points for linezolid?
Five priority signals. Reversible myelosuppression (thrombocytopenia first, then anaemia and leukopenia) after 14 days, weekly FBC on extended courses, resolves on discontinuation. Peripheral and optic neuropathy on the 4-6 month BPaL TB regimens, eye exam and ankle-reflex testing on schedule. Serotonin syndrome with serotonergic drugs (linezolid is a weak reversible non-selective MAO inhibitor): avoid SSRIs, SNRIs, tricyclics, fentanyl, pethidine, tramadol, triptans where possible. Lactic acidosis on prolonged courses (mitochondrial toxicity). Hypoglycaemia with insulin and sulfonylureas. Tyramine-restricted diet on prolonged outpatient use.
Which markets can you ship linezolid into?
WHO Global Drug Facility (GDF) BPaL MDR-TB procurement, country NTPs (South Africa NDOH, Nigeria FMoH NTBLCP, Indonesia BPOM, Philippines DOH NTP, Vietnam NTP, Bangladesh NTP). Hospital antimicrobial supply: UK NHS Trusts, EU hospital pharmacies, GCC (NUPCO, SFDA, MoHAP, DHA, DoH, Kuwait, Qatar, Oman, Bahrain MoH), African public-sector hospitals (NAFDAC, SAHPRA, KEMSA, FDA Ghana, EFDA, TMDA, NDA), LATAM (ANVISA, COFEPRIS), ASEAN. We do not supply into India. Full coverage at markets.
What documentation ships with a linezolid consignment?
Batch-specific Certificate of Analysis (HPLC linezolid assay, related substances per Ph.Eur./USP/JP, water content, dissolution profile, content uniformity for tablets; assay, pH, particulate count, sterility, bacterial endotoxin and container integrity for IV bags), Method of Analysis, bioequivalence study report against Zyvox reference, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate (for MDR-TB), Certificate of Origin, destination-language pack insert with the myelosuppression, neuropathy, serotonin syndrome, MAO-interaction and tyramine restriction warnings, and temperature/humidity logs. CTD Module 3 dossier available against NDA, see dossier preparation.
Send the specifics. You'll have a price inside one working day.
Formulation (600 mg tablet / 600 mg IV bag / 100 mg/5 mL suspension), volume, destination, programme (hospital antimicrobial / GDF MDR-TB / country NTP / NGO), and target delivery. We confirm the WHO PQ alignment per destination as part of the quote. Everything else is on us.