Meropenem injection — supplier from India to the UK, GCC and Africa.

An ultra-broad-spectrum carbapenem for severe pneumonia, febrile neutropenia, meningitis and sepsis with suspected multidrug-resistant Gram-negatives. 500mg and 1g IV vials from Indian WHO-GMP partner sites, with the CTD dossier, WHO-PQ pathway support and stewardship-aligned documentation an ICU pharmacy expects.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
At a glance

Multiple WHO-GMP partner lines · 500mg and 1g IV vials · WHO-PQ pathway supported.

Active ingredient

Meropenem (trihydrate salt on label). Carbapenem beta-lactam. Binds penicillin-binding proteins PBP 2, 3 and 4 to inhibit cell-wall synthesis. Ultra-broad-spectrum across Gram-positive, Gram-negative and anaerobic organisms including Pseudomonas aeruginosa. Stable against most AmpC and extended-spectrum beta-lactamases.

Strengths stocked

500mg and 1g lyophilised vials. Reconstitute 500mg with 10ml water for injection; 1g with 20ml. IV bolus over 3-5 minutes or infusion over 15-30 minutes; extended 3-hour infusion protocols for severe Gram-negative disease supported on request.

Indications

Severe hospital-acquired and ventilator-associated pneumonia; complicated intra-abdominal and urinary tract infections; empirical febrile neutropenia; bacterial meningitis (2g q8h); sepsis with suspected multidrug-resistant Gram-negatives; cystic fibrosis exacerbation with Pseudomonas aeruginosa. Carbapenem-reserve; supply stewardship-aligned.

Storage

Store the lyophilised vial below 25°C. Reconstituted solution is not suitable for long storage: approximately 2-4 hours at room temperature or up to 12-24 hours refrigerated at 2-8°C, depending on diluent. Extended-infusion protocols need ward-level chemical-stability planning.

Shelf life

24 months from manufacture; minimum 18 months at dispatch, or we won't ship.

Pack format

Type I colourless glass vial with bromobutyl rubber stopper and aluminium flip-off seal. Single-vial cartons per strength. Five- and ten-vial outer cartons available for tender supply with batch-level traceability.

Who we supply

ICU pharmacies, tender desks and Global Fund buyers across twenty markets.

India is our origin. We do not sell into the Indian market. Meropenem is exported only.

United Kingdom

NHS critical-care and ICU pharmacies under licensed wholesale supply, and specialist importers under the MHRA (Medicines and Healthcare products Regulatory Agency) Specials / named-patient route when UK licensed supply is constrained — meropenem has appeared intermittently on the MHRA shortage register on specific strengths. Stewardship-aligned cadence: batch sizes matched to hospital-formulary draw-down, not bulk standing order.

Named-patient import, UK →

GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)

Through local licensed importers, against MoH tender awards and hospital pharmacy purchase orders for ICU and haematology-oncology units. CTD dossiers prepared for national registration with SFDA (Saudi Food & Drug Authority), MOHAP (UAE Ministry of Health and Prevention) and the GCC central registration pathway. Arabic-language PIL and Type I glass vial artwork prepared for MoH review.

MoH registration, GCC →

Nigeria, Kenya, Ghana, South Africa

Public-sector critical-care tenders (NAFDAC Nigeria, KEMSA Kenya, CMS Ghana, SAHPRA South Africa), teaching-hospital supply and NGO field-hospital procurement. Meropenem sits on the WHO EML Watch group — Global Fund, UNICEF SD and MSF buyers catered for separately with WHO-PQ-aligned documentation and antimicrobial-stewardship evidence.

Germany

Supply through licensed German importers under §72 AMG, with Qualified Person (QP) certification on arrival. CTD dossier and CoPP prepared for BfArM (Federal Institute for Drugs) recognition. German-language PIL matches the EMA reference SmPC with the valproate-interaction and seizure-risk warnings verbatim.

Pharmacist's note

What the ICU pharmacist actually checks before the first dose.

Adult dose is 500mg to 2g IV every 8 hours, with 2g q8h reserved for meningitis. Paediatric dose is 10-40 mg/kg every 8 hours. Renal dose adjustment kicks in at CrCl <50 ml/min — reduce the dosing frequency, not usually the dose size. Reconstitute 500mg with 10ml and 1g with 20ml water for injection; further dilute in 0.9% NaCl or 5% glucose. Post-reconstitution stability is tight — 2-4 hours at room temperature for bolus use, up to 12-24 hours refrigerated depending on diluent — so extended 3-hour infusions for severe Gram-negative disease need pharmacy-verified chemical-stability data. Watch seizure risk in renal impairment or existing CNS pathology (roughly 0.5%, lower than imipenem's ~1.5% but still a recognised signal). The valproate interaction is the big one: meropenem drops valproate serum levels by 30-80% within 24 hours — do not co-administer, switch the anticonvulsant. Beta-lactam cross-reactivity with documented penicillin allergy sits near 1% — caution if the history is anaphylactic. Procure to stewardship draw-down, not bulk.

Regulatory & quality

The documentation pack a regulator and a Global Fund buyer both ask for.

Meropenem is on the WHO EML Watch group and is WHO-PQ prequalified from multiple Indian manufacturer lines — eligible for Global Fund and UN procurement. 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 and sterility-assurance justification included, with the stability package covering the 24-month lyophilised shelf life.

CoA and MoA, per batch

HPLC assay, related substances, water content (Karl Fischer — critical for a lyophilised carbapenem), residual solvents, sterility per USP <71>, bacterial endotoxin per USP <85>, 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. WHO-PQ status confirmed against the current WHO list where the tender specifies it. Notarised copies in the shipping pack.

Pack insert, labels, artwork

Destination-language PIL to MHRA SmPC, EMA, SFDA, MOHAP, SAHPRA or BfArM style. Valproate-interaction, seizure-risk and renal-adjustment text verbatim from the reference label. Carbapenem-reserve classification noted where destination labelling requires. Artwork QC before print.

Temperature control

Pre-shipment thermal validation confirms the below-25°C specification holds through worst-case transit routes. Continuous in-transit logging; on-arrival inspection with a signed record. Excursion protocol defined before dispatch. Reconstituted-solution stability communicated to the receiving pharmacy.

Pharmacovigilance

Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. Seizure, Clostridioides difficile and anaphylaxis signals tracked on the 15-day expedited reporting track.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Strength split (500mg vs 1g vial counts), pack format (single-vial cartons or 5/10-vial outer packs), destination market, tender / hospital / Global Fund route, and target delivery window.
  2. We route to the right line. Multiple WHO-GMP partner lines sit on the M Care roster for meropenem, several with current WHO-PQ prequalification. Registered markets get facilities with in-country registration; tenders get WHO-PQ lines where the buyer specifies prequalified supply.
  3. Commercial and regulatory offer. FOB / CIF price, lead time, dossier status per destination, WHO-PQ status where relevant, and the documentation pack with the shipment. Inside one working day.
  4. Order, produce, release, ship. QC release on the Indian side with HPLC assay, water content, sterility and endotoxin on the certificate. Temperature-controlled dispatch under 25°C, continuous logging in transit, on-arrival inspection. Photo evidence of seal integrity on request.
  5. After delivery. Batch records, CoA and thermal logs archived for the shelf life of the consignment. Pharmacovigilance contact opened on registration. Seizure and anaphylaxis signals tracked on the 15-day expedited reporting track.
Frequently asked

Meropenem supply — the specific questions.

What strengths of meropenem do you supply?

Meropenem is supplied as 500mg and 1g lyophilised vials — the two standard hospital strengths across MHRA, EMA, SFDA, MOHAP, SAHPRA and BfArM labelling. The 500mg vial reconstitutes with 10ml water for injection and the 1g with 20ml; the solution can be used as a 3-5 minute IV bolus or further diluted in 0.9% NaCl or 5% glucose for a 15-30 minute infusion. Single-vial cartons are standard; 5- and 10-vial hospital outer packs are available against firm tender orders.

Do you supply WHO-PQ prequalified meropenem for Global Fund and UN procurement?

Yes. Multiple Indian WHO-GMP partner lines on the M Care roster hold current WHO Prequalification (WHO-PQ) on meropenem, which is the gating requirement for Global Fund, UNICEF Supply Division, GHSC-PSM and comparable UN procurement routes. Where a tender specifies prequalified supply we route to the WHO-PQ lines; where it doesn't, the broader WHO-GMP roster applies. The PQ status is confirmed against the WHO list at point of offer and the prequalification reference appears in the CoPP pack. See NGO and donor procurement.

How do you handle the meropenem and valproate interaction on the counselling side?

Meropenem reduces valproate serum levels by 30-80% within 24 hours of the first dose — a clinically significant drop that can precipitate breakthrough seizures. Our destination-language pack inserts carry the interaction contraindication verbatim from the reference SmPC, and the standard pharmacist guidance is unambiguous: do not co-administer. Patients on valproate who need empirical meropenem should be switched to an alternative anticonvulsant (levetiracetam, phenytoin with level monitoring, or a benzodiazepine bridge) before the first meropenem dose — not after. The interaction is noted in the stewardship insert we ship alongside the product.

Which markets can you ship meropenem into?

We routinely ship meropenem into the UK (licensed wholesale and MHRA Specials / named-patient import where the UK supply is constrained — intermittent shortage-register listings through 2023-2026), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain — through licensed local importers), sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa — ICU tender and teaching-hospital supply, plus Global Fund procurement where the tender specifies WHO-PQ), and Germany (§72 AMG import channels with QP certification). We do not supply into India.

What documentation is included with a meropenem consignment?

Every consignment ships with a batch-specific Certificate of Analysis (HPLC assay, related substances, water content by Karl Fischer, sterility per USP <71>, bacterial endotoxin per USP <85>, particulate matter), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO-PQ confirmation where applicable, Certificate of Origin, destination-language PIL with valproate-interaction and seizure-risk warnings verbatim, temperature logs, and a carbapenem-stewardship reference insert. Full list under anti-infectives.

How should procurement structure meropenem orders given carbapenem stewardship?

Most hospital formularies restrict meropenem prescribing to infectious-disease or microbiology approval — it is a carbapenem-reserve antibiotic. Procurement should reflect the stewardship draw-down, not bulk standing-order: we match batch size and delivery cadence to a realistic 3-6 month consumption projection and size the first order conservatively so shelf-life pressure does not force unnecessary prescribing. Where Carbapenem-Resistant Enterobacteriaceae (CRE) prevalence exceeds roughly 10% of the local antibiogram, empirical protocols increasingly pair meropenem with a novel beta-lactamase inhibitor; we flag the implication at quote stage.

What are typical lead times for meropenem orders?

For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. Made-to-order batches, 8-12 weeks inclusive of QC release (HPLC, water content, sterility, endotoxin) and destination-specific artwork approval — longer than a solid dosage form because each batch requires full sterility and endotoxin clearance before release. Air-freight to UK or GCC: 3-5 days; sea-freight to Africa: 18-28 days at below-25°C, with continuous in-transit logging and on-arrival inspection.

Meropenem enquiry

Send the specifics. You'll have a price inside one working day.

Strength split, pack format, destination, tender or hospital pharmacy or Global Fund route, target delivery. That's the enquiry. Everything else is on us.

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