WHO-GMP certified EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Liposomal Amphotericin B (L-AmB) Exporter and Supplier

You are sourcing a cold-chain antifungal that hospital pharmacies and central procurers cannot afford to run out of during an invasive fungal outbreak. M Care Exports is an India-based merchant-exporter (trading since 2003, ISO 9001:2015) that supplies liposomal amphotericin B 50mg vials from WHO-GMP manufacturing lines, distinct from the older amphotericin B deoxycholate. We consolidate validated cold-chain batches, compile the CTD dossier and CoPP with you, and quote against tender specifications rather than a shelf price.

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WHO-GMP source linesISO 9001:2015 exporterCoPP & CTD support49+ export marketsSince 2003
Bulk and tender supply

Institutional volumes of L-AmB for hospital and government tenders

Liposomal amphotericin B is a high-value, low-substitution product: it is reserved for the sickest ICU, transplant and immunocompromised patients, so a single stock-out forces a switch to more nephrotoxic deoxycholate. The exporter field is thin because the liposome-encapsulation process is technically demanding and the whole chain runs at 2 to 8 degrees C. M Care Exports positions between that narrow manufacturing base and your import file: we aggregate release-tested lots, hold cold-chain integrity through to the port, and answer tender line-items honestly rather than promising volumes no exporter can guarantee alone.

Reserved, not routine

L-AmB moves in ICU and haematology-oncology quantities, not community-pharmacy runs. We plan supply around your tender award size and treatment-course maths (a mucormycosis course at 5mg/kg can consume dozens of 50mg vials per patient), not against a generic price list.

MOQ set by the batch-release minimum

Minimum order is governed by the source manufacturer's batch-release minimum for a sterile lyophilised injectable product, not an arbitrary figure we invent. We confirm the live minimum per source line at the point of quotation.

Price strictly on request

Amphotericin liposomal pricing swings with the source line, vial count, cold-chain lane and destination registration. We quote per enquiry against your exact specification. We never publish a headline number that would misprice your tender.

Reference brands for equivalence checks

Reference brands on this molecule include AmBisome (Gilead), Fungisome (Lifecare Innovations), Phosome (Cipla) and Amfotex. We name these only so your regulatory team can benchmark equivalence, never as retail "buy this brand" language.

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At a glance

L-AmB 50mg vial: formulation, class and handling at a glance

Active ingredient

Amphotericin B intercalated into a true unilamellar liposome (L-AmB). This is a distinct product from amphotericin B deoxycholate and from amphotericin B lipid complex (ABLC); the three are not interchangeable on a milligram-for-milligram basis.

Strength stocked

50mg per single-dose vial, the global institutional standard presentation. Catalogue lines carried include Amfotex 50mg and AmBisome 50mg.

Formulation and reconstitution

Sterile lyophilised (freeze-dried) powder. Reconstituted with Sterile Water for Injection (no bacteriostatic agent) to a 4mg/mL dispersion, then further diluted in 5% dextrose for infusion. Not diluted with saline.

Cold chain: 2 to 8 degrees C

Vials ship and store refrigerated at 2 to 8 degrees C, protected from freezing and light. We supply validated cold-chain lanes with data-logger options; the reconstituted product has a limited in-use hold window.

Regulatory class

Prescription-only sterile injectable antifungal. ATC J02AA01. Amphotericin B is listed on the WHO Model List of Essential Medicines, and liposomal amphotericin B is WHO-recommended first-line therapy for visceral leishmaniasis and for mucormycosis.

M Care's own credential

ISO 9001:2015 quality-managed trading. We supply from WHO-GMP-listed manufacturing lines; the WHO-GMP and any WHO-PQ status belong to the manufacturer, not to M Care.

Who we supply

Buyers who source liposomal amphotericin B through us

L-AmB demand is concentrated in tertiary and public-health procurement, and it spikes hard: post-COVID mucormycosis surges and kala-azar elimination programmes both drive sudden institutional orders. These are the buyer types we quote for.

Government and central medical stores

National kala-azar / visceral-leishmaniasis elimination programmes and central procurers who buy L-AmB against WHO treatment guidance and need CoPP-backed, tender-compliant documentation.

Hospital and ICU group buyers

Tertiary hospitals and transplant centres stocking for invasive aspergillosis, candidaemia and febrile-neutropenia protocols, where the liposomal form is chosen for its lower nephrotoxicity in already-fragile patients.

Importer-distributors with cold-chain reach

In-market distributors in the GCC, Africa, SE Asia and LatAm who hold a marketing authorisation and need a reliable refrigerated antifungal line to service hospital accounts.

NGO and outbreak-response buyers

Programme buyers responding to mucormycosis clusters or leishmaniasis-endemic caseloads who need documented, release-tested lots at short notice.

Re-tender and gap-fill buyers

Distributors covering a competitor stock-out or a lapsed award who need equivalence documentation to substitute onto an existing L-AmB line item.

Pharmacist’s note

Safety-critical handling notes for L-AmB

This page is professional buyer reference, not medical advice or a prescribing instruction. The most important point for any procurement or clinical team: liposomal amphotericin B is not interchangeable milligram-for-milligram with conventional amphotericin B deoxycholate or with amphotericin B lipid complex. The three products differ in pharmacokinetics, dosing and toxicity, and confusing them at the ward or dispensary level has caused serious dosing errors. Tender and labelling documentation must state the formulation unambiguously.

As reference context only, L-AmB is typically infused at 3 to 5mg/kg/day, with 5mg/kg commonly used in mucormycosis. Its defining clinical advantage over the deoxycholate form is markedly lower nephrotoxicity and fewer infusion-related reactions (fever, chills and rigors), which is why it is preferred in patients with existing renal impairment. It is not free of risk: monitoring for renal function, hypokalaemia, hypomagnesaemia and infusion reactions remains standard, and a test dose plus close observation of the first infusion is common clinical practice.

On handling: the vials are a sterile lyophilised powder requiring reconstitution with Sterile Water for Injection (never a bacteriostatic diluent) and dilution in 5% dextrose, not saline. The whole chain is cold-chain dependent at 2 to 8 degrees C, must not be frozen, and must be protected from light. We supply the manufacturer's full IFU and stability data with each consignment so the receiving pharmacy handles reconstitution and in-use hold times correctly.

Written for professional buyers and importers, not as medical advice. Prescribing decisions sit with the treating clinician and the approved label in your market.

Documentation

Export and registration documents we compile with you

A refrigerated injectable antifungal only clears customs and registers cleanly when the paperwork matches the batch. We assemble the following alongside your regulatory affairs team; the underlying GMP and product-quality credentials originate with the manufacturer.

CTD dossier support

We compile the Common Technical Document module set with you for national registration, drawing the quality (Module 3) data from the source manufacturer's dossier for the specific L-AmB line.

CoPP and free-sale certificate

Certificate of Pharmaceutical Product (WHO format) and Free Sale Certificate arranged from the manufacturing source to satisfy your import authority.

CoA and batch release

Batch-specific Certificate of Analysis with sterility, endotoxin and amphotericin B content data, plus the manufacturer's release documentation for each lot shipped.

Cold-chain and stability pack

Storage-condition attestation (2 to 8 degrees C), stability data, and cold-chain shipment validation with data-logger records where the lane or tender requires them.

Legalised commercial set

Invoice, packing list, and where required chamber-attested or apostilled / consular-legalised export documents matched to the consignee and destination.

How ordering works

How ordering works.

  1. Send your specification Share destination market, presentation (50mg vial), quantity or tender line size, any reference brand you must match, and your target registration status.
  2. We source and quote We identify a WHO-GMP source line, confirm the batch-release minimum and lead time, and return a price-on-request quotation with a documentation checklist.
  3. Dossier and sample alignment We compile the CTD, CoPP and CoA set with your regulatory team and arrange samples or a pilot lot for registration or tender submission where needed.
  4. Cold-chain despatch and tracking On confirmation we book a validated 2 to 8 degrees C lane, despatch with data-logger and full export documents, and track the consignment to your port of entry.
FAQ

Amphotericin B (Liposomal) supply, the specific questions.

What is the difference between liposomal amphotericin B and conventional amphotericin B deoxycholate?

Liposomal amphotericin B (L-AmB) encapsulates the drug in unilamellar liposomes, which sharply reduces nephrotoxicity and infusion reactions compared with the older amphotericin B deoxycholate, and is dosed differently. The two are not interchangeable milligram-for-milligram. When you order from us we confirm the formulation explicitly on every document so there is no ward-level confusion.

Which strength and presentation do you stock?

The 50mg single-dose lyophilised vial, the global institutional standard. Catalogue lines carried include Amfotex 50mg and AmBisome 50mg. Larger tender volumes are consolidated from WHO-GMP source lines against your specification.

Does M Care hold WHO-GMP or WHO-PQ for this product?

No. WHO-GMP and any WHO prequalification belong to the manufacturer of the line we supply from. M Care Exports is an ISO 9001:2015 merchant-exporter: we supply from WHO-GMP-listed manufacturing lines and compile the CoPP, CoA and CTD dossier with you. We never claim a certification we do not hold.

What is the minimum order quantity and price?

The minimum is set by the source manufacturer's batch-release minimum for a sterile lyophilised product, which we confirm per line at quotation. Price is strictly on request: L-AmB pricing moves with the source, vial count, cold-chain lane and destination, so we quote against your exact enquiry rather than publish a figure that could misprice your tender.

How is the cold chain maintained to my port?

L-AmB ships and stores at 2 to 8 degrees C, must not be frozen, and is kept out of light. We book validated refrigerated lanes, offer data-logger monitoring, and supply the storage attestation and stability data so your import authority and receiving pharmacy can verify integrity on arrival.

Can you supply for mucormycosis or kala-azar programme buying?

Yes. Liposomal amphotericin B is WHO-recommended first-line therapy for mucormycosis (5mg/kg is common) and for visceral leishmaniasis (kala-azar), and both drive concentrated institutional demand. We plan supply around programme or tender award size and the treatment-course vial maths, and provide the tender-compliant documentation set.

Can you match a specific reference brand for our registration?

We can benchmark equivalence against reference brands such as AmBisome, Fungisome, Phosome or Amfotex for your regulatory file. We name brands only as equivalence reference, never as retail promotion, and we align the CoA and dossier to whichever registered line your market requires.

Amphotericin B (Liposomal) enquiry

Request a quote for liposomal amphotericin B

Tell us your destination market, tender or order volume in 50mg vials, and any reference brand you must match. We will return a price-on-request quotation, confirm the batch-release minimum from a WHO-GMP source line, and share the cold-chain and documentation plan. Enquiries are answered by people who understand injectable antifungal export, not a generic order desk.

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