Myalepta (metreleptin), sold as Myalept in the US, is a recombinant leptin analogue for the complications of leptin deficiency in lipodystrophy, supplied as an 11.3 mg vial for daily subcutaneous injection and stored at 2 to 8 °C.
M Care Exports supplies Myalepta (metreleptin), made by Chiesi, and the US-labelled version Myalept, to hospital pharmacies, endocrinology and metabolic units, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 11.3 mg vial, send the destination, the quantity and the registration route you need, and we quote per destination.
Metreleptin exporter and bulk supplier from India.
"We need a partner for Myalepta" is a typical enquiry for a rare-disease product, where a hospital or importer may be treating very few patients and needs a reliable source. M Care is a merchant-exporter: we quote against your specification and confirm what your destination registers. Metreleptin has one vial strength on the labels we checked, 11.3 mg of lyophilised powder, which gives 5 mg/mL once it is reconstituted with 2.2 mL of water. The dose is weight-based and daily, so the quantity you need depends on the patient's weight and dose, not on a fixed course. The EU and UK products are Myalepta; the US product is Myalept, sold under a different label with a different population. A quote therefore turns on which label your regulator expects, the number of vials, the cold chain at 2 to 8 °C, any import permit for a rare or unlicensed product, and Incoterms.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Recombinant human leptin analogue, sourced and documented for export.
Metreleptin is a recombinant human leptin analogue used as an adjunct to diet, as replacement therapy for the complications of leptin deficiency in lipodystrophy. The EU and UK label covers generalised lipodystrophy (Berardinelli-Seip or Lawrence syndrome, congenital or acquired) in adults and children aged 2 and over, and partial lipodystrophy (familial or acquired, including Barraquer-Simons syndrome) in patients aged 12 and over when standard treatments have not given adequate metabolic control. The US Myalept label is narrower: congenital or acquired generalised lipodystrophy only, and it states that safety and effectiveness are not established for partial lipodystrophy. The EMA lists Chiesi Farmaceutici S.p.A. as marketing authorisation holder, authorised on 30 July 2018 under exceptional circumstances, with an orphan designation and additional monitoring. The UK SmPC (text revised June 2025) lists Chiesi Limited and a first authorisation date of 19 January 2024. The US DailyMed label lists Chiesi USA, Inc. as labeler and Chiesi Farmaceutici S.p.A. as manufacturer. Each label gives one 11.3 mg vial that makes 5 mg/mL after reconstitution with 2.2 mL.
Active ingredient
Metreleptin. Recombinant human leptin analogue.
Forms and strengths
11.3 mg vial of lyophilised powder (5 mg/mL after reconstitution with 2.2 mL).
Indications
Recombinant human leptin analogue used as an adjunct to diet for the complications of leptin deficiency in lipodystrophy; given once daily by subcutaneous injection, dosed by body weight.
Administration
Subcutaneous. Powder for solution for injection.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers are hospital pharmacists in endocrinology, metabolic and paediatric units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Myalepta 11.3 mg vials for a lipodystrophy patient" or "We need a partner for metreleptin for a named-patient programme". Each destination has its own route, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK. Because lipodystrophy is a rare disease, whether a destination has registered metreleptin, or needs an unlicensed or named-patient import, depends on the destination regulator, and M Care Exports confirms the route per enquiry before quoting.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on metreleptin.
Plan around weight, because dosing is weight-based and once daily. Both labels give 0.06 mg/kg to start for patients at or under 40 kg, 2.5 mg for males over 40 kg and 5 mg for females over 40 kg, adjusted in steps and capped at 0.13 mg/kg or 10 mg a day. The UK SmPC says doses should rise no more often than every 4 weeks. One vial makes 2.2 mL at 5 mg/mL, so a 10 mg dose is 2 mL. The UK SmPC says to let the vial warm for 10 minutes, reconstitute with water for injections, swirl gently and never shake, and use the solution immediately. The US label also allows bacteriostatic water, which lets one vial serve several doses within 3 days in the refrigerator, and specifies preservative-free water for neonates and infants. Under the UK SmPC the water for injections, syringes and needles are supplied separately from the vials, so the order should list them, including the right small-volume syringes. Unopened vials are kept at 2 to 8 °C in the carton, away from light. The UK SmPC gives a 4-year shelf life, and the US patient instructions allow a vial of powder up to 4 hours at room temperature. Warn the clinical team that insulin doses may need reducing, and that both labels recommend tapering rather than stopping abruptly in patients at risk of pancreatitis (over one week in the US label, two weeks in the UK SmPC).
The documentation pack a regulator actually asks for.
Myalepta is a cold-chain biologic. The UK SmPC and the US label both require unopened vials at 2 to 8 °C in the original carton, away from light, and the US label says not to freeze. Export consignments are packed in qualified insulated shippers with temperature loggers, timed to the receiving site. The EU product is authorised under exceptional circumstances because the disease is rare, and is under additional monitoring. The US label carries a boxed warning on neutralising antibodies and T-cell lymphoma, and makes Myalept available only through a REMS programme with certified prescribers and certified pharmacies. That programme is a US requirement, and each destination sets its own rules. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. We state the source and status of each line before quoting, and make no claim of manufacturing.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside metreleptin.
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The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for metreleptin.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Metreleptin supply, the specific questions.
What is the indication for Myalepta?
Myalepta is an adjunct to diet, used as replacement therapy for the complications of leptin deficiency in lipodystrophy. In the EU and UK it covers generalised lipodystrophy in adults and children aged 2 and over, and partial lipodystrophy in patients aged 12 and over when standard treatments have not given adequate metabolic control. The US label for Myalept is limited to congenital or acquired generalised lipodystrophy, and says safety and effectiveness are not established in partial lipodystrophy.
Who makes Myalepta, and is there a generic or biosimilar?
Chiesi is the company named on each label we checked. The EMA lists Chiesi Farmaceutici S.p.A. as marketing authorisation holder, the UK SmPC lists Chiesi Limited, and the US DailyMed label lists Chiesi USA, Inc. as labeler with Chiesi Farmaceutici S.p.A. as manufacturer. A DailyMed search for metreleptin returns only the Chiesi USA label for Myalept, and we found no generic or biosimilar on the EMA or emc pages we checked. M Care Exports is a merchant-exporter and does not manufacture it; we confirm the source and presentation per enquiry.
What is the Myalepta 11.3 mg vial?
It is a vial of lyophilised metreleptin powder containing 11.3 mg. When reconstituted with 2.2 mL of water for injections, each mL holds 5 mg. The UK SmPC lists packs of 1 or 30 vials. The dose is given once daily by subcutaneous injection and is set by weight: a starting 0.06 mg/kg at or under 40 kg, or 2.5 mg for males and 5 mg for females over 40 kg, up to a maximum of 10 mg a day in heavier patients. Under the UK SmPC the water for injections, syringes and needles are supplied separately from the vials.
What is Myalepta's EMA status?
The EMA authorised Myalepta on 30 July 2018 under exceptional circumstances, which means complete efficacy and safety data could not be obtained under normal conditions of use. The medicine has an orphan designation and is under additional monitoring. The holder named on the EMA page is Chiesi Farmaceutici S.p.A. EU status does not decide registration elsewhere, so we check the route in your destination before quoting.
How is the landed price of Myalepta worked out for an importer?
We do not publish prices. For metreleptin the landed price depends on the number of vials the patient's weight and dose require, which label your regulator expects (Myalepta or Myalept), the registration or unlicensed-import route in the destination, 2 to 8 °C cold-chain packing, and Incoterms. M Care Exports quotes per destination once we know these details.
Can I import Myalepta on a named-patient basis if it is not registered in my country?
It depends on the destination regulator. Lipodystrophy is a rare disease, and whether metreleptin is registered in your country, or can be brought in as an unlicensed or named-patient import under a specific permit, is decided by that regulator. M Care Exports does not assume a route. Send the destination and the patient details your regulator requires, and we confirm the route and the documents per enquiry.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.