Medicine
Myalept 11.3 mg/2.2 mL powder for injection
Myalept 11.3 mg/2.2 mL powder for injection is a prescription medicine containing Metreleptin for subcutaneous use, marketed by Chiesi, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
MYALEPT should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) and…
Key facts
- Active ingredient (INN)
- Metreleptin
- Brand
- Myalept
- Strength
- 11.3 mg/2.2 mL
- Dosage form
- Powder for injection
- Route
- Subcutaneous
- Packs
- 1 vial
- Marketing authorisation holder
- Chiesi
- Manufacturer
- Chiesi
- Origin register
- US FDA, United States
- Storage
- MYALEPT should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) and protected from light until preparing for use. Do not freeze MYALEPT. Use with BWFI: when MYALEPT is reconstituted with BWFI, the vial can be used for multiple doses within 3 days when stored in the refrigerator at 36°F to 46°F (2°C to 8°C) and protected from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AA07 Metreleptin
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 March 2015
- Identifiers
- RxCUI 1491629, 1491634DailyMed set ID d3b50bbd-140b-425c-b5ec-d4682aad62bcNDC 10122-210Application BLA125390
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, glass in 1 carton / 2.2 mL in 1 vial, glass | 10122-210-02 | Chiesi | 5 March 2015 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Metreleptin is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy, among other approved uses. MedsAcross supplies Metreleptin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MetreleptinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Myalept prescribing information (Chiesi) · U.S. National Library of Medicine, DailyMed
- Myalepta: European public assessment report (EPAR) · European Medicines Agency
Need Myalept 11.3 mg/2.2 mL powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.