Medicine
Skytrofa 11 mg powder for injection
Skytrofa 11 mg powder for injection is a prescription medicine containing Lonapegsomatropin for subcutaneous use, marketed by Ascendis Pharma Endocrinology, 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
Store SKYTROFA cartridges refrigerated at 36°F to 46°F (2°C to 8°C) in the…
Key facts
- Active ingredient (INN)
- Lonapegsomatropin
- Brand
- Skytrofa
- Strength
- 11 mg
- Dosage form
- Powder for injection
- Route
- Subcutaneous
- Packs
- 4 blister pack
- Marketing authorisation holder
- Ascendis Pharma Endocrinology
- Manufacturer
- Ascendis Pharma Endocrinology
- Origin register
- US FDA, United States
- Storage
- Store SKYTROFA cartridges refrigerated at 36°F to 46°F (2°C to 8°C) in the outer carton to protect from light until the expiration date. Do not freeze.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H01AC09 Lonapegsomatropin
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 August 2021
- Identifiers
- RxCUI 2569603, 2569605, 2569607 +7DailyMed set ID 9229f871-bc61-4ddc-8122-d126d40e36acNDC 73362-010Application BLA761177
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 |
|---|---|---|---|
| 4 blister pack in 1 carton / 1 cartridge in 1 blister pack / 1 injection, powder, lyophilized, for solution in 1 cartridge | 73362-010-01 | Ascendis Pharma Endocrinology | 25 August 2021 |
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
Other strengths and forms of Lonapegsomatropin
Clinical summary
Lonapegsomatropin is a recombinant human growth hormone indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). MedsAcross supplies Lonapegsomatropin 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 LonapegsomatropinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Skytrofa prescribing information (Ascendis Pharma Endocrinology) · U.S. National Library of Medicine, DailyMed
- Skytrofa (previously Lonapegsomatropin Ascendis Pharma): European public assessment report (EPAR) · European Medicines Agency
Need Skytrofa 11 mg 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.