Medicine
Serostim kit
Serostim kit is a prescription medicine containing Somatropin for subcutaneous use, marketed by EMD Serono, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store cartons containing SEROSTIM vials and diluent vials at room temperature…
Key facts
- Active ingredient (INN)
- Somatropin
- Brand
- Serostim
- Dosage form
- Kit
- Route
- Subcutaneous
- Packs
- 1 kit
- Marketing authorisation holder
- EMD Serono
- Manufacturer
- EMD Serono
- Origin register
- US FDA, United States
- Storage
- Store cartons containing SEROSTIM vials and diluent vials at room temperature between 15°C to 30°C (59°F to 86°F). Single-patient use vials (SEROSTIM 4 mg) reconstituted with Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol as a preservative), store refrigerated between 2°C to 8° C (36°F to 46°F) for up to 14 days. Do not freeze reconstituted SEROSTIM vials.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H01AC01 Somatropin
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 August 1996
- Identifiers
- RxCUI 248288, 249453, 346494 +3DailyMed set ID 62b01d29-90f0-45b2-a0c4-3a750ba36c8aNDC 44087-0006, 44087-0005, 44087-0004Application BLA020604
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 kit in 1 carton * 1 mL in 1 vial * 3.5 mL in 1 vial, glass | 44087-0004-7 | EMD Serono | 25 July 1997 |
| 1 kit in 1 carton * 1 mL in 1 vial * 1 mL in 1 vial | 44087-0005-7 | EMD Serono | 23 August 1996 |
| 1 kit in 1 carton * 1 mL in 1 vial * 1 mL in 1 vial | 44087-0006-7 | EMD Serono | 23 August 1996 |
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
Alternatives
Other makers and brands of Somatropin kit.
- Genotropin kitAvailable on requestPfizer LaboratoriesUS FDA12 packs Cold chain
- Humatrope kitAvailable on requestEli LillyUS FDA3 packs
- Omnitrope kitAvailable on requestSandozUS FDA1 pack Cold chain
- Zomacton kitAvailable on requestFerring PharmaceuticalsUS FDA1 pack Cold chain
- Zomacton kitAvailable on requestFerring PharmaceuticalsUS FDA1 pack Cold chain
Other strengths and forms of Somatropin
Clinical summary
Somatropin is a recombinant human growth hormone indicated for pediatric Patients, among other approved uses. It is available as kits and injection for subcutaneous and intramuscular use. MedsAcross supplies Somatropin 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 SomatropinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- HUMATROPE prescribing information (Eli Lilly) · U.S. National Library of Medicine, DailyMed
- NutropinAq: European public assessment report (EPAR) · European Medicines Agency
- Omnitrope: European public assessment report (EPAR) · European Medicines Agency
Need Serostim kit 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.