Medicine
Adzynma kit
Adzynma kit is a prescription medicine containing Apadamtase alfa, marketed by Takeda Pharmaceuticals, 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 at refrigerated temperature 2°C to 8°C (36°F to 46°F) for up to 36…
Key facts
- Active ingredient (INN)
- Apadamtase alfa
- Brand
- Adzynma
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at refrigerated temperature 2°C to 8°C (36°F to 46°F) for up to 36 months from the date of manufacture until expiration date stated on the ADZYNMA vial label and carton. After storage at room temperature, do not return to the refrigerator. Do not freeze. Within this period, ADZYNMA may be stored at room temperature not to exceed 30°C/86°F for a period up to 6 months.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 November 2023
- Identifiers
- DailyMed set ID 22728e96-efa0-46c1-bdd1-ad89a796d5e3NDC 64764-140, 64764-145Application BLA125795
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 * 500 [iu] in 1 vial, single-dose * 5 mL in 1 vial, glass | 64764-140-05 | Takeda Pharmaceuticals | 9 November 2023 |
| 1 kit in 1 carton * 1500 [iu] in 1 vial, single-dose * 5 mL in 1 vial, glass | 64764-145-05 | Takeda Pharmaceuticals | 9 November 2023 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Apadamtase alfa is a prescription medicine indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). It is available as kits. MedsAcross supplies Apadamtase alfa 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 Apadamtase alfaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ADZYNMA prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Adzynma 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.