Medicine
Adynovate kit
Adynovate kit is a prescription medicine containing Antihemophilic factor pegylated, marketed by Takeda Pharmaceuticals Amercia, 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 ADYNOVATE in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze. If…
Key facts
- Active ingredient (INN)
- Antihemophilic factor pegylated
- Brand
- Adynovate
- Dosage form
- Kit
- Packs
- 1 kit and 4 more
- Marketing authorisation holder
- Takeda Pharmaceuticals Amercia
- Manufacturer
- Takeda Pharmaceuticals Amercia
- Origin register
- US FDA, United States
- Storage
- Store ADYNOVATE in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze. If stored at room temperature, write the date on the carton when ADYNOVATE is removed from refrigeration. After storage at room temperature, do not return the product to the refrigerator. ADYNOVATE may be stored at room temperature not to exceed 30°C (86°F) for a period of up to 3 months not to exceed the expiration date.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 13 November 2015
- Identifiers
- RxCUI 1741407, 1741409DailyMed set ID ef290433-997f-4e98-86d6-42f6a99d6d18NDC 0944-4625, 0944-4626, 0944-4623 +4Application BLA125566
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 container in 1 kit / 1 kit in 1 container * 5 mL in 1 vial, glass * 2 mL in 1 vial, glass | 0944-4622-01 | Takeda Pharmaceuticals Amercia | 28 July 2016 |
| 1 kit in 1 carton / 1 container in 1 kit / 1 kit in 1 container * 5 mL in 1 vial, glass * 2 mL in 1 vial, glass | 0944-4623-01 | Takeda Pharmaceuticals Amercia | 13 November 2015 |
| 1 kit in 1 carton / 1 container in 1 kit / 1 kit in 1 container * 5 mL in 1 vial, glass * 2 mL in 1 vial, glass | 0944-4624-01 | Takeda Pharmaceuticals Amercia | 25 October 2016 |
| 1 kit in 1 carton / 1 container in 1 kit / 1 kit in 1 container * 5 mL in 1 vial, glass * 5 mL in 1 vial, glass | 0944-4625-01 | Takeda Pharmaceuticals Amercia | 13 November 2015 |
| 1 kit in 1 carton / 1 container in 1 kit / 1 kit in 1 container * 5 mL in 1 vial, glass * 2 mL in 1 vial, glass | 0944-4626-01 | Takeda Pharmaceuticals Amercia | 25 October 2016 |
| 1 kit in 1 carton / 1 container in 1 kit / 1 kit in 1 container * 5 mL in 1 vial, glass * 2 mL in 1 vial, glass | 0944-4627-01 | Takeda Pharmaceuticals Amercia | 13 November 2015 |
| 1 kit in 1 carton / 1 container in 1 kit / 1 kit in 1 container * 5 mL in 1 vial, glass * 5 mL in 1 vial, glass | 0944-4628-01 | Takeda Pharmaceuticals Amercia | 25 October 2016 |
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
Alternatives
Other makers and brands of Antihemophilic factor pegylated kit.
Clinical summary
Antihemophilic factor pegylated is a prescription medicine indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes, among other approved uses. MedsAcross supplies Antihemophilic factor pegylated 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 Antihemophilic factor pegylatedFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ADYNOVATE prescribing information (Takeda Pharmaceuticals Amercia) · U.S. National Library of Medicine, DailyMed
Need Adynovate 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.