Fibryga kit is a prescription medicine containing Fibrinogen for intravenous use, marketed by Octapharma, 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
Do not freeze. Store FIBRYGA for up to 48 months at +2°C to + 25°C (36°F to…
Key facts
- Active ingredient (INN)
- Fibrinogen
- Brand
- Fibryga
- Dosage form
- Kit
- Route
- Intravenous
- Packs
- 1 kit
- Marketing authorisation holder
- Octapharma
- Manufacturer
- Octapharma
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store FIBRYGA for up to 48 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Store in the original container to protect from light. After reconstitution, do not refrigerate or freeze the FIBRYGA solution.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B02BB01 Fibrinogen
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 October 2017
- Identifiers
- RxCUI 831506, 1947382DailyMed set ID 007a93f4-d84b-1fa9-51ed-32f6140bf423NDC 68982-347Application BLA125612
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 * 50 mL in 1 bottle, glass | 68982-347-01 | Octapharma | 16 October 2017 |
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 Fibrinogen kit.
Clinical summary
Fibrinogen is a prescription medicine indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia, among other approved uses. MedsAcross supplies Fibrinogen 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 FibrinogenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FESILTY prescribing information (Grifols) · U.S. National Library of Medicine, DailyMed
Need Fibryga 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.