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Medicine

Ryplazim 68.8 mg powder for injection

Plasminogen · Intravenous · Kedrion Biopharma
Available on requestPrescription onlyUS FDA

Ryplazim 68.8 mg powder for injection is a prescription medicine containing Plasminogen for intravenous use, marketed by Kedrion Biopharma, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Storage as on the product label

Key facts

Active ingredient (INN)
Plasminogen
Brand
Ryplazim
Strength
68.8 mg
Dosage form
Powder for injection
Route
Intravenous
Packs
1 vial
Marketing authorisation holder
Kedrion Biopharma
Manufacturer
Kedrion Biopharma
Origin register
US FDA, United States
Cold chain
Not required on record
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
4 June 2021
Identifiers
NDC 70573-099Application BLA125659

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

PackCodeLabelerMarketed since
1 vial, glass in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, glass70573-099-02Kedrion Biopharma4 June 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

Clinical information for Plasminogen is on its overview page.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Plasminogen

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

  • US FDA NDC directory · Checked 12 November 2026

Need Ryplazim 68.8 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.