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MedsAcross

Medicine

Zymfentra kit

Infliximab · Celltrion
Available on requestPrescription onlyUS FDA Cold chain

Zymfentra kit is a prescription medicine containing Infliximab, marketed by Celltrion, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store in refrigerator at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Once the…

Key facts

Active ingredient (INN)
Infliximab
Brand
Zymfentra
Dosage form
Kit
Packs
1 kit, 2 kits, 4 kits and 9 more
Marketing authorisation holder
Celltrion
Manufacturer
Celltrion
Origin register
US FDA, United States
Storage
Store in refrigerator at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Once the product has been stored at room temperature, it should not be placed back into the refrigerator. If needed, the product may be stored at room temperature at 20°C to 25°C (68°F to 77°F) for up to 14 days with protection from light.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L04AB02 Infliximab
HS code (indicative)
3002.15Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 March 2024
Identifiers
RxCUI 797544, 2675742, 2675749 +2DailyMed set ID 93a193ab-9f96-4da6-aa7c-31212e81879aNDC 72606-025Application BLA761358

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 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-01Celltrion1 March 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-02Celltrion1 March 2024
4 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-03Celltrion1 March 2024
6 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-04Celltrion1 March 2024
1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-05Celltrion1 March 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-06Celltrion1 March 2024
4 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-07Celltrion1 March 2024
6 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-08Celltrion1 March 2024
1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-09Celltrion1 March 2024
2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-10Celltrion1 March 2024
4 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-11Celltrion1 March 2024
6 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 mL in 1 syringe * 1 mL in 1 packet72606-025-12Celltrion1 March 2024

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
US FDAFirst approved 24 August 1998Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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

Other strengths and forms of Infliximab

Clinical summary

Infliximab is a tumor necrosis factor blocker indicated for crohn's Disease, among other approved uses. It is available as powder for injection, injection and kits for intravenous and subcutaneous use. MedsAcross supplies Infliximab 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 Infliximab

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

Data sources

Need Zymfentra 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.