Medicine
Infliximab 100 mg/10 mL powder for injection
Infliximab 100 mg/10 mL powder for injection is a generic prescription medicine for intravenous use, 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 unopened Infliximab vials in a refrigerator at 2 °C to 8 °C (36 °F to 46…
Key facts
- Active ingredient (INN)
- Infliximab
- Brand
- Sold under the generic name
- Strength
- 100 mg/10 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Manufacturer
- Janssen Biotech
- Origin register
- US FDA, United States
- Storage
- Store unopened Infliximab vials in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F). Once removed from the refrigerator, Infliximab cannot be returned to the refrigerator. If needed, unopened Infliximab vials may be stored at room temperatures up to a maximum of 30 °C (86 °F) for a single period of up to 6 months but not exceeding the original expiration date.
- 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
- 5 October 2021
- Identifiers
- RxCUI 310994DailyMed set ID b05c174f-832c-4321-b34f-2c4ad3742269NDC 57894-160Application BLA103772
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 vial, single-use in 1 box / 10 mL in 1 vial, single-use | 57894-160-01 | Janssen Biotech | 5 October 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.
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 Infliximab 100 mg/10 mL powder for injection.
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 InfliximabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- INFLIXIMAB prescribing information (Janssen Biotech) · U.S. National Library of Medicine, DailyMed
- Remicade: European public assessment report (EPAR) · European Medicines Agency
- Flixabi: European public assessment report (EPAR) · European Medicines Agency
Need Infliximab 100 mg/10 mL 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.