Medicine
Renflexis 100 mg powder for injection
Renflexis 100 mg powder for injection is a prescription medicine containing Infliximab for intravenous use, marketed by Organon, 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 RENFLEXIS ® vials in a refrigerator at 2°C to 8°C (36°F to…
Key facts
- Active ingredient (INN)
- Infliximab
- Brand
- Renflexis
- Strength
- 100 mg
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Organon
- Manufacturer
- Organon
- Origin register
- US FDA, United States
- Storage
- Store unopened RENFLEXIS ® vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Once removed from the refrigerator, RENFLEXIS cannot be returned to the refrigerator. If needed, unopened RENFLEXIS 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
- 21 April 2017
- Identifiers
- RxCUI 1927285, 1927290DailyMed set ID dbf738c4-3fac-4422-a9d8-51d9c83a8789NDC 78206-162Application BLA761054
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 in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 78206-162-01 | Organon | 1 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.
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 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 Renflexis 100 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.