Medicine
Simponi 100 mg/1 mL injection
Simponi 100 mg/1 mL injection is a prescription medicine containing Golimumab for subcutaneous use, marketed by Janssen Biotech, 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
Refrigerate SIMPONI between 36 °F to 46 °F (2 °C to 8 °C) in the original…
Key facts
- Active ingredient (INN)
- Golimumab
- Brand
- Simponi
- Strength
- 100 mg/1 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 1 mL
- Marketing authorisation holder
- Janssen Biotech
- Manufacturer
- Janssen Biotech
- Origin register
- US FDA, United States
- Storage
- Refrigerate SIMPONI between 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light until the time of use. Do not freeze. If needed, SIMPONI may be stored at room temperature up to 77 °F (25 °C) for a maximum single period of 30 days in the original carton to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AB06 Golimumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 May 2013
- Identifiers
- DailyMed set ID f86cb4a7-c358-4136-ae57-b32bda9bba00NDC 57894-071Application BLA125289
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 syringe, glass in 1 carton / 1 mL in 1 syringe, glass | 57894-071-01 | Janssen Biotech | 15 May 2013 |
| 1 syringe in 1 carton / 1 mL in 1 syringe | 57894-071-02 | Janssen Biotech | 15 May 2013 |
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 Golimumab
Clinical summary
Golimumab is a tumor necrosis factor blocker indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), among other approved uses. It is available as injection for subcutaneous and intravenous use. MedsAcross supplies Golimumab 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 GolimumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Simponi prescribing information (Janssen Biotech) · U.S. National Library of Medicine, DailyMed
- Simponi: European public assessment report (EPAR) · European Medicines Agency
- Gobivaz: European public assessment report (EPAR) · European Medicines Agency
Need Simponi 100 mg/1 mL 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.