Medicine
Tremfya 200 mg/2 mL injection
Tremfya 200 mg/2 mL injection is a prescription medicine containing Guselkumab 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
Store in a refrigerator between 2 ºC to 8 ºC (36 ºF to 46 ºF). Do not freeze…
Key facts
- Active ingredient (INN)
- Guselkumab
- Brand
- Tremfya
- Strength
- 200 mg/2 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 2 mL, 2 cartons of 2 mL and 1 more
- Marketing authorisation holder
- Janssen Biotech
- Manufacturer
- Janssen Biotech
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator between 2 ºC to 8 ºC (36 ºF to 46 ºF). Do not freeze. Store in original carton until time of use. Protect from light until use. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AC16 Guselkumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 September 2024
- Identifiers
- RxCUI 1928686, 1928689, 2118739 +7DailyMed set ID 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56NDC 57894-651Application BLA761061
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 in 1 carton / 2 mL in 1 syringe | 57894-651-02 | Janssen Biotech | 11 September 2024 |
| 2 carton in 1 carton / 1 syringe in 1 carton / 2 mL in 1 syringe | 57894-651-04 | Janssen Biotech | 20 March 2025 |
| 1 syringe in 1 carton / 2 mL in 1 syringe | 57894-651-22 | Janssen Biotech | 11 September 2024 |
| 1 syringe in 1 carton / 2 mL in 1 syringe | 57894-651-92 | Janssen Biotech | 11 September 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.
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 Guselkumab
Clinical summary
Guselkumab is an interleukin-23 antagonist indicated for the treatment of adults and pediatric patients 6 years of age and older, among other approved uses. It is available as injection for subcutaneous and intravenous use. MedsAcross supplies Guselkumab 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 GuselkumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TREMFYA prescribing information (Janssen Biotech) · U.S. National Library of Medicine, DailyMed
- Tremfya: European public assessment report (EPAR) · European Medicines Agency
Need Tremfya 200 mg/2 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.