Medicine
Tofacitinib 1 mg/mL oral solution
Tofacitinib 1 mg/mL oral solution is a generic prescription medicine for oral use, made by 5 labelers, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Tofacitinib
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 240 mL, 1 bottle and 1 more
- Manufacturers
- Novadoz PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaHikma PharmaceuticalsIPG Pharmaceuticals5 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Store in the original bottle and carton to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AF01 Tofacitinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 June 2026
- Identifiers
- RxCUI 2478433DailyMed set ID 327f6b60-1a5d-49e6-acff-18603d0ee9d0, cd1b61bf-de03-4198-89f6-f3952b79d2c2, d9cf18a9-e825-49ac-b080-68957c0e79ae +2NDC 72205-121, 71085-099, 0054-0821 +2Application ANDA217298, ANDA219370, ANDA216878 +2
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 240 mL in 1 bottle | 72205-121-81 | Novadoz PharmaceuticalsIndia | 3 June 2026 |
| 1 bottle in 1 carton / 240 mL in 1 bottle | 70095-008-02 | Sun Pharmaceutical IndustriesIndia | 3 June 2026 |
| 1 bottle in 1 carton / 240 mL in 1 bottle | 0054-0821-58 | Hikma Pharmaceuticals | 3 June 2026 |
| 1 bottle in 1 carton / 240 mL in 1 bottle | 71085-099-24 | IPG Pharmaceuticals | 15 June 2026 |
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 Tofacitinib 1 mg/mL oral solution.
Other strengths and forms of Tofacitinib
Clinical summary
Tofacitinib is a janus kinase inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. MedsAcross supplies Tofacitinib 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 TofacitinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- XELJANZ prescribing information (US Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Xeljanz: European public assessment report (EPAR) · European Medicines Agency
Need Tofacitinib 1 mg/mL oral solution 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.