Medicine
Pralatrexate 40 mg/2 mL injection
Pralatrexate 40 mg/2 mL injection is a generic prescription medicine for intravenous use, made by 2 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. 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 refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect…
Key facts
- Active ingredient (INN)
- Pralatrexate
- Brand
- Sold under the generic name
- Strength
- 40 mg/2 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 2 mL
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaFresenius Kabi
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BA05 Pralatrexate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 November 2022
- Identifiers
- RxCUI 1796419, 1796424DailyMed set ID cc3df863-c51c-49c5-283a-d6808fb49258, a5daa583-4965-4564-ad87-41ffe6c08a11NDC 43598-343, 65219-552Application ANDA206183, NDA022468
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 |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 43598-343-23 | Dr. Reddy's LaboratoriesIndia | 4 March 2026 |
| 1 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 65219-552-02 | Fresenius Kabi | 15 November 2022 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 24 September 2009 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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 Pralatrexate 40 mg/2 mL injection.
Other strengths and forms of Pralatrexate
Clinical summary
Pralatrexate is a folate analog metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is available as injection for intravenous use. MedsAcross supplies Pralatrexate 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 PralatrexateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Folotyn prescribing information (Acrotech Biopharma) · U.S. National Library of Medicine, DailyMed
Need Pralatrexate 40 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.