Medicine
Treprostinil 20 mg/20 mL injection
Treprostinil 20 mg/20 mL injection is a generic prescription medicine for intravenous, subcutaneous use, made by 4 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
Unopened vials of treprostinil injection are stable until the date indicated…
Key facts
- Active ingredient (INN)
- Treprostinil
- Brand
- Sold under the generic name
- Strength
- 20 mg/20 mL
- Dosage form
- Injection
- Route
- Intravenous, subcutaneous
- Packs
- 1 vial of 20 mL and 1 more
- Manufacturers
- Alembic PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaSandozTeva Parenteral Medicines
- Origin register
- US FDA, United States
- Storage
- Unopened vials of treprostinil injection are stable until the date indicated when stored at 20° to 25°C (68° to 77°F). / STORAGE AND HANDLING Treprostinil injection is supplied in 20-mL multidose vials as sterile solutions in water for injection, individually packaged in cartons.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B01AC21 Treprostinil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 March 2019
- Identifiers
- RxCUI 349407, 349408, 349409 +1DailyMed set ID 33050ee2-519b-1f0b-d4df-9e14dd329c57, 4a684b13-669d-4721-8ed4-30cc7762b0b8, 473297ca-a872-4052-a053-87dc8f0d3c13 +1NDC 43598-649, 62332-514, 0781-3420 +1Application ANDA210214, ANDA211574, ANDA203649 +1
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 in 1 carton / 20 mL in 1 vial | 62332-514-20 | Alembic PharmaceuticalsIndia | 11 February 2021 |
| 1 vial in 1 carton / 20 mL in 1 vial | 43598-649-11 | Dr. Reddy's LaboratoriesIndia | 13 February 2023 |
| 1 vial, multi-dose in 1 carton / 20 mL in 1 vial, multi-dose | 0781-3420-80 | Sandoz | 25 March 2019 |
| 1 vial, multi-dose in 1 carton / 20 mL in 1 vial, multi-dose | 0703-0666-01 | Teva Parenteral Medicines | 30 September 2019 |
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 Treprostinil 20 mg/20 mL injection.
Other strengths and forms of Treprostinil
Clinical summary
Treprostinil is a prostacycline vasodilator indicated for treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to diminish symptoms associated with exercise, among other approved uses. MedsAcross supplies Treprostinil 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 TreprostinilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Remodulin prescribing information (United Therapeutics) · U.S. National Library of Medicine, DailyMed
- Trepulmix: European public assessment report (EPAR) · European Medicines Agency
Need Treprostinil 20 mg/20 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.