Medicine
Fensolvi 45 mg/0.375 mL extended-release injectable suspension
Fensolvi 45 mg/0.375 mL extended-release injectable suspension is a prescription medicine containing Leuprolide for subcutaneous use, marketed by Tolmar, 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). Once outside the…
Key facts
- Active ingredient (INN)
- Leuprolide
- Brand
- Fensolvi
- Strength
- 45 mg/0.375 mL
- Dosage form
- Extended-release injectable suspension
- Route
- Subcutaneous
- Packs
- 1 syringe of 0.375 mL
- Marketing authorisation holder
- Tolmar
- Manufacturer
- Tolmar
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F). Once outside the refrigerator, this product may be stored in its original packaging at room temperature 15°C to 30°C (59°F to 86°F) for up to eight weeks prior to reconstitution and administration.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L02AE02 Leuprorelin
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 March 2023
- Identifiers
- RxCUI 752884, 2371773DailyMed set ID 2c311700-edf4-4f2a-a468-9875489a6cc7NDC 62935-163Application NDA213150
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 / .375 mL in 1 syringe | 62935-163-60 | Tolmar | 6 March 2023 |
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 9 April 1985 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| 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 Leuprolide 45 mg/0.375 mL extended-release injectable suspension.
Other strengths and forms of Leuprolide
Clinical summary
Leuprolide is a gonadotropin releasing hormone receptor agonist indicated for the treatment of advanced prostate cancer. It is available as kits, extended-release injectable suspension and injectable emulsion for subcutaneous use. MedsAcross supplies Leuprolide 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 LeuprolideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Lupron Depot prescribing information (AbbVie) · U.S. National Library of Medicine, DailyMed
Need Fensolvi 45 mg/0.375 mL extended-release injectable suspension 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.