Medicine
Vyleesi 1.75 mg/0.3 mL injection
Vyleesi 1.75 mg/0.3 mL injection is a prescription medicine containing Bremelanotide for subcutaneous use, marketed by Cosette Pharmaceuticals, 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
Do not freeze. Store at or below 25°C (77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Bremelanotide
- Brand
- Vyleesi
- Strength
- 1.75 mg/0.3 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 4 syringes of 0.3 mL
- Marketing authorisation holder
- Cosette Pharmaceuticals
- Manufacturer
- Cosette Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at or below 25°C (77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 November 2025
- Identifiers
- DailyMed set ID f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcfNDC 0713-0897Application NDA210557
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 |
|---|---|---|---|
| 4 syringe in 1 carton / .3 mL in 1 syringe | 0713-0897-04 | Cosette Pharmaceuticals | 12 November 2025 |
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 21 June 2019 | 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
Clinical summary
Bremelanotide is a melanocortin receptor agonist indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Bremelanotide 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 BremelanotideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Vyleesi prescribing information (Cosette Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Vyleesi 1.75 mg/0.3 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.