Medicine
Azmiro 200 mg/1 mL injection
Azmiro 200 mg/1 mL injection is a prescription medicine containing Testosterone cypionate for intramuscular use, marketed by Azurity 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
Store at 15°C to 25°C (59°F to 77°F), excursions permitted to 2°C to 30°C…
Key facts
- Active ingredient (INN)
- Testosterone cypionate
- Brand
- Azmiro
- Strength
- 200 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 1 syringe of 1 mL, 1 vial of 1 mL
- Marketing authorisation holder
- Azurity Pharmaceuticals
- Manufacturer
- Azurity Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 15°C to 25°C (59°F to 77°F), excursions permitted to 2°C to 30°C (36°F to 86°F). Store product in carton to protect contents from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 October 2024
- Identifiers
- RxCUI 2047882, 2694309, 2694316 +1DailyMed set ID 235b5625-570d-3fba-e063-6394a90aa2d1NDC 24338-055, 24338-056Application NDA216318
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, glass in 1 carton / 1 mL in 1 syringe, glass | 24338-055-01 | Azurity Pharmaceuticals | 4 October 2024 |
| 1 vial in 1 carton / 1 mL in 1 vial | 24338-056-01 | Azurity Pharmaceuticals | 4 October 2024 |
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 2 June 2022 | 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 Testosterone cypionate 200 mg/1 mL injection.
Other strengths and forms of Testosterone cypionate
Clinical summary
Testosterone cypionate is an androgen indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone, among other approved uses. It is available as injection for intramuscular use. MedsAcross supplies Testosterone cypionate 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 Testosterone cypionateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- AZMIRO prescribing information (Azurity Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Azmiro 200 mg/1 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.