Medicine
Oziltus 119 mg/1.7 mL injection
Oziltus 119 mg/1.7 mL injection is a prescription medicine containing Denosumab for subcutaneous use, marketed by Amneal 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. 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 Oziltus refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton…
Key facts
- Active ingredient (INN)
- Denosumab
- Brand
- Oziltus
- Strength
- 119 mg/1.7 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial of 1.7 mL
- Marketing authorisation holder
- Amneal Pharmaceuticals
- Manufacturer
- Amneal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store Oziltus refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Once removed from the refrigerator, Oziltus must not be exposed to temperatures above 25°C (77°F) and must be used within 14 days. Prior to administration, Oziltus may be allowed to reach room temperature up to 25°C (77°F) in the original container.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M05BX04 Denosumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 December 2025
- Identifiers
- RxCUI 2729323, 2729330DailyMed set ID f040a245-1be4-4962-a8b7-a13ee7fac707NDC 70121-2701Application BLA761457
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 vial in 1 carton / 1.7 mL in 1 vial | 70121-2701-1 | Amneal Pharmaceuticals | 23 December 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.
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 Denosumab 119 mg/1.7 mL injection.
Other strengths and forms of Denosumab
Clinical summary
Denosumab is an RANK ligand inhibitor indicated for treatment, among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Denosumab 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 DenosumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Prolia prescribing information (Amgen) · U.S. National Library of Medicine, DailyMed
- Prolia: European public assessment report (EPAR) · European Medicines Agency
- Xgeva: European public assessment report (EPAR) · European Medicines Agency
Need Oziltus 119 mg/1.7 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.