Medicine
Prolia 60 mg/1 mL injection
Prolia 60 mg/1 mL injection is a prescription medicine containing Denosumab for subcutaneous use, marketed by Amgen, 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 Prolia refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton…
Key facts
- Active ingredient (INN)
- Denosumab
- Brand
- Prolia
- Strength
- 60 mg/1 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 1 mL
- Marketing authorisation holder
- Amgen
- Manufacturer
- Amgen
- Origin register
- US FDA, United States
- Storage
- Store Prolia 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, Prolia must not be exposed to temperatures above 25°C (77°F) and must be used within 30 days. Prior to administration, Prolia 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
- 5 June 2010
- Identifiers
- RxCUI 993452, 993456DailyMed set ID 49e5afe9-a0c7-40c4-af9f-f287a80c5c88NDC 55513-710Application BLA125320
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
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 60 mg/1 mL injection.
- Bildyos 60 mg/1 mL injectionAvailable on requestOrganonUS FDA1 pack Cold chain
- Boncresa 60 mg/1 mL injectionAvailable on requestAmneal PharmaceuticalsUS FDA1 pack Cold chain
- Bosaya 60 mg/1 mL injectionAvailable on requestBiocon BiologicsIndiaUS FDA1 pack Cold chain
- Conexxence 60 mg/1 mL injectionAvailable on requestFresenius KabiUS FDA1 pack Cold chain
- Denosumab 60 mg/1 mL injectionAvailable on request—US FDA1 pack Cold chain
- Enoby 60 mg/1 mL injectionAvailable on requestHikma PharmaceuticalsUS FDA1 pack Cold chain
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 Prolia 60 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.