Medicine
Arikayce 590 mg/8.4 mL inhalation suspension
Arikayce 590 mg/8.4 mL inhalation suspension is a prescription medicine containing Amikacin for inhalation use, marketed by Insmed, 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 ARIKAYCE vials refrigerated at 2°C to 8°C (36°F to 46°F) until…
Key facts
- Active ingredient (INN)
- Amikacin
- Brand
- Arikayce
- Strength
- 590 mg/8.4 mL
- Dosage form
- Inhalation suspension
- Route
- Inhalation
- Packs
- 28 vials
- Marketing authorisation holder
- Insmed
- Manufacturer
- Insmed
- Origin register
- US FDA, United States
- Storage
- Store ARIKAYCE vials refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date on vial. Do not freeze. ARIKAYCE can be stored at room temperature up to 25°C (77°F) for up to 4 weeks. Once at room temperature, any unused drug must be discarded at the end of 4 weeks.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D06AX12 Amikacin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 October 2018
- Identifiers
- RxCUI 2059184, 2059189DailyMed set ID 499ab990-2b21-474f-aaba-d86388965f40NDC 71558-590Application NDA207356
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 |
|---|---|---|---|
| 28 vial in 1 carton / 8.4 mL in 1 vial | 71558-590-28 | Insmed | 12 October 2018 |
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
Other strengths and forms of Amikacin
Clinical summary
Amikacin is an aminoglycoside antibacterial indicated in adults, who have limited or no alternative treatment options, among other approved uses. It is available as injection and inhalation suspension for intramuscular and intravenous use. MedsAcross supplies Amikacin 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 AmikacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ARIKAYCE prescribing information (Insmed) · U.S. National Library of Medicine, DailyMed
- Arikayce liposomal: European public assessment report (EPAR) · European Medicines Agency
Need Arikayce 590 mg/8.4 mL inhalation 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.