Medicine
Amitiza 8 mcg capsule
Amitiza 8 mcg capsule is a prescription medicine containing Lubiprostone for oral use, marketed by SpecGx, 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F)…
Key facts
- Active ingredient (INN)
- Lubiprostone
- Brand
- Amitiza
- Strength
- 8 mcg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules
- Marketing authorisation holder
- SpecGx
- Manufacturer
- SpecGx2 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and extreme temperatures.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A06AX03 Lubiprostone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 January 2006
- Identifiers
- RxCUI 616578, 617768, 794639 +1DailyMed set ID 164a2b47-0a52-4bb4-9e71-5342c2e951f4, d474ac6a-444d-4aa6-9986-24be6fcf811dNDC 23635-508, 64764-080Application NDA021908
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 |
|---|---|---|---|
| 60 capsule, gelatin coated in 1 bottle | 23635-508-60 | SpecGx | 1 April 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 31 January 2006 | 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 Lubiprostone 8 mcg capsule.
Other strengths and forms of Lubiprostone
Clinical summary
Lubiprostone is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (CIC) in adults, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Lubiprostone 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 LubiprostoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Lubiprostone prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Amitiza 8 mcg capsule 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.