Medicine
Copiktra 15 mg capsule
Copiktra 15 mg capsule is a prescription medicine containing Duvelisib for oral use, marketed by Secura Bio, 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 20° to 25°C (68° to 77°F), with excursions permitted at 15° to 30°C…
Key facts
- Active ingredient (INN)
- Duvelisib
- Brand
- Copiktra
- Strength
- 15 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 28 capsules, 56 capsules
- Marketing authorisation holder
- Secura Bio
- Manufacturer
- Secura Bio
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), with excursions permitted at 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EM04 Duvelisib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 September 2018
- Identifiers
- RxCUI 2058514, 2058520, 2058523 +1DailyMed set ID e3c5ac56-e1f6-473a-bc73-687836534780NDC 73116-215Application NDA211155
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 capsule in 1 package | 73116-215-28 | Secura Bio | 25 September 2018 |
| 56 capsule in 1 package | 73116-215-56 | Secura Bio | 25 September 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 Duvelisib
Clinical summary
Duvelisib is a prescription medicine indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. MedsAcross supplies Duvelisib 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 DuvelisibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- COPIKTRA prescribing information (Secura Bio) · U.S. National Library of Medicine, DailyMed
Need Copiktra 15 mg 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.