Medicine
Caplyta 21 mg capsule
Caplyta 21 mg capsule is a prescription medicine containing Lumateperone for oral use, marketed by Intra-Cellular Therapies, 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 controlled room temperature 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Lumateperone
- Brand
- Caplyta
- Strength
- 21 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules
- Marketing authorisation holder
- Intra-Cellular Therapies
- Manufacturer
- Intra-Cellular Therapies
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 August 2022
- Identifiers
- DailyMed set ID db730b06-6351-47fd-8183-e61e61bbead5NDC 72060-121Application NDA209500
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 |
|---|---|---|---|
| 30 capsule in 1 bottle | 72060-121-40 | Intra-Cellular Therapies | 9 August 2022 |
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 20 December 2019 | 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
Other strengths and forms of Lumateperone
Clinical summary
Lumateperone is an atypical antipsychotic indicated for treatment of schizophrenia in adults. It is available as capsules for oral use. MedsAcross supplies Lumateperone 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 LumateperoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CAPLYTA prescribing information (Intra-Cellular Therapies) · U.S. National Library of Medicine, DailyMed
Need Caplyta 21 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.