Medicine
Cobenfy kit
Cobenfy kit is a prescription medicine containing Trospium and Xanomeline, marketed by ER Squibb & Sons, 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Trospium and Xanomeline
- Brand
- Cobenfy
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- ER Squibb & Sons
- Manufacturer
- ER Squibb & Sons
- Origin register
- US FDA, United States
- Storage
- Store at 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
- 27 September 2024
- Identifiers
- RxCUI 2694843, 2694850, 2694853 +7DailyMed set ID 8f0e73bf-6025-44f6-ab64-0983322de0dfNDC 0003-5200, 0003-5150Application NDA216158
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 |
|---|---|---|---|
| 1 kit in 1 carton * 1 blister pack in 1 package / 4 capsule, coated pellets in 1 blister pack * 1 blister pack in 1 package / 52 capsule, coated pellets in 1 blister pack | 0003-5200-56 | ER Squibb & Sons | 27 September 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 26 September 2024 | 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 Trospium and Xanomeline
Clinical summary
Trospium and Xanomeline is a fixed-dose combination of a cholinergic muscarinic agonist and a cholinergic muscarinic antagonist indicated for the treatment of schizophrenia in adults. It is available as capsules and kits for oral use. MedsAcross supplies Trospium and Xanomeline 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 Trospium and XanomelineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cobenfy prescribing information (ER Squibb & Sons) · U.S. National Library of Medicine, DailyMed
Need Cobenfy kit 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.