Medicine
Tembexa 10 mg/mL oral suspension
Tembexa 10 mg/mL oral suspension is a prescription medicine containing Brincidofovir for oral use, marketed by Emergent BioDefense Operations Lansing, 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
Do not freeze. Store at 20°C to 25°C (68°F to 77°F), excursions permitted from…
Key facts
- Active ingredient (INN)
- Brincidofovir
- Brand
- Tembexa
- Strength
- 10 mg/mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 65 mL, 1 bottle and 1 more
- Marketing authorisation holder
- Emergent BioDefense Operations Lansing
- Manufacturer
- Emergent BioDefense Operations Lansing
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 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
- 20 April 2022
- Identifiers
- RxCUI 2599525, 2599531DailyMed set ID 0784838e-00bd-4b14-9b7e-653b7fbb7eeaNDC 64678-012Application NDA214460
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 |
|---|---|---|---|
| 65 mL in 1 bottle | 64678-012-01 | Emergent BioDefense Operations Lansing | 20 April 2022 |
| 65 mL in 1 bottle | 64678-012-02 | Emergent BioDefense Operations Lansing | 20 April 2022 |
| 1 bottle in 1 carton / 45 mL in 1 bottle | 64678-012-03 | Emergent BioDefense Operations Lansing | 23 July 2025 |
| 1 bottle in 1 carton / 45 mL in 1 bottle | 64678-012-04 | Emergent BioDefense Operations Lansing | 23 July 2025 |
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 4 June 2021 | 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 Brincidofovir
Clinical summary
Brincidofovir is a prescription medicine indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates, among other approved uses. It is available as oral suspension and tablets. MedsAcross supplies Brincidofovir 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 BrincidofovirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tembexa prescribing information (Emergent BioDefense Operations Lansing) · U.S. National Library of Medicine, DailyMed
Need Tembexa 10 mg/mL oral 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.