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Medicine

Acam2000 powder for injection

Smallpox and mpox (vaccinia) vaccine, live · Percutaneous · Emergent Product Development Gaithersburg
Available on requestPrescription onlyUS FDA

Acam2000 powder for injection is a prescription medicine containing Smallpox and mpox (vaccinia) vaccine, live for percutaneous use, marketed by Emergent Product Development Gaithersburg, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Storage as on the product label

Key facts

Active ingredient (INN)
Smallpox and mpox (vaccinia) vaccine, live
Brand
Acam2000
Dosage form
Powder for injection
Route
Percutaneous
Packs
8 cartons
Marketing authorisation holder
Emergent Product Development Gaithersburg
Manufacturer
Emergent Product Development Gaithersburg
Origin register
US FDA, United States
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
HS code (indicative)
3002.41Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
31 August 2007
Identifiers
NDC 71665-330, 71665-430Application BLA125158

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

PackCodeLabelerMarketed since
8 carton in 1 case / 50 vial, multi-dose in 1 carton / .3 mL in 1 vial, multi-dose71665-330-03Emergent Product Development Gaithersburg31 August 2007
8 carton in 1 case / 50 vial, multi-dose in 1 carton / .3 mL in 1 vial, multi-dose71665-430-03Emergent Product Development Gaithersburg31 August 2007

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

Clinical summary

Clinical information for Smallpox and mpox (vaccinia) vaccine, live is on its overview page.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Smallpox and mpox (vaccinia) vaccine, live

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

  • US FDA NDC directory · Checked 12 November 2026

Need Acam2000 powder for injection 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.