Is Replimune Group, Inc. FDA approved?

Replimune Group, Inc. holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Replimune Group, Inc.'s drugs manufactured?

At registered sites in the United Kingdom, the United States. The FDA register lists Abingdon; Framingham, MA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Replimune Group, Inc. make?

2 products are listed under Replimune Group, Inc. in the openFDA NDC Directory, most often as injection, suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Replimune Group, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 2
Live patents: 0
Countries: 2
Base: United Kingdom

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Replimune LimitedRegistrant: Replimune Group, Inc.	69-70 Innovation Drive Milton Park Milton, Abingdon, OX14 4RQ, United Kingdom (GBR)	Analytical testing	3014028551220754164
Replimune, Inc.Registrant: Replimune Group, Inc.	33 New York Ave., Framingham, Massachusetts (MA) 01701, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3022984544079185250

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: BLA 2.

Dosage form	NDCs
injection, suspension	2

Route	NDCs
intratumor	2

Labeller name on the listing	NDCs
replimune, inc.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Tudriqev	vusolimogene oderparepvec-wtpg	injection, suspension, intratumor	83616-106BLA
Tudriqev	vusolimogene oderparepvec-wtpg	injection, suspension, intratumor	83616-107BLA

Neighbours

Registered in the same town

LFB USA Inc.Framingham, MA
Genzyme CorporationFramingham, MA
Aptuit Global LLCAbingdon, GBR
Basildon Chemical Co., Ltd.Abingdon, GBR

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Enquiry

Common questions

Is Replimune Group, Inc. FDA approved?: Replimune Group, Inc. holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Replimune Group, Inc.'s drugs manufactured?: At registered sites in the United Kingdom, the United States. The FDA register lists Abingdon; Framingham, MA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Replimune Group, Inc. make?: 2 products are listed under Replimune Group, Inc. in the openFDA NDC Directory, most often as injection, suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.