Is Societal CDMO Gainesville Development, LLC FDA approved?

Societal CDMO Gainesville Development, LLC holds 1 FDA-registered establishment in the United States. 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 Societal CDMO Gainesville Development, LLC's drugs manufactured?

The FDA register lists GAINESVILLE, GA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

Societal CDMO Gainesville Development, LLC

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

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Registered sites: 1
Active NDC listings: 0
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Societal CDMO Gainesville Development, LLC	988 CHESTNUT ST SE, GAINESVILLE, Georgia (GA) 30501, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3014727972081311647

Neighbours

Registered in the same town

Apotheca CompanyGainesville, GA
Societal CDMO Gainesville, LLCGainesville, GA

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Enquiry

Common questions

Is Societal CDMO Gainesville Development, LLC FDA approved?: Societal CDMO Gainesville Development, LLC holds 1 FDA-registered establishment in the United States. 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 Societal CDMO Gainesville Development, LLC's drugs manufactured?: The FDA register lists GAINESVILLE, GA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

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.