Is LTS Therapy Systems, LLC FDA approved?

LTS Therapy Systems, LLC holds 3 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 LTS Therapy Systems, LLC's drugs manufactured?

At registered sites in Germany, the United States. The FDA register lists Andernach; West Caldwell, NJ; West St. Paul, MN. Registered operations: analytical testing, finished drug manufacture, packaging.

What drugs does LTS Therapy Systems, LLC make?

1 product is listed under LTS Therapy Systems, LLC in the openFDA NDC Directory, most often as patch, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

LTS Therapy Systems, LLC

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

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Registered sites: 3
Active NDC listings: 1
Live patents: 0
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing3Finished drug manufacture3Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
LTS Lohmann Therapie-Systeme AGRegistrant: LTS Therapy Systems, LLC	Lohmann Strasse 2, Andernach, 56626, Germany (DEU)	Analytical testing, Finished drug manufacture, Packaging	3003387535342693590
LTS Lohmann Therapy Systems Corp.Registrant: LTS Therapy Systems, LLC	21 Henderson Drive, West Caldwell, New Jersey (NJ) 07006, United States (USA)	Analytical testing, Finished drug manufacture, Packaging	1000121692787660513
LTS Therapy Systems, LLC	232 Lothenbach Avenue, West St. Paul, Minnesota (MN) 55118, United States (USA)	Analytical testing, Finished drug manufacture	2182681046758931

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
buprenorphine transdermal system	buprenorphine	patch, extended release, transdermal	58064-408ANDA

Neighbours

Registered in the same town

QUAGEN PHARMACEUTICALS LLCWest Caldwell, NJ · 2 sites
Corporate Mailings, Inc.West Caldwell, NJ

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Enquiry

Common questions

Is LTS Therapy Systems, LLC FDA approved?: LTS Therapy Systems, LLC holds 3 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 LTS Therapy Systems, LLC's drugs manufactured?: At registered sites in Germany, the United States. The FDA register lists Andernach; West Caldwell, NJ; West St. Paul, MN. Registered operations: analytical testing, finished drug manufacture, packaging.
What drugs does LTS Therapy Systems, LLC make?: 1 product is listed under LTS Therapy Systems, LLC in the openFDA NDC Directory, most often as patch, extended release. 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.