Is Shine Spect USA, LLC FDA approved?

Shine Spect USA, 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 Shine Spect USA, LLC's drugs manufactured?

The FDA register lists North Billerica, MA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.

What drugs does Shine Spect USA, LLC make?

4 products are listed under Shine Spect USA, LLC in the openFDA NDC Directory, most often as gas; injection, powder, lyophilized, for solution; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Shine Spect USA, LLC

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

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Registered sites: 1
Active NDC listings: 4
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Shine Spect USA,LLCRegistrant: Shine Spect USA, LLC	325 Treble Cove Rd, North Billerica, Massachusetts (MA) 01862, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	3042513702144915003

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.

Dosage form	NDCs
gas	2
injection, powder, lyophilized, for solution	1
kit	1

Route	NDCs
respiratory (inhalation)	2
intravenous	1

Labeller name on the listing	NDCs
shine spect usa, llc	2
shine spect usa, llc	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	injection, powder, lyophilized, for solution, intravenous	87333-001NDA
NEUROLITE	Bicisate dihydrochloride	kit	87333-006NDA
Xenon	Xenon XE-133	gas, respiratory (inhalation)	87333-127NDA
Xenon	Xenon XE-133	gas, respiratory (inhalation)	87333-128NDA

Neighbours

Registered in the same town

Medical-technical Gases, Inc.North Billerica, MA
SciSafe, Inc.North Billerica, MA
Lantheus Medical Imaging, Inc.North Billerica, MA

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Enquiry

Common questions

Is Shine Spect USA, LLC FDA approved?: Shine Spect USA, 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 Shine Spect USA, LLC's drugs manufactured?: The FDA register lists North Billerica, MA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
What drugs does Shine Spect USA, LLC make?: 4 products are listed under Shine Spect USA, LLC in the openFDA NDC Directory, most often as gas; injection, powder, lyophilized, for solution; kit. 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.