Is Polarean, Inc. FDA approved?

Polarean, Inc. 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 Polarean, Inc.'s drugs manufactured?

The FDA register lists Durham, NC. Registered operations: finished drug manufacture.

What drugs does Polarean, Inc. make?

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

Polarean, Inc.

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 5
Live patents: 2
Exclusivities: 1
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Polarean, Inc.	2500 Meridian Parkway, Suite 175, Durham, North Carolina (NC) 27713, United States (USA)	Finished drug manufacture	3010132318078629330

Catalogue

Drug listings by form and route

5 active NDC listings: 5 human prescription drug. By marketing category: NDA 5.

Dosage form	NDCs
gas	5

Route	NDCs
respiratory (inhalation)	5

Labeller name on the listing	NDCs
polarean, inc.	5

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10583205	XENOVIEWxenon xe-129 hyperpolarized	product	Feb 2035
11052161	XENOVIEWxenon xe-129 hyperpolarized	product	Dec 2035

Product	Exclusivity	Until
XENOVIEWXENON XE-129 HYPERPOLARIZED	NCE New chemical entity	Dec 2027

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
XENOVIEW	xenon Xe 129 hyperpolarized	gas, respiratory (inhalation)	80534-0300NDA
XENOVIEW	xenon Xe 129 hyperpolarized	gas, respiratory (inhalation)	80534-0500NDA
XENOVIEW	xenon Xe 129 hyperpolarized	gas, respiratory (inhalation)	80534-0750NDA
XENOVIEW	xenon Xe 129 hyperpolarized	gas, respiratory (inhalation)	80534-1000NDA
XENOVIEW	xenon Xe 129 hyperpolarized	gas, respiratory (inhalation)	80534-6350NDA

Neighbours

Registered in the same town

Almac Clinical Services, LLCDurham, NC · 3 sites
Merck & Co., Inc.Durham, NC · 2 sites
KBI Biopharma, Inc.Durham, NC · 2 sites
PETNET Solutions, Inc.DURHAM, NC
Novo Nordisk Inc.Durham, NC
Eli Lilly and CompanyDurham, NC
Encube Ethicals LimitedDurham, NC
Oxford Biomedica (UK) LimitedDurham, NC
United Therapeutics CorporationDurham, NC
Aurolife Pharma LLCDurham, NC
Avista Pharma Solutions, Inc. dba CambrexDurham, NC
BioAgilytix Labs, LLCDurham, NC

Compare

Comparable companies in United States

Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals1 site · 4,853 NDC
NuCare Pharmaceuticals,Inc.1 site · 1,393 NDC
Greer Laboratories, Inc.1 site · 1,328 NDC
ASCLEMED USA INC. DBA ENOVACHEM1 site · 789 NDC
Golden State Medical Supply Inc.1 site · 670 NDC
Rising Pharma Holdings, Inc.1 site · 532 NDC
HF Acquisition Co LLC1 site · 363 NDC
ANI Pharmaceuticals, Inc.1 site · 299 NDC
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 site · 273 NDC
Newton Laboratories, Inc.1 site · 271 NDC

Enquiry

Common questions

Is Polarean, Inc. FDA approved?: Polarean, Inc. 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 Polarean, Inc.'s drugs manufactured?: The FDA register lists Durham, NC. Registered operations: finished drug manufacture.
What drugs does Polarean, Inc. make?: 5 products are listed under Polarean, Inc. in the openFDA NDC Directory, most often as gas. 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.