Register entryShortage reported

Exela Pharma Sciences

Registered sites
1
Drug products
24
Live patents
17
Countries
1
Base
United States
Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingsterilize
Sites

Facilities

1
SiteLocationOperationsFEI
Exela Pharma Sciences, LLC.Lenoir, NCUnited StatesAnalytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize3008563008
Alert

Products in shortage

3
DrugPresentationAvailability
Sodium Bicarbonate InjectionSodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5001-5)Available
Sodium Bicarbonate InjectionSodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5011-4)Available
Sodium Bicarbonate InjectionSodium Bicarbonate, Injection, 42 mg/1 mL (NDC 51754-5012-4)Available
Exclusivity

Patents

17

Unexpired Orange Book patents where this company is the application holder.

ProductActive ingredientExpiry
ELCYSCYSTEINE HYDROCHLORIDEJan 2039
GANZYK-RTUGANCICLOVIRSept 2034
Catalogue

Marketed products

24

Showing 24 of 24.

BrandGeneric nameFormCategory
Akovazephedrine sulfateINJECTIONNDA
Akovazephedrine sulfateINJECTIONNDA
BloxiverzNeostigmine MethylsulfateINJECTIONNDA
CUPRIC CHLORIDEcupric chlorideINJECTION, SOLUTIONANDA
ELCYSCysteine HydrochlorideINJECTION, SOLUTIONNDA
ELCYSCysteine HydrochlorideINJECTION, SOLUTIONNDA
GLYRX-PFglycopyrrolateINJECTION, SOLUTIONNDA
GLYRX-PFglycopyrrolateINJECTION, SOLUTIONNDA
GLYRX-PFglycopyrrolateINJECTION, SOLUTIONNDA
GLYRX-PFglycopyrrolateINJECTION, SOLUTIONNDA
NIPRIDE RTUSodium NitroprussideINJECTION, SOLUTIONNDA
NIPRIDE RTUSodium NitroprussideINJECTION, SOLUTIONNDA
Potassium AcetatePotassium AcetateINJECTIONANDA
Sodium BicarbonateSODIUM BICARBONATEINJECTION, SOLUTIONANDA
Sodium BicarbonateSODIUM BICARBONATEINJECTION, SOLUTIONANDA
Sodium BicarbonateSODIUM BICARBONATEINJECTION, SOLUTIONANDA
Sodium BicarbonateSODIUM BICARBONATEINJECTION, SOLUTIONANDA
Sodium BicarbonateSODIUM BICARBONATEINJECTION, SOLUTIONANDA
TRANEXAMIC ACID IN SODIUM CHLORIDEtranexamic acidINJECTION, SOLUTIONNDA
Verapamil HydrochlorideVerapamil HydrochlorideINJECTIONNDA
Verapamil HydrochlorideVerapamil HydrochlorideINJECTIONNDA
Zinc ChlorideZinc ChlorideINJECTIONANDA
caffeine citratecaffeine citrateINJECTIONANDA
caffeine citrateCAFFEINE CITRATESOLUTIONANDA
Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.