Novitium Pharma LLC
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 70 Lake Drive, East Windsor, New Jersey (NJ) 08520, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3012541241 · DUNS 080301870
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBioresearch Monitoring2024-02-16
- NAIDrug Quality Assurance2023-03-31
- NAIDrug Quality Assurance2021-07-08
- VAIDrug Quality Assurance2019-02-04
- NAIDrug Quality Assurance2018-05-09
Drugs this plant is listed as making
67 distinct drugs across 118 products name this site in their FDA label.
- AcetazolamideANI Pharmaceuticals, Inc.
- acyclovirANI Pharmaceuticals, Inc.
- Alendronate SodiumANI Pharmaceuticals, Inc.
- AlprazolamANI Pharmaceuticals, Inc.
- Atenolol and ChlorthalidoneANI Pharmaceuticals, Inc.
- Bisoprolol FumarateNovitium Pharma LLC
- Bisoprolol Fumarate and HydrochlorothiazideANI Pharmaceuticals, Inc.
- CarbamazepineANI Pharmaceuticals, Inc.
- ChlorzoxazoneNovitium Pharma LLC
- Clorazepate DipotassiumANI Pharmaceuticals, Inc.
- Clotrimazole topicalNovitium Pharma LLC
- DapsoneANI Pharmaceuticals, Inc.
- DexamethasoneANI Pharmaceuticals, Inc.
- Dicyclomine HydrochlorideNovitium Pharma LLC
- DigoxinANI Pharmaceuticals, Inc.
- Enalapril maleateBionpharma Inc.
- EstazolamNovitium Pharma LLC
- EstradiolANI Pharmaceuticals, Inc.
- FamotidineANI Pharmaceuticals, Inc.
- FelbamateNovitium Pharma LLC
- FluconazoleGolden State Medical Supply, Inc.
- Fludrocortisone AcetateNovitium Pharma LLC
- Fluphenazine HydrochlorideANI Pharmaceuticals, Inc.
- hydrochlorothiazideANI Pharmaceuticals, Inc.
- HydrocortisoneANI Pharmaceuticals, Inc.
- Hydroxychloroquine SulfateANI Pharmaceuticals, Inc.
- Hydroxyzine HydrochlorideANI Pharmaceuticals, Inc.
- IndomethacinANI Pharmaceuticals, Inc.
- KetoconazoleANI Pharmaceuticals, Inc.
- L-GlutamineANI Pharmaceuticals, Inc.
- LacosamideANI Pharmaceuticals, Inc.
- LevocarnitineANI Pharmaceuticals, Inc.
- LevofloxacinANI Pharmaceuticals, Inc.
- Lidocaine Hydrochloridein shortageNovitium Pharma LLC
- LofexidineANI Pharmaceuticals, Inc.
- Megestrol AcetateANI Pharmaceuticals, Inc.
- MeloxicamANI Pharmaceuticals, Inc.
- MethsuximideANI Pharmaceuticals, Inc.
- MethyltestosteroneANI Pharmaceuticals, Inc.
- NaproxenANI Pharmaceuticals, Inc.
- Naproxen oralANI Pharmaceuticals, Inc.
- NitrofurantoinANI Pharmaceuticals, Inc.
- Omeprazole and Sodium BicarbonateANI Pharmaceuticals, Inc.
- Oxybutynin ChlorideANI Pharmaceuticals, Inc.
- ParoxetineANI Pharmaceuticals, Inc.
- Phenoxybenzamine HydrochlorideNovitium Pharma LLC
- PirfenidoneANI Pharmaceuticals, Inc.
- Potassium chlorideANI Pharmaceuticals, Inc.
- Prazosin HydrochlorideANI Pharmaceuticals, Inc.
- PrednisoneANI Pharmaceuticals, Inc.
- PrucaloprideANI Pharmaceuticals, Inc.
- PyrazinamideANI Pharmaceuticals, Inc.
- Pyridostigmine bromide oralNovitium Pharma LLC
- pyrimethamineVyera Pharmaceuticals LLC
- RifabutinANI Pharmaceuticals, Inc.
- Selegiline HydrochlorideNovitium Pharma LLC
- Sertraline HydrochlorideANI Pharmaceuticals, Inc.
- Sildenafil CitrateANI Pharmaceuticals, Inc.
- Sulfamethoxazole and TrimethoprimANI Pharmaceuticals, Inc.
- TadalafilANI Pharmaceuticals, Inc.
- TerazosinANI Pharmaceuticals, Inc.
- ThiothixeneANI Pharmaceuticals, Inc.
- TranylcypromineNovitium Pharma LLC
- Trihexyphenidyl HydrochlorideNovitium Pharma LLC
- TrimethoprimNovitium Pharma LLC
- ValsartanANI Pharmaceuticals, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.