Leading 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
- 3 Oak Rd, Fairfield, New Jersey (NJ) 07004, United States (USA)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3001611969 · DUNS 079575060
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-10-21
- NAIBioresearch Monitoring2020-08-11
- VAIDrug Quality Assurance2019-01-31
- NAIDrug Quality Assurance2018-08-31
- VAIBioresearch Monitoring2017-04-14
- VAIDrug Quality Assurance2017-04-14
- VAIDrug Quality Assurance2016-03-10
- VAIBioresearch Monitoring2015-03-06
- NAIDrug Quality Assurance2013-06-12
- VAIPostmarket Surv. and Epidemiology2013-06-12
- VAIDrug Quality Assurance2012-01-23
- VAIDrug Quality Assurance2011-01-06
- VAIDrug Quality Assurance2009-10-08
Drugs this plant is listed as making
11 distinct drugs across 24 products name this site in their FDA label.
- Benztropine MesylateLeading Pharma, LLC
- Carbinoxamine MaleateLeading Pharma, LLC
- Clomipramine HydrochlorideLeading Pharma, LLC
- diphenoxylate hydrochloride and atropine sulfateLeading Pharma, LLC
- Folic AcidLeading Pharma, LLC
- Furosemidein shortageLeading Pharma, LLC
- GlycopyrrolateLeading Pharma, LLC
- Lorazepamin shortageLeading Pharma, LLC
- OxazepamLeading Pharma, LLC
- Prochlorperazine MaleateLeading Pharma, LLC
- TheophyllineLeading Pharma, LLC
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.