Sigmapharm Laboratories, 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
- 3375 Progress Drive, Bensalem, Pennsylvania (PA) 19020, United States (USA)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3005444934 · DUNS 556234636
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-12-17
- NAIDrug Quality Assurance2023-02-13
- NAIDrug Quality Assurance2021-12-07
- NAIBioresearch Monitoring2018-06-13
- VAIDrug Quality Assurance2017-06-19
- NAIBioresearch Monitoring2015-06-23
- VAIDrug Quality Assurance2014-11-19
- VAIDrug Quality Assurance2014-03-20
- VAIBioresearch Monitoring2013-08-13
- VAIDrug Quality Assurance2011-12-22
- VAIDrug Quality Assurance2011-05-25
- NAIDrug Quality Assurance2009-09-25
Drugs this plant is listed as making
11 distinct drugs across 24 products name this site in their FDA label.
- Adefovir DipivoxilSigmapharm Laboratories, LLC
- AmbrisentanSigmapharm Laboratories, LLC
- Amiloride HydrochlorideSigmapharm Laboratories, LLC
- AsenapineSigmapharm Laboratories, LLC
- DisulfiramSigmapharm Laboratories, LLC
- DofetilideSigmapharm Laboratories, LLC
- FlucytosineSigmapharm Laboratories, LLC
- GriseofulvinSigmapharm Laboratories, LLC
- Liothyronine SodiumSigmapharm Laboratories, Llc
- Protriptyline HydrochlorideSigmapharm Laboratories, LLC
- Ultramicrosize GriseofulvinSigmapharm Laboratories, 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.