SpecGx 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
- 3600 N. 2nd Street, St. Louis, Missouri (MO) 63147, United States (USA)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 1940521 · DUNS 163205300
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-10-22
- NAIDrug Quality Assurance2022-02-11
- VAIDrug Quality Assurance2019-09-12
- VAIDrug Quality Assurance2016-11-22
- NAIDrug Quality Assurance2014-06-12
- NAIDrug Quality Assurance2013-05-24
- NAIDrug Quality Assurance2010-06-04
- NAIDrug Quality Assurance2010-04-26
Drugs this plant is listed as making
13 distinct drugs across 51 products name this site in their FDA label.
- buprenorphine hydrochloride, naloxone hydrochlorideIndivior Inc.
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine SulfateSpecGx LLC
- dextroamphetamine sulfateSpecGx LLC
- fentanyl transdermalSpecGx LLC
- Hydrocodone Bitartrate And AcetaminophenSpecGx LLC
- IoversolLiebel-Flarsheim Company LLC
- methadone hydrochlorideSpecGx LLC
- Methylphenidate Hydrochloridein shortageShionogi Inc.
- Morphine Sulfatein shortageSpecGx LLC
- Oxycodone HydrochlorideSpecGx 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.