Patheon Softgels Inc.
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
- 4125 Premier Dr, High Point, North Carolina (NC) 27265, United States (USA)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3001451366 · DUNS 002193829
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-07-17
- NAIDrug Quality Assurance2019-01-30
- NAIDrug Quality Assurance2017-08-11
- NAIDrug Quality Assurance2015-01-29
- NAIDrug Quality Assurance2013-09-18
- NAIBioresearch Monitoring2012-09-26
- VAIDrug Quality Assurance2012-07-02
- VAIDrug Quality Assurance2012-06-06
- NAIBioresearch Monitoring2010-09-14
- NAIDrug Quality Assurance2009-09-21
Drugs this plant is listed as making
13 distinct drugs across 27 products name this site in their FDA label.
- Amantadine HydrochlorideBionpharma Inc.
- BenzonatateBionpharma Inc.
- diclofenac potassiumTeva Pharmaceuticals, Inc.
- DronabinolThePharmaNetwork, LLC
- ErgocalciferolBionpharma Inc.
- EthosuximideBionpharma Inc.
- monomethyl fumarateBanner Life Sciences LLC
- NimodipineBionpharma Inc.
- norethindrone acetate and ethinyl estradiol, and ferrous fumarateXiromed, LLC
- omega-3-acid ethyl estersBionpharma Inc.
- ParicalcitolBionpharma Inc.
- ProgesteroneBionpharma Inc.
- Valproic AcidBionpharma 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.