Bora Pharmaceuticals 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
- 6701 Evenstad Drive N, Maple Grove, Minnesota (MN) 55369-6026, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3004106442 · DUNS 119296421
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-08-30
- VAIDrug Quality Assurance2018-12-19
- NAIBioresearch Monitoring2018-06-21
- NAIDrug Quality Assurance2015-12-10
- VAIBioresearch Monitoring2014-03-03
- VAIDrug Quality Assurance2014-03-03
- VAIDrug Quality Assurance2013-03-01
- NAIDrug Quality Assurance2011-02-28
- VAIDrug Quality Assurance2011-02-22
- NAIBioresearch Monitoring2010-10-08
- NAIDrug Quality Assurance2010-10-08
- NAIDrug Quality Assurance2010-09-29
- NAIDrug Quality Assurance2008-10-02
Drugs this plant is listed as making
17 distinct drugs across 56 products name this site in their FDA label.
- amantadine hydrochlorideUpsher-Smith Laboratories, LLC
- Amiodarone HydrochlorideUpsher-Smith Laboratories, LLC
- BaclofenUpsher-Smith Laboratories, LLC
- cholestyramineUpsher-Smith Laboratories, LLC
- Divalproex SodiumUpsher-Smith Laboratories, LLC
- Hydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLC
- midodrine hydrochlorideUpsher-Smith laboratories, LLC
- Morphine Sulfatein shortageUpsher-Smith Laboratories, LLC
- NystatinUpsher-Smith Laboratories, LLC
- Oxybutynin ChlorideUpsher-Smith Laboratories, LLC
- potassium chlorideUpsher-Smith Laboratories, LLC
- Propafenone HydrochlorideUpsher-Smith Laboratories, LLC
- TestosteroneUpsher-Smith Laboratories, LLC
- TopiramateUpsher-Smith Laboratories, LLC
- Warfarin SodiumUpsher-Smith 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.