ANI 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
- 210 Main Street West, Baudette, Minnesota (MN) 56623, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 2111358 · DUNS 148515737
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-12-06
- VAIDrug Quality Assurance2022-11-18
- NAIBioresearch Monitoring2019-04-12
- NAIDrug Quality Assurance2016-07-28
- VAIBioresearch Monitoring2016-07-28
- NAIDrug Quality Assurance2013-09-27
- VAIBioresearch Monitoring2013-09-27
- VAIUnapproved and Misbranded Drugs2012-01-06
- NAIDrug Quality Assurance2011-09-16
- VAIUnapproved and Misbranded Drugs2011-09-16
- NAIDrug Quality Assurance2011-09-15
- VAIDrug Quality Assurance2010-01-29
- NAIDrug Quality Assurance2010-01-28
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- Ultramicrosize Griseofulvin TabletsAmneal Pharmaceuticals of New York 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.