Patheon Puerto Rico, 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
- State Road #670 Km. 2.7, Manati, Puerto Rico (PR) 00674, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3003113148 · DUNS 174050377
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-07-12
- VAIDrug Quality Assurance2019-10-15
- VAIDrug Quality Assurance2018-05-31
- VAIDrug Quality Assurance2016-06-21
- VAIDrug Quality Assurance2015-09-03
- VAIDrug Quality Assurance2014-08-11
- VAIDrug Quality Assurance2013-06-12
- VAIDrug Quality Assurance2011-06-15
- VAIDrug Quality Assurance2009-02-04
Drugs this plant is listed as making
4 distinct drugs across 14 products name this site in their FDA label.
- canagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.
- empagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.
- metformin hydrochlorideSantarus, Inc.
- Methylphenidate Hydrochloridein shortageIronshore Pharmaceuticals 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.