Bora Pharmaceuticals Injectables 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
- 1111 S Paca St, Baltimore, Maryland (MD) 21230, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 1000512361 · DUNS 119352788
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBlood and Blood Products2024-07-25
- VAIDrug Quality Assurance2023-08-10
- OAIDrug Quality Assurance2022-02-18
- VAIDrug Quality Assurance2021-04-16
- NAIDrug Quality Assurance2019-05-10
- VAIBlood and Blood Products2018-06-13
- VAIVaccines and Allergenic Products2018-06-13
- VAIDrug Quality Assurance2016-12-20
- VAIDrug Quality Assurance2015-08-28
- VAIDrug Quality Assurance2014-08-26
- VAIDrug Quality Assurance2014-04-09
- VAIDrug Quality Assurance2012-08-01
- VAIBlood and Blood Products2011-07-22
- VAIDrug Quality Assurance2011-07-22
- VAIDrug Quality Assurance2010-08-27
- VAIVaccines and Allergenic Products2010-08-27
- VAIBlood and Blood Products2009-10-20
- NAIDrug Quality Assurance2009-08-27
Drugs this plant is listed as making
6 distinct drugs across 6 products name this site in their FDA label.
- glucarpidaseBTG International Inc.
- levoleucovorinAcrotech Biopharma Inc
- PegcetacoplanApellis Pharmaceuticals, Inc.
- Sodium NitriteHope Pharmaceuticals
- Sodium Nitrite and Sodium ThiosulfateHope Pharmaceuticals
- Sodium ThiosulfateHope Pharmaceuticals
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.