AptaPharma 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
- 1533 Union Avenue, Pennsauken, New Jersey (NJ) 08110, United States (USA)
- Operations here
- manufacturerelabelrepack
- FDA identifiers
- FEI 3010164738 · DUNS 790523323
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBioresearch Monitoring2024-10-24
- NAIDrug Quality Assurance2019-09-25
- VAIDrug Quality Assurance2018-03-16
- NAIDrug Quality Assurance2014-06-23
Drugs this plant is listed as making
5 distinct drugs across 6 products name this site in their FDA label.
- Aminocaproic AcidFlorida Pharmaceutical Products, LLC
- DexamethasoneKanchan Healthcare Inc
- Fluoxetine hydrochlorideUpsher-Smith Laboratories, LLC
- NystatinKanchan Healthcare Inc
- Oseltamivir PhosphateCipla USA, 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.