Mayne Pharma International Pty Ltd.
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
- Australia
- Registered address
- 1538 Main North Road, Salisbury South, South Australia 5106, Australia (AUS)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3004090027 · DUNS 756003745
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-03-21
- VAIDrug Quality Assurance2019-10-18
- NAIDrug Quality Assurance2017-09-15
- VAIDrug Quality Assurance2015-09-25
- VAIDrug Quality Assurance2013-08-02
- VAIDrug Quality Assurance2009-05-15
Drugs this plant is listed as making
5 distinct drugs across 10 products name this site in their FDA label.
- Carbidopa and LevodopaDr. Reddy's Laboratories Inc
- doxycycline hyclateMayne Pharma Commercial LLC
- guanfacineTakeda Pharmaceuticals America, Inc.
- ItraconazoleMayne Pharma Commercial 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.