IDT AUSTRALIA LTD
Overview
IDT AUSTRALIA LTD is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering ACETAZOLAMIDE USP; HEMATOPORPHYRIN DIACETATE; MINOCYCLINE HYDROCHLORIDE USP; MITOXANTRONE HYDROCHLORIDE USP; THIOTEPA USP.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances IDT AUSTRALIA LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
IDT AUSTRALIA LTD holds 5 active (5 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- MINOCYCLINE HYDROCHLORIDE USPActive2000-10-02
- HEMATOPORPHYRIN DIACETATEActive2000-04-24
- THIOTEPA USPActive1999-06-01
- ACETAZOLAMIDE USPActive1998-05-21
- MITOXANTRONE HYDROCHLORIDE USPActive1997-01-20
FDA compliance signals
1 FDA enforcement record linked to this company.
- warning_letter2018-05-23
FDA Warning Letter (drug product)
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