SANDOZ PRIVATE LTD
Overview
SANDOZ PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering CLOFAZIMINE.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances SANDOZ PRIVATE 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
SANDOZ PRIVATE LTD holds 1 active (14 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.
- CLOFAZIMINEActive2003-06-26
- MEROPENEM WITH SODIUM CARBONATE, STERILE BLENDInactive2014-01-17
- MEROPENEM TRIHYDRATE, STERILEInactive2014-01-08
- DORIPENEM MONOHYDRATE, STERILEInactive2011-10-10
- LANSOPROZOLEInactive2011-06-13
- IMIPENEN STERILEInactive2009-11-25
- IMIPENEM AND CILASTATIN STERILE BLENDInactive2009-11-24
- ESCITALOPRAM OXALATEInactive2009-05-05
- ROSIGLITAZONE MALEATEInactive2006-10-23
- CEFPROZILInactive2004-06-07
- CEFPODOXIME PROXETILInactive2003-04-15
- CEFIXIMEInactive2002-12-17
- CEFUROXIME AXETILInactive2002-01-21
- PYRILAMINE MALEATE USPInactive1998-03-17
FDA compliance signals
7 FDA enforcement records linked to this company.
- 4832024-07-02
Procedures for non-sterile drug products
- 4832019-04-12
Written record of investigation incomplete
- 4832019-04-12
Equipment Design, Size and Location
- 4832019-04-12
Written procedures not established/followed
- 4832019-04-12
Computer control of master formula records
- warning_letter2015-11-02
FDA Warning Letter (drug product)
- warning_letter2015-11-02
FDA Warning Letter (drug product)
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