VALDEPHARM

Overview

VALDEPHARM is an active pharmaceutical ingredient (API) supplier with 8 active FDA Type II Drug Master Files, covering ESTRADIOL BENZOATE; ESTRADIOL HEMIHYDRATE; ESTRADIOL VALERATE; NORETHINDRONE; NORETHINDRONE ACETATE; STERILE ARIPIPRAZOLE MONOHYDRATE.

API / Drug Master Files

VALDEPHARM holds 8 active (9 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.

• STERILE RISPERIDONEActive2017-01-19
• STERILE ARIPIPRAZOLE MONOHYDRATEActive2011-09-16
• NORETHINDRONE ACETATEActive2011-05-25
• NORETHINDRONEActive2011-03-07
• ESTRADIOL VALERATEActive2010-07-02
• ESTRADIOL BENZOATEActive2010-05-18
• ESTRADIOL HEMIHYDRATEActive2009-07-21
• TRAZODONE HYDROCHLORIDEActive1986-12-01
• ETHINYL ESTRADIOLInactive2012-02-13

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to VALDEPHARM in our records. PharmaTek screens the full directory against live FDA enforcement data.