ASPEN OSS BV

Overview

ASPEN OSS BV is an active pharmaceutical ingredient (API) supplier with 40 active FDA Type II Drug Master Files, covering 16-ALPHA-HYDROXYPREDNISOLONE; ASENAPINE MALEATE; BUDESONIDE; BUPRENORPHINE HYDROCHLORIDE; CONJUGATED ESTROGENS TYPE CN; DESMOPRESSIN.

API / Drug Master Files

ASPEN OSS BV holds 40 active (47 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.

• EA-230Active2025-12-18
• ESTRADIOL 3-ACETATEActive2020-12-15
• ASENAPINE MALEATEActive2020-06-10
• CONJUGATED ESTROGENS TYPE CNActive2020-06-09
• FONDAPARINUX SODIUM USPActive2014-11-30
• LEUPRORELIN HIGHLY PURIFIEDActive2014-11-06
• NANDROLONE DECANOATEActive2008-07-03
• VECURONIUM BROMIDEActive2006-12-19
• LEUPRORELINActive2004-03-19
• TETRACOSACTIDEActive2004-02-13
• HYDROXYPROGESTERONE CAPROATEActive2004-01-21
• NALTREXONE HYDROCHLORIDEActive2000-10-18
• TESTOSTERONE UNDECANOATEActive1999-11-18
• NALOXONE HYDROCHLORIDEActive1999-03-19
• GANIRELIXActive1999-02-04

Showing 15 of 47 Drug Master Files.

FDA compliance signals

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