Uetikon GmbH
Uetikon GmbH

Drug Master Files

  API US-DMF   E-DMF   CEP
 Filing date  Filing date
Azelaic Acid &
Azelaic Acid Micronized 		yes 1994 yes Since 1998 various European countries n.a.
yes 2002 yes Since 2003 various European countries n.a.
Ketamine Hydrochloride yes 1988 yes Since 1990, various European countries yes
Methimazole / Thiamazole yes 1986 yes Since 2000, various European countries Scheduled for 2008
Oxeladin Citrate (Ph. Eur. Name: Oxeladin Hydrogen Citrate) no --   Scheduled for
12/2008 		no
Phenylacetic Acid Sodium Salt (Sodium Phenylacetate) yes 1993 no -- n.a.
4-Phenylbutyric Acid Sodium Salt (Sodium Phenylbutyrate) yes 1992 yes 1997 no
Terazosin Hydrochloride Anhydrous   yes 1993 no   -- no


Remarks / further information:

  • n.a. means, that there is no Monograph of the European Pharmacopoeia available, therefore it is not possible to apply for a CEP
  • All DMFs (excepted for Sodium Phenylacetate) are available in the CTD Format
  • Uetikon supported the EDQM in the elaboration of the Ph.Eur. Monographs for Thiamazole, Ketamine Hydrochloride, Oxeladin Hydrogen Citrate and 4-Phenylbutyric Acid Sodium Salt. We have provided samples of batches and impurities.
  • A number of additional DMFs is available for APIs produced under exclusivity.
 
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