Dottikon Exclusive Synthesis AG

Overview

Dottikon Exclusive Synthesis AG is a renowned Swiss company specializing in the production of high-quality active pharmaceutical ingredients (APIs) and intermediates. It provides a broad range of chemical synthesis services, emphasizing safety and sustainability.

Therapeutic areas

API / Drug Master Files

Dottikon Exclusive Synthesis AG holds 2 active (11 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.

• OLSALAZINE SODIUMActive2004-09-13
• ISOSORBIDE DINITRATE, DILUTEDActive1976-05-07
• PENTAERYTHRITOL TETRANITRATE (DILUTED)Inactive2004-01-19
• PANTOPRAZOLE SODIUM SESQUIHYDRATEInactive2003-08-14
• T-3811A05Inactive2002-12-19
• 5-METHOXYINDOL-3-ALDEHYDEInactive2002-01-22
• DB5, IP-DB5Inactive2001-12-06
• 2-CHLORO-3-(4 FLUOROBENZYL)-BENZIMIDE HYDROCHLORIDE(FBI HCL)Inactive2000-11-24
• 6.7-DIHYDRO-3-ETHYL-2-METHYLINDOL-4-ONE (EMOTI)Inactive1996-12-30
• ISOSORBIDE-5-NITRATE EXTENDED RELEASE PREMIXTURE 49.2%Inactive1994-03-18
• DILUTED ISOSORBIDE MONONITRATEInactive1987-01-23

FDA compliance signals

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