- Synergene received Certificate of Suitability (CEP) from EDQM for Fluconazole and Terbinafine Hydrochloride in the year 2022, Ambroxol Hydrochloride and Voriconazole in the year 2024, Losartan Potassium and Fexofenadine Hydrochloride in the year 2025, and Irbesartan and Mebeverine Hydrochloride in the year 2026
- Synergene received IDL from NMPA for Terbinafine Hydrochloride in the year 2024
- Synergene has filed USDMFs for Terbinafine Hydrochloride, Fluconazole, Losartan Potassium, Voriconazole, Escitalopram Oxalate and Irbesartan, and the secondary USDMFs for Escitalopram Oxalate and Terbinafine Hydrochloride
- Synergene has filed JDMFs for Escitalopram Oxalate, Terbinafine Hydrochloride and Luliconazole, and secondary JDMF for Voriconazole
- Synergene has filed a Master File in TPD Health Canada for Fluconazole
- Synergene is currently filing USDMFs and CEPs for various APIs and Intermediates, and also DMFs in China, Japan, Brazil, Singapore to name a few.
- Synergene has so far filed DMFs in more than 50 countries for various APIs and Intermediates
