Meet us at CPHI Messe Frankfurt, Germany from 1-3 November 2022 at Stand No.120A130

DMF Filings & Regulatory Approvals

USA: USFDA Audits: Mar 2015, March 2017, March 2018
US DMF: Homatropine Methyl bromide, Celecoxib, Atropine Sulfate (Active), Chlorzoxazone, Diethyl Carbamazine Citrate, Nitisinone, Probenecid, Dexketoprofen Trometamol
CEP: Atropine Sulfate, Ketoprofen (Filed & Under Registration), Levofloxacin Hemihydrate
WHO Geneva Empanelment
EU: EDMF (Dexketoprofen Trometamol, Homatropine Methyl bromide, Atropine Sulfate
Ketorolac Trometamol, Pregabalin, Levofloxacin Hemihydrate)
Korean MFDS approval ( Dexketoprofen, Ketorolac Trometamol)
Australia: TGA empaneled (Atropine Sulphate)
Russia: MOH registration (Ketorolac Trometamol) & Dexketoprofen Trometamol
Taiwan: FDA registration (Homatropine Methyl bromide, Atropine Sulphate, Levofloxacin Hemihydrate)
Canada: Ketorolac Trometamol & Atropine Sulfate under registration
ANVISA: Homatropine Methyl Bromide, Ketorolac under registration
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