AGOMELATINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Tech Pack- Available, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Agomelatine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Agomelatine IH    
Issue/Submission date 2016-08-22    
ALOGLIPTIN BENZOATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Anagrelide Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07
Filling Details Anagrelide Hydrochloride (IH)    
Issue/Submission date 2016-07-11    
Apremilast USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Aprepitant USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Aprepitant (IH)    
Issue/Submission date 2016-07-11    
Azithromycin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07
Filling Details Azithromycin (BP/USP/Ph. Eur.)    
Issue/Submission date 2016-07-11    
Azithromycin Dihydrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details    
Issue/Submission date    
Bazedoxifene USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Tech Pack- Available, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Beraprost USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Bisoprolol Fumarate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R0-CEP 2013-342-Rev 01 Indian CDSCO WC-0214 Documents - pdf
Status VALID   Valid - 2019-02-07
Filling Details Bisoprolol fumarate Bisoprolol Fumarate (USP)    
Issue/Submission date 2016-02-24 2016-07-11    
Bisoprolol Hemifumarate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details    
Issue/Submission date    
brexpiprazole USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Chloramphenicol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
CoA - pdf
Status   Valid - 2019-02-07
Filling Details Chloramphenicol (BP/USP/Ph. Eur.)    
Issue/Submission date 2016-07-11    
Chloramphenicol palmitate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07 Tech Pack- Available - pdf
Filling Details Chloramphenicol palmitate (BP/USP/Ph. Eur.)    
Issue/Submission date 2016-07-11    
Cinacalcet Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Tech Pack- Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details    
Issue/Submission date    
DABIGATRAN ETEXILATE MESYLATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Dapagliflozin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Droperidol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07
Filling Details Droperidol (BP/USP/Ph. Eur.)    
Issue/Submission date 2016-07-11    
Edoxaban USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Empagliflozin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
ERYTHROMYCIN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R1-CEP 2009-267-Rev 00 Indian CDSCO WC-0214 Documents - pdf
Status VALID   Valid - 2019-02-07 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Erythromycin Erythromycin (BP/USP/Ph. Eur.)    
Issue/Submission date 2016-12-15 2016-07-11    
Erythromycin Estolate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07
Filling Details Erythromycin Estolate (BP/USP/Ph. Eur.)    
Issue/Submission date 2016-07-11    
Erythromycin Ethyl Succinate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Erythromycin Ethyl Succinate (BP/USP/Ph. Eur.)    
Issue/Submission date 2016-07-11    
Erythromycin Stearate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Erythromycin Stearate (USP/Ph. Eur.)    
Issue/Submission date 2016-07-11    
Esmolol Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07
Filling Details Esmolol Hydrochloride (IH)    
Issue/Submission date 2016-07-11    
Fluvoxamine Maleate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Fluvoxamine Maleate (BP/USP)    
Issue/Submission date 2016-07-11    
Landiolol Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07
Filling Details Landiolol Hydrochloride (IH)    
Issue/Submission date 2016-07-11    
Linagliptin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Macitentan USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Mirabegron USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Prochlorperazine Maleate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07
Filling Details Prochlorperazine Maleate (BP/USP/Ph. Eur.)    
Issue/Submission date 2016-07-11    
Rivaroxaban USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Treprostinil Monohydrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 Documents - pdf
Status   Valid - 2019-02-07
Filling Details Treprostinil Monohydrate (IH)    
Issue/Submission date 2016-07-11