Regulatory Updates

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Date Product Update
2020 Aug 11, 2020 Product Aripiprazole Update CEP
Aug 11, 2020 Product Fingolimod Update CEP
Aug 11, 2020 Product Tacrolimus Update CEP
Jul 02, 2020 Product Crisaborole Update US DMF
May 31, 2020 Product Caspofungin Acetate Update New Korea DMF is available
Feb 02, 2020 Product Icatibant Acetate Update New Canada DMF for Icatibant Acetate is available.
Jan 21, 2020 Product Sugammadex Sodium Update New Brazil DMF is available.
Jan 15, 2020 Product Cabazitaxel Update New Canada DMF is available.
2019 Jul 01, 2019 Product Sugammadex Sodium Update New US DMF for is available.
Apr 11, 2019 Product Diroximel Fumarate Update New US DMF is available.
Apr 02, 2019 Product Apremilast Update New Turkey DMF is available.
Apr 02, 2019 Product Sitagliptin Update New EU DMF for Sitagliptin Malate is available.
Mar 20, 2019 Product Cinacalcet HCl Update New China DMF is avaliable.
Feb 14, 2019 Product Brexpiprazole Update New US DMF is available.
Feb 11, 2019 Product Caspofungin Acetate Update New Brazil DMF is available.
2018 Dec 27, 2018 Product Rivaroxaban Update New EU DMF is available.
Dec 25, 2018 Product Dasatinib Anhydrous Update New Canada DMF is available.
Aug 16, 2018 Product Pregabalin Update New Japan DMF is available.
Jul 30, 2018 Product Micafungin Sodium Update New DMF is available.
May 27, 2018 Product Ezetimibe Update New China DMF is available.
Apr 26, 2018 Product Clopidogrel Bisulfate Update New Korea DMF is available.
Apr 26, 2018 Product Clopidogrel Bisulfate Update New REU DMF is available.
Apr 26, 2018 Product Valaciclovir HCl Update New Korean DMF is available.
Mar 27, 2018 Product Rivaroxaban Update New Canada DMF is available.
Mar 27, 2018 Product Rivaroxaban Update New US DMF is available.
Feb 21, 2018 Product Fingolimod Update New Brazil DMF is available.
Feb 21, 2018 Product Sorafenib Update New Canada DMF for Sorafenib Tosylate is available.
2017 Sep 24, 2017 Product Mirtazapine Update New JP DMF is available.
Aug 20, 2017 Product Dasatinib monohydrate Update New EU DMF is available.
Jun 25, 2017 Product Ibrutinib Update US DMF is available.
May 28, 2017 Product Linagliptin Update New CA DMF dated 05/2017 is available.
May 28, 2017 Product Linagliptin Update New KO DMF dated 05/2017 is available.
May 28, 2017 Product Montelukast Sodium Update New US DMF dated 04/2017 is available.
May 28, 2017 Product Rivaroxaban Update New BR DMF dated 04/2017 is available.
May 28, 2017 Product Sorafenib Update New EU DMF for Sorafenib Tosylate dated 03/2017 is available.
Apr 25, 2017 Product Dasatinib monohydrate Update New US DMF dated 04/2017 is available.
Apr 25, 2017 Product Macitentan Update New US DMF dated 03/2017 is available.
Apr 25, 2017 Product Montelukast Sodium Update New Korea DMF dated 03/2017 is available.
Mar 28, 2017 Product Afatinib Update New DMF is now available for reference on the FDA website.
Mar 28, 2017 Product Sildenafil citrate Update New CEP was granted to Teva API's Sildenafil Citrate by EDQM The Certificate includes both Teva Tech and Teva API China manufacturing sites.
Feb 19, 2017 Product Bortezomib Update New Japan DMF dated November 2016 is available.
Jan 05, 2017 Product Cabazitaxel Update New EU DMF dated 12/2016 is available.
Jan 03, 2017 Product Dasatinib Anhydrous Update New EU DMF dated 12/2016 is available.
2016 Dec 19, 2016 Product Fulvestrant Update New IN DMF dated 12/2016 is available.
Nov 15, 2016 Product Febuxostat Update New RU DMF dated 10/2016 is available.
Nov 15, 2016 Product Pregabalin Update New US DMF dated 11/2016 is available.
Sep 25, 2016 Product Dimethyl Fumarate Update New US DMF dated 08/2016 is available.
Sep 25, 2016 Product Dimethyl Fumarate Update New EU DMF dated 09/2016 is available.
Sep 25, 2016 Product Febuxostat Update New CA DMF dated 09/2016 is available.
Sep 25, 2016 Product Sorafenib Update New EU DMF for Sorafenib Tosylate dated 09/2016 is available.
Jul 12, 2016 Product Sunitinib Update New EU DMF for Sunitinib Base dated 07/2016 is available.
Jun 29, 2016 Product Ticagrelor Update New KO DMF dated 06/2016 is available.
Jun 27, 2016 Product Apixaban Update New US DMF dated 06/2016 is available.
Jun 27, 2016 Product Febuxostat Update New CA DMF dated 06/2016 is available.
Jun 27, 2016 Product Icatibant Acetate Update New US DMF for Icatibant Acetate dated 6/2016 is available.
Jun 27, 2016 Product Linagliptin Update New KO DMF dated 06/2016 is available.
May 26, 2016 Product Imatinib Mesylate Update New CEP dated 05/2016 is available.
Apr 25, 2016 Product Perampanel Update New US DMF dated 04/2016 is available.
Mar 13, 2016 Product Linaclotide Update New US DMF dated 03/2016 is available.
Mar 09, 2016 Product Abiraterone Acetate Update New EU DMF dated 02/2016 is available.
Mar 09, 2016 Product Saxagliptin Update EU DMF for Saxagliptin Monohydrate dated 02/2016 is now available in Korea as well.
Feb 23, 2016 Product Sorafenib Update New US DMF for Sorafenib Tosylate dated 02/2016 is available.
Feb 18, 2016 Product Aripiprazole Update New JP DMF dated 02/2016 is available.
Feb 10, 2016 Product Sunitinib malate Update New EU DMF dated 01/2016 is available.
Feb 09, 2016 Product Ulipristal Acetate Update New EU DMF dated 01/2016 is available.
Jan 31, 2016 Product Carfilzomib Update New US DMF dated 01/2016 is available.
Jan 25, 2016 Product Gemcitabine HCl Update Recently we have received approval in Taiwan.
Jan 25, 2016 Product Medroxyprogesterone acetate Update Recently we have received approval in Taiwan.
Jan 25, 2016 Product Olanzapine Update Recently we have received approval in Taiwan.
Jan 25, 2016 Product Oxaliplatin Update Recently we have received approval in Taiwan.
Jan 25, 2016 Product Pravastatin Sodium Update Recently we have received approval in Taiwan.
Jan 25, 2016 Product Simvastatin Update Recently we have received approval for Simvastatin ACNBHT (1.16) in Taiwan.
Jan 03, 2016 Product Anidulafungin Update New EU DMF dated 12/2015 is available.
2015 Nov 18, 2015 Product Pregabalin Update New DMF was approved in Korea.