Symbiotec PharmaSymbiotec Pharma

Regulatory Filings

A portfolio of approx. 100 DMFs organization including 20 CEPs(Certificates of Suitability) and 30 DMFs (Drug Master Filings) and a continual filing strategy.

Cortico Steroids


Products CEP/ASMF US DMF
Abiraterone Acetate To be filed To be filed Q3 2017
Betamethasone R1-CEP 2011-285-Rev 00 US DMF No. 25197
Beclometasone Dipropionate R1-CEP 2005-062-Rev 01 US DMF No. 28137
Betamethasone Dipropionate R0-CEP 2012-079-Rev 01 US DMF No. 25798
Betamethasone Valerate R1-CEP 2008-307-Rev 00 US DMF No. 22062
Clobetasol Propionate R1-CEP 2007-263-Rev 02 US DMF No. 20821
Clobetasone Butyrate R0-CEP 2012-282-Rev 02 To be filed
Cloprednol ASMF Filed To be filed
Clocortolone Pivalate To be filed To be filed
Deflazacort ASMF Filed US DMF No. 24691
Desonide To be filed To be filed
Desoximetasone To be filed US DMF No. 22400
Dexamethasone To be filed in 2017 To be filed in 2017
Dexamethasone Sodium Phosphate To be filed To be filed
Fluandrenolide To be filed To be filed
Flumethasone To be filed US DMF No. 25547
Fluorometholone To be filed To be filed
Flucinolone Acetonide To be filed To be filed in 2017
Fluticasone Furoate To be filed To be filed
Fluticasone Propionate To be filed To be filed
Halobetasol Propionate To be filed US DMF No. 19402
Hydrocortisone To be filed US DMF No. 31349
Hydrocortisone Acetate CEP-2016-228 US DMF NO. 30820
Hydrocortisone Hemisuccinate R0-CEP 2014-12-Rev 00 US DMF No. 29221
Hydrocortisone Sodium Succinate 5 % Buffered Sterile Lyophilized ASMF filed To be filed
Hydrocortisone Valerate To be filed To be filed
Methylprednisolone R0-CEP 2014-15-Rev 02 US DMF No. 27783
Methylprednisolone Acetate R0-CEP 2011-063-Rev 02 US DMF No. 24611
Methylprednisolone Hemisuccinate R1-CEP 2009-187 Rev 01 US DMF No. 22904
MethylPrednisolone Sodium Succinate 3 % (Buffered Sterile Lyophilized) ASMF filed To be filed
Mometasone Furoate R1-CEP 2007-194-Rev 01 US DMF No. 20684
Mometasone Furoate Monohydrate To be filed US DMF No. 25448
Prednisolone To be filed To be filed
Prednisolone Acetate To be filed To be filed
Prednisolone Hemisuccinate ASMF Filed US DMF No. 24630
Prednisolone Sodium Phosphate R0-CEP 2011-149-Rev 03 US DMF No. 23899
Prednisolone Sodium Phosphate (Process 2) R0-CEP-2016-205-Rev 00 -----
Triamcinolone Acetonide R1-CEP 2008-032-Rev 03 US DMF No. 21263
16 - Alpha Hydroxy Prednisolone To be filed US DMF No. 29224
Prednisone To be filed To be filed

Hormones


PRODUCTS CEP/ASMF US DMF
Conjugated Estrogen (Synthetic) To be filed To be filed
Dehydroepiandrosterone (DHEA/Prasteron) To be filed US DMF No. 29004
Desogestrel To be filed US DMF No. 28124
Drospirenone To be filed To be filed
Estradiol Hemihydrate To be filed To be filed in Q4 2017
Estradiol Valerate To be filed To be filed
Esterified Estrogens To be filed US DMF No. 27920
Estrone To be filed To be filed
Ethinyl Estradiol To be filed US DMF No. 26020
Ethynodiol Diacetate To be filed US DMF No. 26021
17-a- Hydroxy Progesterone To be filed US DMF No. 29030
Hydroxy Progesterone Caproate To be filed US DMF No. 30747
Levonorgestrel To be filed US DMF No. 27867
Medroxyprogesterone acetate To be filed To be filed
Nandrolone Decanoate To be filed To be filed
Nandrolone Phenylpropionate To be filed To be filed
Testosterone R0-CEP-2015-314-REV 00 US DMF No. 29869
Testosterone Cypionate To be filed US DMF No. 29023
Testosterone Decanoate To be filed To be filed
Testosterone Eranthate To be filed in 2017 US DMF No. 26166
Testosterone Undecanoate To be filed US DMF No. 25534
Norethisterone Base To be filed To be filed
Testosterone Propionate To be filed US DMF No. 25535

Others


Products CEP/ASMF US DMF
Exemestane To be filed To be filed in 2017
Rocuronium Bromide To be filed To be filed

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