drug master filing cortico-steroid...
TRANSCRIPT
Cortico-Steroid APIs
SYMBIOTEC
DRUG MASTER FILING
01
US DMF No. 025547
US DMF No. 019402
To be filed
To be filed To be filed
To be filed To be filed
To be filed To be filed
To be filed
R0- -Rev-00CEP-2018-054 US DMF No. 031349
R0-CEP-2016-228-Rev-00 US DMF No. 030820
R0-CEP-2014-120-Rev-00 US DMF No. 029221
ASMF filed To be filed
R0-CEP-2014-015-Rev-02 US DMF No. 027783
R1-CEP-2011-063-Rev-00 US DMF No. 024611
R1-CEP-2009-187-Rev-02 US DMF No. 022904
ASMF filed To be filed
R1-CEP-2007-194-Rev-02
To be filed
US DMF No. 020684
US DMF No. 029224
To be filed
To be filed
US DMF No. 025448
R0- -Rev-00CEP-2018-089
To be filed
US DMF No. 032728
ASMF Filed
To be filed
US DMF No. 024630
R1-CEP-2011-149-Rev-00
R0-CEP-2016-205-Rev-00
To be filed
US DMF No. 023899
To be filed
R1-CEP-2008-032-Rev-03 US DMF No. 021263
US DMF No. 028137
To be filed
R1-CEP-2005-062-Rev-01
To be filed
US DMF No. 025197
US DMF No. 025798
To be filed
US DMF No 022400
US DMF No. 024691
R1-CEP-2011-285-Rev-01
R1-CEP-2012-079-Rev-00
R1-CEP-2008-307-Rev-00
R1-CEP-2007-263-Rev-02
US DMF No. 022062
US DMF No. 020821
To be filed
To be filed
ASMF Filed
R1-CEP-2012-282-Rev-00
ASMF Filed
To be filed
To be filed
To be filedTo be filed
To be filed
To be filed
To be filed
To be filed
To be filed
To be filed
To be filed
To be filed
To be filed
To be filed
CEP/ASMF obtained US DMF obtainedProducts
Flumethasone
Fluorometholone
Fluticasone Furoate
Halobetasol Propionate
Hydrocortisone
Hydrocortisone Acetate
Hydrocortisone Hemisuccinate
Hydrocortisone Sodium Succinate 5% (Buffered Sterile Lyophilized)
Methylprednisolone
Methylprednisolone Sodium Succinate 3% (Buffered Sterile Lyophilized)
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Mometasone Furoate
16-α Hydroxy Prednisolone
Mometasone Furoate Monohydrate
Fluocinolone Acetonide
Prednisolone Acetate
Desonide
Prednisolone Hemisuccinate
Clocortolone Pivalate
Prednisolone Sodium Phosphate
Prednisolone Sodium Phosphate (Process-2)
Fluandrenolide
Triamcinolone Acetonide
Fluticasone Propionate
Beclometasone Dipropionate Anhydrous
Abiraterone Acetate
Betamethasone
Clobetasone Butyrate
Deflazacort
Cloprednol
Dexamethasone
Desoximetasone
Betamethasone Valerate
Betamethasone Dipropionate
Clobetasol Propionate
Dexamethasone Sodium Phosphate
Hydrocortisone Valerate
Prednisone
Prednisolone
SYMBIOTEC
Hormone APIs
DRUG MASTER FILING
02
Products CEP/ASMF obtained US DMF obtained
Ethinyl Estradiol
Ethynodiol Diacetate
Levonorgestrel
Estradiol Hemihydrate
Esterified Estrogens
Nandrolone Decanoate
Conjugated Estrogen (Synthetic)
Drospirenone
Nandrolone Phenylpropionate
Dehydroepiandrosterone (DHEA/Prasteron)
Desogestrel
Medroxyprogesterone acetate
To be filed
US DMF No. 029004
US DMF No. 028124
US DMF No. 032885
US DMF No. 034147
US DMF No. 027920
US DMF No. 026021
To be filed
To be filed
US DMF No. 026020
US DMF No. 027867
To be filed
To be filed
R0-CEP-2018-118-Rev-00
To be filed
To be filed
To be filed
To be filed
To be filed
CEP-2020-029
To be filed
To be filed
Testosterone
Testosterone Decanoate
Testosterone Cypionate
Testosterone Propionate
Testosterone Enanthate
Testosterone Undecanoate
Progesterone
Stanolone
US DMF No. 029869
To be filed
US DMF No. 029023
US DMF No. 025535
US DMF No. 026166
US DMF No. 025534
US DMF No. 032709
R0-CEP-2015-314-Rev-00
To be filed
To be filed
To be filed
To be filed
To be filed
Norethisterone Base To be filedTo be filed
To be filed
Estradiol Valerate To be filedTo be filed
Estrone To be filedTo be filed
17-α- Hydroxyprogesterone US DMF No. 029030To be filed
Hydroxyprogesterone Caproate US DMF No. 030747To be filed
To be filed
To be filed
ASMF filed To be filed
SYMBIOTEC
Others APIs
DRUG MASTER FILING
SYMBIOTEC PHARMALAB (P) LIMITED
Corporate Office & Unit I (Rau, Indore)385/2, Pigdamber, Rau, Indore - 453 331 (M.P.) INDIATel. : + 91-731-6676405,06 Fax : +91-731-4201222
E-mail : [email protected] : www.symbiotec.in
Unit II (SEZ, Pithampur) Plot No. 5,6,7 & 8, Special Economic Zone, Phase II, Pharma Zone., Pithampur, Distt. Dhar- 454 774 (M.P.) INDIA
03
CEP/ASMF obtained US DMF obtained
To be filed
To be filed
To be filed
To be filed
Products
Rocuronium Bromide
Exemestane