drug master filing cortico-steroid...

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 : marketing@symbiotec.inhttp : 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