Investor Relations
overview

Regulatory

We have a robust product portfolio of over 60 Corticosteroid and Steroidal-hormone APIs that are supplied globally


Corticosteroid APIs

A robust portfolio comprising 47 DMFs and CEPs for corticosteroid APIs, which are universally applied extensively in critical care setups, as well as across chronic therapeutic areas such as Respiratory, Dermatology, Pain Management, Oncology and Gynecology


Steroidal-Hormone APIs

A robust portfolio comprising 18 DMFs and CEPs for Steroidal-Hormone APIs, which are universally applied for Hormone Replacement

Compliant API Portfolio :

A Comprehensive range of Corticosteroid and Steroidal-Hormone APIs, supported by US Drug Master Files (USDMF) and Ph. Eur. Certificates of Suitability (CEP)


US Drug Master Filing (USDMF)
RAU FACILITY - STEROIDS
DMF#
PRODUCT NAME
028137
Beclomethasone Dipropionate USP (Micronized & Non-Micronized)
025798
Betamethasone Dipropionate
022062
Betamethasone Valerate, USP (Micronized)
020821
Clobetasol Propionate USP
024691
Deflazacort Micronized
022400
Desoximetasone USP (Micronized)
019402
Halobetasol Propionate
029221
Hydrocortisone Hemisuccinate USP
024611
Methylprednisolone Acetate USP
022904
Methylprednisolone Hemisuccinate
025448
Mometasone Furoate Monohydrate
020684
Mometasone Furoate USP (Micronised)
024630
Prednisolone Hemisuccinate
023899
Prednisolone Sodium Phosphate USP
021263
Triamcinolone Acetonide USP
036086
Betamethasone Acetate USP
037466
Betamethasone Sodium Phosphate USP
038162
Dexamethasone USP
029224
16 -Hydroxyprednisolone (Intermediate)
042465
Dexamethasone Sodium Phosphate
SEZ FACILITY- STEROIDS
DMF#
PRODUCT NAME
025197
Betamethasone USP (Micronized)
025547
Flumethasone
027783
Methylprednisolone USP (Micronized)
030820
Hydrocortisone Acetate USP
031349
Hydrocortisone USP
032728
Prednisolone Acetate USP
034505
Prednisolone USP
034637
Methylprednisolone USP (Process 2)
SEZ- HORMONES
DMF#
PRODUCT NAME
029030
17- Hydroxy Progesterone (Intermediate)
029004
Dehydroepiandrosterone (Intermediate)
028124
Desogestrel EP/BP (Micronized)
027920
Esterified Estrogens USP
026020
Ethinyl Estradiol USP (Micronized)
027867
Levonorgestrel EP/USP (Micronized)
029869
Testosterone USP (Micronized)
029023
Testosterone Cypionate USP
026166
Testosterone Enanthate USP
025535
Testosterone Propionate USP (Micronized)
025534
Testosterone Undecanoate
030747
Hydroxyprogesterone Caproate USP
032709
Progesterone USP
032885
Drospirenone
034147
Estradiol Hemihydrate USP
Ph. Eur. Certificate of Suitability (CEP)
RAU FACILITY - STEROIDS
PRODUCT NAME
CEP
Beclometasone Dipropionate, Micronised, Non-Micronised
R1-CEP 2005-062-Rev 02
Betamethasone Dipropionate Micronised
R1-CEP 2012-079-Rev 00
Betamethasone Valerate Micronised
R1-CEP 2008-307-Rev 00
Clobetasone Butyrate Micronised
R1-CEP 2012-282-Rev 00
Clobetasol Propionate Micronised, Non-Micronised
R1-CEP 2007-263-Rev 02
Methylprednisolone Acetate Micronised
R1-CEP 2011-063-Rev 01
Methylprednisolone Hydrogen Succinate
R1-CEP 2009-187-Rev 04
Mometasone Furoate Micronised
CEP 2007-194-Rev 04
Prednisolone Sodium Phosphate
R1-CEP 2011-149-Rev 01
Triamcinolone Acetonide Micronised
R1-CEP 2008-032-Rev 04
Hydrocortisone Hydrogen Succinate
R1-CEP 2014-120-Rev 01
Dexamethasone Micronised
CEP 2023-083-Rev 00
SEZ FACILITY - STEROIDS
PRODUCT NAME
CEP
Betamethasone Micronised
R1-CEP 2011-285-Rev 01
Methylprednisolone Micronised
R1-CEP 2014-015-Rev 01
Prednisolone Sodium Phosphate (Process 2)
R1-CEP 2016-205-Rev 01
Hydrocortisone Acetate Micronised (Grades I and II)
CEP 2016-228-Rev 03
Hydrocortisone Micronised
CEP 2018-054-Rev 02
Prednisolone Acetate Micronised
CEP 2018-089-Rev 02
Prednisolone Micronised
CEP 2020-194-Rev 01
SEZ FACILITY - HORMONES
PRODUCT NAME
CEP
Testosterone Micronised
R1-CEP 2015-314-Rev 01
Drospirenone Micronised, Non-Micronised
CEP 2018-118-Rev 01
Ethinyl Estradiol Micronised
R0-CEP 2020-029-Rev 00
Estradiol Hemihydrate Micronised
R0-CEP 2020-067-Rev 00