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    Chemistry

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    Also known as: 14484-47-0, Azacort, Calcort, Oxazacort, Flantadin, Emflaza
    Molecular Formula
    C25H31NO6
    Molecular Weight
    441.5  g/mol
    InChI Key
    FBHSPRKOSMHSIF-GRMWVWQJSA-N
    FDA UNII
    KR5YZ6AE4B
    Deflazacort
    Deflazacort is a synthetic glucocorticoid prodrug, with anti-inflammatory and immunomodulating properties. Upon administration, the active metabolite of deflazacort, 21-desacetyl deflazacort, binds to and activates tissue glucocorticoid receptors. This results in the inhibition of specific leukocyte functions and the inhibition of proinflammatory cytokine production.
    Deflazacort is a Corticosteroid. The mechanism of action of deflazacort is as a Corticosteroid Hormone Receptor Agonist.
    1 2D Structure

    Deflazacort

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [2-[(1S,2S,4R,8S,9S,11S,12S,13R)-11-hydroxy-6,9,13-trimethyl-16-oxo-5-oxa-7-azapentacyclo[10.8.0.02,9.04,8.013,18]icosa-6,14,17-trien-8-yl]-2-oxoethyl] acetate
    2.1.2 InChI
    InChI=1S/C25H31NO6/c1-13-26-25(20(30)12-31-14(2)27)21(32-13)10-18-17-6-5-15-9-16(28)7-8-23(15,3)22(17)19(29)11-24(18,25)4/h7-9,17-19,21-22,29H,5-6,10-12H2,1-4H3/t17-,18-,19-,21+,22+,23-,24-,25+/m0/s1
    2.1.3 InChI Key
    FBHSPRKOSMHSIF-GRMWVWQJSA-N
    2.1.4 Canonical SMILES
    CC1=NC2(C(O1)CC3C2(CC(C4C3CCC5=CC(=O)C=CC45C)O)C)C(=O)COC(=O)C
    2.1.5 Isomeric SMILES
    CC1=N[C@@]2([C@H](O1)C[C@@H]3[C@@]2(C[C@@H]([C@H]4[C@H]3CCC5=CC(=O)C=C[C@]45C)O)C)C(=O)COC(=O)C
    2.2 Other Identifiers
    2.2.1 UNII
    KR5YZ6AE4B
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Calcort

    2. Dezacor

    3. Emflaza

    4. Zamene

    2.3.2 Depositor-Supplied Synonyms

    1. 14484-47-0

    2. Azacort

    3. Calcort

    4. Oxazacort

    5. Flantadin

    6. Emflaza

    7. Cortax

    8. Deflan

    9. Mdl 458

    10. Mdl-458

    11. L-5458

    12. Kr5yz6ae4b

    13. Mdl458

    14. Dezacor

    15. Lantadin

    16. Dsstox_cid_378

    17. Dsstox_rid_75552

    18. Dsstox_gsid_20378

    19. 2-((6ar,6bs,7s,8as,8bs,11ar,12as,12bs)-7-hydroxy-6a,8a,10-trimethyl-4-oxo-1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro-8bh-naphtho[2',1':4,5]indeno[1,2-d]oxazol-8b-yl)-2-oxoethyl Acetate

    20. Deflazacortum

    21. Decortil

    22. Deflanil

    23. Enzocort

    24. Deflazacort (calcort)

    25. 2-[(4ar,4bs,5s,6as,6bs,9ar,10as,10bs)-5-hydroxy-4a,6a,8-trimethyl-2-oxo-2,4a,4b,5,6,6a,9a,10,10a,10b,11,12-dodecahydro-6bh-naphtho[2',1':4,5]indeno[1,2-d][1,3]oxazol-6b-yl]-2-oxoethyl Acetate

    26. Cas-14484-47-0

    27. Dl-458-it

    28. Unii-kr5yz6ae4b

    29. Deflazacortum [inn-latin]

    30. Deflazacort [usan:inn:ban]

    31. Einecs 238-483-7

    32. Emflaza (tn)

    33. Mfcd00866106

    34. Deflazacort [mi]

    35. Deflazacort [inn]

    36. Deflazacort (usan/inn)

    37. Deflazacort [usan]

    38. Schembl4018

    39. Deflazacort [mart.]

    40. Deflazacort [usp-rs]

    41. Deflazacort [who-dd]

    42. Dl-458it

    43. Gtpl9477

    44. Chembl1201891

    45. Dtxsid9020378

    46. Deflazacort, >=98% (hplc)

    47. Deflazacort [orange Book]

    48. Chebi:135720

    49. Hms3714d15

    50. Bcp08474

    51. Zinc4212809

    52. Tox21_112506

    53. Tox21_301415

    54. Bbl036672

    55. S1888

    56. Stl559051

    57. Akos015895199

    58. Tox21_112506_1

    59. Ccg-220817

    60. Db11921

    61. Ks-1158

    62. Ncgc00255189-01

    63. Ncgc00263521-01

    64. 11beta,21-dihydroxy-2'-methyl-5'betah-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione 21-acetate

    65. Hy-13609

    66. Deflazacort 100 Microg/ml In Acetonitrile

    67. D4523

    68. D03671

    69. T70289

    70. Ab01274724-01

    71. Ab01274724_02

    72. 484d470

    73. Q779118

    74. Q-101371

    75. 3-amino-3-(4-chloro-3-nitro-phenyl)-propionicacid

    76. Deflazacort, United States Pharmacopeia (usp) Reference Standard

    77. 11b,21-dihydroxy-2'-methyl-5'bh-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione 21-acetate

    78. (11beta,16beta)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione

    79. [2-[(1s,2s,4r,8s,9s,11s,12s,13r)-11-hydroxy-6,9,13-trimethyl-16-oxo-5-oxa-7-azapentacyclo[10.8.0.02,9.04,8.013,18]icosa-6,14,17-trien-8-yl]-2-oxoethyl] Acetate

    80. 11.beta.,21-dihydroxy-2'-methyl-5'.beta.h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione 21-acetate

    81. 2-((6ar,6bs,7s,8as,8bs,11ar,12as,12bs)-7-hydroxy-6a,8a,10-trimethyl-4-oxo-2,4,6a,6b,7,8,8a,8b,11a,12,12a,12b-dodecahydro-1h-naphtho[2',1':4,5]indeno[1,2-d]oxazol-8b-yl)-2-oxoethyl Acetate

    82. 5'-beta-h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 11-beta,21-dihydroxy-2'-methyl-, 21-acetate

    83. 5'h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 21-(acetyloxy)-11-hydroxy-2'-methyl-, (11.beta.,16.beta.)-

    84. 5'h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 21-(acetyloxy)-11-hydroxy-2'-methyl-, (11beta,16beta)-

    2.4 Create Date
    2005-08-09
    3 Chemical and Physical Properties
    Molecular Weight 441.5 g/mol
    Molecular Formula C25H31NO6
    XLogP32
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count4
    Exact Mass441.21513771 g/mol
    Monoisotopic Mass441.21513771 g/mol
    Topological Polar Surface Area102 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity996
    Isotope Atom Count0
    Defined Atom Stereocenter Count8
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Deflazacort is indicated for the treatment of Duchenne Muscular Dystrophy (DMD) in patients 2 years of age and older.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Deflazacort exerts anti-inflammatory activity in DMD, likely improving various symptoms, including muscle weakness and cardiorespiratory symptoms in addition to delaying their onset. This allows for an increased quality of life and prevents the necessity for surgical procedures, such as those for scoliosis, which is associated with DMD. Studies showed significant preservation of muscle mass in patients generally treated with 0.9 mg/kg/day of deflazacort compared to a control group. The following findings are based on clinical studies using deflazacort on a long term basis: **Effects on muscle strength** At age 16, individuals treated with long-term deflazacort had 63 4% score in muscle strength compared to a mean muscle strength score of 31 3% for control patients. Significant improvements in climbing stairs and rising from a supine position were also seen in patients taking deflazacort. **Effects on ambulation** Ambulation was significantly higher by 12 years of age and 18 years of age in patients taking deflazacort when compared with the control group. The control group showed a mean loss of ambulation of 2 years sooner than with deflazacort treatment. **Effects on cardiac function** Mean left ventricular ejection fraction (a measure of cardiac function) was higher in patients treated with deflazacort over the long term. Preservation of cardiac function was demonstrated by a mean difference in ejection fraction of about 7%, favoring study groups taking deflazacort over control groups. **Effects on spinal alignment** Children treated with deflazacort also significantly lowered the rate and severity of scoliosis and eliminated the need for scoliosis surgery after long-term treatment.

    5.2 MeSH Pharmacological Classification

    Anti-Inflammatory Agents

    Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)

    Immunosuppressive Agents

    Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DEFLAZACORT
    5.3.2 FDA UNII
    KR5YZ6AE4B
    5.3.3 Pharmacological Classes
    Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
    5.4 ATC Code

    H02AB13

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    H - Systemic hormonal preparations, excl. sex hormones and insulins

    H02 - Corticosteroids for systemic use

    H02A - Corticosteroids for systemic use, plain

    H02AB - Glucocorticoids

    H02AB13 - Deflazacort

    5.5 Absorption, Distribution and Excretion

    Absorption

    Deflazacort is rapidly absorbed after oral administration with peak concentration occurring within 1-2 hours. One pharmacokinetic study determined an AUC (area under the curve) of 280 ng/ml h. The bioavailability of both the oral suspension and tablet are similar. In clinical studies, coadministration of deflazacort crushed with food or applesauce did not affect absorption or bioavailability.

    Route of Elimination

    Urinary excretion is the major route of deflazacort elimination, accounting for about about 70% of the excreted dose. The remainder of the dose (about 30%) is excreted in the feces. Elimination is almost completed by 24 hours post-dose. 21-deflazacort makes up about 18% of the eliminated drug in the urine.

    Volume of Distribution

    One study determined the volume of distribution to be 204 84 L.

    Clearance

    114 27 L/h, according to one noncompartmental pharmacokinetic study. The clearance of corticosteroids is enhanced in hypothyroid patients and increased in patients with hyperthyroidism. Dosing adjustments may be considered according to thyroid status. A study of corticosteroid clearance was performed in patients with a creatinine clearance of 15 mL/min or less, and determined that the active metabolite of deflazacort, 21-deflazacort was similar to that in patients with normal renal clearance.

    5.6 Metabolism/Metabolites

    After oral ingestion, deflazacort is deacetylated at position 21 by plasma esterases, producing the active metabolite 21-deflazacort. 21-deflazacort is then further metabolized by CYP3A4 to inactive metabolite products. Deflazacort 21-OH metabolism is extensive. The metabolite of deflazacort-21-OH is deflazacort 6-beta-OH.

    5.7 Biological Half-Life

    The half-life of deflazacort ranges from 1.1 to 1.9 h

    5.8 Mechanism of Action

    Deflazacort is a corticosteroid prodrug with an active metabolite, 21-deflazacort, which binds to the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects on the body. The exact mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown but likely occurs via its anti-inflammatory activities.

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    01-Mar-2022
    27-Oct-2025
    KGS
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    Average Price (USD/KGS)

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    FDF Dossiers

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    01

    Aucta Pharmaceuticals

    U.S.A
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    AES
    Attending
    • fda
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    Virtual BoothAucta is a global brand that creates better products from proven molecules.

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    Regulatory Info : RX

    Registration Country : USA

    DEFLAZACORT

    Brand Name : PYQUVI

    Dosage Form : SUSPENSION;ORAL

    Dosage Strength : 22.75MG/ML

    Packaging :

    Approval Date : 2025-06-30

    Application Number : 219417

    Regulatory Info : RX

    Registration Country : USA

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    02

    Towa Pharmaceutical

    Japan
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    Neuroscience
    Not Confirmed
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

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    Regulatory Info : Authorized

    Registration Country : Spain

    Deflazacort

    Brand Name : Deflazacort Pensa

    Dosage Form : Tablet

    Dosage Strength : 30MG

    Packaging :

    Approval Date : 2011-04-13

    Application Number : 73882

    Regulatory Info : Authorized

    Registration Country : Spain

    Towa Pharmaceutical

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    03

    Towa Pharmaceutical

    Japan
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    Neuroscience
    Not Confirmed
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

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    Regulatory Info : Suspensed

    Registration Country : Spain

    Deflazacort

    Brand Name : Deflazacort Pensa

    Dosage Form : Tablet

    Dosage Strength : 6MG

    Packaging :

    Approval Date : 2011-04-13

    Application Number : 73883

    Regulatory Info : Suspensed

    Registration Country : Spain

    Towa Pharmaceutical

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    04

    PTC Therapeutics

    U.S.A
    Neuroscience
    Not Confirmed
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    PTC Therapeutics

    U.S.A
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    Neuroscience
    Not Confirmed
    • fda
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    Regulatory Info : RX

    Registration Country : USA

    DEFLAZACORT

    Brand Name : EMFLAZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 6MG

    Packaging :

    Approval Date : 2017-02-09

    Application Number : 208684

    Regulatory Info : RX

    Registration Country : USA

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    05

    PTC Therapeutics

    U.S.A
    Neuroscience
    Not Confirmed
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    PTC Therapeutics

    U.S.A
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    Neuroscience
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    DEFLAZACORT

    Brand Name : EMFLAZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 18MG

    Packaging :

    Approval Date : 2017-02-09

    Application Number : 208684

    Regulatory Info : RX

    Registration Country : USA

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    06

    PTC Therapeutics

    U.S.A
    Neuroscience
    Not Confirmed
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    PTC Therapeutics

    U.S.A
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    Neuroscience
    Not Confirmed
    • fda
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    Regulatory Info : RX

    Registration Country : USA

    DEFLAZACORT

    Brand Name : EMFLAZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 30MG

    Packaging :

    Approval Date : 2017-02-09

    Application Number : 208684

    Regulatory Info : RX

    Registration Country : USA

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    07

    PTC Therapeutics

    U.S.A
    Neuroscience
    Not Confirmed
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    PTC Therapeutics

    U.S.A
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    Neuroscience
    Not Confirmed
    • fda
    • EDQM
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    Digital Content Digital Content

    Regulatory Info : RX

    Registration Country : USA

    DEFLAZACORT

    Brand Name : EMFLAZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 36MG

    Packaging :

    Approval Date : 2017-02-09

    Application Number : 208684

    Regulatory Info : RX

    Registration Country : USA

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    08

    PTC Therapeutics

    U.S.A
    Neuroscience
    Not Confirmed
    arrow

    PTC Therapeutics

    U.S.A
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    DEFLAZACORT

    Brand Name : EMFLAZA

    Dosage Form : SUSPENSION;ORAL

    Dosage Strength : 22.75MG/ML

    Packaging :

    Approval Date : 2017-02-09

    Application Number : 208685

    Regulatory Info : RX

    Registration Country : USA

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    09

    Upsher-Smith Laboratories

    U.S.A
    Neuroscience
    Not Confirmed
    arrow

    Upsher-Smith Laboratories

    U.S.A
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    DEFLAZACORT

    Brand Name : DEFLAZACORT

    Dosage Form : TABLET;ORAL

    Dosage Strength : 6MG

    Packaging :

    Approval Date : 2024-11-05

    Application Number : 216720

    Regulatory Info : RX

    Registration Country : USA

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    10

    Upsher-Smith Laboratories

    U.S.A
    Neuroscience
    Not Confirmed
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    Upsher-Smith Laboratories

    U.S.A
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    DEFLAZACORT

    Brand Name : DEFLAZACORT

    Dosage Form : TABLET;ORAL

    Dosage Strength : 18MG

    Packaging :

    Approval Date : 2024-11-05

    Application Number : 216720

    Regulatory Info : RX

    Registration Country : USA

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    01

    AUCTA

    U.S.A
    arrow
    AES
    Attending
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    • EDQM
    • WHO-GMP

    Virtual BoothAucta is a global brand that creates better products from proven molecules.

    Contact Supplier Contact Supplier
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    DEFLAZACORT

    Brand Name : PYQUVI

    Dosage Form : SUSPENSION;ORAL

    Dosage Strength : 22.75MG/ML

    Approval Date : 2025-06-30

    Application Number : 219417

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Aucta Company Banner

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    02

    AUROBINDO PHARMA LTD

    India
    Neuroscience
    Not Confirmed
    arrow

    AUROBINDO PHARMA LTD

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    DEFLAZACORT

    Brand Name : DEFLAZACORT

    Dosage Form : TABLET;ORAL

    Dosage Strength : 18MG

    Approval Date : 2024-02-09

    Application Number : 217123

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    AUROBINDO PHARMA LTD

    India
    Neuroscience
    Not Confirmed
    arrow

    AUROBINDO PHARMA LTD

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    DEFLAZACORT

    Brand Name : DEFLAZACORT

    Dosage Form : TABLET;ORAL

    Dosage Strength : 30MG

    Approval Date : 2024-02-09

    Application Number : 217123

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    04

    AUROBINDO PHARMA LTD

    India
    Neuroscience
    Not Confirmed
    arrow

    AUROBINDO PHARMA LTD

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    DEFLAZACORT

    Brand Name : DEFLAZACORT

    Dosage Form : TABLET;ORAL

    Dosage Strength : 36MG

    Approval Date : 2024-02-09

    Application Number : 217123

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    05

    PTC THERAP

    U.S.A
    Neuroscience
    Not Confirmed
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    PTC THERAP

    U.S.A
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : Yes

    TE Code : AB

    DEFLAZACORT

    Brand Name : EMFLAZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 6MG

    Approval Date : 2017-02-09

    Application Number : 208684

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    06

    SUN PHARM

    India
    Neuroscience
    Not Confirmed
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    SUN PHARM

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    DEFLAZACORT

    Brand Name : DEFLAZACORT

    Dosage Form : TABLET;ORAL

    Dosage Strength : 6MG

    Approval Date : 2025-03-18

    Application Number : 217741

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    07

    SUN PHARM

    India
    Neuroscience
    Not Confirmed
    arrow

    SUN PHARM

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    DEFLAZACORT

    Brand Name : DEFLAZACORT

    Dosage Form : TABLET;ORAL

    Dosage Strength : 18MG

    Approval Date : 2025-03-18

    Application Number : 217741

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    08

    SUN PHARM

    India
    Neuroscience
    Not Confirmed
    arrow

    SUN PHARM

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    DEFLAZACORT

    Brand Name : DEFLAZACORT

    Dosage Form : TABLET;ORAL

    Dosage Strength : 30MG

    Approval Date : 2025-03-18

    Application Number : 217741

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    09

    ZYDUS LIFESCIENCES

    India
    Neuroscience
    Not Confirmed
    arrow

    ZYDUS LIFESCIENCES

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    DEFLAZACORT

    Brand Name : JAYTHARI

    Dosage Form : TABLET;ORAL

    Dosage Strength : 30MG

    Approval Date : 2025-04-08

    Application Number : 219254

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    ZYDUS LIFESCIENCES

    India
    Neuroscience
    Not Confirmed
    arrow

    ZYDUS LIFESCIENCES

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    DEFLAZACORT

    Brand Name : JAYTHARI

    Dosage Form : TABLET;ORAL

    Dosage Strength : 36MG

    Approval Date : 2025-04-08

    Application Number : 219254

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Europe

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    01

    Towa Pharmaceutical Sa

    Japan
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Contact Supplier Contact Supplier
    Flag Japan
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Authorized

    Registration Country : Spain

    Deflazacort

    Brand Name : Deflazacort Pensa

    Dosage Form : Tablet

    Dosage Strength : 30MG

    Packaging :

    Approval Date : 2011-04-13

    Application Number : 73882

    Regulatory Info : Authorized

    Registration Country : Spain

    Towa Pharmaceutical

    Portfolio PDF

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    02

    Towa Pharmaceutical Sa

    Japan
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Contact Supplier Contact Supplier
    Flag Japan
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Suspensed

    Registration Country : Spain

    Deflazacort

    Brand Name : Deflazacort Pensa

    Dosage Form : Tablet

    Dosage Strength : 6MG

    Packaging :

    Approval Date : 2011-04-13

    Application Number : 73883

    Regulatory Info : Suspensed

    Registration Country : Spain

    Towa Pharmaceutical

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    03

    Cinfa Laboratories Sa

    Spain
    Neuroscience
    Not Confirmed
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    Cinfa Laboratories Sa

    Spain
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Authorized

    Registration Country : Spain

    Deflazacort

    Brand Name : Deflazacort Cinfa

    Dosage Form : Tablet

    Dosage Strength : 30MG

    Packaging :

    Approval Date : 2011-04-13

    Application Number : 73873

    Regulatory Info : Authorized

    Registration Country : Spain

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    04

    Faes Farma Sa

    Spain
    Neuroscience
    Not Confirmed
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    Faes Farma Sa

    Spain
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Authorized

    Registration Country : Spain

    Deflazacort

    Brand Name : Dezacor

    Dosage Form : Tablet

    Dosage Strength : 30MG

    Packaging :

    Approval Date : 1990-03-01

    Application Number : 57816

    Regulatory Info : Authorized

    Registration Country : Spain

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    05

    Faes Farma Sa

    Spain
    Neuroscience
    Not Confirmed
    arrow

    Faes Farma Sa

    Spain
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Regulatory Info : Authorized

    Registration Country : Spain

    Deflazacort

    Brand Name : Defal

    Dosage Form : Tablet

    Dosage Strength : 6MG

    Packaging :

    Approval Date : 2008-02-22

    Application Number : 69632

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Normon Laboratories Sa

    Spain
    Neuroscience
    Not Confirmed
    arrow

    Normon Laboratories Sa

    Spain
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info : Authorized

    Registration Country : Spain

    Deflazacort

    Brand Name : Deflazacort Normon

    Dosage Form : Tablet

    Dosage Strength : 30MG

    Packaging :

    Approval Date : 2011-04-12

    Application Number : 73850

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    Laboratorios Menarini Sa

    Italy
    Neuroscience
    Not Confirmed
    arrow

    Laboratorios Menarini Sa

    Italy
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Italy
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Authorized

    Registration Country : Spain

    Deflazacort

    Brand Name : Zamene

    Dosage Form : Tablet

    Dosage Strength : 30MG

    Packaging :

    Approval Date : 1990-07-01

    Application Number : 58655

    Regulatory Info : Authorized

    Registration Country : Spain

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    08

    TEOFARMA Srl

    Country
    Neuroscience
    Not Confirmed
    arrow

    TEOFARMA Srl

    Country
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Italy

    Deflazacort

    Brand Name : Flantadin

    Dosage Form :

    Dosage Strength : 10 Cpr 6 Mg  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    09

    LAB.GUIDOTTI SpA

    Country
    Neuroscience
    Not Confirmed
    arrow

    LAB.GUIDOTTI SpA

    Country
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Italy

    Deflazacort

    Brand Name : Deflan

    Dosage Form :

    Dosage Strength : 10 Cpr 30 Mg  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    10

    Xgx Pharma Aps

    Country
    Neuroscience
    Not Confirmed
    arrow

    Xgx Pharma Aps

    Country
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Country
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Approved

    Registration Country : Sweden

    Deflazakort

    Brand Name : Deflazacort Xgx Pharma

    Dosage Form : Tablet

    Dosage Strength : 30mg

    Packaging :

    Approval Date : 19/11/2021

    Application Number : 20190102000108

    Regulatory Info : Approved

    Registration Country : Sweden

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    Listed Dossiers

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    01

    Caristar Laboratories

    India
    Neuroscience
    Not Confirmed
    arrow

    Caristar Laboratories

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Deflazacort

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 30MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    01

    Caristar Laboratories

    India
    Neuroscience
    Not Confirmed
    arrow

    Caristar Laboratories

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info :

    Deflazacort

    Dosage : Tablet

    Dosage Strength : 30MG

    Brand Name :

    Approval Date :

    Application Number :

    Registration Country : India

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    02

    Delius Pharmaceuticals

    India
    Neuroscience
    Not Confirmed
    arrow

    Delius Pharmaceuticals

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Deflazacort

    Brand Name : Delflaz 6

    Dosage Form : Tablet

    Dosage Strength : 6MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    02

    Delius Pharmaceuticals

    India
    Neuroscience
    Not Confirmed
    arrow

    Delius Pharmaceuticals

    India
    arrow
    Neuroscience
    Not Confirmed
    • fda
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    Vega Biotech Pvt. Ltd.

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    Deflazacort

    Brand Name : Cerdef

    Dosage Form : TABLET

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    Vega Biotech Pvt. Ltd.

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    Packaging : 10 x 10 Alu Alu

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    10

    ZRS LABS

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    ZRS LABS

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    01

    Brand Name : Emflaza

    U.S.A
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    Company : Ptc Therapeutic

    Deflazacort

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    Brand Name : Emflaza

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    Company : Ptc Therapeutic

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    Drug Cost (USD) : 11,065,608

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    Brand Name : Emflaza

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    Company : Ptc Therapeutic

    Deflazacort

    Drug Cost (USD) : 7,596,448

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    Prescribers : 73

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    04

    Brand Name : Emflaza

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    Company : Ptc Therapeutic

    Deflazacort

    Drug Cost (USD) : 5,876,991

    Year : 2020

    Prescribers : 61

    Prescriptions : 748

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    05

    Brand Name : Emflaza

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    Company : Ptc Therapeutic

    Deflazacort

    Drug Cost (USD) : 2,645,232

    Year : 2019

    Prescribers : 50

    Prescriptions : 353

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    Brand Name : Emflaza

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    Company : Marathon/Ptc Th

    Deflazacort

    Drug Cost (USD) : 1,222,583

    Year : 2019

    Prescribers : 43

    Prescriptions : 177

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    Brand Name : Emflaza

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    Company : Marathon/Ptc Th

    Deflazacort

    Drug Cost (USD) : 3,523,041

    Year : 2018

    Prescribers : 56

    Prescriptions : 509

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    Brand Name : Deflan

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    LAB.GUIDOTTI SpA

    Deflazacort

    Dosage Form :

    Dosage Strength : 10 Cpr 6 Mg  

    Price Per Pack (Euro) : 6.59

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

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    Brand Name : Deflan

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    Brand Name : Deflan

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    LAB.GUIDOTTI SpA

    Deflazacort

    Dosage Form :

    Dosage Strength : 10 Cpr 30 Mg  

    Price Per Pack (Euro) : 20.02

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

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    Brand Name : Deflan

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    LAB.GUIDOTTI SpA

    Deflazacort

    Dosage Form :

    Dosage Strength : Gtt Os 13 Ml 22.75 Mg/Ml  

    Price Per Pack (Euro) : 17.91

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

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    Brand Name : Flantadin

    Country
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    TEOFARMA Srl

    Deflazacort

    Dosage Form :

    Dosage Strength : 10 Cpr 6 Mg  

    Price Per Pack (Euro) : 6.59

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

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    Brand Name : Flantadin

    Country
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    Neuroscience
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    Brand Name : Flantadin

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    Neuroscience
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    Deflazacort

    Dosage Form :

    Dosage Strength : 10 Cpr 30 Mg  

    Price Per Pack (Euro) : 20.02

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

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    Brand Name : Flantadin

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    Brand Name : Flantadin

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    Deflazacort

    Dosage Form :

    Dosage Strength : Gtt Os 13 Ml 22.75 Mg/Ml  

    Price Per Pack (Euro) : 17.91

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class C

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    Deflazacort (1 kg) API needed in India [ENA24035]
    A company that focuses on the manufacturing of various finished formulations is looking for suppliers of Deflazacort (1 kg) API for development purposes. The suppliers must support this enquiry with DMF & CoA.
    15 Sep 2025

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    15 Sep 2025

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    15 Sep 2025

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    Deflazacort (6 kg) API needed in India [ENA23238]
    A company that focuses on the manufacturing and marketing of various finished formulations is looking for suppliers of Deflazacort (6 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    14 Jun 2025

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    14 Jun 2025

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    14 Jun 2025

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    IP Grade Deflazacort (1 kg) API needed in India [ENA23107]
    A company that focuses on the manufacturing of various finished pharmaceuticals, nutraceuticals, cosmetics, and ayurvedic formulations is looking for suppliers of IP Grade Deflazacort (1 kg) API for development purposes. The suppliers must support this enquiry with CoA.
    31 May 2025

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    31 May 2025

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    31 May 2025

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    Deflazacort (4.5 kg) API needed in India [ENA21592]
    A company that focuses on manufacturing of tablets, capsules, oral suspensions and injectables for human & veterinary use is looking for suppliers of Deflazacort (4.5 kg) API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.
    30 Dec 2024

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    30 Dec 2024

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    30 Dec 2024

    india-flag.png
    IP Grade Deflazacort API needed in India [ENA20061]
    A company that focuses on manufacturing and marketing of various finished formulations is looking for suppliers of IP Grade Deflazacort API for commercial purposes. The suppliers must support this enquiry with CoA.
    22 Jul 2024

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    22 Jul 2024

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    22 Jul 2024

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    Deflazacort (6 kg - 10 kg) API needed in India [ENA19205]
    A company that focuses on the development of unique generic and specialty pharmaceuticals through an internal product development model and licensing in the later stages is looking for suppliers of Deflazacort (6 kg - 10 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    16 Mar 2024

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    16 Mar 2024

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    16 Mar 2024

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    Deflazacort API needed in the United States [ENA17501]
    A technology-based product company that focuses on the development and commercialization of branded specialty products is looking for suppliers of Deflazacort API for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
    08 Jul 2023

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    08 Jul 2023

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    08 Jul 2023

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    Deflazacort (2 kg) API needed in India [ENA17427]
    A pharmaceutical manufacturing company that deals in beta-lactam, non-beta-lactam and food supplements for both tablets and capsules is looking for suppliers of Deflazacort (2 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    29 Jun 2023

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    29 Jun 2023

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    29 Jun 2023

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    Various APIs needed in India [ENA17324]
    A company that deals in various pharmaceutical products like injections, syrups & hygiene products is looking for suppliers of Various APIs for commercial purposes. The suppliers must support this enquiry with CoA. 1. Faropenem (15 kg) API 2. Deflazacort (2 kg) API
    16 Jun 2023

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    16 Jun 2023

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    16 Jun 2023

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    Deflazacort (5 kg) API needed in India [ENA16889]
    A company that deals in the distribution of various pharmaceutical products is looking for suppliers of Deflazacort (5 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    14 Apr 2023

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    14 Apr 2023

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    14 Apr 2023

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    ABOUT THIS PAGE

    Looking for 14484-47-0 / Deflazacort API manufacturers, exporters & distributors?

    Deflazacort manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Deflazacort API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Deflazacort manufacturer or Deflazacort supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Deflazacort manufacturer or Deflazacort supplier.

    PharmaCompass also assists you with knowing the Deflazacort API Price utilized in the formulation of products. Deflazacort API Price is not always fixed or binding as the Deflazacort Price is obtained through a variety of data sources. The Deflazacort Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Deflazacort

    Synonyms

    14484-47-0, Azacort, Calcort, Oxazacort, Flantadin, Emflaza

    Cas Number

    14484-47-0

    Unique Ingredient Identifier (UNII)

    KR5YZ6AE4B

    About Deflazacort

    Deflazacort is a synthetic glucocorticoid prodrug, with anti-inflammatory and immunomodulating properties. Upon administration, the active metabolite of deflazacort, 21-desacetyl deflazacort, binds to and activates tissue glucocorticoid receptors. This results in the inhibition of specific leukocyte functions and the inhibition of proinflammatory cytokine production.

    Zamene Manufacturers

    A Zamene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zamene, including repackagers and relabelers. The FDA regulates Zamene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zamene API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Zamene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Zamene Suppliers

    A Zamene supplier is an individual or a company that provides Zamene active pharmaceutical ingredient (API) or Zamene finished formulations upon request. The Zamene suppliers may include Zamene API manufacturers, exporters, distributors and traders.

    click here to find a list of Zamene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Zamene USDMF

    A Zamene DMF (Drug Master File) is a document detailing the whole manufacturing process of Zamene active pharmaceutical ingredient (API) in detail. Different forms of Zamene DMFs exist exist since differing nations have different regulations, such as Zamene USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Zamene DMF submitted to regulatory agencies in the US is known as a USDMF. Zamene USDMF includes data on Zamene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zamene USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Zamene suppliers with USDMF on PharmaCompass.

    Zamene WC

    A Zamene written confirmation (Zamene WC) is an official document issued by a regulatory agency to a Zamene manufacturer, verifying that the manufacturing facility of a Zamene active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zamene APIs or Zamene finished pharmaceutical products to another nation, regulatory agencies frequently require a Zamene WC (written confirmation) as part of the regulatory process.

    click here to find a list of Zamene suppliers with Written Confirmation (WC) on PharmaCompass.

    Zamene NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Zamene as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Zamene API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Zamene as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Zamene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zamene NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Zamene suppliers with NDC on PharmaCompass.

    Zamene GMP

    Zamene Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Zamene GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Zamene GMP manufacturer or Zamene GMP API supplier for your needs.

    Zamene CoA

    A Zamene CoA (Certificate of Analysis) is a formal document that attests to Zamene's compliance with Zamene specifications and serves as a tool for batch-level quality control.

    Zamene CoA mostly includes findings from lab analyses of a specific batch. For each Zamene CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Zamene may be tested according to a variety of international standards, such as European Pharmacopoeia (Zamene EP), Zamene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zamene USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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