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    Chemistry

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    Also known as: 104206-65-7, Orfadin, 2-(2-nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione, Nitisone, Ntbc, 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione
    Molecular Formula
    C14H10F3NO5
    Molecular Weight
    329.23  g/mol
    InChI Key
    OUBCNLGXQFSTLU-UHFFFAOYSA-N
    FDA UNII
    K5BN214699
    Nitisinone
    Nitisinone is a synthetic reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase. It is used in the treatment of hereditary tyrosinemia type 1. It is sold under the brand name Orfadin.
    Nitisinone is a 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor. The mechanism of action of nitisinone is as a Hydroxyphenylpyruvate Dioxygenase Inhibitor, and Cytochrome P450 2C9 Inhibitor, and Cytochrome P450 2E1 Inducer, and Organic Anion Transporter 1 Inhibitor, and Organic Anion Transporter 3 Inhibitor.
    1 2D Structure

    Nitisinone

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[2-nitro-4-(trifluoromethyl)benzoyl]cyclohexane-1,3-dione
    2.1.2 InChI
    InChI=1S/C14H10F3NO5/c15-14(16,17)7-4-5-8(9(6-7)18(22)23)13(21)12-10(19)2-1-3-11(12)20/h4-6,12H,1-3H2
    2.1.3 InChI Key
    OUBCNLGXQFSTLU-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CC(=O)C(C(=O)C1)C(=O)C2=C(C=C(C=C2)C(F)(F)F)[N+](=O)[O-]
    2.2 Other Identifiers
    2.2.1 UNII
    K5BN214699
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-(2-nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione

    2. 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione

    3. Ntbc Cpd

    4. Orfadin

    2.3.2 Depositor-Supplied Synonyms

    1. 104206-65-7

    2. Orfadin

    3. 2-(2-nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione

    4. Nitisone

    5. Ntbc

    6. 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione

    7. 2-[2-nitro-4-(trifluoromethyl)benzoyl]cyclohexane-1,3-dione

    8. 2-(2-nitro-4-trifluoromethylbenzoyl)cyclohexane-1,3-dione

    9. Sc 0735

    10. Sc-0735

    11. 2-(alpha,alpha,alpha-trifluoro-2-nitro-p-tuluoyl)-1,3-cyclohexanedione

    12. 1,3-cyclohexanedione, 2-[2-nitro-4-(trifluoromethyl)benzoyl]-

    13. 2-{[2-nitro-4-(trifluoromethyl)phenyl]carbonyl}cyclohexane-1,3-dione

    14. Chembl1337

    15. Chebi:50378

    16. 1,3-cyclohexanedione, 2-(2-nitro-4-(trifluoromethyl)benzoyl)-

    17. Mfcd01752192

    18. Sc0735

    19. K5bn214699

    20. Nitisinone [inn]

    21. Nitisinone [usan:inn]

    22. Nitisinona

    23. Nitisinonum

    24. Smr002529592

    25. Orfadin (tn)

    26. Nitisinone (jan/usan/inn)

    27. Unii-k5bn214699

    28. Nityr

    29. Fe-0200

    30. 2-[2-nitro-4-(trifluoromethyl)benzoyl]-1,3-cyclohexanedione

    31. Nitisinone [mi]

    32. Nitisinone [jan]

    33. Nitisinone [usan]

    34. Nitisinone [vandf]

    35. Nitisinone [mart.]

    36. Nitisinone [who-dd]

    37. Bidd:pxr0129

    38. Mls004774025

    39. Mls006011955

    40. Nitisinone [ema Epar]

    41. Schembl338795

    42. Ambz0071

    43. Gtpl6834

    44. Dtxsid9042673

    45. Nitisinone [orange Book]

    46. Nitisinone, >=95% (hplc)

    47. Schembl15996621

    48. Hms3740a15

    49. Hms3870k03

    50. Bcp15276

    51. Hy-b0607

    52. Bdbm50088804

    53. Nsc773149

    54. Rb3134

    55. S5325

    56. Akos015891363

    57. Akos015994590

    58. Zinc100014475

    59. Am62666

    60. Ccg-222085

    61. Db00348

    62. Ex-6233

    63. Nsc-773149

    64. Sb19017

    65. Ncgc00185778-01

    66. Ncgc00185778-02

    67. Ncgc00185778-04

    68. Ncgc00185778-07

    69. Ac-26934

    70. Sy047291

    71. Db-014936

    72. Ft-0672739

    73. D05177

    74. A800922

    75. Sr-01000940576

    76. J-505680

    77. Q3877355

    78. Sr-01000940576-2

    79. Ntbc; Nitisone; Sc0735; Sc 0735; Sc-0735

    80. Z1514110653

    81. 1,3-cyclohexanedione,2-[2-nitro-4-(trifluoromethyl)benzoyl]-

    82. 2-(2-nitro-4-(trifluoromethyl)-benzoyl)cyclohexane-1,3-dione

    83. 2-[2-nitro-4-(trifluoromethyl)benzoyl]cyclohexane-1,3-dione;nitisinone

    84. 2-(.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-p-tuluoyl)-1,3-cyclohexanedione

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 329.23 g/mol
    Molecular Formula C14H10F3NO5
    XLogP32.3
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count2
    Exact Mass329.05110691 g/mol
    Monoisotopic Mass329.05110691 g/mol
    Topological Polar Surface Area97 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity524
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameOrfadin
    PubMed HealthNitisinone (By mouth)
    Drug ClassesGastrointestinal Agent
    Drug LabelOrfadin contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1). Nitisinone occurs as white to...
    Active IngredientNitisinone
    Dosage FormCapsule
    RouteOral
    Strength5mg; 2mg; 10mg
    Market StatusPrescription
    CompanySwedish Orphan

    2 of 2  
    Drug NameOrfadin
    PubMed HealthNitisinone (By mouth)
    Drug ClassesGastrointestinal Agent
    Drug LabelOrfadin contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1). Nitisinone occurs as white to...
    Active IngredientNitisinone
    Dosage FormCapsule
    RouteOral
    Strength5mg; 2mg; 10mg
    Market StatusPrescription
    CompanySwedish Orphan

    4.2 Drug Indication

    Used as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1.

    FDA Label

    Hereditary tyrosinemia type 1 (HT 1)

    Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.

    Alkaptonuria (AKU)

    Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).

    Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

    Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.

    Treatment of tyrosinemia type 1

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Hereditary tyrosinemia type 1 occurs due to a deficiency in fumarylacetoacetase (FAH), the final enzyme in the tyrosine catabolic pathway. Nitisinone inhibits catabolism of tyrosine by preventing the catabolic intermediates. In patients with HT-1, these catabolic intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate, which are responsible for the observed liver and kidney toxicity. Succinylacetone can also inhibit the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate, a neurotoxin responsible for the porphyric crises characteristic of HT-1.

    5.2 MeSH Pharmacological Classification

    Enzyme Inhibitors

    Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    NITISINONE
    5.3.2 FDA UNII
    K5BN214699
    5.3.3 Pharmacological Classes
    Cytochrome P450 2C9 Inhibitors [MoA]; Cytochrome P450 2E1 Inducers [MoA]; Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA]; Organic Anion Transporter 1 Inhibitors [MoA]; Organic Anion Transporter 3 Inhibitors [MoA]; 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC]
    5.4 ATC Code

    A16AX04

    A16AX04

    A16AX04

    A - Alimentary tract and metabolism

    A16 - Other alimentary tract and metabolism products

    A16A - Other alimentary tract and metabolism products

    A16AX - Various alimentary tract and metabolism products

    A16AX04 - Nitisinone

    5.5 Absorption, Distribution and Excretion

    Absorption

    The capsule and liquid formulations are bioequivalent in both the plasma concentration-time curve and maximum plasma concentration (Cmax).

    5.6 Biological Half-Life

    ~54 hours

    5.7 Mechanism of Action

    Nitisinone is a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme upstream of fumarylacetoacetate hydrolyase (FAH) in the tyrosine catabolic pathway. By inhibiting the normal catabolism of tyrosine in patients with hereditary tyrosinemia type 1 (HT-1), nitisinone prevents the accumulation of the catabolic intermediates maleylacetoacetate and fumarylacetoacetate.

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    05

    Zydus Lifesciences Ltd

    Israel
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    CPhI WW Frankfurt
    Booth #6.1A32

    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-12-22

    Pay. Date : 2016-10-11

    DMF Number : 30680

    Submission : 2016-10-19

    Status : Active

    Type : II

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    EU WC

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    01

    Nuray Chemicals Private Limited

    India
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    AES 2024
    Not Confirmed
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    Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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    Nitisinone IH

    Date of Issue : 2024-02-20

    Valid Till : 2026-12-06

    Written Confirmation Number : WC-0416

    Address of the Firm : Plot No. 111 SIDCO Industrial Estate, Kakkalur Thiruvallur-602003 Tamil Nadu, In...

    Nuray Chemicals

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    02

    Saurav Chemicals

    India
    AES 2024
    Not Confirmed
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    Saurav Chemicals

    India
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    AES 2024
    Not Confirmed
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    Nitisinone IH

    Date of Issue : 2021-09-17

    Valid Till : 2022-08-13

    Written Confirmation Number : WC-0171Amendment

    Address of the Firm : (Unit-III), Village-Bhagwanpur, Barwala Road, Derabassi, Dist-Mohali (Punjab)

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    03

    Sionc Pharmaceuticals

    India
    AES 2024
    Not Confirmed
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    Sionc Pharmaceuticals

    India
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    AES 2024
    Not Confirmed
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    Nitisinone IH

    Date of Issue : 2020-07-23

    Valid Till : 2023-05-11

    Written Confirmation Number : WC-0273

    Address of the Firm : Plot No. 34A, J.N.Pharma City, Thanam (V), Parawada (M), Vishakhapatnam-District...

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    NDC API

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    01

    Bachem AG

    Switzerland
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    AES 2024
    Not Confirmed
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    Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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    NITISINONE

    NDC Package Code : 55463-0034

    Start Marketing Date : 2004-08-17

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

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    02

    NURAY CHEMICALS PRIVATE LIMITED

    India
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    AES 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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    NITISINONE

    NDC Package Code : 58159-037

    Start Marketing Date : 2020-02-05

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (35kg/35kg)

    Marketing Category : BULK INGREDIENT

    Nuray Chemicals

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    03

    Amino Chemicals Ltd

    Malta
    AES 2024
    Not Confirmed
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    Amino Chemicals Ltd

    Malta
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    AES 2024
    Not Confirmed
    • fda
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    NITISINONE

    NDC Package Code : 66005-0046

    Start Marketing Date : 2015-09-10

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    04

    Anthem Biosciences Pvt Ltd

    India
    AES 2024
    Not Confirmed
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    Anthem Biosciences Pvt Ltd

    India
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    AES 2024
    Not Confirmed
    • fda
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    • WHO-GMP
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    NITISINONE

    NDC Package Code : 76438-004

    Start Marketing Date : 2019-06-18

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT FOR HUMAN P...

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    05

    Saurav Chemicals Limited

    India
    AES 2024
    Not Confirmed
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    Saurav Chemicals Limited

    India
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    AES 2024
    Not Confirmed
    • fda
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    NITISINONE

    NDC Package Code : 43235-0016

    Start Marketing Date : 2020-03-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    06

    Sionc Pharmaceutical Private Limite...

    India
    AES 2024
    Not Confirmed
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    Sionc Pharmaceutical Private Limite...

    India
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    AES 2024
    Not Confirmed
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    NITISINONE

    NDC Package Code : 76055-0043

    Start Marketing Date : 2019-07-24

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    Suven Pharmaceuticals Limited

    India
    AES 2024
    Not Confirmed
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    Suven Pharmaceuticals Limited

    India
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    AES 2024
    Not Confirmed
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    NITISINONE

    NDC Package Code : 68022-7058

    Start Marketing Date : 2018-12-26

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR HUMAN P...

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    Listed Suppliers

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    01

    Biophore India Pharmaceuticals Pvt ...

    India
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    AES 2024
    Not Confirmed
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    Nitisinone

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

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    02

    Nuray Chemicals Private Limited

    India
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    AES 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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    Nitisinone

    About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

    Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.
    Nuray Chemicals

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    03

    HRV Global Life Sciences

    India
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    CPHI Middle east
    Attending
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    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Nitisinone

    About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

    HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
    HRV Global Life Sciences

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    04

    Omgene Life Sciences Pvt. Ltd

    India
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    AES 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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    Digital Content Digital Content

    Nitisinone

    About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

    Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
    Omgene Company Banner

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    05

    Alven Laboratories

    Czech Republic
    AES 2024
    Not Confirmed
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    Alven Laboratories

    Czech Republic
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    AES 2024
    Not Confirmed
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    Nitisinone

    About the Company : Alven strengths lie in the development of highly complex molecules, technological leadership and efficiency in production. All our R&D work is driven by basic rule – the result o...

    Alven strengths lie in the development of highly complex molecules, technological leadership and efficiency in production. All our R&D work is driven by basic rule – the result of the laboratory work leads to technologically suitable and highly efficient processes for commercial production. Ultimate emphasis on technological efficiency and optimised synthetic processes allow cost leadership combined with environmental sustainability.
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    06

    Danesh Kimia Pharmed

    Iran
    AES 2024
    Not Confirmed
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    Danesh Kimia Pharmed

    Iran
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    AES 2024
    Not Confirmed
    • fda
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    Nitisinone

    About the Company : Danesh Kimia Pharmed Co. was established on 2011 by industrial and university researchers in order to invest on the production of new pharmaceutical molecules and their ready to us...

    Danesh Kimia Pharmed Co. was established on 2011 by industrial and university researchers in order to invest on the production of new pharmaceutical molecules and their ready to use pharmaceutical dosage forms. The company is known as the pioneer generic producer for new entities and ready to use pharmaceutical formulations made by research and production units. It has created a production line for anticancer active ingredients in Baran Chemical and Pharmaceutical Co., molecules in low quantity with high value such as Fingolimod, Nitisinone, Bosentan, etc.
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    07

    Hetero Drugs

    India
    AES 2024
    Not Confirmed
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    Hetero Drugs

    India
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    AES 2024
    Not Confirmed
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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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    Nitisinone

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    08

    Saurav Chemicals

    India
    AES 2024
    Not Confirmed
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    Saurav Chemicals

    India
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    AES 2024
    Not Confirmed
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    Nitisinone

    About the Company : Established in the early 90’s SCL offers a wide range of Active Pharmaceutical Ingredients and Intermediates to its customers worldwide. SCL’s products are exported to Europe, ...

    Established in the early 90’s SCL offers a wide range of Active Pharmaceutical Ingredients and Intermediates to its customers worldwide. SCL’s products are exported to Europe, Japan, Russia, South and Central America, ASEAN, W. Asia, MENA regions. SCL’s manufacturing facilities have been built to comply with EU GMP and U.S. FDA norms, and the API facility has been successfully certified as EU GMP compliant five times by the European Authorities. Latest certification was carried out by German Health Authority.
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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"NITISINONE","year":"2021","qtr":"Q1","strtotime":1609698600,"product":"NITISINONE ((OTHERS) (B.NO.NTN200003 M:0","address":"SCF.287, MOTOR MARKET,MANIMAJRA,","city":"CHANDIGARH.","supplier":"SAURAV CHEMICALS","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"THE MANAGER ..","customerCountry":"ARGENTINA","quantity":"0.03","actualQuantity":"0.03","unit":"KGS","unitRateFc":"120000","totalValueFC":"3377.2","currency":"USD","unitRateINR":8233333.333333334,"date":"04-Jan-2021","totalValueINR":"247000","totalValueInUsd":"3377.2","indian_port":"DELHI AIR","hs_no":"29147990","bill_no":"7658750","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"SCF.287, MOTOR MARKET,MANIMAJRA,, CHANDIGARH.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1658255400,"product":"NITISINONE (IN HOUSE) BATCH.NO.NTN200003","address":"PLOT NO. 370. IND. AREA PHASE 2,PA NCHKULA","city":"PANCHKULA,HARYANA","supplier":"SAURAV CHEMICALS","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"QUIBI S.A. PRODUCTOR Y SERVICIOS FA","customerCountry":"COLOMBIA","quantity":"0.17","actualQuantity":"0.17","unit":"KGS","unitRateFc":"120000","totalValueFC":"19907.8","currency":"USD","unitRateINR":9311764.7058823518,"date":"20-Jul-2022","totalValueINR":"1583000","totalValueInUsd":"19907.8","indian_port":"DELHI AIR","hs_no":"29147990","bill_no":"2934735","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"PLOT NO. 370. IND. AREA PHASE 2,PA NCHKULA, PANCHKULA,HARYANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1673893800,"product":"NITISINONE (IN-HOUSE)(OTHER VEG ALKALOID","address":"PLOT NO. 370. IND. AREA PHASE 2,PA NCHKULA","city":"PANCHKULA,HARYANA","supplier":"SAURAV CHEMICALS","supplierCountry":"INDIA","foreign_port":"LONDON METROPOLITAN","customer":"TO THE ORDER OF","customerCountry":"UNITED KINGDOM","quantity":"0.04","actualQuantity":"0.04","unit":"KGS","unitRateFc":"120000","totalValueFC":"4806.8","currency":"USD","unitRateINR":9825000,"date":"17-Jan-2023","totalValueINR":"393000","totalValueInUsd":"4806.8","indian_port":"DELHI AIR","hs_no":"29147990","bill_no":"7035764","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"PLOT NO. 370. IND. AREA PHASE 2,PA NCHKULA, PANCHKULA,HARYANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683570600,"product":"NITISINONE IN HOUSE OTHR VEG ALKALOIDSNTRL OR RPRDCD BY SYNTHS THR SALTS ESTRSETHERSAND OTHER DRVTVS","address":"PLOT NO. 370. IND. AREA PHASE 2,PA NCHKULA","city":"PANCHKULA,HARYANA","supplier":"SAURAV CHEMICALS","supplierCountry":"INDIA","foreign_port":"LONDON HEATHROW","customer":"TO THE ORDER","customerCountry":"UNITED KINGDOM","quantity":"0.16","actualQuantity":"0.16","unit":"KGS","unitRateFc":"120000","totalValueFC":"18849.3","currency":"USD","unitRateINR":9693750,"date":"09-May-2023","totalValueINR":"1551000","totalValueInUsd":"18849.3","indian_port":"DELHI AIR","hs_no":"29147990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"PLOT NO. 370. IND. AREA PHASE 2,PA NCHKULA, PANCHKULA,HARYANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683657000,"product":"NITISINONE IN HOUSE OTHR VEG ALKALOIDSNTRL OR RPRDCD BY SYNTHS THR SALTS ESTRSETHERSAND OTHER DRVTVS","address":"PLOT NO. 370. IND. AREA PHASE 2,PA NCHKULA","city":"PANCHKULA,HARYANA","supplier":"SAURAV CHEMICALS","supplierCountry":"INDIA","foreign_port":"LONDON HEATHROW","customer":"TO THE ORDER","customerCountry":"UNITED KINGDOM","quantity":"0.16","actualQuantity":"0.16","unit":"KGS","unitRateFc":"120000","totalValueFC":"18849.3","currency":"USD","unitRateINR":9693750,"date":"10-May-2023","totalValueINR":"1551000","totalValueInUsd":"18849.3","indian_port":"DELHI AIR","hs_no":"29147990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"PLOT NO. 370. IND. AREA PHASE 2,PA NCHKULA, PANCHKULA,HARYANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699900200,"product":"NITISINONE (IN-HOUSE). BATCH NO.NTN200005,MFG.DATE.:01.02.2020,RE-TEST DATE.: 31.01.2024,","address":"SCF.287, MOTOR MARKET,","city":"CHANDIGARH.","supplier":"SAURAV CHEMICALS","supplierCountry":"INDIA","foreign_port":"LONDON - HEATHROW","customer":"TO THE ORDER OF","customerCountry":"UNITED KINGDOM","quantity":"0.08","actualQuantity":"0.08","unit":"KGS","unitRateFc":"120000","totalValueFC":"9487.1","currency":"USD","unitRateINR":9875000,"date":"14-Nov-2023","totalValueINR":"790000","totalValueInUsd":"9487.1","indian_port":"Delhi Air","hs_no":"29147990","bill_no":"5348154","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"SCF.287, MOTOR MARKET,, CHANDIGARH.","customerAddress":""}]
    04-Jan-2021
    14-Nov-2023
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    (KGS)    		 Average Price
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    FDF Dossiers

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    01

    Omgene Life Sciences Pvt. Ltd

    India
    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
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    Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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    Regulatory Info :

    Registration Country : India

    Nitisinone

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 2MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Omgene Company Banner

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    02

    Omgene Life Sciences Pvt. Ltd

    India
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    Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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    Registration Country : India

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    Dosage Form : Tablet

    Dosage Strength : 10MG

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    Registration Country : India

    Omgene Company Banner

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    03

    Omgene Life Sciences Pvt. Ltd

    India
    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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    Flag India
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    Regulatory Info :

    Registration Country : India

    Nitisinone

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 5MG

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    Registration Country : India

    Omgene Company Banner

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    04

    Eton Pharmaceuticals

    U.S.A
    Medlab Asia & Asia Health
    Not Confirmed
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    Eton Pharmaceuticals

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2023-05-25

    Application Number : 216201

    Regulatory Info : RX

    Registration Country : USA

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    05

    MEDUNIK CANADA

    Canada
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    MEDUNIK CANADA

    Canada
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    Regulatory Info : RX

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2022-05-26

    Application Number : 212390

    Regulatory Info : RX

    Registration Country : USA

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    06

    Swedish Orphan Biovitrum AB

    Sweden
    Medlab Asia & Asia Health
    Not Confirmed
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    Swedish Orphan Biovitrum AB

    Sweden
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    Regulatory Info :

    Registration Country : Sweden

    nitisinon

    Brand Name : Orfadin

    Dosage Form : ORAL SUSPENSION

    Dosage Strength : 4 MG/ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    07

    Swedish Orphan Biovitrum AB

    Sweden
    Medlab Asia & Asia Health
    Not Confirmed
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    Swedish Orphan Biovitrum AB

    Sweden
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    Regulatory Info :

    Registration Country : Italy

    Nitisinone

    Brand Name : Orfadin

    Dosage Form : Nitisinone 10Mg 60 Units Oral Use

    Dosage Strength : 60 cps 10 mg vial

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    08

    Swedish Orphan Biovitrum AB

    Sweden
    Medlab Asia & Asia Health
    Not Confirmed
    arrow

    Swedish Orphan Biovitrum AB

    Sweden
    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Norway

    Nitisinone

    Brand Name : Orfadin

    Dosage Form : Capsule, hard

    Dosage Strength : 5 mg

    Packaging : Bottle

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

    blank

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    09

    Swedish Orphan Biovitrum AB

    Sweden
    Medlab Asia & Asia Health
    Not Confirmed
    arrow

    Swedish Orphan Biovitrum AB

    Sweden
    arrow
    Medlab Asia & Asia Health
    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 :

    Registration Country : Italy

    Nitisinone

    Brand Name : ORFADIN

    Dosage Form : Hard Capsule For Oral Use

    Dosage Strength : 5 mg

    Packaging : 60 UNITS 5 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    10

    Torrent Pharmaceuticals Limited

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Torrent Pharmaceuticals Limited

    India
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    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : DISCN

    Registration Country : USA

    NITISINONE

    Brand Name : NITISINONE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 2023-01-09

    Application Number : 215908

    Regulatory Info : DISCN

    Registration Country : USA

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