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    Biophore, its subsidiary Zenara, receive first approval for Cannabidiol in India

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    09 Sep 2022

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    01 1Abemaciclib

    02 1Acitretin

    03 1Acoramidis Hydrochloride

    04 1Acrivastine

    05 1Adagrasib

    06 1Agomelatine

    07 1Alosetron Hydrochloride

    08 1Aminocaproic Acid

    09 1Amorolfine Hydrochloride

    10 1Apomorphine Hydrochloride

    11 2Asciminib

    12 1Ataluren

    13 1Avapritinib

    14 1Avatrombopag Maleate

    15 1Belinostat

    16 1Bempedoic Acid

    17 1Bendamustine Hydrochloride

    18 1Benserazide Hydrochloride

    19 1Bilastine

    20 1Bortezomib

    21 1Brexpiprazole

    22 1Calcium Gluconate

    23 1Calcobutrol

    24 2Cannabidiol

    25 1Capivasertib

    26 1Carfilzomib

    27 2Cariprazine Hydrochloride

    28 1Cenobamate

    29 1Cetrorelix Acetate

    30 1Chlorambucil

    31 1Chlorpromazine Hydrochloride

    32 1Chlorzoxazone

    33 2Cladribine

    34 1Clofarabine

    35 1Clomipramine Hydrochloride

    36 1Copper Sulfate

    37 1Copper Sulphate Pentahydrate

    38 1Crisaborole

    39 1Cyclen

    40 1Cysteamine Bitartrate

    41 1DOTA

    42 1Dantrolene Sodium

    43 1Darolutamide

    44 1Decitabine

    45 1Delgocitinib

    46 1Diatrizoate Meglumine

    47 1Diatrizoate Sodium

    48 1Diazoxide

    49 2Dichlorphenamide

    50 1Dimethyl Fumarate

    51 1Disodium Hydrogen Phosphate

    52 1Docosanol

    53 1Dofetilide

    54 1Edaravone

    55 1Edoxaban Tosylate

    56 1Elacestrant

    57 1Elafibranor

    58 1Elagolix Sodium

    59 2Eliglustat

    60 1Eltrombopag

    61 1Ertugliflozin

    62 1Erythromycin Lactobionate

    63 1Ethacrynate Sodium

    64 2Ethacrynic Acid

    65 1Ethiodized Oil

    66 2Favipiravir

    67 1Fenfluramine Hydrochloride

    68 2Fenoprofen Calcium

    69 1Ferric Citrate

    70 1Fezolinetant

    71 1Fluorescein

    72 1Fluorescein Sodium

    73 1Fluphenazine

    74 1Fosaprepitant

    75 1Frovatriptan Succinate Hydrate

    76 1Fruquintinib

    77 1Gadobenic Acid

    78 1Gadobutrol

    79 1Gadolinium Dtpa

    80 1Gadolinium Ethoxybenzyl Dtpa

    81 1Gadoterate Meglumine

    82 2Gadoteridol

    83 1Icatibant Acetate

    84 1Indapamide

    85 1Indigo Carmine

    86 1Indocyanine Green

    87 1Iodixanol

    88 1Iohexol

    89 1Iopamidol

    90 3Iron Sucrose

    91 1Isavuconazonium Sulfate

    92 1Isoproterenol Hydrochloride

    93 1Isosulfan Blue

    94 1Isotretinoin

    95 1L-Glutamine

    96 1Lanreotide Acetate

    97 1Lazertinib

    98 1Lercanidipine Hydrochloride

    99 1Letermovir

    100 1Liothyronine Sodium

    101 1Lorlatinib

    102 1Lotilaner

    103 1Manganese Sulfate

    104 1Maralixibat Chloride

    105 1Mavacamten

    106 1Melatonin

    107 1Melphalan

    108 1Melphalan Hydrochloride

    109 1Methazolamide

    110 1Methylene Blue

    111 1Methyltyrosine

    112 1Metolazone

    113 2Mexiletine

    114 1Mitapivat

    115 2Molnupiravir

    116 1Momelotinib Hydrochloride

    117 1Monosodium Phosphate

    118 1Nadolol

    119 2Naphazoline Hydrochloride

    120 1Naphazoline Nitrate

    121 1Nelarabine

    122 1Nilutamide

    123 1Nimodipine

    124 1Niraparib Tosylate

    125 1Nirmatrelvir

    126 1Nitazoxanide

    127 1Nitisinone

    128 1Obeticholic Acid

    129 1Olaparib

    130 1Osilodrostat Phosphate

    131 1Palbociclib

    132 1Penicillamine

    133 1Pentetic Acid

    134 1Permethrin

    135 1Pimavanserin Tartrate

    136 1Pitolisant Hydrochloride

    137 1Plerixafor

    138 1Potassium Dihydrogen Phosphate

    139 2Potassium Phosphate

    140 1Primidone

    141 1Procainamide Hydrochloride

    142 1Prochlorperazine

    143 1Prochlorperazine Edisylate

    144 1Prochlorperazine Maleate

    145 1Prucalopride Succinate

    146 2Ramelteon

    147 1Regadenoson Monohydrate

    148 1Resmetirom

    149 1Ribociclib

    150 1Riociguat

    151 1Risdiplam

    152 1Ritlecitinib

    153 1Rucaparib Camsylate

    154 1Rupatadine Fumarate

    155 1Ruxolitinib Phosphate

    156 2Safinamide Methanesulfonate

    157 2Sapropterin Hydrochloride

    158 1Seladelpar Lysine

    159 1Selenious Acid

    160 1Selexipag

    161 1Selumetinib

    162 1Sepiapterin

    163 1Sildenafil Citrate

    164 1Sincalide

    165 1Sodium Nitroprusside

    166 1Sodium Thiosulfate

    167 1Sparsentan

    168 1Sugammadex Sodium

    169 1Sulfobutylether-β-Cydodextrin (SBECD)

    170 2Suvorexant

    171 1Suzetrigine

    172 1Tafamidis

    173 1Tafamidis Meglumine

    174 1Taurolidine

    175 1Tavaborole

    176 1Tegaserod

    177 1Temozolomide

    178 1Terazosin HCl

    179 1Thiamine Hydrochloride

    180 1Thyroxine

    181 1Tiopronin

    182 1Tipiracil Hydrochloride

    183 2Tolvaptan

    184 1Tretinoin

    185 1Trientine Hydrochloride

    186 1Trientine Tetrahydrochloride

    187 1Trifluridine

    188 1Trofinetide

    189 2Urapidil Hydrochloride

    190 1Valsartan

    191 1Vigabatrin

    192 1Viloxazine Hydrochloride

    193 1Vismodegib

    194 2Vitamin K1

    195 1Xanomeline

    196 1Zileuton

    197 1Zinc Sulfate Heptahydrate

    198 1Zinc Sulphate

    199 1Zofenopril Calcium

    200 1Blank

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    01

    Mexiletine

    India

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    CPhI North America
    Booth #1015
    • fda
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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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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-09-01

    Pay. Date : 2020-08-06

    DMF Number : 34668

    Submission : 2020-03-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-384 - Rev 00

    Issue Date : 2022-05-17

    Type : Chemical

    Substance Number : 1029

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 73435-007

    Start Marketing Date : 2020-02-10

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Biophore

    02

    Naphazoline Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI North America
    Booth #1015
    • fda
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    • WHO-GMP
    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35833

    Submission : 2021-04-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-117 - Rev 00

    Issue Date : 2023-11-27

    Type : Chemical

    Substance Number : 730

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm :

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    NDC Package Code : 73435-014

    Start Marketing Date : 2021-11-18

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    Biophore

    03

    Cannabidiol

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI North America
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-03-14

    Pay. Date : 2022-02-22

    DMF Number : 35992

    Submission : 2021-06-03

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 73435-015

    Start Marketing Date : 2021-10-05

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Biophore

    04

    Chlorambucil

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI North America
    Booth #1015
    • fda
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-12-01

    Pay. Date : 2015-09-09

    DMF Number : 28956

    Submission : 2015-05-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-136 - Rev 01

    Issue Date : 2024-02-22

    Type : Chemical

    Substance Number : 137

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    Biophore

    05

    Chlorpromazine Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI North America
    Booth #1015
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-07-05

    Pay. Date : 2017-06-19

    DMF Number : 31479

    Submission : 2017-06-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-266 - Rev 00

    Issue Date : 2023-03-08

    Type : Chemical

    Substance Number : 475

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 73435-001

    Start Marketing Date : 2019-11-05

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Biophore

    06

    Cladribine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI North America
    Booth #1015
    • fda
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    • WHO-GMP
    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-11-09

    Pay. Date : 2021-09-28

    DMF Number : 36221

    Submission : 2021-08-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-078 - Rev 00

    Issue Date : 2024-06-03

    Type : Chemical

    Substance Number : 2174

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    Biophore

    07

    Clomipramine Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI North America
    Booth #1015
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-10-21

    Pay. Date : 2016-08-22

    DMF Number : 30814

    Submission : 2016-08-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-288 - Rev 02

    Issue Date : 2025-11-24

    Type : Chemical

    Substance Number : 889

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    Biophore

    08

    Diazoxide

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI North America
    Booth #1015
    • fda
    • EDQM
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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-01-19

    Pay. Date : 2017-12-21

    DMF Number : 32335

    Submission : 2017-12-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-298 - Rev 02

    Issue Date : 2023-05-15

    Type : Chemical

    Substance Number : 550

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    Biophore

    09

    Dichlorphenamide

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI North America
    Booth #1015
    • fda
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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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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-11-01

    Pay. Date : 2020-09-24

    DMF Number : 35203

    Submission : 2020-09-12

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-02-26

    Written Confirmation Number : WC-0511

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 73435-011

    Start Marketing Date : 2020-12-23

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (15kg/15kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Biophore

    10

    Ethacrynic Acid

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI North America
    Booth #1015
    • fda
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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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    Virtual Booth Virtual Booth
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-12-17

    Pay. Date : 2015-09-08

    DMF Number : 29429

    Submission : 2015-06-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-288 - Rev 01

    Issue Date : 2025-02-19

    Type : Chemical

    Substance Number : 457

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    Biophore
    Contact Biophore India Pharmaceuticals Pvt Ltd and get a quotation

    Biophore India Pharmaceuticals Pvt Ltd is a supplier offers 214 products (APIs, Excipients or Intermediates).

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