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    Approved Drug Products in Australia

    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.

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    Allsino Pharma excels in R&D & manufacturing of RSMs, GMP intermediates, & APIs; ISO-certified, GMP-compliant, accredited by NMPA.

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    01 8Sanofi-aventis Healthcare Pty Ltd

    02 184sanofi-aventis Australia Pty Ltd

    03 210AbbVie Pty Ltd

    04 321Aspen Pharmacare Australia Pty Limited

    05 83Strides Pharma Science Pty Ltd

    06 143M Pharmaceuticals Australia Pty Ltd

    07 37A.Menarini Australia Pty Limited

    08 2ACCELAGEN PTY LTD

    09 68AFT Pharmaceuticals (AU) Pty Ltd

    10 1AMICUS THERAPEUTICS PTY LTD

    11 6ANTENGENE (AUS) PTY. LTD.

    12 8AUPHARMA PTY LTD

    13 6Abbott Australasia Pty Ltd

    14 85Accord Healthcare Pty. Ltd.

    15 2Actavis Pty Ltd

    16 19Alcon Laboratories (Australia) Pty Ltd

    17 38Alexion Pharmaceuticals Australasia Pty Ltd

    18 1Alphapharm PTY Ltd

    19 1477Alphapharm Pty Ltd

    20 42Amdipharm Mercury (Australia) Pty Limited

    21 85Amgen Australia Pty Limited

    22 1091Apotex Pty Ltd

    23 491Arrotex Pharmaceuticals Pty Ltd

    24 935Arrow Pharma Pty Ltd

    25 1Ascensia Diabetes Care Australia Pty Limited

    26 39Astellas Pharma Australia Pty Ltd

    27 160AstraZeneca Pty Ltd

    28 88Avallon Pharmaceuticals Pty Limited

    29 1B. Braun Australia Pty Ltd

    30 24BAXTER HEALTHCARE PTY LTD

    31 32BSN medical (Aust.) Pty Ltd

    32 2BTC Speciality Health Pty Ltd

    33 9Bausch & Lomb (Australia) Pty Ltd

    34 90Bayer Australia Ltd

    35 6BeiGene AUS Pty Ltd

    36 4Beiersdorf Australia Ltd

    37 13Besins Healthcare Australia Pty Ltd

    38 14BioMarin Pharmaceutical Australia Pty Ltd

    39 30Biogen Australia Pty Ltd

    40 2Biomed Aust Pty Limited

    41 2Blackmores Limited

    42 116Boehringer Ingelheim Pty Ltd

    43 18Boucher & Muir Pty Ltd

    44 11Bridgewest Perth Pharma Pty Ltd

    45 234Bristol-Myers Squibb Australia Pty Ltd

    46 8CNS Pharma Pty Ltd

    47 8Camurus Pty Ltd

    48 1Care Pharmaceuticals Pty Limited

    49 200Celltrion Healthcare Australia Pty Ltd

    50 31Chiesi Australia Pty Ltd

    51 1Church & Dwight (Australia) Pty Ltd

    52 37Cipla Australia Pty Ltd

    53 126Clinect Pty Ltd

    54 1Colgate Oral Care

    55 16Coloplast Pty Ltd

    56 6Contact Lens Centre Australia Limited

    57 21ConvaTec Australia Pty Ltd

    58 15Cortex Health Pty Ltd

    59 2De Fries Industries Pty Ltd

    60 29Dr Falk Pharma Australia Pty Ltd

    61 198Dr Reddy's Laboratories (Australia) Pty Ltd

    62 18EUGIA PHARMA (AUSTRALIA) PTY LTD

    63 9Echo Therapeutics Pty Ltd

    64 22Ego Pharmaceuticals Pty Ltd

    65 34Eisai Australia Pty Ltd

    66 45Eli Lilly Australia Pty Ltd

    67 3Encapsulate Pharma Pty Ltd

    68 35Ferring Pharmaceuticals Pty Limited

    69 3Fresenius Kabi Australia Pty Limited

    70 8Galderma Australia Pty Ltd

    71 13Gedeon Richter Australia Pty Ltd

    72 362Generic Health Pty Ltd

    73 23Gilead Sciences Pty Limited

    74 88GlaxoSmithKline Australia Pty Ltd

    75 2Glenmark Pharmaceuticals (Australia) Pty Ltd

    76 2HALEON AUSTRALIA PTY LTD

    77 4HAMELN PHARMA PTY. LTD.

    78 7Indivior Pty Ltd

    79 21InterPharma Pty Ltd

    80 40Ipsen Pty Ltd

    81 6JAZZ PHARMACEUTICALS ANZ PTY LTD

    82 262Janssen-Cilag Pty Ltd

    83 2Johnson & Johnson Medical Pty Ltd

    84 8Johnson & Johnson Pacific Pty Limited

    85 5Juniper Biologics Pty Ltd

    86 274Juno Pharmaceuticals Pty Ltd

    87 6KCI Medical Australia Pty Ltd

    88 6KYOWA KIRIN AUSTRALIA PTY LTD

    89 4Kendall Australasia Pty Ltd

    90 8Key Pharmaceuticals Pty Ltd

    91 2Lawley Pharmaceuticals Pty Ltd

    92 29Leo Pharma Pty Ltd

    93 61Link Medical Products Pty Ltd

    94 7Lohmann & Rauscher Pty Ltd

    95 29Lundbeck Australia Pty Ltd

    96 3Lupin Ltd

    97 1MAXX PHARMA PTY LTD

    98 20MEDISON PHARMA AUSTRALIA PTY LIMITED

    99 1MS Health Pty Ltd

    100 25Mayne Pharma International Pty Ltd

    101 12Mayne Products Pty Ltd

    102 1Medical Developments International Limited

    103 72Medsurge Healthcare Pty Ltd

    104 4Medtas Pty Ltd

    105 2Mentholatum Australasia Pty Ltd

    106 65Merck Healthcare Pty Ltd

    107 53Merck Sharp & Dohme (Australia) Pty Ltd

    108 58Molnlycke Health Care Pty Ltd

    109 132Mundipharma Pty Limited

    110 1NEON HEALTHCARE PTY LIMITED

    111 3NICE-PAK PRODUCTS PTY. LTD.

    112 5Nestle Australia Ltd

    113 1Norgine Pty. Ltd.

    114 16Nova Pharmaceuticals Australasia Pty Ltd

    115 555Novartis Pharmaceuticals Australia Pty Limited

    116 32Novo Nordisk Pharmaceuticals Pty. Limited

    117 70Nutricia Australia Pty Limited

    118 4Omegapharm Pty Ltd

    119 2Oraderm Pharmaceuticals Pty Ltd

    120 1Oral B Laboratories Pty Ltd

    121 71Organon Pharma Pty Ltd

    122 4Orion Laboratories Pty. Ltd.

    123 29Orion Pharma (Aus) Pty Limited

    124 12Orpharma Pty Ltd

    125 14Otsuka Australia Pharmaceutical Pty. Ltd

    126 5PERRIGO AUSTRALIA PTY LIMITED

    127 2PHERO PHARMA PTY LTD

    128 20Paul Hartmann Pty Ltd

    129 40Petrus Pharmaceuticals Pty Ltd

    130 624Pfizer Australia Pty Ltd

    131 68Pharmaco (Australia) Limited

    132 370Pharmacor Pty Limited

    133 28Phebra Pty Ltd

    134 12Pierre Fabre Australia Pty Ltd

    135 1Pro Pharmaceuticals Group Pty. Ltd.

    136 2Procter & Gamble Pharmaceuticals Australia Pty Ltd

    137 13Reach Pharmaceuticals Pty Ltd

    138 3Reckitt Benckiser (Australia) Pty Limited

    139 15Recordati Rare Diseases Australia Pty. Ltd.

    140 257Roche Products Pty Ltd

    141 1SSL Australia Pty Ltd

    142 12STADA Pharmaceuticals Australia Pty Limited

    143 3SUBSTANCE PTY LTD

    144 1437Sandoz Pty Ltd

    145 8SciGen (Australia) Pty Limited

    146 16Seekwell Pty Ltd

    147 47Seqirus (Australia) Pty Ltd

    148 50Servier Laboratories (Aust.) Pty. Ltd.

    149 10Sigma Company Limited

    150 52Smith & Nephew Pty Limited

    151 5Southern Cross Pharma Pty Ltd

    152 23Southern XP Pty Ltd

    153 4Specialised Therapeutics Australia Pty Ltd

    154 4Specialised Therapeutics Pharma Pty Ltd

    155 1Specialised Therapeutics Pm Pty Ltd

    156 6Stallergenes Australia Pty Ltd

    157 233Sun Pharma ANZ Pty Ltd

    158 10Swedish Orphan Biovitrum Pty Ltd

    159 4Taiho Pharma Oceania Pty Ltd

    160 105Takeda Pharmaceuticals Australia Pty. Ltd.

    161 1Te Arai BioFarma Limited

    162 8Terumo BCT Australia Pty Limited

    163 181Teva Pharma Australia Pty Ltd

    164 1Teva Pharmaceutical Industries

    165 5The Trustee for ORSPEC PHARMA UNIT TRUST

    166 20Theramex Australia Pty Ltd

    167 86UCB Australia Proprietary Limited

    168 1Unilever Australia Limited

    169 2Unomedical Pty Ltd

    170 51Upjohn Australia Pty Ltd

    171 25Urgo Medical Australia Pty Ltd

    172 38Vertex Pharmaceuticals (Australia) Pty. Ltd.

    173 92Viatris Pty Ltd

    174 6Vifor Pharma Pty Limited

    175 18ViiV Healthcare Pty Ltd

    176 50Vitaflo Australia Pty Limited

    177 511WAGNER PHARMACEUTICALS PTY LTD

    178 60iNova Pharmaceuticals (Australia) Pty Limited

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    01

    Alphapharm PTY Ltd

    Australia
    EPS
    Not Confirmed
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    Alphapharm PTY Ltd

    Australia
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    Regulatory Info :

    Registration Country : Australia

    ACAMPROSATE CALCIUM

    Brand Name : Campral

    Dosage Form : Tablet

    Dosage Strength : 333mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    02

    Alphapharm Pty Ltd

    Australia
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    Alphapharm Pty Ltd

    Australia
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    Registration Country : Australia

    Olmesartan + amlodipine + hydrochlorothiazide

    Brand Name : Sevikar HCT 20/5/12.5

    Dosage Form : Tablet

    Dosage Strength : 20MG

    Packaging : 30

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    03

    Lupin Ltd

    India
    EPS
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    Lupin Ltd

    India
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    Registration Country : Australia

    Atorvastatin; Ezetimibe

    Brand Name : Ezetast

    Dosage Form : Tablet

    Dosage Strength : 20MG; 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    04

    Lupin Ltd

    India
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    India
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    Regulatory Info :

    Registration Country : Australia

    Atorvastatin; Ezetimibe

    Brand Name : Ezetast

    Dosage Form : Tablet

    Dosage Strength : 10MG; 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    05

    Lupin Ltd

    India
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    Lupin Ltd

    India
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    Regulatory Info :

    Registration Country : Australia

    Atorvastatin; Ezetimibe

    Brand Name : Ezetast

    Dosage Form : Tablet

    Dosage Strength : 40MG; 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    06

    Pfizer Australia Pty Ltd

    Canada
    EPS
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    Pfizer Australia Pty Ltd

    Canada
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    Regulatory Info :

    Registration Country : Australia

    Sunitinib

    Brand Name : Sutent

    Dosage Form : capsule

    Dosage Strength : 12.5 mg

    Packaging : 28

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    07

    Sandoz Pty Ltd

    Switzerland
    EPS
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    Sandoz Pty Ltd

    Switzerland
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    Regulatory Info :

    Registration Country : Australia

    Sunitinib

    Brand Name : Sunitinib Sandoz

    Dosage Form : capsule

    Dosage Strength : 12.5 mg

    Packaging : 28

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    08

    Teva Pharmaceutical Industries

    Israel
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    Israel
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    Registration Country : Israel

    Lenalidomide Hydrochloride

    Brand Name : Lenalidomide - teva

    Dosage Form : Capsule

    Dosage Strength : 25MG

    Packaging : Blister Pack

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Israel

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    09

    Norgine Pty. Ltd.

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    EPS
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    Regulatory Info :

    Registration Country : Australia

    Rifaximin

    Brand Name : Xifaxan

    Dosage Form :

    Dosage Strength :

    Packaging : 56

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    10

    Novartis Pharmaceuticals Australia Pty L...

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    Regulatory Info :

    Registration Country : Australia

    Dabrafenib

    Brand Name : Tafinlar

    Dosage Form :

    Dosage Strength :

    Packaging : 120

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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