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    Home > Medical News > Medical World News > NMPA Releases Catalogue of Reference Preparations for Generic Drugs (62nd Batch)

    NMPA Releases Catalogue of Reference Preparations for Generic Drugs (62nd Batch)

    • Last Update: 2023-02-03
    • Source: Internet
    • Author: User
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    After the review and determination of the Expert Committee for Quality and Efficacy Consistency Evaluation of Generic Drugs of the State Medical Products Administration, the catalogue of reference preparations for generic drugs (the 62nd batch)
    is hereby released.
    Notice is hereby given
    .
    Annex: Generic Reference Preparations Catalogue (62nd Batch)
    serial number Generic name of the drug English name/trade name specification Licensees Note 1 Note 2
    1.  
    Bosentan dispersible tablets Bosentan Dispersible Tablets/Tracleer 32mg Actelion Pharmaceuticals Ltd Original drugs marketed in China Original research import
    1.  
    Sinimod tablets Siponimod Tablets/Mayzent 0.
    25mg (based on C58H70F6N4O6)
    Novartis Pharma Ag/Novartis Pharma Schweiz AG Original drugs marketed in China Original research import
    1.  
    Sinimod tablets Siponimod Tablets/Mayzent 2mg (based on C58H70F6N4O6) Novartis Pharma Ag/Novartis Pharma Schweiz AG Original drugs marketed in China Original research import
    1.  
    Darolutamide tablets Darolutamide Tablets/Nubeqa 300mg Bayer Healthcare Pharmaceuticals Inc.
    Original drugs marketed in China Original research import
    1.  
    Compound electrolyte injection Multiple Electrolytes Injection 500ml Shanghai Baxter Medical Supplies Co.
    , Ltd
    Drugs produced by foreign original research enterprises in China determined by audit Original research real estate
    1.  
    Dorzolamide timolol maleate eye drops Dorzolamide Hydrochloride Timolol Maleate Eye Drops /Cosopt Contains dorzolamide 20mg/ml (2.
    0%) and timolol 5mg/ml (0.
    5%)
    Thea Pharma Inc Original research products are not imported American Orange Book
    1.  
    Technetium [99mTc] pentinate injection Technetium[99mtc] Pentetate Injection / Draximage Dtpa N/A Jubilant Draximage Inc Dba Jubilant Radiopharma Original drugs have not been imported American Orange Book
    1.  
    Technetium [99mTc]methylenediphosphonate injection Technetium[99mtc] Methylenediphosphonate Injection / Draximage Mdp-25 N/A Jubilant Draximage Inc Dba Jubilant Radiopharma Original drugs have not been imported American Orange Book
    1.  
    Technetium [99mTc] methoxyisonitrile injection Technetium[99mtc] Sestamibi Injection / Cardiolite N/A Lantheus Medical Imaging Inc Original drugs have not been imported American Orange Book
    1.  
    Angiotensin II injection Angiotensin II Injection/Giapreza 2.
    5mg/mL
    La Jolla Pharma Llc Original drugs have not been imported American Orange Book
    1.  
    Sirolimus for injection (albumin-bound type) Sirolimus Protein-Bound Particles For Injectable Suspension (Albumin-Bound)/Fyarro 100mg Aadi Bioscience Inc.
    Original drugs have not been imported American Orange Book
    1.  
    Belinstim for injection Belinostat For Injection/ Beleodaq 500mg/Vial Spectrum Pharmaceuticals,Inc.
    /Acrotech Biopharma Llc
    Original drugs have not been imported American Orange Book
    1.  
    Omeprazole magnesium/amoxicillin/rifabutine enteric-coated capsules Amoxicillin;Omeprazole Magnesium; Rifabutin Enteric Capsules/Talicia Omeprazole magnesium (equivalent to omeprazole 10 mg), amoxicillin 250 mg, rifabutine 12.
    5 mg
    Redhill Biopharma Ltd.
    Original drugs have not been imported American Orange Book
    1.  
    Nitazoxanide dry suspension Nitazoxanide For Oral Suspension/Alinia 100mg/5ml Romark Laboratories Original drugs have not been imported American Orange Book
    1.  
    Compound electrolyte injection Multiple Electrolytes Injection, Type 1/ Plasma-Lyte A Injection PH7.
    4
    500ml、1000ml Baxter Healthcare Corporation Original drugs have not been imported American Orange Book
    1.  
    Veroxazine hydrochloride sustained-release capsules Viloxazine Hydrochloride Extended-Release Capsules / Qelbree 100mg Supernus Pharmaceuticals Original drugs have not been imported American Orange Book
    1.  
    Veroxazine hydrochloride sustained-release capsules Viloxazine Hydrochloride Extended-Release Capsules / Qelbree 150mg Supernus Pharmaceuticals Original drugs have not been imported American Orange Book
    1.  
    Veroxazine hydrochloride sustained-release capsules Viloxazine Hydrochloride Extended-Release Capsules / Qelbree 200mg Supernus Pharmaceuticals Original drugs have not been imported American Orange Book
    1.  
    Alendronate sodium oral solution Alendronate Sodium Tablets  Solution EQ 70MG base /75ML Hikma Pharmaceuticals Usa Inc Internationally recognized homogeneous medicine American Orange Book
    1.  
    Lidocaine ointment Lidocaine Ointment/ Xylocaine 5% Aspen Pharma Trading Limited Original drugs have not been imported Listed in the EU
    1.  
    Benzometronidazole oral suspension Metronidazole Benzoateoral Suspension / Flagyl 125 mg metronidazole / 5 ml (equivalent to 200 mg benzoyl metronidazole / 5 ml) Sanofi-Aventis, S.
    A.
    Original drugs have not been imported Listed in the EU
    1.  
    Miconazole nitrate vaginal cream Miconazole Nitrate Vaginal Cream 2% Janssen/Johnson & Johnson Original drugs have not been imported Listed in the EU
    1.  
    Sodium technetium [99mTc] acid injection Sodium Pertechnetate [99mtc] Injection / ウルトラテクネカウ 0.
    925, 1.
    85, 2.
    78, 3.
    70, 4.
    63, 5.
    55, 7.
    40, 11.
    1, 14.
    8, 18.
    5GBq (99Mo-99mTc generator)
    Fuji フイルムToyama Chemical Co.
    , Ltd.
    / PDRファーマ
    Original drugs have not been imported Available in Japan
    1.  
    Vitamin D oral solution Vitamin D Oral Solution/Uvedose 2ml: 2.
    5mg (100,000)
    Laboratoires Crinex Original drugs have not been imported Available in France
    1.  
    Multiple trace element injection (III) Multi-Trace Elements Injection (III) 10ml Fresenius Kabi Norge AS Original drugs marketed in China Original research import
    1.  
    Etebant acetate injection Icatibant Acetate Injection 3ml: 30mg (based on C59H89N19O13S) Shire Pharmaceuticals Ireland Limited The original research drug on the domestic market Original research import
    1.  
    Rivaroxaban dry suspension Rivaroxaban Granules For Oral Suspension/ Xarelto 51.
    7mg
    Bayer AG Original drugs marketed in China Original research import
    1.  
    Rivaroxaban dry suspension Rivaroxaban Granules For Oral Suspension/ Xarelto 103.
    4mg
    Bayer AG Original drugs marketed in China Original research import
    1.  
    Cyclosporine eye drops (III) Ciclosporin Eye Drops(III)  0.
    3ml:0.
    3mg (0.
    1%)
    Santen Oy Original drugs marketed in China Original research import
    1.  
    Cilostazol tablets Cilostazol Tablets/Peida 50mg Zhejiang Otsuka Pharmaceutical Co.
    , Ltd
    Drugs produced by foreign original research enterprises in China determined by audit Original research real estate
    1.  
    Alanyl glutamine injection Alanyl Glutamine Injection 100ml:20g Fresenius Kabi Warey Pharmaceutical Co.
    , Ltd
    Drugs produced by foreign original research enterprises in China determined by audit Original research real estate
    1.  
    Olopatadine hydrochloride eye drops Olopatadine Hydrochloride Ophthalmic Solution/Pataday 0.
    1%(5ml:5mg)
    Alcon Laboratories Inc Original drugs have not been imported American Orange Book
    1.  
    Low-calcium peritoneal dialysate (lactate) Low Magnesium, Low Calcium Peritoneal Dialysis Solution With 4.
    25% Glucose (2L/bag, 5L/bag)
    Fresenius Medical Care North America Original drugs have not been imported American Orange Book
    1.  
    Low-calcium peritoneal dialysate (lactate) Low Magnesium, Low Calcium Peritoneal Dialysis Solution With 2.
    5% Glucose (2L/bag, 5L/bag)
    Fresenius Medical Care North America Original drugs have not been imported American Orange Book
    1.  
    Low-calcium peritoneal dialysate (lactate) Low Magnesium, Low Calcium Peritoneal Dialysis Solution With 1.
    5% Glucose (2L/bag, 5L/bag)
    Fresenius Medical Care North America Original drugs have not been imported American Orange Book
    1.  
    Tiotropium bromide powder inhaler Tiotropium Bromide Powder For Inhalation/Spiriva 18 ΜG (ACCORDING TO TIOTROPIUM, EQUIVALENT TO 22.
    5 ΜG OF TIOTROPIUM BROMIDE MONOHYDRATE)
    Boehringer Ingelheim International Gmbh Original drugs have not been imported American Orange Book
    1.  
    Methylene blue injection Methylthionine Chloride Injection/ Provayblue 50mg/10ml(5mg/ml) Provepharm SAS Original drugs have not been imported American Orange Book
    1.  
    Paliperidone sustained-release tablets Paliperidone Extend-Release Tablets 9mg Janssen Pharmaceuticals, Inc.
    Original drugs have not been imported American Orange Book
    1.  
    Bemeiprost eye drops Bimatoprost Eye Drops/Lumigan 0.
    01%
    Allergan Inc.
    Original drugs have not been imported American Orange Book
    1.  
    Acetazolamide sustained-release capsules Acetazolamide Extended-Release Capsules 500mg Cadila Healthcare Limited Internationally recognized homogeneous medicine American Orange Book
    1.  
    Budesonide formoterol inhalation powder nebult (I) Budesonide And Formoterol Fumarate Powder For Inhalation (I) / Symbicort Mite Turbuhaler Each vial contains 60 μg of budesonide and 4.
    5 μg of formoterol fumarate
    Astrazeneca AB Original drugs have not been imported Listed in the EU
    1.  
    Budesonide formoterol inhalation powder nebul (II) Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Turbuhaler Each vial contains 60 μg of budesonide and 4.
    5 μg of formoterol fumarate
    Astrazeneca AB Original drugs have not been imported Listed in the EU
    1.  
    Budesonide formoterol inhalation powder nebul (II) Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Turbuhaler Each 120 pipes contain budesonide 160 μg and formoterol fumarate 4.
    5 μg
    Astrazeneca AB Original drugs have not been imported Listed in the EU
    1.  
    Budesonide formoterol inhalation powder nebul (II) Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Forte Turbuhaler Each 60 suction, each inhalation contains budesonide 320 μg and formoterol fumarate 9 μg Astrazeneca AB Original drugs have not been imported Listed in the EU
    1.  
    Cetirizine hydrochloride drops Cetirizine Dihydrochloride Oral Drops 10mg/ml(20ml) UCB Pharma Original drugs have not been imported Listed in the EU
    1.  
    Clarithromycin sustained-release tablets Clarithromycin Modified-Release Tablets / Klacid SR)/ Klacid RM/ KLACID UNIDÍA/ Klacid SR/ Klacid Uno/ Klacid LA/ Klacid SR/ Biclar Uno/ Klacid XL 500mg Mylan Healthcare B.
    V.
    / Mylan Italia  S.
    R.
    L.
    / Mylan IRE Healthcare Limited/ MYLAN HEALTHCARE Gmbh/ Mylan Healthcare Sp.
    Z O.
    O.
    / Mylan IRE Healthcare Limited/ Mylan EPD Bvba/Sprl/ Mylan IRE Healthcare Limited
    Original drugs have not been imported Listed in the EU
    1.  
    Miconazole nitrate cream Miconazole Nitrate Cream 2% Janssen/Johnson & Johnson Original drugs have not been imported Listed in the EU
    1.  
    Sildenafil citrate injection Sildenafil Citrate Injection/Revatio 12.
    5ml: 10mg (in terms of sildenafil)
    Upjohn EESV Original drugs have not been imported Listed in the EU
    1.  
    Landiolol hydrochloride for injection Landiolol Hydrochloride For Injection/onoact 12.
    5 mg (in terms of landiolol hydrochloride)
    Ono Sasa Industrial Co.
    , Ltd
    Original drugs have not been imported Available in Japan
    1.  
    Landiolol hydrochloride for injection Landiolol Hydrochloride For Injection/onoact 150 mg (in terms of landiolol hydrochloride) Ono Sasa Industrial Co.
    , Ltd
    Original drugs have not been imported Available in Japan
    1.  
    Mitiglinide calcium tablets Mitiglinide Calcium Tablets/Glufast 5mg Kissei Pharmaceutical Co.
    , Ltd.
    /キッセイ Co.
    , Ltd
    Original drugs have not been imported Available in Japan
    1.  
    Polyethylene glycol sodium potassium powder/compound polyethylene glycol (3350) electrolyte dispersion MOVICOL Chocolate 13.
    9g Sachet, Powder For Oral Solution/ MOVICOL
    13.
    9g
    Norgine Limited Original drugs have not been imported Available in the UK
    1.  
    Acetylcysteine injection Acetylcysteine Injection/Flumil /Fluimucil 3ml:300mg Zambon S.
    A.
    U /Zambon Gmbh
    Original drugs have not been imported Listed in the EU
    1.  
    Aspartate pasireotide injection Pasireotide Diaspeartate Injection 1ml:0.
    6mg
    Recordati AG Original drugs have not been imported Available in Switzerland
    1.  
    Ursodeoxycholic acid tablets Ursodeoxycholic Acid Tablets/ Delursan 0.
    25g
    TEVA B.
    V.
    Original drugs have not been imported Available in France
    4-16 Ibuprofen softgels Ibuprofen Soft Capsules/Advil 0.
    2g
    Pfizer Inc/ Glaxosmithkline Consumer Healthcare Holdings Us Llc American Orange Book Increase licensee Glaxosmithkline Consumer Healthcare Holdings Us Llc
    7-64 Lithium carbonate sheets Lithium Carbonate Tablets/TERALITHE 0.
    25g
    SANOFI-AVENTIS France Original drugs have not been imported There is no restriction on the country of listing and the place of origin
    8-71 Pentoxifylline sustained-release tablets Pentoxifylline  Modified Release Tablets/Trental 400mg Aventis Pharma Limited/Sanofi/Sanofi-Produtos Farmaceuticos Lda Listed in the EU Increase licensee Sanofi-Produtos Farmaceuticos LDA
    23-349 Doxorubicin hydrochloride liposomal injection Doxorubicin Hydrochloride Liposome Injection/Caelyx /Caelyx Pegylated Liposomal 10ml:20mg Janssen-Cilag International NV /Baxter Holding B.
    V.
    Original drugs have not been imported Add licensee Baxter Holding B.
    V.
    ; add trade name Caelyx Pegylated Liposomal
    23-350 Doxorubicin hydrochloride liposomal injection Doxorubicin Hydrochloride Liposome Injection/Caelyx /Caelyx Pegylated Liposomal 25ml:50mg Janssen-Cilag International NV /Baxter Holding B.
    V.
    Original drugs have not been imported Add licensee Baxter Holding B.
    V.
    ; add trade name Caelyx Pegylated Liposomal
    53-71 Trizidone capsules Terizidon Capsules 250mg Riemser Pharma Gmbh/Esteve Pharmaceuticals Gmbh Internationally recognized homogeneous medicine The licensee was changed and the changed licensee, Esteve Pharmaceuticals Gmbh, was added
    56-62 Adapalene peroxybenzoyl gel Adapalene And Benzoyl Peroxide Gel/Epiduo 0.
    1%; 2.
    5% (Packing: 5g, 15g, 30g, 45g, 60g, 90g/tube and 15g, 30g, 45g, 60g/pump)
    Galderma Nordic AB/ Galderma International S.
    A.
    S/ Galderma International/ Galderma Benelux B.
    V.
    / Galderma Laboratorium Gmbh/ Laboratorios Galderma S.
    A.
    / Galderma Italia S.
    P.
    A.
    / Galderma ( UK) Limited
    Original drugs have not been imported Increase of licensee Galderma International S.
    A.
    S/ Galderma International/ Galderma Benelux B.
    V.
    / Galderma Laboratorium Gmbh/ Laboratorios Galderma S.
    A.
    / Galderma Italia S.
    P.
    A.
    / Galderma (UK) Limited
    8-218 Tadalafil tablets Tadalafil Tablets/Cialis 5mg Eli Lilly Nederland B.
    V.
    /A.
    Menarini GmbH
    Original research import Change of licensee, add the change of licensee A.
    Menarini GmbH
    16-4 Tadalafil tablets Tadalafil Tablets/CIALIS 20mg Eli Lilly Nederland B.
    V.
    /A.
    Menarini GmbH
    Original research import Change of licensee, add the change of licensee A.
    Menarini GmbH
    16-5 Tadalafil tablets Tadalafil Tablets/CIALIS 10mg Eli Lilly Nederland B.
    V.
    /A.
    Menarini GmbH
    Original research import Change of licensee, add the change of licensee A.
    Menarini GmbH
    16-6 Tadalafil tablets Tadalafil Tablets/CIALIS 2.
    5mg
    Eli Lilly Nederland B.
    V.
    /A.
    Menarini GmbH
    Original research import Change of licensee, add the change of licensee A.
    Menarini GmbH
    22-228 Mephalan hydrochloride for injection Melphalan Hydrochloride for Injection/EVOMELA 50mg Spectrum Pharmaceuticals, Inc.
    / Acrotech Biopharma,LLC      
    Original drugs marketed in China Change of licensee, addition of post-change licensee Acrotech Biopharma, LLC
    23-67  Imidzolastine sustained-release tablets Mizolastine Sustained Release Tablets / Mizollen 10mg Therabel Pharmaceuticals Limited/ Therabel Healthcare Limited Original drugs marketed in China Change of licensee, add the changed licensee Therabel Healthcare Limited
    24-62  Nttacapone tablets Entacapone Tablets/Comtan 0.
    2g
    Orion Pharma AG/Orion Corporation Original drugs marketed in China Change of licensee, addition of changed licensee Orion Corporation
    27-426  Amlodipine Benazepril capsules Amlodipine and Benazepril Hydrochloride Capsules/Lotrel Amlodipine 5 mg; Benazepril hydrochloride 10 mg Novartis Pharmaceuticals Corp Original drugs have not been imported The English name was updated to Amlodipine and Benazepril Hydrochloride Capsules
    remark 1.
    The generic names, dosage forms, etc.
    of the varieties listed in the catalogue that have not yet been marketed in China shall be subject to the approval of the Pharmacopoeia Commission
    .
    2.
    After the publication of the reference preparation catalog, the varieties that have not been officially released will be subject to special research and released
    separately according to the research results.
    3.
    Reference preparations listed in the EU include the same drug
    listed in the UK.
    4.
    In addition to meeting their quality requirements, the selection of unimported reference preparations for generic drug research must also meet the requirements of the current version of the Chinese Pharmacopoeia and relevant guidelines
    .
    5.
    Radiopharmaceuticals are different from ordinary chemical drugs, with certain particularities such as radioactivity, timeliness, according to the characteristics of radioactive activity administration, etc.
    , reference preparations are mainly used to clarify their research and development goals and basic requirements, and can be studied
    according to their drug characteristics while combining the availability of reference preparations.
    State Food and Drug Administration December 19, 2022
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