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    Also known as: Pharmorubicin, 56390-09-1, Ellence, Epirubicin hcl, Farmorubicin, Farmorubicina
    Molecular Formula
    C27H30ClNO11
    Molecular Weight
    580.0  g/mol
    InChI Key
    MWWSFMDVAYGXBV-FGBSZODSSA-N
    FDA UNII
    22966TX7J5
    Epirubicin Hydrochloride
    An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA.
    1 2D Structure

    Epirubicin Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (7S,9S)-7-[(2R,4S,5R,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione;hydrochloride
    2.1.2 InChI
    InChI=1S/C27H29NO11.ClH/c1-10-22(31)13(28)6-17(38-10)39-15-8-27(36,16(30)9-29)7-12-19(15)26(35)21-20(24(12)33)23(32)11-4-3-5-14(37-2)18(11)25(21)34;/h3-5,10,13,15,17,22,29,31,33,35-36H,6-9,28H2,1-2H3;1H/t10-,13-,15-,17-,22-,27-;/m0./s1
    2.1.3 InChI Key
    MWWSFMDVAYGXBV-FGBSZODSSA-N
    2.1.4 Canonical SMILES
    CC1C(C(CC(O1)OC2CC(CC3=C2C(=C4C(=C3O)C(=O)C5=C(C4=O)C(=CC=C5)OC)O)(C(=O)CO)O)N)O.Cl
    2.1.5 Isomeric SMILES
    C[C@H]1[C@@H]([C@H](C[C@@H](O1)O[C@H]2C[C@@](CC3=C2C(=C4C(=C3O)C(=O)C5=C(C4=O)C(=CC=C5)OC)O)(C(=O)CO)O)N)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    22966TX7J5
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4' Epi Adriamycin

    2. 4' Epi Doxorubicin

    3. 4' Epi Dxr

    4. 4' Epiadriamycin

    5. 4' Epidoxorubicin

    6. 4'-epi-adriamycin

    7. 4'-epi-doxorubicin

    8. 4'-epi-dxr

    9. 4'-epiadriamycin

    10. 4'-epidoxorubicin

    11. Ellence

    12. Epi Cell

    13. Epi-cell

    14. Epicell

    15. Epilem

    16. Epirubicin

    17. Farmorubicin

    18. Farmorubicina

    19. Farmorubicine

    20. Hydrochloride, Epirubicin

    21. Imi 28

    22. Imi-28

    23. Imi28

    24. Nsc 256942

    25. Nsc-256942

    26. Nsc256942

    27. Pharmorubicin

    2.3.2 Depositor-Supplied Synonyms

    1. Pharmorubicin

    2. 56390-09-1

    3. Ellence

    4. Epirubicin Hcl

    5. Farmorubicin

    6. Farmorubicina

    7. Imi-28

    8. 4'-epidoxorubicin Hydrochloride

    9. Epirubicin Ebewe

    10. Epirubicin (hydrochloride)

    11. Nsc-759195

    12. Mls001401404

    13. Nsc 256942

    14. Pidorubicin

    15. Wp-697

    16. 22966tx7j5

    17. 4'-epi-adriamycin Hydrochloride

    18. Smr000466308

    19. 56390-09-1 (hcl)

    20. (8s,10s)-10-(((2r,4s,5r,6s)-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione Hydrochloride

    21. Epirubitec

    22. 4'-epi-adriamycin

    23. Epidoxorubicin Hydrochloride

    24. (7s,9s)-7-[(2r,4s,5r,6s)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7h-tetracene-5,12-dione;hydrochloride

    25. Ccris 4477

    26. Einecs 260-145-2

    27. Unii-22966tx7j5

    28. Ellence (tn)

    29. 4'-epi-doxorubicin

    30. Epirubicin Hydrochlorid

    31. 4'-epidoxorubicin Hcl

    32. Cpd000466308

    33. Epirubicin Hydrochloride [usan:usp:jan]

    34. E-adm

    35. 4'-epi-dx

    36. Schembl3165

    37. (1s,3s)-3-glycoloyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-alpha-l-arabino-hexopyranoside Hydrochloride

    38. Mls000759412

    39. 4-epidoxorubicin Hydrochloride

    40. Epirubicin Hcl [vandf]

    41. Chembl1200981

    42. Dtxsid50860297

    43. Pharmakon1600-01505708

    44. Amy10308

    45. Ex-a2654

    46. Epirubicin Hcl (4'-epidoxorubicin)

    47. Epirubicin Hydrochloride [mi]

    48. Hy-13624a

    49. Mfcd00941448

    50. Nsc759195

    51. S1223

    52. Epirubicin Hydrochloride (jp17/usp)

    53. Epirubicin Hydrochloride [jan]

    54. Bcp9000651

    55. Ccg-100950

    56. Cs-1773

    57. Epirubicin Hydrochloride [usan]

    58. Nc00200

    59. Epirubicin Hydrochloride [mart.]

    60. Epirubicin Hydrochloride [usp-rs]

    61. Epirubicin Hydrochloride [who-dd]

    62. (8s-cis)-10-((3-amino-2,3,6-trideoxy-alpha-l-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxynaphthacene-5,12-dione Hydrochloride

    63. 5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-l-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, Hydrochloride, (8s-cis)-

    64. 5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-l-arabinohexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, Hydrochloride, (8s,10s)-

    65. As-75323

    66. Epirubicin Hydrochloride, >=90% (hplc)

    67. E0840

    68. Epirubicin Hydrochloride [orange Book]

    69. D02214

    70. D83113

    71. Epirubicin Hydrochloride [ep Monograph]

    72. Epirubicin Hydrochloride [usp Monograph]

    73. Sr-01000763557

    74. Q-101406

    75. Sr-01000763557-3

    76. Q27253634

    77. Epirubicin Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    78. Epirubicin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    79. Epirubicin Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    80. (1s,3s)-3-glycoloyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-.alpha.-l-arabino-hexopyranoside Hydrochloride

    81. (8s,10s)-10-(((2r,4s,5r,6s)-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dionehydrochloride

    82. (8s,10s)-10-((2r,4s,5r,6s)-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yloxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione Hydrochloride

    83. (8s,10s)-10-{[(2r,4s,5r,6s)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy}-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-5,7,8,9,10,12-hexahydrotetracene-5,12-dione Hydrochloride

    84. 5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-.alpha.-l-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, Hydrochloride, (8s-cis)-

    85. 5,12-naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-l-arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-, Hydrochloride (1:1), (8s,10s)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 580.0 g/mol
    Molecular Formula C27H30ClNO11
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count12
    Rotatable Bond Count5
    Exact Mass579.1507385 g/mol
    Monoisotopic Mass579.1507385 g/mol
    Topological Polar Surface Area206 Ų
    Heavy Atom Count40
    Formal Charge0
    Complexity977
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameEllence
    Drug LabelELLENCE Injection (epirubicin hydrochloride injection) is an anthracycline cytotoxic agent, intended for intravenous administration. ELLENCE is supplied as a sterile, clear, red solution and is available in polypropylene vials containing 50 and 200 m...
    Active IngredientEpirubicin hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength200mg/100ml (2mg/ml); 50mg/25ml (2mg/ml)
    Market StatusPrescription
    CompanyPfizer

    2 of 4  
    Drug NameEpirubicin hydrochloride
    Drug LabelEpirubicin hydrochloride injection is an anthracycline cytotoxic agent, intended for intravenous administration. Epirubicin hydrochloride injection is supplied as a sterile, clear, red solution and is available invials containing 50 mg and 200 mg o...
    Active IngredientEpirubicin hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength200mg/100ml (2mg/ml); 50mg/25ml (2mg/ml); 150mg/75ml (2mg/ml); 10mg/5ml (2mg/ml)
    Market StatusPrescription
    CompanyActavis Elizabeth; Fresenius Kabi Usa; Hospira; Fresenius Kabi Oncol; Ebewe Pharma; Onco Therapies; Teva Pharms Usa; Eurohlth Intl; Cipla; Hisun Pharm Hangzhou; Akorn

    3 of 4  
    Drug NameEllence
    Drug LabelELLENCE Injection (epirubicin hydrochloride injection) is an anthracycline cytotoxic agent, intended for intravenous administration. ELLENCE is supplied as a sterile, clear, red solution and is available in polypropylene vials containing 50 and 200 m...
    Active IngredientEpirubicin hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength200mg/100ml (2mg/ml); 50mg/25ml (2mg/ml)
    Market StatusPrescription
    CompanyPfizer

    4 of 4  
    Drug NameEpirubicin hydrochloride
    Drug LabelEpirubicin hydrochloride injection is an anthracycline cytotoxic agent, intended for intravenous administration. Epirubicin hydrochloride injection is supplied as a sterile, clear, red solution and is available invials containing 50 mg and 200 mg o...
    Active IngredientEpirubicin hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength200mg/100ml (2mg/ml); 50mg/25ml (2mg/ml); 150mg/75ml (2mg/ml); 10mg/5ml (2mg/ml)
    Market StatusPrescription
    CompanyActavis Elizabeth; Fresenius Kabi Usa; Hospira; Fresenius Kabi Oncol; Ebewe Pharma; Onco Therapies; Teva Pharms Usa; Eurohlth Intl; Cipla; Hisun Pharm Hangzhou; Akorn

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antibiotics, Antineoplastic

    Chemical substances, produced by microorganisms, inhibiting or preventing the proliferation of neoplasms. (See all compounds classified as Antibiotics, Antineoplastic.)

    Topoisomerase II Inhibitors

    Compounds that inhibit the activity of DNA TOPOISOMERASE II. Included in this category are a variety of ANTINEOPLASTIC AGENTS which target the eukaryotic form of topoisomerase II and ANTIBACTERIAL AGENTS which target the prokaryotic form of topoisomerase II. (See all compounds classified as Topoisomerase II Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Anthracyclines [CS]; Topoisomerase Inhibitors [MoA]; Anthracycline Topoisomerase Inhibitor [EPC]

    API Reference Price

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(EPIRUBICIN HYDROCHLORIDE PRECIP. PH. EUR)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"TEVA API","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"59","unit":"GMS","unitRateFc":"115","totalValueFC":"6864.8","currency":"USD","unitRateINR":"9654.3","date":"06-Feb-2024","totalValueINR":"569600.75","totalValueInUsd":"6864.8","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"2002997","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"Piet Hein Building, Piet Heinkade 107 1019 GM Amsterdam The Netherlands Amsterdam, , Netherlands Tel.:31- Netherlands","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707157800,"product":"EPIRUBICIN HYDROCHLORIDE EP\/BP\/IP\/USP\/PH.EUR. (EPIRUBICIN HYDROCHLORIDE PRECIP. PH. EUR)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"TEVA API","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.09","actualQuantity":"90","unit":"GMS","unitRateFc":"115","totalValueFC":"10471.8","currency":"USD","unitRateINR":"9654.3","date":"06-Feb-2024","totalValueINR":"868882.5","totalValueInUsd":"10471.8","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"2002997","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"Piet Hein Building, Piet Heinkade 107 1019 GM Amsterdam The Netherlands Amsterdam, , Netherlands Tel.:31- Netherlands","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707676200,"product":"EPIRUBICIN HYDROCHLORIDE EP","address":"304,TOWN CENTRE,","city":"MUMBAI \/ MAHARASHTRA","supplier":"APC PHARMACEUTICALS & CHEMICALS LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.005","unit":"KGS","unitRateFc":"200000","totalValueFC":"1011.8","currency":"USD","unitRateINR":"16790000","date":"12-Feb-2024","totalValueINR":"83950","totalValueInUsd":"1011.8","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"2100248","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"UNIT 1003, BANK OF EAST ASIA HARBOUR VIEW CENTRE, NO. 56, GLOUCESTER ROAD, WAN CHAI, HONG KONG","customerAddress":"304,TOWN CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714674600,"product":"EPIRUBICIN HYDROCHLORIDE PH. 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    02-Jan-2021
    28-Oct-2024
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    DOSAGE - INJECTABLE;INJECTION - 200MG/100ML (...DOSAGE - INJECTABLE;INJECTION - 200MG/100ML (2MG/ML)

    USFDA APPLICATION NUMBER - 50778

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    DOSAGE - INJECTABLE;INJECTION - 50MG/25ML (2M...DOSAGE - INJECTABLE;INJECTION - 50MG/25ML (2MG/ML)

    USFDA APPLICATION NUMBER - 50778

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    ABOUT THIS PAGE

    Epirubicin Hydrochloride Manufacturers

    A Epirubicin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epirubicin Hydrochloride, including repackagers and relabelers. The FDA regulates Epirubicin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epirubicin Hydrochloride 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 Epirubicin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Epirubicin Hydrochloride Suppliers

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

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

    Epirubicin Hydrochloride USDMF

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

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

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

    Epirubicin Hydrochloride JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Epirubicin Hydrochloride Drug Master File in Japan (Epirubicin Hydrochloride JDMF) empowers Epirubicin Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Epirubicin Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Epirubicin Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Epirubicin Hydrochloride suppliers with JDMF on PharmaCompass.

    Epirubicin Hydrochloride KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Epirubicin Hydrochloride Drug Master File in Korea (Epirubicin Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Epirubicin Hydrochloride. The MFDS reviews the Epirubicin Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Epirubicin Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Epirubicin Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Epirubicin Hydrochloride API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Epirubicin Hydrochloride suppliers with KDMF on PharmaCompass.

    Epirubicin Hydrochloride CEP

    A Epirubicin Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Epirubicin Hydrochloride Certificate of Suitability (COS). The purpose of a Epirubicin Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Epirubicin Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Epirubicin Hydrochloride to their clients by showing that a Epirubicin Hydrochloride CEP has been issued for it. The manufacturer submits a Epirubicin Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Epirubicin Hydrochloride CEP holder for the record. Additionally, the data presented in the Epirubicin Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Epirubicin Hydrochloride DMF.

    A Epirubicin Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Epirubicin Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Epirubicin Hydrochloride suppliers with CEP (COS) on PharmaCompass.

    Epirubicin Hydrochloride WC

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

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

    Epirubicin Hydrochloride 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 Epirubicin Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Epirubicin Hydrochloride 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 Epirubicin Hydrochloride 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 Epirubicin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Epirubicin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

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

    Epirubicin Hydrochloride GMP

    Epirubicin Hydrochloride 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 Epirubicin Hydrochloride 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 Epirubicin Hydrochloride GMP manufacturer or Epirubicin Hydrochloride GMP API supplier for your needs.

    Epirubicin Hydrochloride CoA

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

    Epirubicin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Epirubicin Hydrochloride 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.

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