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    Also known as: Amikacin disulfate, 39831-55-5, Pierami, Amikin, Amikacin bis(sulphate), Kaminax
    Molecular Formula
    C22H47N5O21S2
    Molecular Weight
    781.8  g/mol
    InChI Key
    FXKSEJFHKVNEFI-GCZBSULCSA-N
    FDA UNII
    N6M33094FD
    Amikacin Sulfate
    A broad-spectrum antibiotic derived from KANAMYCIN. It is reno- and oto-toxic like the other aminoglycoside antibiotics.
    1 2D Structure

    Amikacin Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-4-amino-N-[(1R,2S,3S,4R,5S)-5-amino-2-[(2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4-[(2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide;sulfuric acid
    2.1.2 InChI
    InChI=1S/C22H43N5O13.2H2O4S/c23-2-1-8(29)20(36)27-7-3-6(25)18(39-22-16(34)15(33)13(31)9(4-24)37-22)17(35)19(7)40-21-14(32)11(26)12(30)10(5-28)38-21;2*1-5(2,3)4/h6-19,21-22,28-35H,1-5,23-26H2,(H,27,36);2*(H2,1,2,3,4)/t6-,7+,8-,9+,10+,11-,12+,13+,14+,15-,16+,17-,18+,19-,21+,22+;;/m0../s1
    2.1.3 InChI Key
    FXKSEJFHKVNEFI-GCZBSULCSA-N
    2.1.4 Canonical SMILES
    C1C(C(C(C(C1NC(=O)C(CCN)O)OC2C(C(C(C(O2)CO)O)N)O)O)OC3C(C(C(C(O3)CN)O)O)O)N.OS(=O)(=O)O.OS(=O)(=O)O
    2.1.5 Isomeric SMILES
    C1[C@@H]([C@H]([C@@H]([C@H]([C@@H]1NC(=O)[C@H](CCN)O)O[C@@H]2[C@@H]([C@H]([C@@H]([C@H](O2)CO)O)N)O)O)O[C@@H]3[C@@H]([C@H]([C@@H]([C@H](O3)CN)O)O)O)N.OS(=O)(=O)O.OS(=O)(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    N6M33094FD
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. A.m.k

    2. Amikacin

    3. Amikacina Medical

    4. Amikacina Normon

    5. Amikafur

    6. Amikalem

    7. Amikason's

    8. Amikayect

    9. Amikin

    10. Amiklin

    11. Amukin

    12. Bb K 8

    13. Bb K8

    14. Bb-k 8

    15. Bb-k8

    16. Bbk 8

    17. Bbk8

    18. Biclin

    19. Biklin

    20. Gamikal

    21. Kanbine

    22. Medical, Amikacina

    23. Normon, Amikacina

    24. Oprad

    25. Sulfate, Amikacin

    26. Yectamid

    2.3.2 Depositor-Supplied Synonyms

    1. Amikacin Disulfate

    2. 39831-55-5

    3. Pierami

    4. Amikin

    5. Amikacin Bis(sulphate)

    6. Kaminax

    7. Bb-k8

    8. Arikayce

    9. Amikacin Sulphate

    10. Amikacin Disulphate

    11. Amikacin (disulfate)

    12. Amikacin (as Sulfate)

    13. Amikacin Sulfate Salt

    14. Amikacin Disulfate Salt

    15. N6m33094fd

    16. Nsc-755846

    17. Amikafur

    18. Amitrex

    19. Biodacyn

    20. Chemacin

    21. Fabianol

    22. Likacin

    23. Biklin

    24. Kancin-gap

    25. Antibiotic Bb-k8 Sulfate

    26. (2s)-4-amino-n-[(1r,2s,3s,4r,5s)-5-amino-2-(3-amino-3-deoxy-alpha-d-glucopyranosyloxy)-4-(6-amino-6-deoxy-alpha-d-glucopyranosyloxy)-3-hydroxycyclohexyl]-2-hydroxybutanamide Disulfate

    27. Amikacin (sulfate)

    28. O-3-amino-3-deoxy-alpha-d-glucopyranosyl-(1->4)-o-(6-amino-6-deoxy-alpha-d-glucopyranosyl-(1->6))-n(3)-(4-amino-l-2-hydroxybutyryl)-2-deoxy-l-streptamine Sulfate (1:2)

    29. Nn-k 8

    30. Einecs 254-648-6

    31. Amikan

    32. Unii-n6m33094fd

    33. Amikacini Sulfas

    34. Amikacin Sulfate [usan:usp:jan]

    35. Amikin (tn)

    36. Amikin In Sodium Chloride 0.9% In Plastic Container

    37. (2s)-4-amino-n-[(1r,2s,3s,4r,5s)-5-amino-2-[(2s,3r,4s,5s,6r)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4-[(2r,3r,4s,5s,6r)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]

    38. Amikacin Sulfate In Sodium Chloride 0.9% In Plastic Container

    39. Bay-416651 Sulfate

    40. Amikacin Sulfate [mi]

    41. Amikacin Sulfate [jan]

    42. Amikacin Sulfate (jp17/usp)

    43. Chebi:2638

    44. Schembl1649432

    45. Amikacin Sulfate [usan]

    46. Amikacin Sulfate [vandf]

    47. Chembl4208954

    48. Hy-b0509b

    49. Amikacin Sulfate [mart.]

    50. Amikacin Sulfate [usp-rs]

    51. Amikacin Sulfate [who-dd]

    52. Amikacini Sulfas [who-ip]

    53. Dtxsid601045247

    54. Mfcd00167475

    55. S3065

    56. Amikacin Sulfate [green Book]

    57. Akos025310105

    58. Amikacin Sulfate [ep Impurity]

    59. Amikacin Sulfate [orange Book]

    60. Amikacin Sulfate [ep Monograph]

    61. Ccg-270466

    62. Cs-3493

    63. Nsc 755846

    64. Amikacin Sulfate [usp Monograph]

    65. As-13777

    66. D-streptamine, O-3-amino-3-deoxy-alpha-d-glucopyranosyl-(1-6)-o-(6-amino-6-deoxy-alpha-d-glucopyranosyl-(1-4))-n(sup 1)-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (s)-, Sulfate (1:2)(salt)

    67. O-3-amino-3-deoxy-alpha-d-glucopyranosyl-(1-4)-o-(6-amino-6-deoxy-alpha-d-glucopyranosyl-(1-6))-n(sup 3)-(4-amino-l-2-hydroxybutyryl)-2-deoxy-l-streptamine Sulfate (1:2)

    68. D00865

    69. 831a555

    70. Q27105754

    71. Amikacin Sulfate, European Pharmacopoeia (ep) Reference Standard

    72. Amikacin Disulfate Salt, Potency: 674-786 Mug Per Mg (as Amikacin Base)

    73. Amikacin Sulfate, United States Pharmacopeia (usp) Reference Standard

    74. Amikacin For System Suitability, European Pharmacopoeia (ep) Reference Standard

    75. Amikacin Sulfate, Pharmaceutical Secondary Standard; Certified Reference Material

    76. (2s)-4-amino-n-{(1r,2s,3s,4r,5s)-5-amino-2-[(3-amino-3-deoxy-alpha-d-glucopyranosyl)oxy]-4-[(6-amino-6-deoxy-alpha-d-glucopyranosyl)oxy]-3-hydroxycyclohexyl}-2-hydroxybutanamide Sulfate (1:2)

    77. (s)-4-amino-n-((1r,2s,3s,4r,5s)-5-amino-2-(((2s,3r,4s,5s,6r)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2h-pyran-2-yl)oxy)-4-(((2r,3r,4s,5s,6r)-6-(aminomethyl)-3,4,5-trihydroxytetrahydro-2h-pyran-2-yl)oxy)-3-hydroxycyclohexyl)-2-hydroxybutanamide Bis(sulfate)

    78. D-streptamine, O-3-amino-3-deoxy-.alpha.-d-glucopyranosyl-(1->6)-o-(6-amino-6-deoxy-.alpha.-d-glucopyranosyl-(1->4))-n(sup 1)-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (s)-, Sulfate (1:2) (salt)

    79. D-streptamine, O-3-amino-3-deoxy-.alpha.-d-glucopyranosyl-(1->6)-o-(6-amino-6-deoxy-.alpha.-d-glucopyranosyl-(1->4))-n(sup 1)-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (s)-, Sulphate (1:2) (salt)

    80. D-streptamine, O-3-amino-3-deoxy-alpha-d-glucopyranosyl-(1.fwdarw.6)-o-(6-amino-6-deoxy-alpha-d-glucopyranosyl-(1.fwdarw.4))-n1-((2s)-4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, Sulfate (1:2) (salt)

    81. O-3-amino-3-deoxy-.alpha.-d-glucopyranosyl-(1->4)-o-(6-amino-6-deoxy-.alpha.-d-glucopyranosyl-(1->6))-n(sup 3)-(4-amino-l-2-hydroxybutyryl)-2-deoxy-l-streptamine Sulfate (1:2)

    82. O-3-amino-3-deoxy-.alpha.-d-glucopyranosyl-(1->4)-o-(6-amino-6-deoxy-.alpha.-d-glucopyranosyl-(1->6))-n(sup 3)-(4-amino-l-2-hydroxybutyryl)-2-deoxy-l-streptamine Sulphate (1:2)

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 781.8 g/mol
    Molecular Formula C22H47N5O21S2
    Hydrogen Bond Donor Count17
    Hydrogen Bond Acceptor Count25
    Rotatable Bond Count10
    Exact Mass781.22049587 g/mol
    Monoisotopic Mass781.22049587 g/mol
    Topological Polar Surface Area498 Ų
    Heavy Atom Count50
    Formal Charge0
    Complexity900
    Isotope Atom Count0
    Defined Atom Stereocenter Count16
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameAmikacin sulfate
    Drug LabelAmikacin Sulfate Injection USP is a semi-synthetic aminoglycoside antibiotic derived from kanamycin. D-Streptamine,O-3-amino-3-deoxy--D-glucopyranosyl-(16)-O-[6-amino-6-deoxy--D-glucopyranosyl-(14)]-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy...
    Active IngredientAmikacin sulfate
    Dosage FormInjectable
    RouteInjection
    Strengtheq 50mg base/ml; eq 250mg base/ml
    Market StatusPrescription
    CompanyEmcure Pharms; Teva Pharms Usa; Eurohlth Intl

    2 of 2  
    Drug NameAmikacin sulfate
    Drug LabelAmikacin Sulfate Injection USP is a semi-synthetic aminoglycoside antibiotic derived from kanamycin. D-Streptamine,O-3-amino-3-deoxy--D-glucopyranosyl-(16)-O-[6-amino-6-deoxy--D-glucopyranosyl-(14)]-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy...
    Active IngredientAmikacin sulfate
    Dosage FormInjectable
    RouteInjection
    Strengtheq 50mg base/ml; eq 250mg base/ml
    Market StatusPrescription
    CompanyEmcure Pharms; Teva Pharms Usa; Eurohlth Intl

    4.2 Drug Indication

    Treatment of nontuberculous mycobacterial lung infection, Treatment of Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis

    Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Bacterial Agents

    Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Aminoglycosides [CS]; Aminoglycoside Antibacterial [EPC]
    5.3 ATC Code

    J01GB06

    API Reference Price

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SEZ\/MUMBAI","hs_no":"29419090","bill_no":"2083064","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT SEZ MUMBAI","supplierAddress":"UNIT 2 OF LG 1, MIRROR TOWER, 61 MO DY ROAD, TSIM SHA TSUI, KOWLOON HON G KONG Kowloon, , HONG KONG HONG KONG","customerAddress":"305 AGGARWAL CITY SQUARE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748197800,"product":"AMIKACIN SULPHATE IP (IGST LIST-1\/ITEM NO.1) (ITEM LIST-3 ITEM NO.1 )AMIKACIN SULPHATE IP (IGST LIST-1\/ITEM NO.1) (ITEM LIST-3 IT","address":"H.NO 240, GF, BURARI,NORTH DELHI,","city":"DELHI,DELHI","supplier":"CLINI EXPERTS SERVICES ASIA PTE LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"TRANSTREE EXPRESS PRIVATE LTD","customerCountry":"INDIA","quantity":"3015.00","actualQuantity":"3015","unit":"KGS","unitRateFc":"110","totalValueFC":"336318.6","currency":"N\/A","unitRateINR":"9504","date":"26-May-2025","totalValueINR":"28654560","totalValueInUsd":"336318.6","indian_port":"Delhi PPG ICD","hs_no":"29419090","bill_no":"2278538","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"10 ANSON ROAD #11-20 INTERNATIONAL PLAZA SINGAPORE 079903 Singapore, , SINGAPORE SINGAPORE","customerAddress":"H.NO 240, GF, BURARI,NORTH DELHI,"}]
    19-Jan-2022
    26-May-2025
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    01

    Brand Name : Amikacin Sulfate

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    Company :

    Amikacin Sulfate

    Drug Cost (USD) : 1,105,232

    Year : 2022

    Prescribers : 2827

    Prescriptions : 11414

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    Brand Name : Arikayce

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    Company :

    Amikacin Liposomal/Neb.Accessr

    Drug Cost (USD) : 126,923,540

    Year : 2022

    Prescribers : 1925

    Prescriptions : 9160

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    03

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    Company :

    Amikacin Sulfate

    Drug Cost (USD) : 1,166,913

    Year : 2021

    Prescribers : 2855

    Prescriptions : 11338

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    04

    Brand Name : Arikayce

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    Company :

    Amikacin Liposomal/Neb.Accessr

    Drug Cost (USD) : 102,789,694

    Year : 2021

    Prescribers : 1730

    Prescriptions : 8064

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    05

    Brand Name : Amikacin Sulfate

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    Company :

    Amikacin Sulfate

    Drug Cost (USD) : 1,321,260

    Year : 2020

    Prescribers : 3453

    Prescriptions : 11600

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    06

    Brand Name : Amikacin Sulfate

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    Indo Livestock Expo
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    Company :

    Amikacin Sulfate

    Drug Cost (USD) : 1,478,423

    Year : 2019

    Prescribers : 4410

    Prescriptions : 13402

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    07

    Brand Name : Amikacin Sulfate

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    Indo Livestock Expo
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    Brand Name : Amikacin Sulfate

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    Company :

    Amikacin Sulfate

    Drug Cost (USD) : 1,788,517

    Year : 2018

    Prescribers : 5224

    Prescriptions : 16488

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    08

    Brand Name : Amikacin Sulfate

    Country
    arrow
    Indo Livestock Expo
    Not Confirmed

    Brand Name : Amikacin Sulfate

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    Indo Livestock Expo
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    Company :

    Amikacin Sulfate

    Drug Cost (USD) : 1,720,914

    Year : 2017

    Prescribers : 5528

    Prescriptions : 15774

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    09

    Brand Name : Amikacin Sulfate

    Country
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    Indo Livestock Expo
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    Brand Name : Amikacin Sulfate

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    Indo Livestock Expo
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    Company :

    Amikacin Sulfate

    Drug Cost (USD) : 1,646,111

    Year : 2016

    Prescribers : 5864

    Prescriptions : 16434

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    10

    Brand Name : Amikacin Sulfate

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    Indo Livestock Expo
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    Brand Name : Amikacin Sulfate

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    Company :

    Amikacin Sulfate

    Drug Cost (USD) : 1,324,079

    Year : 2015

    Prescribers : 5969

    Prescriptions : 15713

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    ABOUT THIS PAGE

    Looking for 39831-55-5 / Amikacin Sulfate API manufacturers, exporters & distributors?

    Amikacin Sulfate manufacturers, exporters & distributors 1

    99

    PharmaCompass offers a list of Amikacin Sulfate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Amikacin Sulfate manufacturer or Amikacin Sulfate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amikacin Sulfate manufacturer or Amikacin Sulfate supplier.

    PharmaCompass also assists you with knowing the Amikacin Sulfate API Price utilized in the formulation of products. Amikacin Sulfate API Price is not always fixed or binding as the Amikacin Sulfate Price is obtained through a variety of data sources. The Amikacin Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Amikacin Sulfate

    Synonyms

    Amikacin disulfate, 39831-55-5, Pierami, Amikin, Amikacin bis(sulphate), Kaminax

    Cas Number

    39831-55-5

    Unique Ingredient Identifier (UNII)

    N6M33094FD

    About Amikacin Sulfate

    A broad-spectrum antibiotic derived from KANAMYCIN. It is reno- and oto-toxic like the other aminoglycoside antibiotics.

    Amikacin Sulfate Manufacturers

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

    Amikacin Sulfate Suppliers

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

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

    Amikacin Sulfate USDMF

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

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

    click here to find a list of Amikacin Sulfate suppliers with USDMF on PharmaCompass.

    Amikacin Sulfate 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 Amikacin Sulfate Drug Master File in Japan (Amikacin Sulfate JDMF) empowers Amikacin Sulfate 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 Amikacin Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Amikacin Sulfate 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 Amikacin Sulfate suppliers with JDMF on PharmaCompass.

    Amikacin Sulfate KDMF

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

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

    After submitting a Amikacin Sulfate 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 Amikacin Sulfate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Amikacin Sulfate suppliers with KDMF on PharmaCompass.

    Amikacin Sulfate CEP

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

    A Amikacin Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amikacin Sulfate 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 Amikacin Sulfate suppliers with CEP (COS) on PharmaCompass.

    Amikacin Sulfate 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 Amikacin Sulfate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Amikacin Sulfate suppliers with NDC on PharmaCompass.

    Amikacin Sulfate GMP

    Amikacin Sulfate 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 Amikacin Sulfate 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 Amikacin Sulfate GMP manufacturer or Amikacin Sulfate GMP API supplier for your needs.

    Amikacin Sulfate CoA

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

    Amikacin Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Amikacin Sulfate 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.

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