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    Chemistry

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    Also known as: 117772-70-0, Vinzam, Toraseptol, Azithromycin (hydrate), Azitro, 5fd1131i7s
    Molecular Formula
    C38H76N2O14
    Molecular Weight
    785.0  g/mol
    InChI Key
    SRMPHJKQVUDLQE-KUJJYQHYSA-N
    FDA UNII
    5FD1131I7S
    Azithromycin Dihydrate
    A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.
    1 2D Structure

    Azithromycin Dihydrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one;dihydrate
    2.1.2 InChI
    InChI=1S/C38H72N2O12.2H2O/c1-15-27-38(10,46)31(42)24(6)40(13)19-20(2)17-36(8,45)33(52-35-29(41)26(39(11)12)16-21(3)48-35)22(4)30(23(5)34(44)50-27)51-28-18-37(9,47-14)32(43)25(7)49-28;;/h20-33,35,41-43,45-46H,15-19H2,1-14H3;2*1H2/t20-,21-,22+,23-,24-,25+,26+,27-,28+,29-,30+,31-,32+,33-,35+,36-,37-,38-;;/m1../s1
    2.1.3 InChI Key
    SRMPHJKQVUDLQE-KUJJYQHYSA-N
    2.1.4 Canonical SMILES
    CCC1C(C(C(N(CC(CC(C(C(C(C(C(=O)O1)C)OC2CC(C(C(O2)C)O)(C)OC)C)OC3C(C(CC(O3)C)N(C)C)O)(C)O)C)C)C)O)(C)O.O.O
    2.1.5 Isomeric SMILES
    CC[C@@H]1[C@@]([C@@H]([C@H](N(C[C@@H](C[C@@]([C@@H]([C@H]([C@@H]([C@H](C(=O)O1)C)O[C@H]2C[C@@]([C@H]([C@@H](O2)C)O)(C)OC)C)O[C@H]3[C@@H]([C@H](C[C@H](O3)C)N(C)C)O)(C)O)C)C)C)O)(C)O.O.O
    2.2 Other Identifiers
    2.2.1 UNII
    5FD1131I7S
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Azadose

    2. Azithromycin

    3. Azithromycin Monohydrate

    4. Azitrocin

    5. Azythromycin

    6. Cp 62993

    7. Cp-62993

    8. Cp62993

    9. Dihydrate, Azithromycin

    10. Goxal

    11. Monohydrate, Azithromycin

    12. Sumamed

    13. Toraseptol

    14. Ultreon

    15. Vinzam

    16. Zentavion

    17. Zithromax

    18. Zitromax

    2.3.2 Depositor-Supplied Synonyms

    1. 117772-70-0

    2. Vinzam

    3. Toraseptol

    4. Azithromycin (hydrate)

    5. Azitro

    6. 5fd1131i7s

    7. 117772-70-0 (dihydrate)

    8. Azithromycin Hydrate

    9. Azitromax

    10. Misultina

    11. Tromix

    12. Azadose

    13. Ribotrex

    14. Ultreon

    15. Zenstavion

    16. Azatek

    17. Goxal

    18. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-(((2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-2-ethyl-3,4,10-trihydroxy-13-(((2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yl)oxy)-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one Dihydrate

    19. Azithromycin (as Dihydrate)

    20. Odaz

    21. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-11-{[3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl]oxy}-1-oxa-6-azacyclopentadecan-13-yl 2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranoside Dihydrate

    22. Aciphar

    23. Acitrocin

    24. Azidromic

    25. Azitral

    26. Azitrix

    27. Azitrom

    28. Azitrox

    29. Azitroxil

    30. Azimix

    31. Unii-5fd1131i7s

    32. Azitrona Klonal

    33. 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A Dihydrate

    34. Azithromycin [mart.]

    35. Schembl134723

    36. Chebi:34546

    37. Dtxsid80922539

    38. Azithromycin Dihydrate 100 Microg/ml In Acetonitrile

    39. Azithromycin Hydrate [jan]

    40. Azithromycin Dihydrate [mi]

    41. Ac-093

    42. Hy-17506a

    43. Azithromycin Dihydrate [vandf]

    44. Akos015896370

    45. Azithromycin Dihydrate [who-dd]

    46. Azithromycin Dihydrate, >=98% (hplc)

    47. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-13-((2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl)oxy)-1-oxa-6-azacyclopentadecan-15-one Dihydrate

    48. 1-oxa-6-azacyclopentadecan-15-one, 13-((2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl)oxy)-, Dihydrate, (2r-(2r*,3s*,4r*,5r*,8r*,10r*,11r*,12s*,13s*,14r*))-

    49. Azithromycin Dihydrate [orange Book]

    50. Azithromycin Dihydrate [ep Monograph]

    51. Azithromycin Dihydrate [usp Monograph]

    52. 772a700

    53. N-methyl-11-aza-10-deoxo-10-dihydro Erythromycin A

    54. Q27116139

    55. Azithromycin, United States Pharmacopeia (usp) Reference Standard

    56. N-methyl-11-aza-10-deoxo-10-dihydroerythromycin A Dihydrate

    57. Azithromycin, Pharmaceutical Secondary Standard; Certified Reference Material

    58. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-(((2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-2-ethyl-3,4,10-trihydroxy-13-(((2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yl)oxy)-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-onedihydrate

    59. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-o

    60. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one;dihydrate

    61. 1-oxa-6-azacyclopentadecan-15-one, 13-[(2,6-dideoxy-3-c-methyl-3-o-methyl-?-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-?-d-xylo-hexopyranosyl]oxy]-, Dihydrate, (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 785.0 g/mol
    Molecular Formula C38H76N2O14
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count16
    Rotatable Bond Count7
    Exact Mass784.52965510 g/mol
    Monoisotopic Mass784.52965510 g/mol
    Topological Polar Surface Area182 Ų
    Heavy Atom Count54
    Formal Charge0
    Complexity1150
    Isotope Atom Count0
    Defined Atom Stereocenter Count18
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    Anti-Bacterial Agents

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

    4.2 FDA Pharmacological Classification
    4.2.1 Pharmacological Classes
    Macrolides [CS]; Macrolide Antimicrobial [EPC]

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LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"168.5","totalValueFC":"85100.8","currency":"USD","unitRateINR":"14676.4","date":"31-Jan-2025","totalValueINR":"7338175","totalValueInUsd":"85100.8","indian_port":"Madras Sea","hs_no":"29419090","bill_no":"8108448","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F PLAZA 88 NO 88 YEUNG UK ROAD TSUEN WAN,NT, HONG KONG CH INA, , CHINA","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741717800,"product":"AZITHROMYCIN DIHYDRATE USP(BATCH NO.A20250113, A20250114)(20DRUMS)AZITHROMYCIN","address":"5TH FLOOR,LAXMI NARAYAN COMPLEX,","city":"BANGALORE","supplier":"HANGZHOU DAWN RAY ","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"BAL PHARMA","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"143","totalValueFC":"72476","currency":"USD","unitRateINR":"12555.4","date":"12-Mar-2025","totalValueINR":"6277700","totalValueInUsd":"72476","indian_port":"Bangalore Air","hs_no":"29419090","bill_no":"8836883","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"CO., LTD 1613, GUANGYIN BUILDING, NO.42 E.FENGQI ROAD, HANGZHOU 3100 2 CHINA CHINA","customerAddress":"5TH FLOOR,LAXMI NARAYAN COMPLEX,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742495400,"product":"AZITHROMYCIN DIHYDRATE USP43\/IP2022\/EP11","address":"98, GOVT.INDUSTRIAL AREA,","city":"MUMBAI.","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AJANTA PHARMA LIMITED","customerCountry":"INDIA","quantity":"1100.00","actualQuantity":"1100","unit":"KGS","unitRateFc":"140","totalValueFC":"155213.3","currency":"USD","unitRateINR":"12222","date":"21-Mar-2025","totalValueINR":"13444200","totalValueInUsd":"155213.3","indian_port":"Dahez-SEZ","hs_no":"29415000","bill_no":"9009164","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.6,WEIWU ROAD, HANGZHOU GULF SHAN YU ECONOMIC AND TECHNOLOGICAL DEVEL SDNF China","customerAddress":"98, GOVT.INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742495400,"product":"AZITHROMYCIN DIHYDRATE USP","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"3650.00","actualQuantity":"3650","unit":"KGS","unitRateFc":"165.5","totalValueFC":"608834.2","currency":"USD","unitRateINR":"14448.2","date":"21-Mar-2025","totalValueINR":"52735747.5","totalValueInUsd":"608834.2","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29419090","bill_no":"9024038","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F PLAZA 88 NO 88 YEUNG OFFICE F, 32\/F PLAZA 88 NO 88 YEUNG SDNF Hong Kong","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742927400,"product":"AZITHROMYCIN - AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER)AZITHROMYCIN - AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST W","address":"OM SHANTI COMPLEX,","city":"LUDHIANA, PUNJAB","supplier":"HENGDIAN GROUP","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"MAGBRO HEALTH CARE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"350.00","actualQuantity":"350","unit":"KGS","unitRateFc":"139","totalValueFC":"49033.3","currency":"USD","unitRateINR":"12134.7","date":"26-Mar-2025","totalValueINR":"4247145","totalValueInUsd":"49033.3","indian_port":"JNPT","hs_no":"29419090","bill_no":"9114887","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"13F, T1, HENGDIAN CENTER, NO. 136 F UCHUN ROAD, SHANGCHENG DISTRICT, HA NGZHOU,CHINA China","customerAddress":"OM SHANTI COMPLEX,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"AZITHROMYCIN USP (AZITHROMYCIN DIHYDRATE USP) AZITHROMYCINUSP (AZITHROMYCIN DIHYDRATE USP)","address":"357, G.I.D.C. SACHIN","city":"SURAT\/GUJARAT","supplier":"HANGZHOU DAWN RAY ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GLOBELA PHARMA","customerCountry":"INDIA","quantity":"881.93","actualQuantity":"881.93","unit":"KGS","unitRateFc":"134.4","totalValueFC":"119456.4","currency":"N\/A","unitRateINR":"11732.2","date":"29-Mar-2025","totalValueINR":"10347020.6","totalValueInUsd":"119456.4","indian_port":"JNPT","hs_no":"29419090","bill_no":"9178332","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1613 GUANGYIN BUILDING, NO.42 E.FEN GQI ROAD, HANGZHOU, 310012, CHINA SDNF China","customerAddress":"357, G.I.D.C. SACHIN"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743359400,"product":"AZITHROMYCIN DIHYDRATE USP AZITHROMYCIN DIHYDRATE USP","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"CSPC PHARMACEUTICAL GROUP","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"52.00","actualQuantity":"52","unit":"KGS","unitRateFc":"159","totalValueFC":"8333.1","currency":"USD","unitRateINR":"13880.7","date":"31-Mar-2025","totalValueINR":"721796.4","totalValueInUsd":"8333.1","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"9208699","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.88 YANGZI ROAD, ECONOMIC AND TEC HNOLOGICAL DEVELOPMENT ZONE, SHIJIA ZHUANG, HEBEI, CHINA China","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743359400,"product":"AZITHROMYCIN DIHYDRATE USP AZITHROMYCIN DIHYDRATE USP","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"CSPC PHARMACEUTICAL GROUP","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"90.00","actualQuantity":"90","unit":"KGS","unitRateFc":"159","totalValueFC":"14422.7","currency":"USD","unitRateINR":"13880.7","date":"31-Mar-2025","totalValueINR":"1249263","totalValueInUsd":"14422.7","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"9208699","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.88 YANGZI ROAD, ECONOMIC AND TEC HNOLOGICAL DEVELOPMENT ZONE, SHIJIA ZHUANG, HEBEI, CHINA China","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743359400,"product":"AZITHROMYCIN DIHYDRATE USP AZITHROMYCIN DIHYDRATE USP","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"CSPC PHARMACEUTICAL GROUP","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"2688.00","actualQuantity":"2688","unit":"KGS","unitRateFc":"159","totalValueFC":"430759.2","currency":"USD","unitRateINR":"13880.7","date":"31-Mar-2025","totalValueINR":"37311321.6","totalValueInUsd":"430759.2","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"9208699","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.88 YANGZI ROAD, ECONOMIC AND TEC HNOLOGICAL DEVELOPMENT ZONE, SHIJIA ZHUANG, HEBEI, CHINA China","customerAddress":"159, C.S.T. ROAD,"}]
    04-Jan-2021
    31-Mar-2025
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    ABOUT THIS PAGE

    Looking for 117772-70-0 / Azithromycin Dihydrate API manufacturers, exporters & distributors?

    Azithromycin Dihydrate manufacturers, exporters & distributors 1

    29

    PharmaCompass offers a list of Azithromycin Dihydrate 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 Azithromycin Dihydrate manufacturer or Azithromycin Dihydrate supplier for your needs.

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

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

    API | Excipient name

    Azithromycin Dihydrate

    Synonyms

    117772-70-0, Vinzam, Toraseptol, Azithromycin (hydrate), Azitro, 5fd1131i7s

    Cas Number

    117772-70-0

    Unique Ingredient Identifier (UNII)

    5FD1131I7S

    About Azithromycin Dihydrate

    A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.

    Azithromycin Monohydrate Manufacturers

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

    Azithromycin Monohydrate Suppliers

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

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

    Azithromycin Monohydrate USDMF

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

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

    click here to find a list of Azithromycin Monohydrate suppliers with USDMF on PharmaCompass.

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

    Azithromycin Monohydrate CEP

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

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

    Azithromycin Monohydrate WC

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

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

    Azithromycin Monohydrate 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 Azithromycin Monohydrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Azithromycin Monohydrate suppliers with NDC on PharmaCompass.

    Azithromycin Monohydrate GMP

    Azithromycin Monohydrate 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 Azithromycin Monohydrate 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 Azithromycin Monohydrate GMP manufacturer or Azithromycin Monohydrate GMP API supplier for your needs.

    Azithromycin Monohydrate CoA

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

    Azithromycin Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Azithromycin Monohydrate 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.

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