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    Chemistry

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    Also known as: 643-22-1, Abboticine, Bristamycin, Erypar, Dowmycin e, Wyamycin s
    Molecular Formula
    C55H103NO15
    Molecular Weight
    1018.4  g/mol
    InChI Key
    YAVZHCFFUATPRK-YZPBMOCRSA-N
    FDA UNII
    LXW024X05M
    Erythromycin Stearate
    Erythromycin Stearate is the stearate salt form of erythromycin, a broad-spectrum, topical macrolide antibiotic with antibacterial activity. Erythromycin stearate diffuses through the bacterial cell membrane and reversibly binds to the 50S subunit of the bacterial ribosome. This prevents bacterial protein synthesis. Erythromycin stearate may be bacteriostatic or bactericidal in action, depending on the concentration of the drug at the site of infection and the susceptibility of the organism involved.
    1 2D Structure

    Erythromycin Stearate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-6-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-7,12,13-trihydroxy-4-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,7,9,11,13-hexamethyl-oxacyclotetradecane-2,10-dione;octadecanoic acid
    2.1.2 InChI
    InChI=1S/C37H67NO13.C18H36O2/c1-14-25-37(10,45)30(41)20(4)27(39)18(2)16-35(8,44)32(51-34-28(40)24(38(11)12)15-19(3)47-34)21(5)29(22(6)33(43)49-25)50-26-17-36(9,46-13)31(42)23(7)48-26;1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20/h18-26,28-32,34,40-42,44-45H,14-17H2,1-13H3;2-17H2,1H3,(H,19,20)/t18-,19-,20+,21+,22-,23+,24+,25-,26+,28-,29+,30-,31+,32-,34+,35-,36-,37-;/m1./s1
    2.1.3 InChI Key
    YAVZHCFFUATPRK-YZPBMOCRSA-N
    2.1.4 Canonical SMILES
    CCCCCCCCCCCCCCCCCC(=O)O.CCC1C(C(C(C(=O)C(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)O)(C)O
    2.1.5 Isomeric SMILES
    CCCCCCCCCCCCCCCCCC(=O)O.CC[C@@H]1[C@@]([C@@H]([C@H](C(=O)[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)O)(C)O
    2.2 Other Identifiers
    2.2.1 UNII
    LXW024X05M
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Gallimycin

    2.3.2 Depositor-Supplied Synonyms

    1. 643-22-1

    2. Abboticine

    3. Bristamycin

    4. Erypar

    5. Dowmycin E

    6. Wyamycin S

    7. Pfizer-e

    8. Erythrocin Stearate

    9. Gallimycin

    10. Sk-erythromycin

    11. Erythromycin Octadecanoate (salt)

    12. Nsc-756747

    13. Nci-c55674

    14. Lxw024x05m

    15. Eratrex

    16. Meberyt

    17. Qidmycin

    18. Ethril

    19. Ethril 250

    20. Ethril 500

    21. Erythromycin Stearate (salt)

    22. Erythromycin, Stearate (salt)

    23. Erythromycin Steraric Acid Salt

    24. Ccris 1504

    25. Oe 7

    26. Hsdb 4178

    27. Einecs 211-396-1

    28. Unii-lxw024x05m

    29. Stearic Acid, Compd. With Erythromycin (1:1)

    30. Bristamycin (tn)

    31. Octadecanoic Acid, Compd. With Erythromycin (1:1)

    32. Erythromycini Stearas

    33. Erythromycin Stearate [usp:ban:jan]

    34. Chembl1200510

    35. Chebi:34742

    36. Hms501d19

    37. Erythromycin Stearate [mi]

    38. Erythromycin Stearate/ >550ug/mg

    39. Hms3264b08

    40. Pharmakon1600-01500281

    41. Erythromycin Stearate (jp17/usp)

    42. Erythromycin Stearate [jan]

    43. Erythromycin Stearate [hsdb]

    44. Ccg-39117

    45. Erythromycin Stearate [vandf]

    46. Mfcd00084690

    47. Nsc756747

    48. Erythromycin Stearate [mart.]

    49. Erythromycin Stearate [usp-rs]

    50. Erythromycin Stearate [who-dd]

    51. Erythromycin Stearate [who-ip]

    52. Nsc 756747

    53. Ncgc00180891-01

    54. Erythromycin Stearate [orange Book]

    55. Sbi-0207065.p001

    56. Erythromycin Stearate [usp Impurity]

    57. Hy-108875

    58. Cs-0031206

    59. Erythromycin Stearate [usp Monograph]

    60. Erythromycini Stearas [who-ip Latin]

    61. D02184

    62. Erythromycin Stearate For Impurity S Identification

    63. Sr-01000872741

    64. Sr-01000872741-1

    65. W-104851

    66. Q27283244

    67. Erythromycin Stearate, Antibiotic For Culture Media Use Only

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 1018.4 g/mol
    Molecular Formula C55H103NO15
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count16
    Rotatable Bond Count23
    Exact Mass1017.73277158 g/mol
    Monoisotopic Mass1017.73277158 g/mol
    Topological Polar Surface Area231 Ų
    Heavy Atom Count71
    Formal Charge0
    Complexity1380
    Isotope Atom Count0
    Defined Atom Stereocenter Count18
    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 2  
    Drug NameErythrocin stearate
    Drug LabelERYTHROCIN STEARATE Filmtab tablets (erythromycin stearate tablets, USP) are an antibacterial product containing the stearate salt of erythromycin in a unique film coating.Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly...
    Active IngredientErythromycin stearate
    Dosage FormTablet
    RouteOral
    Strengtheq 250mg base
    Market StatusPrescription
    CompanyArbor Pharms

    2 of 2  
    Drug NameErythrocin stearate
    Drug LabelERYTHROCIN STEARATE Filmtab tablets (erythromycin stearate tablets, USP) are an antibacterial product containing the stearate salt of erythromycin in a unique film coating.Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly...
    Active IngredientErythromycin stearate
    Dosage FormTablet
    RouteOral
    Strengtheq 250mg base
    Market StatusPrescription
    CompanyArbor Pharms

    4.2 Therapeutic Uses

    ITS ACTIONS & USES ARE IDENTICAL TO THOSE OF ERYTHROMYCIN.

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1124

    ERYTHROMYCIN MAY BE USEFUL FOR DISSEMINATED GONOCOCCAL DISEASE IN PREGNANT PT WHO IS ALLERGIC TO PENICILLIN... 13 PT...TREATED WITH 500 MG OF ERYTHROMYCIN... STEARATE, GIVEN ORALLY EVERY 6 HR FOR 5 DAYS, SHOWED RAPID CLINICAL & BACTERIOLOGICAL RESPONSES.

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1225

    ANTIBACTERIAL AGENT

    MEDICATION (VET): ANTIBACTERIAL AGENT

    4.3 Drug Warning

    ...ERYTHROMYCIN & ITS DERIV SELDOM CAUSE SERIOUS ADVERSE REACTIONS.

    American Medical Association, AMA Department of Drugs. AMA Drug Evaluations. 4th ed. Chicago: American Medical Association, 1980., p. 1258

    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.)

    Gastrointestinal Agents

    Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion. (See all compounds classified as Gastrointestinal Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Macrolide Antimicrobial [EPC]; Macrolide [EPC]; Macrolides [CS]; Decreased Sebaceous Gland Activity [PE]
    5.3 Absorption, Distribution and Excretion

    PEAK CONCN IN PLASMA...0.3-0.5 UG/ML 4 HR AFTER ORAL ADMIN OF 250 MG OF BASE & ARE 0.3-1.9 UG/ML AFTER...500-MG TABLET. VARIOUS ESTERS OF ERYTHROMYCIN HAVE BEEN PREPARED TO...IMPROVE STABILITY & FACILITATE ABSORPTION. ...CONCN OF ERYTHROMYCIN IN PLASMA ARE LITTLE DIFFERENT IF STEARATE IS GIVEN ORALLY.

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1223

    ...DIFFUSES READILY INTO INTRACELLULAR FLUIDS, & ANTIBACTERIAL ACTIVITY... ACHIEVED AT...ALL SITES EXCEPT BRAIN & CSF. ...ONE OF FEW ANTIBIOTICS THAT PENETRATES INTO PROSTATIC FLUID, CONCN ARE APPROX 40% OF...PLASMA. EXTENT OF BINDING...TO PLASMA PROTEINS VARIES...PROBABLY EXCEEDS 70% IN ALL.../FORMS OF DRUG/. /ERYTHROMYCIN/

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1223

    ERYTHROMYCIN BASE IS ADEQUATELY ABSORBED FROM UPPER PART OF SMALL INTESTINE; IT IS INACTIVATED BY GASTRIC JUICE... FOOD IN STOMACH DELAYS ITS ULTIMATE ABSORPTION. /ERYTHROMYCIN/

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1223

    ERYTHROMYCIN TRAVERSES PLACENTAL BARRIER; & CONCN OF DRUG IN FETAL PLASMA ARE ABOUT 5-20% OF THOSE IN MATERNAL CIRCULATION. /ERYTHROMYCIN/

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1223

    For more Absorption, Distribution and Excretion (Complete) data for ERYTHROMYCIN STEARATE (11 total), please visit the HSDB record page.

    5.4 Metabolism/Metabolites

    IT IS HYDROLYZED IN SMALL INTESTINE & IN TISSUES TO YIELD ERYTHROMYCIN.

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1124

    5.5 Mechanism of Action

    ...INHIBIT PROTEIN SYNTH BY BINDING TO 50 S RIBOSOMAL SUBUNITS OF SENSITIVE MICROORGANISMS. ... ASSOC BETWEEN ERYTHROMYCIN & RIBOSOME IS REVERSIBLE BUT TAKES PLACE ONLY WHEN 50 S SUBUNIT IS FREE FROM TRNA MOLECULES BEARING NASCENT PEPTIDE CHAINS. PRODN...OF HIGHLY POLYMERIZED HOMOPEPTIDES IS SUPPRESSED. /ERYTHROMYCIN/

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1223

    THE NONIONIZED FORM OF THE DRUG IS CONSIDERABLY MORE PERMEABLE TO CELLS, & THIS PROBABLY EXPLAINS INCREASED ANTIMICROBIAL ACTIVITY THAT IS OBSERVED AT ALKALINE PH. /ERYTHROMYCIN/

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1223

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ANNIE BESANT ROAD, WORLI, Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694457000,"product":"ERYTHROMYCIN STEARATE BP","address":"25, PULIYUR II MAIN ROAD,","city":"CHENNAI, TAMILNADU","supplier":"SM BIOMED","supplierCountry":"MALAYSIA","foreign_port":"PENANG (GEORGETOWN)","customer":"MEDOPHARM PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"52","totalValueFC":"157769.9","currency":"USD","unitRateINR":"4365.4","date":"12-Sep-2023","totalValueINR":"13096200","totalValueInUsd":"157769.9","indian_port":"Madras Sea","hs_no":"29415000","bill_no":"7790834","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"PENANG (GEORGETOWN)","supplierAddress":"LOT 90,SUNGAI PETANI INDUSTRIALESTATE 08000, SUNGAI PETANI, KEDAHSDNF MALAYSIA","customerAddress":"25, PULIYUR II MAIN ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697135400,"product":"ERYTHROMYCIN STEARATE","address":"25, PULIYUR II MAIN ROAD,","city":"CHENNAI, TAMILNADU","supplier":"LINARIA CHEMICALS","supplierCountry":"THAILAND","foreign_port":"LAEM CHABANG","customer":"MEDOPHARM PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"60","totalValueFC":"182473.5","currency":"USD","unitRateINR":"5062.4","date":"13-Oct-2023","totalValueINR":"15187137.4","totalValueInUsd":"182473.5","indian_port":"Madras Sea","hs_no":"29415000","bill_no":"8292263","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"8\/6,CATHAY HOUSE, 1ST FLOORNORTH SATHORN ROAD, SILOMBANGRAK, BANGKOK 10500 THAILAND","customerAddress":"25, PULIYUR II MAIN ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699554600,"product":"ERYTHROMYCIN STEARATE","address":"25, 2ND PULIYUR MAIN ROAD,","city":"CHENNAI, TAMILNADU","supplier":"LINARIA CHEMICALS","supplierCountry":"THAILAND","foreign_port":"LAEM CHABANG","customer":"MEDOPHARM PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1400.00","actualQuantity":"1400","unit":"KGS","unitRateFc":"60","totalValueFC":"84956.2","currency":"USD","unitRateINR":"5053.1","date":"10-Nov-2023","totalValueINR":"7074381.22","totalValueInUsd":"84956.2","indian_port":"Madras Sea","hs_no":"29415000","bill_no":"8712113","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"8\/6,CATHAY HOUSE, 1ST FLOORNORTH SATHORN ROAD, SILOMBANGRAK, BANGKOK 10500 THAILAND","customerAddress":"25, 2ND PULIYUR MAIN ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734719400,"product":"ERYTHROMYCIN STEARATE BP\/USP (ERYTHROMYCIN STEARATE) ERYTHROMYCIN STEARATE","address":"25, 2ND PULIYUR MAIN ROAD,","city":"CHENNAI, TAMILNADU","supplier":"LINARIA CHEMICALS","supplierCountry":"THAILAND","foreign_port":"LAEM CHABANG","customer":"MEDOPHARM PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"60","totalValueFC":"182225.7","currency":"USD","unitRateINR":"5161.2","date":"21-Dec-2024","totalValueINR":"15483537.07","totalValueInUsd":"182225.7","indian_port":"Madras Sea","hs_no":"29415000","bill_no":"7375157","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"8\/6,CATHAY HOUSE, 1ST FLOOR, NORTH SATHORN ROAD, SILOM BANGRAK, BANGKOK 10500 THAILAND","customerAddress":"25, 2ND PULIYUR MAIN ROAD,"}]
    06-Jan-2021
    31-Dec-2024
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    ABOUT THIS PAGE

    Looking for 643-22-1 / Erythromycin Stearate API manufacturers, exporters & distributors?

    Erythromycin Stearate manufacturers, exporters & distributors 1

    87

    PharmaCompass offers a list of Erythromycin Stearate 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 Erythromycin Stearate manufacturer or Erythromycin Stearate supplier for your needs.

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

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

    API | Excipient name

    Erythromycin Stearate

    Synonyms

    643-22-1, Abboticine, Bristamycin, Erypar, Dowmycin e, Wyamycin s

    Cas Number

    643-22-1

    Unique Ingredient Identifier (UNII)

    LXW024X05M

    About Erythromycin Stearate

    Erythromycin Stearate is the stearate salt form of erythromycin, a broad-spectrum, topical macrolide antibiotic with antibacterial activity. Erythromycin stearate diffuses through the bacterial cell membrane and reversibly binds to the 50S subunit of the bacterial ribosome. This prevents bacterial protein synthesis. Erythromycin stearate may be bacteriostatic or bactericidal in action, depending on the concentration of the drug at the site of infection and the susceptibility of the organism involved.

    Erythromycin Stearate Manufacturers

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

    Erythromycin Stearate Suppliers

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

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

    Erythromycin Stearate USDMF

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

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

    click here to find a list of Erythromycin Stearate suppliers with USDMF on PharmaCompass.

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

    Erythromycin Stearate CEP

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

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

    Erythromycin Stearate WC

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

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

    Erythromycin Stearate 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 Erythromycin Stearate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Erythromycin Stearate suppliers with NDC on PharmaCompass.

    Erythromycin Stearate GMP

    Erythromycin Stearate 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 Erythromycin Stearate 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 Erythromycin Stearate GMP manufacturer or Erythromycin Stearate GMP API supplier for your needs.

    Erythromycin Stearate CoA

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

    Erythromycin Stearate CoA mostly includes findings from lab analyses of a specific batch. For each Erythromycin Stearate 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.

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