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    Chemistry

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    Also known as: 53994-73-3, Cephaclor, Ceclor, Cefaclor anhydrous, Cefaclorum, Kefral
    Molecular Formula
    C15H14ClN3O4S
    Molecular Weight
    367.8  g/mol
    InChI Key
    QYIYFLOTGYLRGG-GPCCPHFNSA-N
    FDA UNII
    3Z6FS3IK0K
    Cefaclor
    Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN.
    Cefaclor anhydrous is a Cephalosporin Antibacterial.
    1 2D Structure

    Cefaclor

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (6R,7R)-7-[[(2R)-2-amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
    2.1.2 InChI
    InChI=1S/C15H14ClN3O4S/c16-8-6-24-14-10(13(21)19(14)11(8)15(22)23)18-12(20)9(17)7-4-2-1-3-5-7/h1-5,9-10,14H,6,17H2,(H,18,20)(H,22,23)/t9-,10-,14-/m1/s1
    2.1.3 InChI Key
    QYIYFLOTGYLRGG-GPCCPHFNSA-N
    2.1.4 Canonical SMILES
    C1C(=C(N2C(S1)C(C2=O)NC(=O)C(C3=CC=CC=C3)N)C(=O)O)Cl
    2.1.5 Isomeric SMILES
    C1C(=C(N2[C@H](S1)[C@@H](C2=O)NC(=O)[C@@H](C3=CC=CC=C3)N)C(=O)O)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    3Z6FS3IK0K
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((aminophenylacetyl)amino)-3-chloro-8-oxo-, (6r-(6alpha,7beta(r*)))-

    2. Ceclor

    3. Cefaclor Anhydrous

    4. Cefaclor Monohydrate

    5. Keclor

    6. Lilly 99638

    7. S 6472

    8. S-6472

    9. S6472

    2.3.2 Depositor-Supplied Synonyms

    1. 53994-73-3

    2. Cephaclor

    3. Ceclor

    4. Cefaclor Anhydrous

    5. Cefaclorum

    6. Kefral

    7. Panoral

    8. Raniclor

    9. Cefaclor [inn]

    10. Cefaclor Hydrate

    11. Cefaclorum [inn-latin]

    12. 3-chloro-7-d-(2-phenylglycinamido)-3-cephem-4-carboxylic Acid

    13. 143059-69-2

    14. S 6472

    15. Cefaclor Impurity C

    16. Chebi:3478

    17. Ccl

    18. 3z6fs3ik0k

    19. Mls000069617

    20. (6r,7r)-7-[[(2r)-2-amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    21. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid,7-[[(2r)-aminophenylacetyl]amino]-3-chloro-8-oxo-, (6r,7r)-

    22. 53994-73-3 (free)

    23. (6r,7r)-7-((r)-2-amino-2-phenylacetamido)-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    24. (6r,7r)-7-{[(2r)-2-amino-2-phenylacetyl]amino}-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    25. Ncgc00022612-04

    26. Alfacet

    27. Smr000058250

    28. Dsstox_cid_2748

    29. Dsstox_rid_76713

    30. Dsstox_gsid_22748

    31. Dystaclor Mr

    32. L-kefral

    33. Ceclor Cd

    34. Alenfral (tn)

    35. (6r,7r)-7-((r)-2-amino-2-phenylacetamido)-3-chloro-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid

    36. (6r,7r)-7-[(2r)-2-amino-2-phenylacetamido]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    37. Cas-53994-73-3

    38. Unii-3z6fs3ik0k

    39. Cefaclorimpurityc

    40. S-6472

    41. Cefaclor,(s)

    42. (6r,7r)-7-(((2r)-2-amino-2-phenylacetyl)amino)-3-chloro-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid

    43. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2r)-2-amino-2-phenylacetyl)amino)-3-chloro-8-oxo-, (6r,7r)-

    44. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[[(2r)-2-amino-2-phenylacetyl]amino]-3-chloro-8-oxo-, (6r,7r)-

    45. Einecs 258-909-5

    46. Mfcd00151471

    47. Cefaclor (jp17)

    48. Spectrum_001070

    49. Specplus_000947

    50. Cefaclor [jan]

    51. Cefaclor [mi]

    52. Prestwick0_000485

    53. Prestwick0_001102

    54. Prestwick1_000485

    55. Prestwick1_001102

    56. Prestwick2_000485

    57. Prestwick2_001102

    58. Prestwick3_000485

    59. Prestwick3_001102

    60. Spectrum2_001189

    61. Spectrum3_001858

    62. Spectrum4_000093

    63. Spectrum5_001727

    64. Cefaclor [who-dd]

    65. Chembl680

    66. Epitope Id:117133

    67. Schembl33540

    68. Bspbio_000349

    69. Bspbio_001204

    70. Bspbio_003276

    71. Kbiogr_000386

    72. Kbioss_001550

    73. Cid_51039

    74. Mls001424193

    75. Divk1c_007043

    76. Spectrum1500771

    77. Spbio_001237

    78. Spbio_002270

    79. Spbio_003082

    80. Bpbio1_000385

    81. Bpbio1_001326

    82. Dtxsid3022748

    83. Bdbm42131

    84. Kbio1_001987

    85. Kbio2_001550

    86. Kbio2_004118

    87. Kbio2_006686

    88. Kbio3_002777

    89. Bcpp000294

    90. Hms1571m06

    91. Hms1921g22

    92. Hms2052c11

    93. Hms2092k08

    94. Hms2233m13

    95. Pharmakon1600-01500771

    96. (6r,7r)-7-[[(2s)-2-amino-1-oxo-2-phenylethyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    97. Hy-b0198

    98. Zinc3812869

    99. Tox21_110880

    100. Ccg-40264

    101. Nsc757422

    102. Akos024282614

    103. Tox21_110880_1

    104. Bcp9000501

    105. Cefaclor, Analytical Reference Material

    106. Db00833

    107. Nc00354

    108. 7beta-{[(2r)-2-amino-2-phenylacetyl]amino}-3-chloro-3,4-didehydrocepham-4-carboxylic Acid

    109. Ncgc00015260-22

    110. Ncgc00022612-05

    111. Ncgc00022612-06

    112. Ncgc00022612-07

    113. Ncgc00022612-10

    114. Ncgc00022612-11

    115. 7-((2r)-2-amino-2-phenylacetylamino)(7r,7ar)-3-chloro-6-oxo-2h,7h-azetidino[2, 1-b]1,3-thiazine-4-carboxylic Acid

    116. As-74992

    117. Sbi-0051606.p002

    118. Ab00052174

    119. C3478

    120. C-2461

    121. C06877

    122. D00256

    123. Ab00052174_15

    124. Ab00052174_16

    125. Cefaclor, Antibiotic For Culture Media Use Only

    126. A900728

    127. Q415167

    128. Sr-05000001556

    129. Sr-05000001556-1

    130. Brd-k20338176-002-03-5

    131. 7-(d-2-amino-2-phenylacetamido)-3-chloro-3-cephem-4-carboxylic

    132. (6r,7r)-7-((s)-2-amino-2-phenylacetamido)-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    133. (6r,7r)-7-[(r)-2-amino-2-phenylacetamido]-3-chloro-8-oxo-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic Acid

    134. (6r,7r)-7-[[(2r)-2-amino-2-phenyl-acetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    135. (6r,7r)-7-[[(2r)-2-azaniumyl-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

    136. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((aminophenylacetyl)amino)-3-chloro-8-oxo-, (6r-(6-alpha,7-beta(r*)))-

    2.4 Create Date
    2005-06-29
    3 Chemical and Physical Properties
    Molecular Weight 367.8 g/mol
    Molecular Formula C15H14ClN3O4S
    XLogP3-1.8
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count4
    Exact Mass367.0393548 g/mol
    Monoisotopic Mass367.0393548 g/mol
    Topological Polar Surface Area138 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity606
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameCefaclor
    PubMed HealthCefaclor (By mouth)
    Drug ClassesAntibiotic
    Drug LabelCefaclor is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The molecular formula for cefaclor is C15H14ClN3O4SH2O and the...
    Active IngredientCefaclor
    Dosage FormTablet, extended release; Capsule; For suspension
    RouteOral
    Strengtheq 375mg base/5ml; eq 250mg base/5ml; eq 500mg base; eq 187mg base/5ml; eq 250mg base; eq 125mg base/5ml; eq 375mg base
    Market StatusPrescription
    CompanyTeva; Yung Shin Pharm; Hikma

    2 of 2  
    Drug NameCefaclor
    PubMed HealthCefaclor (By mouth)
    Drug ClassesAntibiotic
    Drug LabelCefaclor is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The molecular formula for cefaclor is C15H14ClN3O4SH2O and the...
    Active IngredientCefaclor
    Dosage FormTablet, extended release; Capsule; For suspension
    RouteOral
    Strengtheq 375mg base/5ml; eq 250mg base/5ml; eq 500mg base; eq 187mg base/5ml; eq 250mg base; eq 125mg base/5ml; eq 375mg base
    Market StatusPrescription
    CompanyTeva; Yung Shin Pharm; Hikma

    4.2 Drug Indication

    For the treatment of certain infections caused by bacteria such as pneumonia and ear, lung, skin, throat, and urinary tract infections.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Cefaclor is a second generation cephalosporin antibiotic with a spectrum resembling first-generation cephalosporins. In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell-wall synthesis. As indicated by _in vitro_ and _in vivo_ clinical studies, cefaclor was shown to be effective against most strains of Gram positive aerobes - Staphylococci (including coagulase-positive, coagulase-negative, and penicillinase-producing strains), Streptococcus pneumoniae, Streptococcus pyogenes (group A ß-hemolytic streptococci), as well as Gram-negative aerobes - Escherichia coli, Haemophilus influenzae (including ß-lactamase-producing ampicillin-resistant strains), Klebsiella sp, and Proteus mirabilis.

    5.2 MeSH Pharmacological Classification

    Anti-Bacterial Agents

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

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    CEFACLOR ANHYDROUS
    5.3.2 FDA UNII
    3Z6FS3IK0K
    5.3.3 Pharmacological Classes
    Cephalosporins [CS]; Cephalosporin Antibacterial [EPC]
    5.4 ATC Code

    J - Antiinfectives for systemic use

    J01 - Antibacterials for systemic use

    J01D - Other beta-lactam antibacterials

    J01DC - Second-generation cephalosporins

    J01DC04 - Cefaclor

    5.5 Absorption, Distribution and Excretion

    Absorption

    Well absorbed after oral administration, independent of food intake.

    Route of Elimination

    Approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours, the greater portion being excreted within the first 2 hours.

    5.6 Metabolism/Metabolites

    No appreciable biotransformation in liver (approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours).

    5.7 Biological Half-Life

    0.6-0.9 hour

    5.8 Mechanism of Action

    Cefaclor, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins. It is possible that cefaclor interferes with an autolysin inhibitor.

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Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1629829800,"product":"CEFACLOR MONOHYDRATE (PURICLOR POWDER CEFACLOR WHITE)","address":"ACME PLAZA, ANDHERI KURLA ROAD,ANDHERI EAST","city":"MUMBAI, MAHARASHTRA.","supplier":"CENTRIENT PHARMACEUTICALS","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"230","totalValueFC":"116601","currency":"USD","unitRateINR":"17296","date":"25-Aug-2021","totalValueINR":"8648000","totalValueInUsd":"116601","indian_port":"BOMBAY AIR","hs_no":"29419090","bill_no":"5186406","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,ANDHERI EAST"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1636914600,"product":"CEFACLOR MONOHYDRATE (PURICLOR POWDER CEFACLOR WHITE)","address":"SPARC TANDALJA","city":"VADODARA","supplier":"CENTRIENT PHARMACEUTICALS","supplierCountry":"CHINA","foreign_port":"NA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"230","totalValueFC":"116665.8","currency":"USD","unitRateINR":"17376.5","date":"15-Nov-2021","totalValueINR":"8688250","totalValueInUsd":"116665.8","indian_port":"BOMBAY AIR","hs_no":"29419090","bill_no":"6253054","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SPARC TANDALJA"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1639161000,"product":"CEFACLOR MONOHYDRATE (PURICLOR POWDER CEFACLOR 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PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"252","totalValueFC":"500409.1","currency":"USD","unitRateINR":"19895.4","date":"02-Jul-2022","totalValueINR":"39790800","totalValueInUsd":"500409.1","indian_port":"BOMBAY AIR","hs_no":"29419090","bill_no":"9375356","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SPARC TANDALJA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659119400,"product":"CEFACLOR, BATCH NO. 22052204402","address":"SURVEY NO.144 & 146, VILLAGE,HARIP URA, TAL. SAVLI,","city":"DIST VADODARA GUJARAT,GUJARAT","supplier":"ZHEJIANG ANGLIKANG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"BHARAT PARENTERALS LIMITED","customerCountry":"INDIA","quantity":"42.24","actualQuantity":"42.24","unit":"KGS","unitRateFc":"235","totalValueFC":"10105.3","currency":"USD","unitRateINR":"19023.3","date":"30-Jul-2022","totalValueINR":"803542.08","totalValueInUsd":"10105.3","indian_port":"AHMEDABAD AIR","hs_no":"29419090","bill_no":"9785712","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.144 & 146, VILLAGE,HARIP URA, TAL. SAVLI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727721000,"product":"CEFACLOR USP, BATCH NO. 4001CJ81LK (PHARMACEUTICAL RAW MATERIAL)","address":"SURVEY NO.144 146, VILLAGE","city":"DIST.VADODARA, GUJARAT","supplier":"ZHEJIANG RANTO PHARMACEUTICAL INDUS","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"BHARAT PARENTERALS LIMITED","customerCountry":"INDIA","quantity":"37.00","actualQuantity":"37","unit":"KGS","unitRateFc":"238","totalValueFC":"8866.1","currency":"USD","unitRateINR":"20134.8","date":"01-Oct-2024","totalValueINR":"744987.6","totalValueInUsd":"8866.1","indian_port":"Ahmedabad Air","hs_no":"29419090","bill_no":"5904806","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"ROOM 1708 BUILDING B, OCEAN INTERNATIONAL CENTER, GONGSHU, DISTRICT HANGZHOU, ZHEJIANG CHINA","customerAddress":"SURVEY NO.144 146, VILLAGE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734719400,"product":"PURICLOR (R) POWDER CEFACLOR WHITE CEFACLOR MONOHYDRATE PURICLOR (R) POWDER CEFACLOR WHITE CEFACLOR MONOHYDRATE","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"CENTRIENT PHARMACEUTICALS","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"275.00","actualQuantity":"275","unit":"KGS","unitRateFc":"300","totalValueFC":"83452.5","currency":"USD","unitRateINR":"25785","date":"21-Dec-2024","totalValueINR":"7090875","totalValueInUsd":"83452.5","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"7388168","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"A. FLEMINGLAAN 1, 2613 AX DELFT P.O.BOX 425, 2600 AK DELFT NL","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"}]
    03-Jan-2021
    28-Mar-2025
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    ABOUT THIS PAGE

    Looking for 53994-73-3 / Cefaclor API manufacturers, exporters & distributors?

    Cefaclor manufacturers, exporters & distributors 1

    94

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

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

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

    API | Excipient name

    Cefaclor

    Synonyms

    53994-73-3, Cephaclor, Ceclor, Cefaclor anhydrous, Cefaclorum, Kefral

    Cas Number

    53994-73-3

    Unique Ingredient Identifier (UNII)

    3Z6FS3IK0K

    About Cefaclor

    Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN.

    Ceclor CD Manufacturers

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

    Ceclor CD Suppliers

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

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

    Ceclor CD USDMF

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

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

    click here to find a list of Ceclor CD suppliers with USDMF on PharmaCompass.

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

    Ceclor CD KDMF

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

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

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

    click here to find a list of Ceclor CD suppliers with KDMF on PharmaCompass.

    Ceclor CD CEP

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

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

    Ceclor CD WC

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

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

    Ceclor CD 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 Ceclor CD as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Ceclor CD suppliers with NDC on PharmaCompass.

    Ceclor CD GMP

    Ceclor CD 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 Ceclor CD 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 Ceclor CD GMP manufacturer or Ceclor CD GMP API supplier for your needs.

    Ceclor CD CoA

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

    Ceclor CD CoA mostly includes findings from lab analyses of a specific batch. For each Ceclor CD 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.

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