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Erythromycin Ethyl Succinate

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 11 USDMF, 4 CEP/COS, 1 JDMF, 4 EU WC, 6 NDC API, 14 Listed Suppliers, $ API Reference Price

20 API Suppliers
11 USDMF
4 CEP/COS
1 JDMF
4 EU WC
6 NDC API
14 Listed Suppliers
$ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

58 FDF Dossiers, 42 FDA Orange Book, 3 Europe, 4 Australia, 9 Listed Dossiers

58 FDF Dossiers
42 FDA Orange Book
3 Europe
4 Australia
9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

GRANULE;ORAL - EQ 200MG BASE/5ML, GRANULE;ORAL - EQ 400MG BASE/5ML

drugProductComposition
GRANULE;ORAL - EQ 200MG BASE/5ML
GRANULE;ORAL - EQ 400MG BASE/5ML

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 6 DKSH, 1 Pharm-RX Chemical, 3 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 6 Actylis, 2 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 1 Corel Pharma Chem, 3 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 10 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 12 Kerry, 1 Kima Chemical, 14 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 2 Prachin Chemical, 17 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 9 Sigachi Industries, 1 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders, 32 Thickeners and Stabilizers, 29 Direct Compression, 27 Solubilizers, 18 Lubricants & Glidants, 17 Co-Processed Excipients, 16 Topical, 16 Coating Systems & Additives, 15 Granulation, 14 Controlled & Modified Release, 14 Disintegrants & Superdisintegrants, 12 Film Formers & Plasticizers, 11 Parenteral, 10 Taste Masking, 7 Rheology Modifiers, 7 Emulsifying Agents, 5 Chewable & Orodispersible Aids, 4 API Stability Enhancers, 2 Coloring Agents, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 4 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
4 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 4 Finished Drug Prices

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3 US Medicaid Prescriptions
4 Finished Drug Prices

MARKET PLACE

3 APIs

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3 APIs

REF. STANDARDS & IMPURITIES

5 EDQM , 1 USP , 1 Others

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5 EDQM
1 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 87

MARKET PLACE

API

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

4,856,851

Annual Reports (USD Million)

Finished Drug Prices

172 RELATED EXCIPIENT COMPANIES

309EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 1264-62-6, Erythroped, Pediamycin, Eryped, Wyamycin e, Erythromycin ethyl succinate

Molecular Formula

C₄₃H₇₅NO₁₆

Molecular Weight

862.1 g/mol

InChI Key

NSYZCCDSJNWWJL-YXOIYICCSA-N

FDA UNII

1014KSJ86F

A macrolide antibiotic, produced by Streptomyces erythreus. This compound is an ester of erythromycin base and succinic acid. It acts primarily as a bacteriostatic agent. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins.

1 2D Structure

Erythromycin Ethyl Succinate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-O-[(2S,3R,4S,6R)-4-(dimethylamino)-2-[[(3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-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-2,10-dioxo-oxacyclotetradec-6-yl]oxy]-6-methyloxan-3-yl] 1-O-ethyl butanedioate

2.1.2 InChI

InChI=1S/C43H75NO16/c1-15-29-43(11,52)36(48)24(5)33(47)22(3)20-41(9,51)38(25(6)34(26(7)39(50)57-29)59-32-21-42(10,53-14)37(49)27(8)56-32)60-40-35(28(44(12)13)19-23(4)55-40)58-31(46)18-17-30(45)54-16-2/h22-29,32,34-38,40,48-49,51-52H,15-21H2,1-14H3/t22-,23-,24+,25+,26-,27+,28+,29-,32+,34+,35-,36-,37+,38-,40+,41-,42-,43-/m1/s1

2.1.3 InChI Key

NSYZCCDSJNWWJL-YXOIYICCSA-N

2.1.4 Canonical SMILES

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)OC(=O)CCC(=O)OCC)(C)O)C)C)O)(C)O

2.1.5 Isomeric SMILES

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)OC(=O)CCC(=O)OCC)(C)O)C)C)O)(C)O

2.2 Other Identifiers

2.2.1 UNII

1014KSJ86F

2.3 Synonyms

2.3.1 MeSH Synonyms

1. E-mycin E

2. Emycin E

3. Eryped

4. Erythroped

5. Ethyl Succinate, Eyrthromycin

6. Ethylsuccinate, Erythromycin

7. Eyrthromycin Ethyl Succinate

8. Monomycin

9. Pediamycin

10. Succinate, Eyrthromycin Ethyl

11. Wyamycin E

2.3.2 Depositor-Supplied Synonyms

1. 1264-62-6

2. Erythroped

3. Pediamycin

4. Eryped

5. Wyamycin E

6. Erythromycin Ethyl Succinate

7. Erythromycin, 2'-(ethyl Butanedioate)

8. Wyamycin

9. Erythromycin 2'-(ethyl Butanedioate)

10. E.e.s.

11. Mls001074901

12. 41342-53-4

13. Nsc-756758

14. Erythromycin-ethyl Succinate

15. Succinic Acid, Monoethyl Ester, Monoester With Erythromycin

16. Chebi:31555

17. Erythrocin Ethyl Succinate

18. 1014ksj86f

19. E-mycin E

20. Smr000058868

21. Erythromycin 2'-(ethyl Succinate)

22. Anamycin

23. Arpimycin

24. Ery-ped

25. Pediamycin 400

26. Ees Granules

27. E.e.s

28. Erythromycin, Ethyl Succinate

29. Ees (antiobiotic)

30. Hsdb 3075

31. Erythromycin Ethylsuccinate [jan]

32. Erythromycin, Mono(ethyl Succinate)

33. Einecs 215-033-8

34. Brn 0077638

35. Esinol

36. Unii-1014ksj86f

37. Erythromycin, Mono(ethyl Succinate) (ester)

38. Ncgc00183038-01

39. E-mycin-e

40. E.e.s 200

41. E.e.s 400

42. Eryped (tn)

43. Durapaediat

44. Eryliquid

45. Refkas

46. Erythrocin W (tn)

47. Erythromycin Ethylsuccinate [usp:jan]

48. Spectrum_001046

49. Spectrum2_000983

50. Spectrum3_000419

51. Spectrum4_000536

52. Spectrum5_000668

53. Erythromycin-ethylsuccinate

54. Dsstox_cid_2993

55. Dsstox_rid_76821

56. Dsstox_gsid_22993

57. Erythromycin A Ethylsuccinate

58. Schembl18259

59. Bspbio_001978

60. Kbiogr_001171

61. Kbioss_001526

62. 4-18-00-07416 (beilstein Handbook Reference)

63. Mls000028651

64. Mls001076672

65. Succinicacid,monoethylester,monoesterwitherythromycin

66. Divk1c_000764

67. Spectrum1500279

68. Spbio_001045

69. Cid_443953

70. Chembl1200688

71. Dtxsid4022993

72. Bdbm96262

73. E.e.s. (tn)

74. Hms502g06

75. Kbio1_000764

76. Kbio2_001526

77. Kbio2_004094

78. Kbio2_006662

79. Kbio3_001198

80. Ninds_000764

81. Sterile Erythromycin Ethylsuccinate

82. Hms1923i21

83. Hms2091d03

84. Pharmakon1600-01500279

85. Erithromycin Ethyl Succinate

86. Hy-b0957

87. 2'-(ethyl Butanedioate)erythromycin

88. Tox21_113497

89. Ccg-40201

90. Lmpk05000001

91. Mfcd00084692

92. Nsc756758

93. S4060

94. Akos008145410

95. Zinc169356230

96. Cs-4434

97. Nsc 756758

98. Erythromycin Ethylsuccinate (jp17/usp)

99. Erythromycin Ethylsuccinate [mi]

100. Idi1_000764

101. Erythromycin (as Ethyl Succinate)

102. Ncgc00021382-03

103. 4-o-[(2s,3r,4s,6r)-4-(dimethylamino)-2-[[(3r,4s,5s,6r,7r,9r,11r,12r,13s,14r)-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-2,10-dioxo-oxacyclotetradec-6-yl]oxy]-6-methyloxan-3-yl] 1-o-ethyl Butanedioate

104. Erythromycin Ethylsuccinate [hsdb]

105. Cas-1264-62-6

106. Erythromycin Ethylsuccinate [vandf]

107. Sbi-0051367.p003

108. Erythromycin Ethylsuccinate [usp-rs]

109. Erythromycin Ethylsuccinate [who-dd]

110. Erythromycin Ethylsuccinate [who-ip]

111. Erythromycin Ethyl Succinate [mart.]

112. D01361

113. Ab00051980_11

114. Ab00051980_12

115. Erythromycin Ethylsuccinate [orange Book]

116. A805556

117. Erythromycin Ethylsuccinate [ep Monograph]

118. Erythromycin Ethylsuccinate [usp Monograph]

119. Erythromycini Ethylsuccinas [who-ip Latin]

120. Sr-05000001617

121. Eryzole Component Erythromycin Ethylsuccinate

122. Sr-05000001617-1

123. Erythromycin Ethylsuccinate Component Of Eryzole

124. Pediazole Component Erythromycin Ethylsuccinate

125. Q27114406

126. Erythromycin Ethylsuccinate Component Of Pediazole

127. Erythromycin Ethylsuccinate For Impurity P Identification

128. Sterile Erythromycin Ethylsuccinate [usp Monograph]

129. Oxo-oxacyclotetradec-6-yl]oxy]-6-methyloxan-3-yl] 1-o-ethyl Butanedioate

130. (2s,3r,4s,6r)-4-(dimethylamino)-2-(((3r,4s,5s,6r,7r,9r,11r,12r,13s,14r)-14-ethyl-7,12,13-trihydroxy-4-(((2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yl)oxy)-3,5,7,9,11,13-hexamethyl-2,10-dioxooxacyclotetradecan-6-yl)oxy)-6-methyltetrahydro-2h-pyran-3-yl Ethyl Succinate

131. (3r*,4s*,5s*,6r*,7r*,9r*,11r*,12r*,13s*,14r*)-4-((2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy)-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-((2- Ethyl Butanedioate -3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl)oxy)oxacyclotetradecane-2,10-dione

132. 4-o-[(2s,3r,4s,6r)-4-(dimethylamino)-2-[[(3r,4s,5s,6r,7r,9r,11r,12r,13s,14r)-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-2,10-di

133. O4-[(2s,3r,4s,6r)-4-(dimethylamino)-2-[[(3r,4s,5s,6r,7r,9r,11r,12r,13s,14r)-14-ethyl-7,12,13-trihydroxy-4-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyl-tetrahydropyran-2-yl]oxy-3,5,7,9,11,13-hexamethyl-2,10-dioxo-oxacyclotetradec-6-yl]oxy]-6-methyl-tetrahydropyran-3-yl] O1-ethyl Butanedioate

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₄₃H₇₅NO₁₆
Molecular Weight	862.1 g/mol
XLogP3	3.4
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	17
Rotatable Bond Count	14
Exact Mass	861.50858530 g/mol
Monoisotopic Mass	861.50858530 g/mol
Topological Polar Surface Area	226 Å²
Heavy Atom Count	60
Formal Charge	0
Complexity	1450
Isotope Atom Count	0
Defined Atom Stereocenter Count	18
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 12
Drug Name	E.e.s. 200
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Suspension
Route	Oral
Strength	eq 200mg base/5ml
Market Status	Prescription
Company	Arbor Pharms

2 of 12
Drug Name	E.e.s. 400
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Tablet; Suspension
Route	Oral
Strength	eq 400mg base/5ml; eq 400mg base
Market Status	Prescription
Company	Arbor Pharms

3 of 12
Drug Name	Eryped
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Granule
Route	Oral
Strength	eq 400mg base/5ml; eq 200mg base/5ml
Market Status	Prescription
Company	Arbor Pharms

4 of 12
Drug Name	Erythromycin ethylsuccinate
Drug Label	Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are...
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Tablet
Route	Oral
Strength	eq 400mg base
Market Status	Prescription
Company	Arbor Pharms

5 of 12
Drug Name	Pediamycin
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Suspension
Route	Oral
Strength	eq 200mg base/5ml
Market Status	Prescription
Company	Arbor Pharms

6 of 12
Drug Name	Pediamycin 400
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Suspension
Route	Oral
Strength	eq 400mg base/5ml
Market Status	Prescription
Company	Arbor Pharms

7 of 12
Drug Name	E.e.s. 200
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Suspension
Route	Oral
Strength	eq 200mg base/5ml
Market Status	Prescription
Company	Arbor Pharms

8 of 12
Drug Name	E.e.s. 400
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Tablet; Suspension
Route	Oral
Strength	eq 400mg base/5ml; eq 400mg base
Market Status	Prescription
Company	Arbor Pharms

9 of 12
Drug Name	Eryped
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Granule
Route	Oral
Strength	eq 400mg base/5ml; eq 200mg base/5ml
Market Status	Prescription
Company	Arbor Pharms

10 of 12
Drug Name	Erythromycin ethylsuccinate
Drug Label	Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are...
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Tablet
Route	Oral
Strength	eq 400mg base
Market Status	Prescription
Company	Arbor Pharms

11 of 12
Drug Name	Pediamycin
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Suspension
Route	Oral
Strength	eq 200mg base/5ml
Market Status	Prescription
Company	Arbor Pharms

12 of 12
Drug Name	Pediamycin 400
Active Ingredient	Erythromycin ethylsuccinate
Dosage Form	Suspension
Route	Oral
Strength	eq 400mg base/5ml
Market Status	Prescription
Company	Arbor Pharms

4.2 Therapeutic Uses

Antibiotics, Macrolide; Enzyme Inhibitors; Gastrointestinal Agents; Protein Synthesis Inhibitors

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

RELATIVELY NONIRRITATING...& THUS IS WELL SUITED TO IM INJECTION. ...ITS ACTIONS & USES ARE ESSENTIALLY THOSE OF ERYTHROMYCIN...INTO WHICH IT IS CONVERTED IN THE BODY.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1123

ERYTHROMYCIN IS...ANTIMICROBIAL... ERYTHROMYCIN IS.../ACTIVE/ AGAINST MOST GRAM-POSITIVE BACTERIA, MANY ANAEROBES...& LEGIONNAIRE'S BACILLUS. /ERYTHROMYCIN/

Miller, R. R., and D. J. Greenblatt. Handbook of Drug Therapy. New York: Elsevier North Holland, 1979., p. 55

ERYTHROMYCIN MAY BE...BACTERIOSTATIC OR BACTERICIDAL DEPENDING ON NATURE OF MICROORGANISM & CONCN OF DRUG. ...MOST EFFECTIVE IN VITRO AGAINST GRAM-POSITIVE COCCI SUCH AS STAPHYLOCOCCUS AUREUS (PENICILLIN G SENSITIVE OR RESISTANT), GROUP A STREPTOCOCCI, ENTEROCOCCI & PNEUMOCOCCI; MANY GRAM-POSITIVE BACILLI... /ERYTHROMYCIN/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1224

A REVIEW OF THE ANTIMICROBIAL SPECTRUM, PHARMACOLOGY & THERAPEUTIC USE OF ERYTHROMYCIN & ITS DERIVATIVES. (REF 24).

MEADE RH; DRUG THERAPY REVIEWS; ANTIMICROBIAL SPECTRUM, PHARMACOLOGY & THERAPEUTIC USE OF ERYTHROMYCIN & ITS DERIVATIVES; AM J HOSP PHARM 36, SEPT 1979, 1185-1189

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

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.)

Anti-Bacterial Agents

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

Enzyme Inhibitors

Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)

Protein Synthesis Inhibitors

Compounds which inhibit the synthesis of proteins. They are usually ANTI-BACTERIAL AGENTS or toxins. Mechanism of the action of inhibition includes the interruption of peptide-chain elongation, the blocking the A site of ribosomes, the misreading of the genetic code or the prevention of the attachment of oligosaccharide side chains to glycoproteins. (See all compounds classified as Protein Synthesis Inhibitors.)

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

ERYTHROMYCIN ETHYLSUCCINATE IS PARTIALLY DISSOCIATED IN INTESTINE; BOTH ERYTHROMYCIN & UNDISSOCIATED ESTER ARE ABSORBED &, IN THE BLOOD, THE ESTER IS HYDROLYZED TO RELEASE FREE ERYTHROMYCIN.

Miller, R. R., and D. J. Greenblatt. Handbook of Drug Therapy. New York: Elsevier North Holland, 1979., p. 54

ERYTHROMYCIN ETHYLSUCCINATE...IS ADEQUATELY ABSORBED FOLLOWING ORAL ADMINISTRATION, PARTICULARLY WHEN THE STOMACH IS EMPTY. PEAK CONCENTRATIONS IN PLASMA ARE 1.5 UG/ML (0.5 UG/ML OF BASE) 1 TO 2 HR AFTER ADMINISTRATION OF A 500 MG TABLET.

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

IN PATIENTS, MEAN BILE LEVELS OF ERYTHROMYCIN WERE APPROXIMATELY 10 TIMES HIGHER THAN CORRESPONDING SERUM CONCN 1 HR AFTER IV (ERYTHROMYCIN LACTOBIONATE) & IM (ERYTHROMYCIN SUCCINATE) INJECTION.

CHELVAN P ET AL; BILIARY EXCRETION OF ERYTHROMYCIN AFTER PARENTERAL ADMINISTRATION; BR J CLIN PHARMACOL 8(3) 233 (1979)

IN HEALTHY ADULT SUBJECTS & IN ADULT PATIENTS WITH BRONCHIAL INFECTIONS, PHARMACOKINETICS OF VARIOUS FORMULATIONS OF ERYTHROMYCIN WERE STUDIED. ERYTHROMYCIN ETHYLSUCCINATE WAS BETTER THAN ERYTHROMYCIN STEARATE FOR ORAL TREATMENT IN THAT IT WAS RAPIDLY & CONSISTENTLY ABSORBED.

SIMON C; CURR MED RES OPIN 6(8) 17 (1980)

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API Reference Price

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Quantity (KGS) & Unit rate (USD/KGS) over time

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DOSAGE - GRANULE;ORAL - EQ 200MG BASE/5ML

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DOSAGE - GRANULE;ORAL - EQ 400MG BASE/5ML

USFDA APPLICATION NUMBER - 50207

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ABOUT THIS PAGE

Erythromycin Ethyl Succinate Manufacturers

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

Erythromycin Ethyl Succinate Suppliers

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

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

Erythromycin Ethyl Succinate USDMF

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

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

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

Erythromycin Ethyl Succinate 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 Ethyl Succinate Drug Master File in Japan (Erythromycin Ethyl Succinate JDMF) empowers Erythromycin Ethyl Succinate 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 Ethyl Succinate JDMF during the approval evaluation for pharmaceutical products. At the time of Erythromycin Ethyl Succinate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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Erythromycin Ethyl Succinate CEP

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

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

Erythromycin Ethyl Succinate WC

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

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

Erythromycin Ethyl Succinate 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 Ethyl Succinate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Erythromycin Ethyl Succinate GMP

Erythromycin Ethyl Succinate 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 Ethyl Succinate 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 Ethyl Succinate GMP manufacturer or Erythromycin Ethyl Succinate GMP API supplier for your needs.

Erythromycin Ethyl Succinate CoA

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

Erythromycin Ethyl Succinate CoA mostly includes findings from lab analyses of a specific batch. For each Erythromycin Ethyl Succinate 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 Ethyl Succinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Erythromycin Ethyl Succinate EP), Erythromycin Ethyl Succinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Erythromycin Ethyl Succinate 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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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

20 API Suppliers

11 USDMF

4 CEP/COS

1 JDMF

4 EU WC

6 NDC API

14 Listed Suppliers

$ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

58 FDF Dossiers

42 FDA Orange Book

3 Europe

4 Australia

9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

GRANULE;ORAL - EQ 200MG BASE/5ML

GRANULE;ORAL - EQ 400MG BASE/5ML

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

5 SPI Pharma

2 Seqens

6 DKSH

1 Pharm-RX Chemical

3 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

10 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pfanstiehl

6 Actylis

2 Aeon Procare

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

21 BASF

1 Corel Pharma Chem

3 DFE Pharma

1 Doshion Polyscience

2 Finar

10 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

12 Kerry

1 Kima Chemical

14 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

3 Pluviaendo

2 Prachin Chemical

17 Roquette

7 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

9 Sigachi Industries

1 The Dow Chemical Company

1 Ulanqab Kema New Material

2 Valens Pharmachem

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders

32 Thickeners and Stabilizers

29 Direct Compression

27 Solubilizers

18 Lubricants & Glidants

17 Co-Processed Excipients

16 Topical

16 Coating Systems & Additives

15 Granulation

14 Controlled & Modified Release

14 Disintegrants & Superdisintegrants

12 Film Formers & Plasticizers

11 Parenteral