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Erythromycin Stearate

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

27 API Suppliers, 18 USDMF, 1 CEP/COS, 1 JDMF, 2 EU WC, 2 NDC API, 13 Listed Suppliers, $ API Reference Price

27 API Suppliers
18 USDMF
1 CEP/COS
1 JDMF
2 EU WC
2 NDC API
13 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

86 FDF Dossiers, 25 FDA Orange Book, 4 Canada, 4 Australia, 32 South Africa, 21 Listed Dossiers

86 FDF Dossiers
25 FDA Orange Book
4 Canada
4 Australia
32 South Africa
21 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 3 DKSH, 2 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 3 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 18 BASF, 1 Corel Pharma Chem, 1 Doshion Polyscience, 2 Finar, 4 Gangwal Chemicals, 2 Ingredion Pharma Solutions, 1 Kerry, 1 Kima Chemical, 5 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 8 Roquette, 3 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Sigachi Industries, 1 The Dow Chemical Company, 2 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

24 Fillers, Diluents & Binders, 19 Solubilizers, 15 Direct Compression, 15 Thickeners and Stabilizers, 12 Topical, 10 Coating Systems & Additives, 10 Granulation, 9 Controlled & Modified Release, 9 Disintegrants & Superdisintegrants, 7 Co-Processed Excipients, 7 Taste Masking, 7 Film Formers & Plasticizers, 6 Parenteral, 5 Emulsifying Agents, 4 Rheology Modifiers, 4 Chewable & Orodispersible Aids, 2 Coloring Agents, 2 Surfactant & Foaming Agents

excipientsByApplications
24 Fillers, Diluents & Binders
19 Solubilizers
15 Direct Compression
15 Thickeners and Stabilizers
12 Topical
10 Coating Systems & Additives
10 Granulation
9 Controlled & Modified Release
9 Disintegrants & Superdisintegrants
7 Co-Processed Excipients
7 Taste Masking
7 Film Formers & Plasticizers
6 Parenteral
5 Emulsifying Agents
4 Rheology Modifiers
4 Chewable & Orodispersible Aids
2 Coloring Agents
2 Surfactant & Foaming Agents

DIGITAL CONTENT

1 NEWS #PharmaBuzz

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1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

globalSalesInformation
1 US Medicaid Prescriptions

MARKET PLACE

7 APIs

marketPlace
7 APIs

REF. STANDARDS & IMPURITIES

5 EDQM , 1 USP , 1 Others

otherSolutions
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)

$ 54

MARKET PLACE

API

FDF

0INTERMEDIATES

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)

4,804

Annual Reports (USD Million)

Finished Drug Prices

87 RELATED EXCIPIENT COMPANIES

167EXCIPIENTS BY APPLICATIONS

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 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 Formula	C₅₅H₁₀₃NO₁₅
Molecular Weight	1018.4 g/mol
Hydrogen Bond Donor Count	6
Hydrogen Bond Acceptor Count	16
Rotatable Bond Count	23
Exact Mass	1017.73277158 g/mol
Monoisotopic Mass	1017.73277158 g/mol
Topological Polar Surface Area	231 Å²
Heavy Atom Count	71
Formal Charge	0
Complexity	1380
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	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Erythrocin stearate
Drug Label	ERYTHROCIN 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 Ingredient	Erythromycin stearate
Dosage Form	Tablet
Route	Oral
Strength	eq 250mg base
Market Status	Prescription
Company	Arbor Pharms

2 of 2
Drug Name	Erythrocin stearate
Drug Label	ERYTHROCIN 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 Ingredient	Erythromycin stearate
Dosage Form	Tablet
Route	Oral
Strength	eq 250mg base
Market Status	Prescription
Company	Arbor 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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API Reference Price

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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":"Q1","strtotime":1709404200,"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":"3300.00","actualQuantity":"3300","unit":"KGS","unitRateFc":"60","totalValueFC":"200252.2","currency":"USD","unitRateINR":"5038.8","date":"03-Mar-2024","totalValueINR":"16628098.08","totalValueInUsd":"200252.2","indian_port":"Madras Sea","hs_no":"29415000","bill_no":"2407324","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"8\/6,CATHAY HOUSE, 1ST FLOORSATHORN NUA ROAD, SILOMBANGRAK, BANGKOK 10500 THAILAND","customerAddress":"25, 2ND PULIYUR MAIN ROAD,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ABOUT THIS PAGE

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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Erythromycin Stearate

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers

18 USDMF

1 CEP/COS

1 JDMF

2 EU WC

2 NDC API

13 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

86 FDF Dossiers

25 FDA Orange Book

4 Canada

4 Australia

32 South Africa

21 Listed Dossiers

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18 BASF

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2 Finar

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1 Kerry

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1 Novo Excipients

1 Pharmatrans-Sanaq

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8 Roquette

3 Seppic

2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Sigachi Industries

1 The Dow Chemical Company

2 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

24 Fillers, Diluents & Binders

19 Solubilizers

15 Direct Compression

15 Thickeners and Stabilizers

12 Topical

10 Coating Systems & Additives

10 Granulation

9 Controlled & Modified Release

9 Disintegrants & Superdisintegrants

7 Co-Processed Excipients

7 Taste Masking

7 Film Formers & Plasticizers

6 Parenteral

5 Emulsifying Agents

4 Rheology Modifiers

4 Chewable & Orodispersible Aids

2 Coloring Agents

2 Surfactant & Foaming Agents

DIGITAL CONTENT

1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

MARKET PLACE

7 APIs

REF. STANDARDS & IMPURITIES

5 EDQM