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Also known as: Roxithromycin, 80214-83-1, Roxithromycine, Roxithromycinum, Roxitromicina, Ru 965
Molecular Formula
C41H76N2O15
Molecular Weight
837.0  g/mol
InChI Key
RXZBMPWDPOLZGW-XMRMVWPWSA-N
FDA UNII
21KOF230FA

Roxithromycin
Semisynthetic derivative of erythromycin. It is concentrated by human phagocytes and is bioactive intracellularly. While the drug is active against a wide spectrum of pathogens, it is particularly effective in the treatment of respiratory and genital tract infections.
1 2D Structure

Roxithromycin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(3R,4S,5S,6R,7R,9R,10E,11S,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-10-(2-methoxyethoxymethoxyimino)-3,5,7,9,11,13-hexamethyl-oxacyclotetradecan-2-one
2.1.2 InChI
InChI=1S/C41H76N2O15/c1-15-29-41(10,49)34(45)24(4)31(42-53-21-52-17-16-50-13)22(2)19-39(8,48)36(58-38-32(44)28(43(11)12)18-23(3)54-38)25(5)33(26(6)37(47)56-29)57-30-20-40(9,51-14)35(46)27(7)55-30/h22-30,32-36,38,44-46,48-49H,15-21H2,1-14H3/b42-31+/t22-,23-,24+,25+,26-,27+,28+,29-,30+,32-,33+,34-,35+,36-,38+,39-,40-,41-/m1/s1
2.1.3 InChI Key
RXZBMPWDPOLZGW-XMRMVWPWSA-N
2.1.4 Canonical SMILES
CCC1C(C(C(C(=NOCOCCOC)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
CC[C@@H]1[C@@]([C@@H]([C@H](/C(=N/OCOCCOC)/[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
21KOF230FA
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Biaxsig

2. Claramid

3. Infectoroxit

4. Macrosil

5. Mtw-roxithromycin

6. Rotesan

7. Rotramin

8. Roxi 1a Pharma

9. Roxi Basics

10. Roxi Tad

11. Roxi Von Ct

12. Roxi-paed 1a Pharma

13. Roxi-puren

14. Roxi-q

15. Roxi-saar

16. Roxi-wolff

17. Roxibeta

18. Roxidura

19. Roxigamma

20. Roxigrn

21. Roxihexal

22. Roxithro-lich

23. Roxithromycin

24. Ru 28965

25. Ru 965

26. Ru-28965

27. Ru-965

28. Ru28965

29. Ru965

30. Rulid

2.3.2 Depositor-Supplied Synonyms

1. Roxithromycin

2. 80214-83-1

3. Roxithromycine

4. Roxithromycinum

5. Roxitromicina

6. Ru 965

7. Ru 28965

8. Ru-965

9. Rulid

10. Chebi:48935

11. Nsc-758443

12. Erythromycin 9-(o-((2-methoxyethoxy)methyl)oxime)

13. 21kof230fa

14. Ru-28965

15. 9-(o-((2-methoxyethoxy)methyl)oxime)erythromycin

16. (9e)-erythromycin 9-(o-((2-methoxyethoxy)methyl)oxime)

17. (e)-roxithromycin

18. Roxithromycine [french]

19. Roxithromycinum [latin]

20. Roxitromicina [spanish]

21. (3r,4s,5s,6r,7r,9r,11s,12r,13s,14r,e)-6-(((2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-14-ethyl-7,12,13-trihydroxy-4-(((2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yl)oxy)-10-(((2-methoxyethoxy)methoxy)imino)-3,5,7,9,11,13-hexamethyloxacyclotetradecan-2-one

22. Rulide (tn)

23. 9-[o-[(2-methoxyethoxy)methyl]oxime]erythromycin

24. Sr-05000001850

25. Chebi:48844

26. Unii-21kof230fa

27. Erythromycin, 9-(o-((2-methoxyethoxy)methyl)oxime), (9e)-

28. Ccris 3461

29. Roxithromycin,(s)

30. (3r,4s,5s,6r,7r,9r,10e,11s,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-10

31. Roxithromycin [usan:inn:ban:jan]

32. Rc2952

33. Brn 4286925

34. Spectrum5_001058

35. Roxithromycin [mi]

36. Roxithromycin [inn]

37. Roxithromycin [jan]

38. Roxithromycin [usan]

39. Schembl65985

40. Bspbio_002717

41. Roxithromycin [mart.]

42. Spectrum1503276

43. 9-[o-(2-methoxyethoxymethyl)-oxime] Of Erythromycin

44. Erythromycin, 9-(o-((2-methoxyethoxy)methyl)oxime)

45. Roxithromycin [who-dd]

46. Chembl1214185

47. Hms501d04

48. Hms1922o19

49. Hms2093c11

50. Hms3714l09

51. Pharmakon1600-01503276

52. Roxithromycin (jp17/usan/inn)

53. Roxithromycin [ep Impurity]

54. Hy-b0435

55. Roxithromycin [ep Monograph]

56. Bdbm50248154

57. Ccg-39329

58. Mfcd00214389

59. Nsc758443

60. Zinc96061888

61. Akos015969730

62. Db00778

63. Nsc 758443

64. Idi1_000382

65. Ncgc00178510-01

66. Roxithromycin 100 Microg/ml In Methanol

67. (3r,4s,5s,6r,7r,9r,10e,11s,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-10-(2-methoxyethoxymethoxyimino)-3,5,7,9,11,13-hexamethyl-oxacyclotetradecan-2-one

68. Roxithromycin 1000 Microg/ml In Methanol

69. Sbi-0051809.p002

70. Roxithromycin 100 Microg/ml In Acetonitrile

71. D01710

72. Ab00052342_02

73. Sr-05000001850-1

74. Sr-05000001850-2

75. Brd-k38684403-001-03-9

76. Brd-k38684403-001-05-4

77. Q27895851

78. 9-[o-[(2-methoxyethoxy)methyl]oxime]erythromycin, (9e)-

79. (e)-erythromycin-9-(o-((2-methoxyethoxy)methyl)oxime)

80. Erythromycin 9-(e)-(o-((2-methoxyethoxy)methyl)oxime)

81. Erythromycin A, 9-(o-(2-methoxyethoxymethyl)-oxime)

82. (3r,4s,5s,6r,7r,9r,10e,11s,12r,13s,14r)-4-(2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyloxy)-14-ethyl-7,12,13-trihydroxy-10-{[(2-methoxyethoxy)methoxy]imino}-6-[3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyloxy]-3,5,7,9,11,13-hexamethyloxacyclotetradecan-2-one

83. (3r,4s,5s,6r,7r,9r,10e,11s,12r,13s,14r)-6-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyl-tetrahydropyran-2-yl]oxy-14-ethyl-7,12,13-trihydroxy-4-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyl-tetrahydropyran-2-yl]oxy-10-(2-methoxyethoxymethoxyimino)-3,5,7,9,11,13-hexamethyl-oxacyclotetradecan-2-one

84. (3r,4s,5s,6r,7r,9r,10e,11s,12r,13s,14r)-6-{[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-{[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yl]oxy}-10-{[(2-methoxyethoxy)m

85. (3r,4s,5s,6r,7r,9r,10e,11s,12r,13s,14r)-6-{[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-{[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yl]oxy}-10-{[(2-methoxyethoxy)methoxy]imino}-3,5,7,9,11,13-hexamethyloxacyclotetradecan-2-one

86. (3r,4s,5s,6r,7r,9r,10e,11s,12r,13s,14r)-6-{[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yl]oxy}-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-hexamethyloxacyclotetradecane-2,10-dione 10-{o-[(2-methoxyethoxy)methyl]oxime} (non-preferred Name)

87. (3r,4s,5s,6r,7r,9r,11s,12r,13s,14r)-4-((2,6dideoxy-3-c-methyl-3-o-methyl-.alpha.-l-ribo-hexopyranosyl)oxy)-14-ethyl-7,12,13-trihydroxy-10-((e)((2-methoxyethoxy)methoxy)imino)-3,5,7,9,11,13hexamethyl-6-((3,4,6-trideoxy-3-(dimethylamino)-.beta.-d-xylohexopyranosyl)oxy)oxacyclotetradecan-2-one

88. (3r,4s,5s,6r,7r,9r,11s,12r,13s,14r)-4-(2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyloxy)-14-ethyl-7,12,13-trihydroxy-10-{[(2-methoxyethoxy)methoxy]imino}-6-[3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyloxy]-3,5,7,9,11,13-hexamethyloxacyclotetradecan-2-one

89. (3r,4s,5s,6r,7r,9r,11s,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-10-(2,4,7-trioxa-1-azaoctan-1-ylidene)-1-oxacyclotetradecan-2-one

90. (3r,4s,5s,6r,7r,9r,11s,12r,13s,14r,e)-6-(((2s,3r,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-14-ethyl-7,12,13-trihydroxy-4-(((2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yl)oxy)-10-(((2-methoxyethoxy)methoxy)imino)-3,5,7,9,11,13-hexamethyloxacyclotetradecan-2-one

2.4 Create Date
2006-07-15
3 Chemical and Physical Properties
Molecular Weight 837.0 g/mol
Molecular Formula C41H76N2O15
XLogP33.1
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count17
Rotatable Bond Count13
Exact Mass836.52456972 g/mol
Monoisotopic Mass836.52456972 g/mol
Topological Polar Surface Area217 Ų
Heavy Atom Count58
Formal Charge0
Complexity1310
Isotope Atom Count0
Defined Atom Stereocenter Count18
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Used to treat respiratory tract, urinary and soft tissue infections.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Roxithromycin has the following antibacterial spectrum in vitro: Streptococcus agalactiae, Streptococcus pneumoniae (Pneumococcus), Neisseria meningitides (Meningococcus), Listeria monocytogenes, Mycoplasma pneumoniae, Chlamydia trachomatis, Ureaplasma urealyticum, Legionella pneumophila, Helicobacter (Campylobacter), Gardnerella vaginalis, Bordetella pertussis, Moraxella catarrhalis (Branhamella Catarrhalis), and Haemophilus ducreyi. Roxithromycin is highly concentrated in polymorphonuclear leukocytes and macrophages, achieving intracellular concentrations greater than those outside the cell. Roxithromycin enhances the adhesive and chemotactic functions of these cells which in the presence of infection produce phagocytosis and bacterial lysis. Roxithromycin also possesses intracellular bactericidal activity.


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 ATC Code

J - Antiinfectives for systemic use

J01 - Antibacterials for systemic use

J01F - Macrolides, lincosamides and streptogramins

J01FA - Macrolides

J01FA06 - Roxithromycin


5.4 Absorption, Distribution and Excretion

Absorption

Very rapidly absorbed and diffused into most tissues and phagocytes.


5.5 Metabolism/Metabolites

Hepatic. Roxithromycin is only partially metabolised, more than half the parent compound being excreted unchanged. Three metabolites have been identified in urine and faeces: the major metabolite is descladinose roxithromycin, with N-mono and N-di-demethyl roxithromycin as minor metabolites. The respective percentage of roxithromycin and these three metabolites is similar in urine and faeces.


5.6 Biological Half-Life

12 hours


5.7 Mechanism of Action

Roxithromycin prevents bacterial growth by interfering with their protein synthesis. It binds to the 50S subunit of bacterial ribosomes and inhibits the translocation of peptides.


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CHEMIE PHARMIE LIMITED","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"103","totalValueFC":"104208.5","currency":"USD","unitRateINR":"8650.2","date":"13-Sep-2023","totalValueINR":"8650163.93","totalValueInUsd":"104208.5","indian_port":"JNPT","hs_no":"29419090","bill_no":"7804930","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"LTD NO.61 NORTH YUEDONG ROAD, SHAOXING CITY ,ZHEJIANG PROVINCESDNF CHINA","customerAddress":"5\/C SHREE LAXMI INDUSTRAIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696876200,"product":"ROXITHROMYCIN IP\/EP","address":"57, 5TH FLOOR, BAJAJ BHAVAN,,NARIM","city":"MUMBAI,MAHARASHTRA","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SHAH C J ","customerCountry":"INDIA","quantity":"750.00","actualQuantity":"750","unit":"KGS","unitRateFc":"105","totalValueFC":"79621.2","currency":"USD","unitRateINR":"8835.8","date":"10-Oct-2023","totalValueINR":"6626812.5","totalValueInUsd":"79621.2","indian_port":"JNPT","hs_no":"29415000","bill_no":"8228114","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.6, WEIWU ROADHANGZHOU GULF SHANGYUECONOMIC AND TECHNOLOGIAL ,DEVELOPM CN","customerAddress":"57, 5TH FLOOR, BAJAJ BHAVAN,,NARIM"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697049000,"product":"ROXITHROMYCIN IP\/EP CHINA MADE","address":"501-502,AMBA SADAN,","city":"MUMBAI,MAHARASHTRA","supplier":"ZHEJIANG ZHENYUAN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GENERAL IMPORT COMPANY (INDIA) PRIVATE LIMITED","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"102","totalValueFC":"51612","currency":"USD","unitRateINR":"8591.3","date":"12-Oct-2023","totalValueINR":"4295633.41","totalValueInUsd":"51612","indian_port":"JNPT","hs_no":"29419090","bill_no":"8257078","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":". LTD61 NORTH YUEDONG ROAD,SHAOXING, ZHEJIANG,SDNF CHINA","customerAddress":"501-502,AMBA SADAN,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698863400,"product":"ROXITHROMYCIN IP\/USP (FORM 10 LICENSE NO: IL\/BD-013317BD-709 DT:19.04.2023 VT:28.02.2026)","address":"NO.14, KRUMBIGAL ROAD","city":"BANGALORE","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"DOVE PHARMACEUTICALS","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"104","totalValueFC":"10516","currency":"USD","unitRateINR":"8756.8","date":"02-Nov-2023","totalValueINR":"875680","totalValueInUsd":"10516","indian_port":"Madras Sea","hs_no":"29415000","bill_no":"8595596","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"LTD, NO 6 WEIWU ROAD, HANGZHOU GULFSHANGYU INDUSTRIAL ZONEZHEJIANG CHINA","customerAddress":"NO.14, KRUMBIGAL ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705602600,"product":"ROXITHROMYCIN EP\/IP","address":"BEETAL HOUSE, 99, MADANGIR","city":"NEW DELHI","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DEL TRADE INTERNATIONAL ","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"107","totalValueFC":"32481.7","currency":"USD","unitRateINR":"8998.7","date":"19-Jan-2024","totalValueINR":"2699610","totalValueInUsd":"32481.7","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"9728995","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.6 WEIWU ROAD HANGZHOU GULF SHANGYU ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE ZHEJIANG P.R. CHINA - 3 CHINA","customerAddress":"BEETAL HOUSE, 99, MADANGIR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706639400,"product":"ROXITHROMYCIN EP\/IP","address":"42,MAHANT ROAD,3,VILE PARLE","city":"MUMBAI,MAHARASHTRA","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"PRATISTHA PHARMA","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"103","totalValueFC":"26056.2","currency":"USD","unitRateINR":"8662.3","date":"31-Jan-2024","totalValueINR":"2165575","totalValueInUsd":"26056.2","indian_port":"JNPT","hs_no":"29419090","bill_no":"9914172","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO. 06, WEIWU ROAD, HANGZHOU GULF SHANGY U ECONOMIC AND TECHNOLOGICALDEVELOPMENT ZONE ZHEJIANG P.R.CHINA CHINA","customerAddress":"42,MAHANT ROAD,3,VILE PARLE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717439400,"product":"ROXITHROMYCIN IP\/EP","address":"501, SWASTIK CHAMBER","city":"MUMBAI","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"FARMACHEM LIFE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"498.70","actualQuantity":"498.7","unit":"KGS","unitRateFc":"101","totalValueFC":"50949.1","currency":"USD","unitRateINR":"8528.6","date":"04-Jun-2024","totalValueINR":"4253200.92","totalValueInUsd":"50949.1","indian_port":"JNPT","hs_no":"29419019","bill_no":"3820859","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.6,WEIWU ROAD,HANGZHOU GULF, SHANGYU INDUSTRIAL ZONE, ZHEJIANG, CHINA China","customerAddress":"501, SWASTIK CHAMBER"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722796200,"product":"ROXITHROMYCIN EP\/IP","address":"CADILA CORPORATE CAMPUS","city":"AHMEDABAD, GUJARAT","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"CADILA PHARMACEUTICALS","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"110.5","totalValueFC":"11145","currency":"USD","unitRateINR":"9348.3","date":"05-Aug-2024","totalValueINR":"934830","totalValueInUsd":"11145","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"4891009","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":",LTDNO.6 WEIWU ROAD, HANGZHOU GULFSHANGYU ECONOMIC AND TECHNOLOGICALDEVELOPMENT ZONE, ZHEJIANG CHINA","customerAddress":"CADILA CORPORATE CAMPUS"}]
27-Feb-2021
26-Dec-2024
KGS
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Average Price (USD/KGS)

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Total Value (USD)

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

API Imports and Exports

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ABOUT THIS PAGE

Roxithromycin Manufacturers

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

Roxithromycin Suppliers

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

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

Roxithromycin USDMF

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

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

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

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

Roxithromycin KDMF

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

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

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

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

Roxithromycin CEP

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

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

Roxithromycin WC

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

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

Roxithromycin GMP

Roxithromycin 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 Roxithromycin 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 Roxithromycin GMP manufacturer or Roxithromycin GMP API supplier for your needs.

Roxithromycin CoA

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

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

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