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Chemistry

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Also known as: 90098-04-7, Proamipide, Mucosta, 111911-87-6, Opc-12759, Rebamipide hydrate
Molecular Formula
C19H15ClN2O4
Molecular Weight
370.8  g/mol
InChI Key
ALLWOAVDORUJLA-UHFFFAOYSA-N
FDA UNII
LR583V32ZR

Rebamipide
Rebamipide is a quinolinone derivative with anti-ulcer and anti-inflammatory activities. Rebamipide induces cyclooxygenase 2 (COX2) synthesis which results in an increase in endogenous prostaglandin synthesis in the gastric mucosa. This agent also inhibits H. pylori-induced production of tumor necrosis factor (TNF) alpha and subsequent inflammation of the gastric mucosa. In addition, rebamipide scavenges oxygen-derived free radicals that potentially cause mucosal injury, and stimulates prostaglandin EP4 receptor gene expression followed by mucous secretion, thereby enhancing the gastric mucosal defense.
1 2D Structure

Rebamipide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[(4-chlorobenzoyl)amino]-3-(2-oxo-1H-quinolin-4-yl)propanoic acid
2.1.2 InChI
InChI=1S/C19H15ClN2O4/c20-13-7-5-11(6-8-13)18(24)22-16(19(25)26)9-12-10-17(23)21-15-4-2-1-3-14(12)15/h1-8,10,16H,9H2,(H,21,23)(H,22,24)(H,25,26)
2.1.3 InChI Key
ALLWOAVDORUJLA-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC=C2C(=C1)C(=CC(=O)N2)CC(C(=O)O)NC(=O)C3=CC=C(C=C3)Cl
2.2 Other Identifiers
2.2.1 UNII
LR583V32ZR
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-(4-chlorobenzoylamino)-3-(2(1h)-quinolinon-4-yl)propionic Acid

2. Opc 12759

3. Opc-12759

4. Rebamipide, (+)-isomer

5. Rebamipide, (-)-isomer

2.3.2 Depositor-Supplied Synonyms

1. 90098-04-7

2. Proamipide

3. Mucosta

4. 111911-87-6

5. Opc-12759

6. Rebamipide Hydrate

7. Pramipide

8. Rebator

9. 2-(4-chlorobenzoylamino)-3-(1,2-dihydro-2-oxo-4-quinolyl)propionic Acid

10. 139344-42-6

11. 2-[(4-chlorobenzoyl)amino]-3-(2-oxo-1h-quinolin-4-yl)propanoic Acid

12. Nsc-758955

13. 2-(4-chlorobenzamido)-3-(2-oxo-1,2-dihydroquinolin-4-yl)propanoic Acid

14. Lr583v32zr

15. Mfcd00866895

16. Ncgc00095161-01

17. 2-(4-chlorobenzamido)-3-[2(1h)-quinolinon-4-yl]propionic Acid

18. Dsstox_cid_25937

19. Dsstox_rid_81235

20. Dsstox_gsid_45937

21. Rebamipidum

22. Rebamipide [inn:jan]

23. 2-[(4-chlorobenzoyl)amino]-3-(2-hydroxyquinolin-4-yl)propanoic Acid

24. Rebamipidum [inn-latin]

25. 2-[[(4-chlorophenyl)-oxomethyl]amino]-3-(2-oxo-1h-quinolin-4-yl)propanoic Acid

26. Opc 12759

27. Cas-90098-04-7

28. Ccris 3585

29. Sr-05000001520

30. Unii-lr583v32zr

31. N-[(4-chlorophenyl)carbonyl]-3-(2-oxo-1,2-dihydroquinolin-4-yl)alanine

32. Dispersered72

33. 2-[(4-chlorophenyl)carbonylamino]-3-(2-oxidanylidene-1h-quinolin-4-yl)propanoic Acid

34. Rebamipide-[d4]

35. Mucosta (tn)

36. Rebamipide [mi]

37. Rebamipide [inn]

38. Rebamipide [jan]

39. Spectrum2_000039

40. Spectrum3_001959

41. Rebamipide (jp17/inn)

42. (+-)-2-(4-chlorobenzoylamino)-3-(2(1h)-quinolinon-4-yl)propionic Acid

43. (+-)-1,2-dihydro-alpha-((4-chlorobenzoyl)amino)-2-oxo-4-quinolinepropanoic Acid

44. Rebamipide [who-dd]

45. Bspbio_003559

46. Gtpl871

47. Mls006011883

48. Schembl221527

49. Spectrum1505310

50. Spbio_000137

51. Rebamipide 111911-87-6

52. Chembl1697771

53. Dtxsid8045937

54. Chebi:93814

55. Kbio3_002880

56. Opc-759

57. Hms1922b20

58. Hms2090l13

59. Hms3655l11

60. Hms3714a15

61. Pharmakon1600-01505310

62. Bcp07230

63. Hy-b0360

64. Opc12759

65. Tox21_111460

66. Bbl011328

67. Ccg-39619

68. Nsc758955

69. S2032

70. Stk577121

71. Stl146407

72. 2-(4-chlorobenzamido)-3-(2-oxo-1,2-dihydro-4-quinolyl)propanoic Acid

73. Akos005501649

74. Akos005721106

75. Tox21_111460_1

76. Ac-6841

77. Ac-7588

78. Db11656

79. Nsc 758955

80. 2-(4-chloro-benzoylamino)-3-(2-oxo-1,2-dihydro-quinolin-4-yl)-propionic Acid

81. 4-quinolinepropanoic Acid, 1,2-dihydro-alpha-((4-chlorobenzoyl)amino)-2-oxo-, (+-)-

82. Ncgc00095161-02

83. Ncgc00095161-03

84. Ncgc00095161-04

85. Ncgc00095161-05

86. Bc164330

87. Smr003309276

88. Sy057250

89. Vs-02924

90. Sbi-0207054.p001

91. Ft-0630971

92. Ft-0655225

93. R0085

94. Sw199113-2

95. D01121

96. Ab01275518-01

97. Ab01275518_02

98. Ab01275518_03

99. 911r876

100. A802443

101. A843443

102. A900081

103. Q-201660

104. Q7301602

105. Sr-05000001520-1

106. Sr-05000001520-2

107. Sr-05000001520-3

108. Brd-a15909516-001-02-5

109. Brd-a15909516-001-03-3

110. 2-(4-chlorobenzoylamino)-3-(2-quinolon-4-yl)propionic Acid

111. 2-(4-chlorobenzoylamino)-3-[2(1h)-quinolinon-4-yl] Propionic Acid

112. 2-(4-chlorobenzoylamino)-3-[2(1h)-quinolinon-4-yl]propionic Acid

113. N-[(4-chlorophenyl)carbonyl]-3-(2-hydroxyquinolin-4-yl)alanine

114. 2-(4-chlorobenzamido)-3-(2-oxo-1,2-dihydroquinolin-4-yl)propanoicacid

115. 2-(4-chlorobenzoylamino)-3-(2-oxo-1,2-dihydroquinolin-4-yl)propionic Acid

116. 4-quinolinepropanoicacid,a-[(4-chlorobenzoyl)amino]-1,2-dihydro-2-oxo-

117. (+/-)-.alpha.-(p-chlorobenzamido)-1,2-dihydro-2-oxo-4-quinolinepropionic Acid

118. (+/-)-2-(4-chlorobenzoylamino)-3-(2(1h)-quinolinon-4-yl)-propionic Acid

119. 2-[(4-chlorophenyl)formamido]-3-(2-oxo-1,2-dihydroquinolin-4-yl)propanoic Acid

120. 4-quinolinepropanoic Acid, .alpha.-((4-chlorobenzoyl)amino)-1,2-dihydro-2-oxo-

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 370.8 g/mol
Molecular Formula C19H15ClN2O4
XLogP32.4
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count5
Exact Mass370.0720347 g/mol
Monoisotopic Mass370.0720347 g/mol
Topological Polar Surface Area95.5 Ų
Heavy Atom Count26
Formal Charge0
Complexity598
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

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.)


Antioxidants

Naturally occurring or synthetic substances that inhibit or retard oxidation reactions. They counteract the damaging effects of oxidation in animal tissues. (See all compounds classified as Antioxidants.)


Anti-Ulcer Agents

Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)


4.2 ATC Code

A - Alimentary tract and metabolism

A02 - Drugs for acid related disorders

A02B - Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

A02BX - Other drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

A02BX14 - Rebamipide


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Jiangxi Synergy Pharmaceutical

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Centaur Pharmaceuticals

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Polaris AI Pharma

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Epoch Labs

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DongWha Pharm

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Saurav Chemicals

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Aurore Life Sciences

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Macleods Pharmaceuticals Limited

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JDMF

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REBAMIPIDE JP

Registration Number : 229MF10024

Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...

Initial Date of Registration : 2017-01-31

Latest Date of Registration : 2017-01-31

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Rebamipide (for manufacturing only)

Registration Number : 224MF10123

Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture

Initial Date of Registration : 2012-07-09

Latest Date of Registration : 2012-07-09

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Rebamipide "M"

Registration Number : 222MF10239

Registrant's Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, P. R. China

Initial Date of Registration : 2010-10-06

Latest Date of Registration : 2010-10-06

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Rebamipide "SL"

Registration Number : 228MF10089

Registrant's Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, P. R. China

Initial Date of Registration : 2016-04-15

Latest Date of Registration : 2016-04-15

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Rebamipide

Registration Number : 224MF10078

Registrant's Address : Zhejiang Provincial Chemical and Medical Raw Material Base Linhai Zone Duqiao town, L...

Initial Date of Registration : 2012-03-30

Latest Date of Registration : 2013-06-11

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Rebamipide

Registration Number : 230MF10081

Registrant's Address : Zhejiang Provincial Chemical and Medical Raw Material Base Linhai Zone Duqiao town, L...

Initial Date of Registration : 2018-07-09

Latest Date of Registration : 2018-07-09

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Rebamipide (for manufacturing only)

Registration Number : 222MF10259

Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do Korea

Initial Date of Registration : 2010-11-18

Latest Date of Registration : 2010-11-18

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Japanese Pharmacopoeia Rebamipide

Registration Number : 229MF10220

Registrant's Address : Plot No. 370, Industrial Area, Phase-II, Panchkula, Haryana State, India

Initial Date of Registration : 2017-12-18

Latest Date of Registration : 2017-12-18

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Rebamipide

Registration Number : 227MF10124

Registrant's Address : The Batra Center, No. 28, Sardar Patel Road, Guindy, Chennai 600 032. India

Initial Date of Registration : 2015-04-22

Latest Date of Registration : 2015-04-22

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Rebamipide

Registration Number : 223MF10143

Registrant's Address : 122, Xuqing Road, Xuguan Industry Park Suzhou, Jiangsu P. R. China

Initial Date of Registration : 2011-09-28

Latest Date of Registration : 2013-12-18

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Rebamipide

About the Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with...

Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with vast experience across the pharmaceutical value chain, the company is on a mission to become the most preferred partner for pharmaceuticals. At Aurore, we aim to push the boundaries to manufacture and deliver high quality products that can be relied upon by both customers and regulators. Our thrust on rapidly adding capabilities have led us to acquire, integrate and expand our reach across the geographies.
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Rebamipide

About the Company : Centaur accepts change as a constant, and continuously innovates to remain significant. Centaur has built knowledge sharing relationships with the pharmaceutical majors in areas of...

Centaur accepts change as a constant, and continuously innovates to remain significant. Centaur has built knowledge sharing relationships with the pharmaceutical majors in areas of product development, custom synthesis, contract research and contract manufacturing. Centaur formulations and API are exported across 5 continents and more than 60 countries including regulated markets. Centaur ranks among India's TOP 50 pharmaceutical companies by prescriptions (CMarc) and by stockist audit (ORG-IMS). Centaur's All-India network includes a 1000 strong sales force that covers 250,000 doctors and 250,000 retailers every month.
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DongWha Pharm

South Korea
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Rebamipide

About the Company : DongWha is the company that "serves customers by making good medicines and is managed with the rewards generated by benefits of good medicines." Under its corporate philosophy that...

DongWha is the company that "serves customers by making good medicines and is managed with the rewards generated by benefits of good medicines." Under its corporate philosophy that places the foremost priority on health and safety of its customers, it continues to work toward happiness of customers. Based on respect for the shared value that "we work diligently in our youth and live fruitful lives in old age." it serves every customer faithfully by fostering ownership and faith among its members.
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Epoch Labs

India
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Rebamipide

About the Company : Epoch-Labs is a Hyderabad, India based Research Organization that gives science administrations to expansive pharmaceutical organization, agrochemical organizations crosswise over ...

Epoch-Labs is a Hyderabad, India based Research Organization that gives science administrations to expansive pharmaceutical organization, agrochemical organizations crosswise over globe to quicken their R&D programs from revelation to creation. As an exploration driven and client centered organization, Epoch-Labs administrations are intended to abbreviate the revelation and improvement time through financially savvy and productive outsourcing answers for our clients.
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Rebamipide

About the Company : Fuan Pharmaceutical (Group) Co., Ltd. was established on February 25, 2004. The company is located in Chongqing Changshou Economic and Technological Development Zone, covering an a...

Fuan Pharmaceutical (Group) Co., Ltd. was established on February 25, 2004. The company is located in Chongqing Changshou Economic and Technological Development Zone, covering an area of about 100 acres, a construction area of over 30,000 square meters, and a registered capital of 1.189 billion yuan. It is the first company in Changshou Economic and Technological Development Zone successfully listed on the Shenzhen GEM. The company has 9 wholly-owned and holding subsidiaries. In March 2008, Fuan Pharmaceutical Group Chongqing Lybon Pharm-Tech Co
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Rebamipide

About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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Rebamipide

About the Company : Zhejiang Liaoyuan Pharmaceutical Co., Ltd., established in 1994, is a cGMP-certified manufacturer of APIs and intermediates. As the world’s largest supplier of 2-Thiophene Ethano...

Zhejiang Liaoyuan Pharmaceutical Co., Ltd., established in 1994, is a cGMP-certified manufacturer of APIs and intermediates. As the world’s largest supplier of 2-Thiophene Ethanol and 2-Thiophene Ethylamine, the company specializes in anticoagulants and antidepressants, including Clopidogrel, Ticlopidine, Mirtazapine, and Duloxetine. With cutting-edge facilities and experienced scientists, Liaoyuan delivers high-quality products and offers custom manufacturing services, meeting global pharmaceutical industry standards.
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Polaris AI Pharma

South Korea
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Rebamipide

About the Company : Polaris AI Pharma is a dynamic company specializing in innovative pharmaceutical solutions. Leveraging cutting-edge AI technology, it focuses on drug discovery, development, and op...

Polaris AI Pharma is a dynamic company specializing in innovative pharmaceutical solutions. Leveraging cutting-edge AI technology, it focuses on drug discovery, development, and optimization to address unmet medical needs. Committed to advancing healthcare, Polaris AI Pharma combines scientific expertise with digital innovation to deliver impactful treatments.
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Polaris AI Pharma

South Korea
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South Korea
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Rebamipide

About the Company : Polaris AI Pharma is a dynamic company specializing in innovative pharmaceutical solutions. Leveraging cutting-edge AI technology, it focuses on drug discovery, development, and op...

Polaris AI Pharma is a dynamic company specializing in innovative pharmaceutical solutions. Leveraging cutting-edge AI technology, it focuses on drug discovery, development, and optimization to address unmet medical needs. Committed to advancing healthcare, Polaris AI Pharma combines scientific expertise with digital innovation to deliver impactful treatments.
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Rebamipide

About the Company : Established in 1984, R L Fine Chem Pvt. Ltd. is one of the fastest growing API companies, with a leadership position in several APIs such as antihistamines, antidepressants and mus...

Established in 1984, R L Fine Chem Pvt. Ltd. is one of the fastest growing API companies, with a leadership position in several APIs such as antihistamines, antidepressants and muscle relaxants. Acquired by private equity groups in 2016, it is one of India’s leading manufacturers of psychotropic substances. It supplies over 60 APIs to customers in more than 62 countries from FDA and EU-approved locations. R L Fine Chem is a technology-driven company with a focus on the in-house manufacture of key intermediates for our APIs. The company currently operates out of four facilities in the Indian states of Karnataka and Andhra Pradesh.
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10-Oct-2022
17-May-2025
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ABOUT THIS PAGE

Looking for 90098-04-7 / Rebamipide API manufacturers, exporters & distributors?

Rebamipide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Rebamipide

Synonyms

90098-04-7, Proamipide, Mucosta, 111911-87-6, Opc-12759, Rebamipide hydrate

Cas Number

90098-04-7

Unique Ingredient Identifier (UNII)

LR583V32ZR

About Rebamipide

Rebamipide is a quinolinone derivative with anti-ulcer and anti-inflammatory activities. Rebamipide induces cyclooxygenase 2 (COX2) synthesis which results in an increase in endogenous prostaglandin synthesis in the gastric mucosa. This agent also inhibits H. pylori-induced production of tumor necrosis factor (TNF) alpha and subsequent inflammation of the gastric mucosa. In addition, rebamipide scavenges oxygen-derived free radicals that potentially cause mucosal injury, and stimulates prostaglandin EP4 receptor gene expression followed by mucous secretion, thereby enhancing the gastric mucosal defense.

Rebamipide Manufacturers

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

Rebamipide Suppliers

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

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

Rebamipide USDMF

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

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

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

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

Rebamipide KDMF

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

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

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

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

Rebamipide WC

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

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

Rebamipide 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 Rebamipide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Rebamipide GMP

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

Rebamipide CoA

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

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

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