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ACTIVE PHARMA INGREDIENTS

96 API Suppliers, 31 USDMF, 15 CEP/COS, 20 JDMF, 22 EU WC, 13 KDMF, 12 NDC API, 50 Listed Suppliers, $ API Reference Price

96 API Suppliers
31 USDMF
15 CEP/COS
20 JDMF
22 EU WC
13 KDMF
12 NDC API
50 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

350 FDF Dossiers, 15 FDA Orange Book, 145 Europe, 12 Canada, 73 Australia, 5 South Africa, 100 Listed Dossiers

350 FDF Dossiers
15 FDA Orange Book
145 Europe
12 Canada
73 Australia
5 South Africa
100 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - 10MG, CAPSULE, DELAYED RELEASE;ORAL - 5MG, TABLET, DELAYED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 20MG

drugProductComposition
CAPSULE, DELAYED RELEASE;ORAL - 10MG
CAPSULE, DELAYED RELEASE;ORAL - 5MG
TABLET, DELAYED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, DELAYED RELEASE;ORAL - 20MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 2 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 7 DKSH, 7 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 37 BASF, 1 Clariant, 14 Corel Pharma Chem, 6 DFE Pharma, 3 Finar, 13 Gangwal Chemicals, 12 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 34 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

relatedExcipients
1 Minakem
1 Evonik
2 Rochem International Inc
18 SPI Pharma
2 Seqens
7 DKSH
7 Faran Shimi Pharmaceutical
5 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
12 Gangwal Healthcare
7 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 ACG Worldwide
5 Actylis
1 Aeon Procare
3 Alcedo Pharmachem
10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Avesta Pharma
37 BASF
1 Clariant
14 Corel Pharma Chem
6 DFE Pharma
3 Finar
13 Gangwal Chemicals
12 Ideal Cures Pvt Ltd
3 Ingredion Pharma Solutions
34 Kerry
4 Kima Chemical
6 Lonza Capsugel
18 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
2 Nomisma Healthcare
4 Novo Excipients
5 Pharmatrans-Sanaq
7 Pluviaendo
5 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
18 Roquette
13 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
3 The Dow Chemical Company
1 Ulanqab Kema New Material
2 Valens Pharmachem
4 Vasa Pharmachem
1 Vertellus

EXCIPIENTS BY APPLICATIONS

77 Fillers, Diluents & Binders, 75 Coating Systems & Additives, 45 Controlled & Modified Release, 44 Direct Compression, 41 Disintegrants & Superdisintegrants, 33 Granulation, 33 Solubilizers, 31 Thickeners and Stabilizers, 26 Lubricants & Glidants, 22 Parenteral, 20 Taste Masking, 20 Topical, 20 Film Formers & Plasticizers, 18 Chewable & Orodispersible Aids, 17 Co-Processed Excipients, 12 Emulsifying Agents, 7 API Stability Enhancers, 7 Rheology Modifiers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 139 Finished Drug Prices, 12 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
139 Finished Drug Prices
12 Annual Reports

MARKET PLACE

50 APIs, 10 FDF Dossiers, 1 EXCIPIENTS

marketPlace
50 APIs
10 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

patents
6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP , 2 JP , 15 Others

otherSolutions
3 USP
2 JP
15 Others

ANALYTICAL

1 BioAnalytical Methods, 2 Analytical Methods

otherMethods
1 BioAnalytical Methods
2 Analytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 277

MARKET PLACE

API

FDF

19INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

350

FDF Dossiers

FDA Orange Book

145

Europe

Canada

Australia

South Africa

100

Listed Dossiers

1DRUGS 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)

33,838,170

Annual Reports (USD Million)

1,253

Finished Drug Prices

324 RELATED EXCIPIENT COMPANIES

568EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 117976-90-6, Rebeprazole sodium, Pariet, Aciphex, Rabeprazole sodium salt, Dexrabeprazole sodium

Molecular Formula

C₁₈H₂₀N₃NaO₃S

Molecular Weight

381.4 g/mol

InChI Key

KRCQSTCYZUOBHN-UHFFFAOYSA-N

FDA UNII

3L36P16U4R

A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.

1 2D Structure

Rabeprazole

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;2-[[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methylsulfinyl]benzimidazol-1-ide

2.1.2 InChI

InChI=1S/C18H20N3O3S.Na/c1-13-16(19-9-8-17(13)24-11-5-10-23-2)12-25(22)18-20-14-6-3-4-7-15(14)21-18;/h3-4,6-9H,5,10-12H2,1-2H3;/q-1;+1

2.1.3 InChI Key

KRCQSTCYZUOBHN-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=C(C=CN=C1CS(=O)C2=NC3=CC=CC=C3[N-]2)OCCCOC.[Na+]

2.2 Other Identifiers

2.2.1 UNII

3L36P16U4R

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1h-benzimidazole, 2-(((4-(3-methoxypropoxy)-3-methyl-2-pyridinyl)methyl)sulfinyl)-, Sodium Salt

2. 2-((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methylsulfinyl)-1h-benzimidazole

3. Aciphex

4. Dexrabeprazole

5. E 3810

6. E3810

7. Ly 307640

8. Ly-307640

9. Ly307640

10. Pariet

11. Rabeprazole

12. Sodium, Rabeprazole

2.3.2 Depositor-Supplied Synonyms

1. 117976-90-6

2. Rebeprazole Sodium

3. Pariet

4. Aciphex

5. Rabeprazole Sodium Salt

6. Dexrabeprazole Sodium

7. Rabeprazole (sodium)

8. (s)-rabeprazole Sodium Salt

9. Aciphex Sprinkle

10. Ly307640 Sodium

11. Sodium Rabeprazole

12. Rabeprazole Sodium [usan]

13. Idiazole

14. Rabeprazole Na

15. Chebi:8769

16. 171440-19-0

17. Ly-307640

18. E3810

19. E-3810 Sodium

20. Sodium;2-[[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methylsulfinyl]benzimidazol-1-ide

21. Ly-307640 Sodium

22. 3l36p16u4r

23. 1h-benzimidazole, 2-(((4-(3-methoxypropoxy)-3-methyl-2-pyridinyl)methyl)sulfinyl)-, Sodium Salt

24. 2-(((4-(3-methoxypropoxy)-3-methyl-2-pyridyl)methyl)sulfinyl)benzimidazole Sodium Salt

25. Nsc-759270

26. Dsstox_cid_24205

27. Dsstox_rid_80118

28. Dsstox_gsid_44205

29. 1h-benzimidazole, 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-, Sodium Salt (1:1)

30. Rabicip

31. Pepcia

32. Aciphex Sodium

33. Ly 307640 Sodium

34. Habeprazole Sodium

35. Sodium 2-((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methylsulfinyl)benzo[d]imidazol-1-ide

36. Sodium 2-({[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methyl}sulfinyl)benzimidazol-1-ide

37. Smr000550493

38. Cas-117976-90-6

39. Ncgc00159518-02

40. E 3810

41. Pariete

42. Unii-3l36p16u4r

43. Pariprazole Sodium

44. Dexrabeprazolesodium

45. Rebeprazole Sodium;

46. Aciphex (tn)

47. Pariet (tn)

48. Rebeprazole Sodium Salt

49. Rabeprazole Sodium- Bio-x

50. Mls001165734

51. Mls006010621

52. Schembl140494

53. Rabeprazole Na [vandf]

54. Chembl1200930

55. Dtxsid3044205

56. Rabeprazole Sodium [jan]

57. Hy-b0656a

58. Rabeprazole Sodium (jp17/usp)

59. Ex-a176

60. Hms2093h10

61. Hms2231e04

62. Hms3373b05

63. Rabeprazole Sodium [mart.]

64. Bcp06639

65. Rabeprazole Sodium [usp-rs]

66. Rabeprazole Sodium [who-dd]

67. Tox21_111736

68. Tox21_302317

69. Ac-715

70. Bdbm50247881

71. Mfcd02092688

72. Rabeprazole Sodium Salt [mi]

73. S4665

74. Rabeprazole Sodium, >=98% (hplc)

75. Akos015895734

76. Akos015962116

77. Akos025310160

78. Tox21_111736_1

79. Am81231

80. Ccg-213574

81. Ccg-268423

82. Nsc 759270

83. Rabeprazole Sodium [orange Book]

84. Ncgc00159518-05

85. Ncgc00255838-01

86. Rabeprazole Sodium [ep Monograph]

87. As-13338

88. Br167318

89. Rabeprazole Sodium [usp Monograph]

90. Ft-0631090

91. Ft-0689461

92. R0115

93. C07865

94. D00724

95. F17418

96. 976r906

97. Sr-01000799133

98. J-010726

99. Q-201655

100. Sr-01000799133-2

101. Q27108142

102. [2-[[4-(3-methoxypropoxy)-3-methyl-2-pyridyl]methylsulfinyl]benzimidazol-1-yl]sodium

103. Sodium;2-[[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methylsulfinyl]-1h-benzimidazole

104. 1h-benzimidazole,2-[[[4-(3-methoxypropoxy)- 3-methyl-2-pyridinyl]methyl]sulfinyl]-,sodium Salt

105. 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole, Sodium Salt

106. Sodium 2-(((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide

2.4 Create Date

2007-02-09

3 Chemical and Physical Properties

Molecular Formula	C₁₈H₂₀N₃NaO₃S
Molecular Weight	381.4 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	8
Exact Mass	381.11230696 g/mol
Monoisotopic Mass	381.11230696 g/mol
Topological Polar Surface Area	81.5 Å²
Heavy Atom Count	26
Formal Charge	0
Complexity	446
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
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 4
Drug Name	Aciphex
PubMed Health	Rabeprazole (By mouth)
Drug Classes	Antiulcer, Gastric Acid Secretion Inhibitor
Drug Label	The active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
Active Ingredient	Rabeprazole sodium
Dosage Form	Tablet, delayed release
Route	oral; Oral
Strength	20mg
Market Status	Prescription
Company	Eisai; Eisai Medcl Res

2 of 4
Drug Name	Rabeprazole sodium
Drug Label	The active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
Active Ingredient	Rabeprazole sodium
Dosage Form	Tablet, delayed release
Route	Oral
Strength	20mg
Market Status	Prescription
Company	Mylan Pharms; Kremers Urban Dev; Teva Pharms Usa; Torrent Pharms; Lupin; Dr Reddys Labs

3 of 4
Drug Name	Aciphex
PubMed Health	Rabeprazole (By mouth)
Drug Classes	Antiulcer, Gastric Acid Secretion Inhibitor
Drug Label	The active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
Active Ingredient	Rabeprazole sodium
Dosage Form	Tablet, delayed release
Route	oral; Oral
Strength	20mg
Market Status	Prescription
Company	Eisai; Eisai Medcl Res

4 of 4
Drug Name	Rabeprazole sodium
Drug Label	The active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
Active Ingredient	Rabeprazole sodium
Dosage Form	Tablet, delayed release
Route	Oral
Strength	20mg
Market Status	Prescription
Company	Mylan Pharms; Kremers Urban Dev; Teva Pharms Usa; Torrent Pharms; Lupin; Dr Reddys Labs

4.2 Drug Indication

Treatment of duodenal ulcer, Treatment of gastric ulcer, Treatment of gastro-oesophageal reflux disease, Treatment of Helicobacter pylori in patients with peptic ulcer disease, Treatment of Zollinger-Ellison syndrome

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

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.)

Proton Pump Inhibitors

Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX. (See all compounds classified as Proton Pump Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Proton Pump Inhibitors [MoA]; Proton Pump Inhibitor [EPC]

API SUPPLIERS

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USDMF

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CEP/COS

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JDMF

01

Metrochem API Pvt. Ltd.

India

Duphat

Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Contact Supplier

India

Virtual Booth

Digital Content

Rabeprazole Sodium

Registration Number : 221MF10282

Registrant's Address : Flat No. 302, Bhanu Enclave, Sunder Nagar, Erragadda, Hyderabad-500038, Telangana, In...

Initial Date of Registration : 2009-12-22

Latest Date of Registration : 2009-12-22

02

Dr. Reddy's Laboratories Ltd.

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

RABEPRAZOLE SODIUM

Registration Number : 303MF10057

Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

Initial Date of Registration : 2021-04-02

Latest Date of Registration : 2021-04-02

03

DAEWOONG BIO INC.

South Korea

Duphat

Not Confirmed

04

Eisai Co., Ltd.

Japan

Duphat

Not Confirmed

05

Quimica Syntetica S. A.

Spain

Duphat

Not Confirmed

06

Quimica Syntetica S. A.

Spain

Duphat

Not Confirmed

07

Shanghai Pharma Group Changzhou Kon...

China

Duphat

Not Confirmed

08

Yoshindo Co., Ltd.

Japan

Duphat

Not Confirmed

09

Zhuhai Rundu Pharmaceutical Co. , L...

China

Duphat

Not Confirmed

10

Zhuhai Rundu Pharmaceutical Co. , L...

China

Duphat

Not Confirmed

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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RABEPRAZOLE SODIUM BATCH NO.RBS\/2210366 MANUFACTURING DT.OCT-22 - 300 KGS","address":"1701 B-WING,LOTUS CORPORATE PARK,W ,ESTERN EXPRESS HIGHWAY, GOREGAON ,EAST ,","city":"MUMBAI","supplier":"KYONGBO PHARMACEUTICAL CO LIMITED","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"NA","customer":"AMOLI ORGANICS","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"335","totalValueFC":"102908.3","currency":"USD","unitRateINR":"28131","date":"02-Aug-2023","totalValueINR":"8524547.372","totalValueInUsd":"102908.3","indian_port":"JNPT\/ NHAVA SHEVA SEA","hs_no":"29333990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SOUTH KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1701 B-WING,LOTUS CORPORATE PARK,W ,ESTERN EXPRESS HIGHWAY, GOREGAON ,EAST ,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690914600,"product":"STOCK RETURNED - RABEPRAZOLE SODIUM BATCH NO.RBS\/2302041 MANUFACTURING DT.JAN-23 - 200 KGS","address":"1701 B-WING,LOTUS CORPORATE PARK,W ,ESTERN EXPRESS HIGHWAY, GOREGAON ,EAST ,","city":"MUMBAI","supplier":"KYONGBO PHARMACEUTICAL CO LIMITED","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"NA","customer":"AMOLI ORGANICS","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"335","totalValueFC":"68482.1","currency":"USD","unitRateINR":"28080.4","date":"02-Aug-2023","totalValueINR":"5672800.892","totalValueInUsd":"68482.1","indian_port":"JNPT\/ NHAVA SHEVA SEA","hs_no":"29333990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SOUTH KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1701 B-WING,LOTUS CORPORATE PARK,W ,ESTERN EXPRESS HIGHWAY, GOREGAON ,EAST ,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724697000,"product":"RABEPRAZOLE PELLETS 8.50 PERCENT","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"1250.00","actualQuantity":"1250","unit":"KGS","unitRateFc":"14.7","totalValueFC":"18628.1","currency":"USD","unitRateINR":"1250","date":"27-Aug-2024","totalValueINR":"1562500","totalValueInUsd":"18628.1","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29333990","bill_no":"5268821","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pellets","supplierPort":"VISAKHAPATNAM SEZ","supplierAddress":"PLOT NO.5, PHASE-2, VSEZ, DUVVADA, VISAKHAPATNAM SDNF India","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"RABEPRAZOLE SODIUM PELLETS 8.5 PERCENT","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"MM FARMACHEM D O O","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"274.13","actualQuantity":"274.13","unit":"KGS","unitRateFc":"69","totalValueFC":"19151.7","currency":"USD","unitRateINR":"5854.7","date":"03-Sep-2024","totalValueINR":"1604935.2","totalValueInUsd":"19151.7","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29333990","bill_no":"5397758","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pellets","supplierPort":"ZAGREB","supplierAddress":"RADNICKA CESTA 54 R3 5TH FLOOR 10000 ZAGREB SDNF Croatia","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"RABEPRAZOLE SODIUM PELLETS 8.5 PERCENT","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"MM FARMACHEM D.O.O","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"4.49","actualQuantity":"4.49","unit":"KGS","unitRateFc":"69","totalValueFC":"313.2","currency":"USD","unitRateINR":"5861.6","date":"25-Oct-2024","totalValueINR":"26318.36","totalValueInUsd":"313.2","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29333990","bill_no":"6319641","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pellets","supplierPort":"ZAGREB","supplierAddress":"RADNICKA CESTA 54, R3\/5TH FLOOR 1000 ZAGREB, HRVATSKA SDNF Croatia","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731522600,"product":"RABEPRAZOLE PELLETS 8.50 PERCENT","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"14.7","totalValueFC":"14812.5","currency":"USD","unitRateINR":"1250","date":"14-Nov-2024","totalValueINR":"1250000","totalValueInUsd":"14812.5","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29333990","bill_no":"6674812","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pellets","supplierPort":"VISAKHAPATNAM SEZ","supplierAddress":"PLOT NO.5, PHASE-2, VSEZ, DUVVADA, VISAKHAPATNAM SDNF India","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"}]

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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Drugs in Development

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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 10MG

USFDA APPLICATION NUMBER - 204736

DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 5MG

USFDA APPLICATION NUMBER - 204736

DOSAGE - TABLET, DELAYED RELEASE;ORAL - 10MG ...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20973

DOSAGE - TABLET, DELAYED RELEASE;ORAL - 20MG

USFDA APPLICATION NUMBER - 20973

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ABOUT THIS PAGE

Rabeprazole Manufacturers

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

Rabeprazole Suppliers

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

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

Rabeprazole USDMF

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

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

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

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

Rabeprazole KDMF

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

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

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

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

Rabeprazole CEP

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

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

Rabeprazole WC

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

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

Rabeprazole 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 Rabeprazole as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Rabeprazole GMP

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

Rabeprazole CoA

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

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

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

96 API Suppliers

31 USDMF

15 CEP/COS

20 JDMF

22 EU WC

13 KDMF

12 NDC API

50 Listed Suppliers

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DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

350 FDF Dossiers

15 FDA Orange Book

145 Europe

12 Canada

73 Australia

5 South Africa

100 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - 10MG

CAPSULE, DELAYED RELEASE;ORAL - 5MG

TABLET, DELAYED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - 20MG

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3 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

37 BASF

1 Clariant

14 Corel Pharma Chem

6 DFE Pharma

3 Finar

13 Gangwal Chemicals

12 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

34 Kerry

4 Kima Chemical

6 Lonza Capsugel

18 Microlex e.U

1 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

4 Novo Excipients

5 Pharmatrans-Sanaq

7 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

3 The Dow Chemical Company

1 Ulanqab Kema New Material

2 Valens Pharmachem

TABLET, DELAYED RELEASE;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons