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Chemistry

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Also known as: 138786-67-1, Pantoloc, Protonix, Pantecta, Zurcal, Pantoprazole sodium salt
Molecular Formula
C16H14F2N3NaO4S
Molecular Weight
405.4  g/mol
InChI Key
YNWDKZIIWCEDEE-UHFFFAOYSA-N

Pantoprazole Sodium
2-pyridinylmethylsulfinylbenzimidazole proton pump inhibitor that is used in the treatment of GASTROESOPHAGEAL REFLUX and PEPTIC ULCER.
1 2D Structure

Pantoprazole Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
2.1.2 InChI
InChI=1S/C16H14F2N3O4S.Na/c1-23-13-5-6-19-12(14(13)24-2)8-26(22)16-20-10-4-3-9(25-15(17)18)7-11(10)21-16;/h3-7,15H,8H2,1-2H3;/q-1;+1
2.1.3 InChI Key
YNWDKZIIWCEDEE-UHFFFAOYSA-N
2.1.4 Canonical SMILES
COC1=C(C(=NC=C1)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC(F)F)OC.[Na+]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. By 1023

2. By-1023

3. By1023

4. Pantoprazole

5. Protonix

6. Sk And F 96022

7. Sk And F-96022

8. Sk And F96022

9. Skf 96022

10. Skf-96022

11. Skf96022

2.2.2 Depositor-Supplied Synonyms

1. 138786-67-1

2. Pantoloc

3. Protonix

4. Pantecta

5. Zurcal

6. Pantoprazole Sodium Salt

7. Skf96022 Sodium

8. By-1023 Sodium

9. Chebi:50270

10. Sodium;5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

11. Pantozol Control

12. 5-(difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl) Sulfinyl)-1h-benzimidazole Sodium

13. Dsstox_cid_24215

14. Dsstox_rid_80123

15. Dsstox_gsid_44215

16. Sodium 5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide

17. Sodium 5-(difluoromethoxy)-2-((3,4-dimethoxypyridin-2-yl)methylsulfinyl)benzo[d]imidazol-1-ide

18. Cas-138786-67-1

19. Anagastra

20. Inipomp

21. Pantorc

22. Peptazol

23. Ulcotenal

24. Citrel

25. Apton

26. Rifun

27. Pantoprazole Sodium;

28. By1023 (sodium)

29. Pantoprazole Sodium,(s)

30. Skf96022 (sodium)

31. Schembl3543

32. Mls001424073

33. Pantoprazole Sodium Monohydrate

34. Chembl1200408

35. Dtxsid7044215

36. Dz-2352a

37. Hms2051l19

38. Hms3393l19

39. Hms3715d12

40. Act02633

41. Tox21_112996

42. Tox21_302362

43. Mfcd01658543

44. S4538

45. Akos015994677

46. Ccg-100980

47. Ks-1093

48. Nc00230

49. S86p671

50. Sb17369

51. By-1023/sk&f-96022

52. Ncgc00255835-01

53. Smr000469592

54. Ft-0602602

55. Ft-0673508

56. A807440

57. B-8610-23/sk&f-96022-z

58. J-516336

59. B-8510-29

60. Q27122012

61. Sodium 5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl] Benzimidazol-1-ide

62. 5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-1h-benzo[d]imidazole, Sodium Salt

63. 5-(difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridyl)methylsulfinyl]benzimidazol-1-ide; Sodium;pantoprazole Sodium

64. Sodium 5-(difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole

65. Sodium 5-(difluoromethoxy)-2-{[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide

2.2.3 Other Synonyms

1. Pantozol

2. S-pantoprazole

3. Pantoprazole

2.3 Create Date
2007-02-09
3 Chemical and Physical Properties
Molecular Weight 405.4 g/mol
Molecular Formula C16H14F2N3NaO4S
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count10
Rotatable Bond Count7
Exact Mass405.05707772 g/mol
Monoisotopic Mass405.05707772 g/mol
Topological Polar Surface Area90.8 Ų
Heavy Atom Count27
Formal Charge0
Complexity497
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NamePantoprazole sodium
Drug LabelThe active ingredient in pantoprazole sodium delayed-release tablets USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid...
Active IngredientPantoprazole sodium
Dosage FormInjectable; Tablet, delayed release
Routeinjection; Iv (infusion); Oral
Strengtheq 20mg base; eq 40mg base/vial; eq 40mg base; 40mg
Market StatusTentative Approval; Prescription
CompanyWockhardt; Mylan Pharms; Hetero Labs Ltd V; Teva Parenteral; Teva; Apotex; Aurobindo Pharma; Torrent Pharms; Sun Pharma Global; Perrigo R And D; Actavis Elizabeth; Macleods Pharms; Jubilant Generics; Kudco Ireland; Ranbaxy Labs; Dr Reddys Labs; Akorn

2 of 4  
Drug NameProtonix iv
Active IngredientPantoprazole sodium
Dosage FormInjectable
RouteIv (infusion)
Strengtheq 40mg base/vial
Market StatusPrescription
CompanyWyeth Pharms

3 of 4  
Drug NamePantoprazole sodium
Drug LabelThe active ingredient in pantoprazole sodium delayed-release tablets USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid...
Active IngredientPantoprazole sodium
Dosage FormInjectable; Tablet, delayed release
Routeinjection; Iv (infusion); Oral
Strengtheq 20mg base; eq 40mg base/vial; eq 40mg base; 40mg
Market StatusTentative Approval; Prescription
CompanyWockhardt; Mylan Pharms; Hetero Labs Ltd V; Teva Parenteral; Teva; Apotex; Aurobindo Pharma; Torrent Pharms; Sun Pharma Global; Perrigo R And D; Actavis Elizabeth; Macleods Pharms; Jubilant Generics; Kudco Ireland; Ranbaxy Labs; Dr Reddys Labs; Akorn

4 of 4  
Drug NameProtonix iv
Active IngredientPantoprazole sodium
Dosage FormInjectable
RouteIv (infusion)
Strengtheq 40mg base/vial
Market StatusPrescription
CompanyWyeth Pharms

4.2 Drug Indication

Short-term treatment of reflux symptoms (e. g. heartburn, acid regurgitation) in adults.


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]
5.3 ATC Code

A02BC02


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LTD","customerCountry":"INDIA","quantity":"623.96","actualQuantity":"623.955","unit":"KGS","unitRateFc":"133","totalValueFC":"93694.1","currency":"EURO","unitRateINR":"12504.1","date":"27-Nov-2023","totalValueINR":"7801988.06","totalValueInUsd":"93694.1","indian_port":"Madras Air","hs_no":"29339990","bill_no":"8959255","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C\/EINSTEIN ,8-28108ALCOBENDASMADRID (SPAIN) ES","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714761000,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE PH.EUR, PN21080182,PN21080192,PN21080193(EXP VIDE SB NO:5336212\/16-10-21\/SI3621122086)","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"ACINO PHARMA AG","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"HETERO DRUGS LTD","customerCountry":"INDIA","quantity":"677.40","actualQuantity":"677.4","unit":"KGS","unitRateFc":"170","totalValueFC":"119620.5","currency":"USD","unitRateINR":"14719.3","date":"04-May-2024","totalValueINR":"9970866.42","totalValueInUsd":"119620.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3329930","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BASLE","supplierAddress":"BIRSWEG 2CG-4253 MIESBERGSDNF CH","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728930600,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE PH.EUR (VIDE RE IMPORT SBNO: 9436199 DT:26.04.2024)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"DELORBIS PHARMAZEUTICALS LTD","supplierCountry":"INDIA","foreign_port":"LARNACA","customer":"MSN LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"484.76","actualQuantity":"484.76","unit":"KGS","unitRateFc":"165","totalValueFC":"80769.2","currency":"USD","unitRateINR":"14000.3","date":"15-Oct-2024","totalValueINR":"6786761.19","totalValueInUsd":"80769.2","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"6127010","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LARNACA","supplierAddress":"17,ATHINON STREET, NICOSIA-2643 CRY PRUS SDNF Cyprus","customerAddress":"MSN HOUSE, PLOT NO. C-24,"}]
05-Jan-2022
30-Jun-2025
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DOSAGE - POWDER;INTRAVENOUS - EQ 40MG BASE/VI...DOSAGE - POWDER;INTRAVENOUS - EQ 40MG BASE/VIAL

USFDA APPLICATION NUMBER - 209463

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 20987

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 40...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 40MG BASE

USFDA APPLICATION NUMBER - 20987

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DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BAS...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BASE/VIAL

USFDA APPLICATION NUMBER - 20988

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ABOUT THIS PAGE

Looking for 138786-67-1 / Pantoprazole Sodium API manufacturers, exporters & distributors?

Pantoprazole Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pantoprazole Sodium

Synonyms

138786-67-1, Pantoloc, Protonix, Pantecta, Zurcal, Pantoprazole sodium salt

Cas Number

138786-67-1

About Pantoprazole Sodium

2-pyridinylmethylsulfinylbenzimidazole proton pump inhibitor that is used in the treatment of GASTROESOPHAGEAL REFLUX and PEPTIC ULCER.

Pantoprazole Manufacturers

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

Pantoprazole Suppliers

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

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

Pantoprazole USDMF

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

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

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

Pantoprazole KDMF

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

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

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

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

Pantoprazole CEP

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

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

Pantoprazole WC

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

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

Pantoprazole 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 Pantoprazole as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pantoprazole GMP

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

Pantoprazole CoA

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

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

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