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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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PLC","customerCountry":"BANGLADESH","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"80","totalValueFC":"7737.4","currency":"USD","unitRateINR":6623.3699999999999,"date":"30-Apr-2025","totalValueINR":"662337","totalValueInUsd":"7737.4","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"1402403","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"78\/A,VENGALARAO NAGAR, ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649701800,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE PH.EUR (RE-IMP VIDE SB.NO4337297 DT:07.08.2020)","address":"H NO 8-3-680 OPP VISHAL TOWERS,LIC COLONY YELLAREDDYGUDA","city":"HYDERABAD,TELANGANA","supplier":"KMK CHEMICALS FZ-LLC","supplierCountry":"INDIA","foreign_port":"NA","customer":"KEKULE PHARMA LIMITED","customerCountry":"INDIA","quantity":"975.00","actualQuantity":"975","unit":"KGS","unitRateFc":"115","totalValueFC":"114132.8","currency":"USD","unitRateINR":"8832","date":"12-Apr-2022","totalValueINR":"8611200","totalValueInUsd":"114132.8","indian_port":"HYDERABAD AIR","hs_no":"29333990","bill_no":"8249656","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"H NO 8-3-680 OPP VISHAL TOWERS,LIC COLONY YELLAREDDYGUDA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649701800,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE PH.EUR (RE-IMP VIDE SB.NO4337714 DT:07.08.2020)","address":"H NO 8-3-680 OPP VISHAL TOWERS,LIC COLONY YELLAREDDYGUDA","city":"HYDERABAD,TELANGANA","supplier":"KMK CHEMICALS FZ-LLC","supplierCountry":"INDIA","foreign_port":"NA","customer":"KEKULE PHARMA LIMITED","customerCountry":"INDIA","quantity":"2375.00","actualQuantity":"2375","unit":"KGS","unitRateFc":"115","totalValueFC":"278015.9","currency":"USD","unitRateINR":"8832","date":"12-Apr-2022","totalValueINR":"20976000","totalValueInUsd":"278015.9","indian_port":"HYDERABAD AIR","hs_no":"29333990","bill_no":"8249656","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"H NO 8-3-680 OPP VISHAL TOWERS,LIC COLONY YELLAREDDYGUDA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1660156200,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE USP (BATCH NO.: PN21070093)","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"VARTIA PHARMA PTE LTD","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"302.52","actualQuantity":"302.52","unit":"KGS","unitRateFc":"209","totalValueFC":"65089.3","currency":"USD","unitRateINR":"17119.4","date":"11-Aug-2022","totalValueINR":"5178968.13","totalValueInUsd":"65089.3","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"9965959","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1660156200,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE USP (BATCH NO.: PN21070094)","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"VARTIA PHARMA PTE LTD","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"303.75","actualQuantity":"303.75","unit":"KGS","unitRateFc":"209","totalValueFC":"65353.9","currency":"USD","unitRateINR":"17119.4","date":"11-Aug-2022","totalValueINR":"5200025.02","totalValueInUsd":"65353.9","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"9965959","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1680287400,"product":"(RE-IMPORT) PANTOPRAZOLE SODIUM SESQUIHYDRATE PH EUR (BATCHNO: PN22030105 & PN22030106)(SB NO:9225367, 26.03.22)","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"SANDOZ AG LICHTSTRASSE 35 4056 BASEL SWITZERLAN","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"605.39","actualQuantity":"605.386","unit":"KGS","unitRateFc":"145","totalValueFC":"92061","currency":"USD","unitRateINR":"12462.7","date":"01-Apr-2023","totalValueINR":"7544743.61","totalValueInUsd":"92061","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"5327320","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718044200,"product":"PANTOPRAZOLE SODIUM EP BATCH NO. TDPPZNF015 (RE-IMPORT AFTERREJECTION) (VIDE SB NO. 6496315 DT. 03.01.2024)","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"TEVA PHARMA SLU","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"399.00","actualQuantity":"399","unit":"KGS","unitRateFc":"119","totalValueFC":"50727.7","currency":"USD","unitRateINR":"10613.3","date":"11-Jun-2024","totalValueINR":"4234720.86","totalValueInUsd":"50727.7","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"3932978","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"C\/ANABEL SEGURA 11 B- EDIFICIO ALBATROS - 28108 ALCOBENDAS (MADRID)SDNF SPAIN","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"}]
01-Jan-2022
30-Apr-2025
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DRUG PRODUCT COMPOSITIONS

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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

12

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.

Rifun Manufacturers

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

Rifun Suppliers

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

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

Rifun USDMF

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

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

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

Rifun KDMF

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

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

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

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

Rifun CEP

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

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

Rifun WC

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

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

Rifun 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 Rifun as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Rifun GMP

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

Rifun CoA

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

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

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