Synopsis
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DRUG PRODUCT COMPOSITIONS0
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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
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
1. Pantozol
2. S-pantoprazole
3. Pantoprazole
| Molecular Weight | 405.4 g/mol |
|---|---|
| Molecular Formula | C16H14F2N3NaO4S |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 7 |
| Exact Mass | 405.05707772 g/mol |
| Monoisotopic Mass | 405.05707772 g/mol |
| Topological Polar Surface Area | 90.8 Ų |
| Heavy Atom Count | 27 |
| Formal Charge | 0 |
| Complexity | 497 |
| 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 |
| 1 of 4 | |
|---|---|
| Drug Name | Pantoprazole sodium |
| Drug Label | The 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 Ingredient | Pantoprazole sodium |
| Dosage Form | Injectable; Tablet, delayed release |
| Route | injection; Iv (infusion); Oral |
| Strength | eq 20mg base; eq 40mg base/vial; eq 40mg base; 40mg |
| Market Status | Tentative Approval; Prescription |
| Company | Wockhardt; 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 Name | Protonix iv |
| Active Ingredient | Pantoprazole sodium |
| Dosage Form | Injectable |
| Route | Iv (infusion) |
| Strength | eq 40mg base/vial |
| Market Status | Prescription |
| Company | Wyeth Pharms |
| 3 of 4 | |
|---|---|
| Drug Name | Pantoprazole sodium |
| Drug Label | The 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 Ingredient | Pantoprazole sodium |
| Dosage Form | Injectable; Tablet, delayed release |
| Route | injection; Iv (infusion); Oral |
| Strength | eq 20mg base; eq 40mg base/vial; eq 40mg base; 40mg |
| Market Status | Tentative Approval; Prescription |
| Company | Wockhardt; 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 Name | Protonix iv |
| Active Ingredient | Pantoprazole sodium |
| Dosage Form | Injectable |
| Route | Iv (infusion) |
| Strength | eq 40mg base/vial |
| Market Status | Prescription |
| Company | Wyeth Pharms |
Short-term treatment of reflux symptoms (e. g. heartburn, acid regurgitation) in adults.
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.)
A02BC02
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Rev. Date :
Pay. Date :
DMF Number : 36375
Submission : 2021-12-28
Status : Active
Type : II
Certificate Number : R0-CEP 2021-427 - Rev 00
Issue Date : 2022-11-02
Type : Chemical
Substance Number : 2296
Status : Valid
Date of Issue : 2022-03-24
Valid Till : 2025-03-17
Written Confirmation Number : WC-0004
Address of the Firm :
NDC Package Code : 49716-334
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End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Certificate Number : CEP 2023-421 - Rev 00
Issue Date : 2024-07-16
Type : Chemical
Substance Number : 2296
Status : Valid
Date of Issue : 2024-12-09
Valid Till : 2027-02-26
Written Confirmation Number : WC-0494
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DMF Number : 35577
Submission : 2021-03-29
Status : Active
Type : II
Certificate Number : CEP 2021-168 - Rev 01
Issue Date : 2024-06-21
Type : Chemical
Substance Number : 2296
Status : Valid
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm :
NDC Package Code : 42765-001
Start Marketing Date : 2018-01-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Review : Reviewed
Rev. Date : 2019-02-07
Pay. Date : 2019-02-01
DMF Number : 17103
Submission : 2004-01-20
Status : Active
Type : II
Certificate Number : R1-CEP 2010-319 - Rev 01
Issue Date : 2017-03-28
Type : Chemical
Substance Number : 2296
Status : Valid
Date of Issue : 2022-06-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035a
Address of the Firm :
NDC Package Code : 55111-051
Start Marketing Date : 2004-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
About the Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermediates and specialty ch...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Suanfarma, at the Core of a Better Life.
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Pantoprazole Sodium Sesquihydrate
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Jai Radhe Sales is your partner for all your sourcing needs.
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Average Price (USD/KGS) |
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Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
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Dosage Form : Lyophilised Injection
Dosage Strength : 40MG/Vial
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 20mg
Packaging :
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Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 40mg
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB
Brand Name : PANTOPRAZOLE SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2023-12-11
Application Number : 217282
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB
Brand Name : PANTOPRAZOLE SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 40MG BASE
Approval Date : 2023-12-11
Application Number : 217282
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : PANTOPRAZOLE SODIUM
Dosage Form : FOR SUSPENSION, DELAYED RELEASE;ORAL
Dosage Strength : EQ 40MG BASE
Approval Date : 2023-10-27
Application Number : 216139
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : PANTOPRAZOLE SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2012-09-28
Application Number : 202038
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AP
Brand Name : PANTOPRAZOLE SODIUM
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 40MG BASE/VIAL
Approval Date : 2024-08-01
Application Number : 216021
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : PANTOPRAZOLE SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2012-02-16
Application Number : 200821
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : PANTOPRAZOLE SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 40MG BASE
Approval Date : 2012-02-16
Application Number : 200821
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : PANTOPRAZOLE SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2024-04-25
Application Number : 215880
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD :
TE Code :
Brand Name : PANTOPRAZOLE SODIUM
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 40MG
Approval Date :
Application Number : 22226
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code :
Brand Name : PANTOPRAZOLE SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2007-08-02
Application Number : 77056
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pantoprazole Zentiva
Dosage Form : Filmtabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Enteric Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
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DOSAGE - POWDER;INTRAVENOUS - EQ 40MG BASE/VI...DOSAGE - POWDER;INTRAVENOUS - EQ 40MG BASE/VIAL
USFDA APPLICATION NUMBER - 209463
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 20987
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 40...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 20987
DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BAS...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BASE/VIAL
USFDA APPLICATION NUMBER - 20988
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ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Pantoprazole API and other APIs are published in this directory by the FDA.
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.
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 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.
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).
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