Synopsis
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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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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
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Rev. Date : 2019-02-07
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Submission : 2004-01-20
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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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DMF Number : 18779
Submission : 2005-09-15
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PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
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DMF Number : 17118
Submission : 2004-01-26
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Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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Pantoprazole sodium sesquihydrate
Registrant Name : Takeda Pharmaceutical Company Korea Co., Ltd.
Registration Date : 2022-04-18
Registration Number : 20220418-209-J-1270
Manufacturer Name : PMC ISOCHEM
Manufacturer Address : 4 Rue Marc Sangnier, 45300 PITHIVIERS, France
Pantoprazole sodium sesquihydrate
Registrant Name : Dong-A ST Co., Ltd.
Registration Date : 2021-03-04
Registration Number : 20210304-209-J-855
Manufacturer Name : Apitoria Pharma Private Limi...
Manufacturer Address : Unit-I, Sy.No. 379, 385, 386, 388 - 396, Borpatla Village, Hatnoora Mandal, Sangaredd...
Pantoprazole sodium sesquihydrate anhydrous
Registrant Name : Hiple Co., Ltd.
Registration Date : 2025-06-02
Registration Number : 20210422-209-J-949(2)
Manufacturer Name : Cipla Limited
Manufacturer Address : Old Madras Road, Virgonagar Post, Bangalore-560 049, India
Pantoprazole sodium sesquihydrate
Registrant Name : UNUST Co., Ltd.
Registration Date : 2021-04-22
Registration Number : 20210422-209-J-949
Manufacturer Name : Cipla Limited
Manufacturer Address : Old Madras Road, Virgonagar Post, Bangalore-560 049, India
Pantoprazole sodium sesquihydrate
Registrant Name : Genewone Science Co., Ltd.
Registration Date : 2025-04-16
Registration Number : 20210422-209-J-949(1)
Manufacturer Name : Cipla Limited
Manufacturer Address : Old Madras Road, Virgonagar Post, Bangalore-560 049, India
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2021-06-10
Registration Number : 20210610-209-J-1019
Manufacturer Name : Hetero Drugs Limited (Unit-I...
Manufacturer Address : Sy.No.213, 214 & 255, Bonthapally Village, Gummadidala Mandal Sangareddy District Tel...
S-pantoprazole sodium trihydrate
Registrant Name : MFC Co., Ltd.
Registration Date : 2023-01-12
Registration Number : 20230112-209-J-1436
Manufacturer Name : MFC Co., Ltd.
Manufacturer Address : 35 Cheongwon Industrial Complex 7-gil, Mado-myeon, Hwaseong-si, Gyeonggi-do
S-pantoprazole sodium trihydrate
Registrant Name : Redox Bio Co., Ltd.
Registration Date : 2022-02-04
Registration Number : 20220204-209-J-1174
Manufacturer Name : Redox Bio Co., Ltd.
Manufacturer Address : 83, Yakjakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Hyundai Bioland Co., Ltd.
Registration Date : 2021-04-14
Registration Number : 20180817-209-J-88(4)
Manufacturer Name : Vasudha Pharma Chem Limited,...
Manufacturer Address : Unit-II, Plot No.79, Jawaharlal Nehru Pharma City, Thanam Village, Parawada Mandal, A...
Registrant Name : Hanyoung Farm Co., Ltd.
Registration Date : 2023-03-10
Registration Number : 20180817-209-J-88(5)
Manufacturer Name : Vasudha Pharma Chem Limited
Manufacturer Address : Unit-II, Plot No. 79, Jawaharlal Nehru Pharma City, Thanam(V), Parawada, Visakhapatna...
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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
NDC Package Code : 49716-334
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
NDC Package Code : 42765-001
Start Marketing Date : 2018-01-23
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Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC Package Code : 55111-051
Start Marketing Date : 2004-01-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
NDC Package Code : 68069-0005
Start Marketing Date : 2010-07-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
NDC Package Code : 49632-160
Start Marketing Date : 2014-03-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
NDC Package Code : 62207-981
Start Marketing Date : 2022-05-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65897-1009
Start Marketing Date : 2021-08-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 14501-0025
Start Marketing Date : 2010-03-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52286-0013
Start Marketing Date : 2009-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49452-4972
Start Marketing Date : 2015-04-01
End Marketing Date : 2026-12-31
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Marketing Category : BULK INGREDIENT
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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
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Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Pantoprazole Sodium Sesquihydrate
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
Jai Radhe Sales is your partner for all your sourcing needs.
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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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Drugs in Development
Details:
Pantoprazole Sodium Delayed-Release tablets are indicated for short-term treatment of Erosive Esophagitis Associated with GERD and Pathological Hypersecretory Conditions.
Lead Product(s): Pantoprazole Sodium,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Protonix-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 13, 2023
Lead Product(s) : Pantoprazole Sodium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Limited Received ANDA Approval for Pantoprazole Sod Delayed-Release Tablets
Details : Pantoprazole Sodium Delayed-Release tablets are indicated for short-term treatment of Erosive Esophagitis Associated with GERD and Pathological Hypersecretory Conditions.
Product Name : Protonix-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 13, 2023
Details:
Protonix IV-Generic is a potassium-transporting ATPase inhibitor, small molecule drug candidate, which is indicated for the treatment of gastroesophageal reflux disease.
Lead Product(s): Pantoprazole Sodium,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Protonix IV-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 03, 2025
Lead Product(s) : Pantoprazole Sodium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Alembic announces USFDA final approval for Pantoprazole Sodium for Injection, 40 mg/vial
Details : Protonix IV-Generic is a potassium-transporting ATPase inhibitor, small molecule drug candidate, which is indicated for the treatment of gastroesophageal reflux disease.
Product Name : Protonix IV-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 03, 2025
Details:
OPENTOP D (pantoprazole Sodium and domperidone) Delayed-Release tablets are indicated for short-term treatment of Erosive Esophagitis Associated with GERD.
Lead Product(s): Pantoprazole Sodium,Domperidone
Therapeutic Area: Gastroenterology Brand Name: Opentop D
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 28, 2024
Lead Product(s) : Pantoprazole Sodium,Domperidone
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Royal Sense Launches Multiple Products in Pharmaceutical Category
Details : OPENTOP D (pantoprazole Sodium and domperidone) Delayed-Release tablets are indicated for short-term treatment of Erosive Esophagitis Associated with GERD.
Product Name : Opentop D
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 28, 2024
Details:
Sitravatinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Sitravatinib,Pantoprazole Sodium,Famotidine
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 22, 2021
Lead Product(s) : Sitravatinib,Pantoprazole Sodium,Famotidine
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study to Explore the Effect of Acid-reducing Agents
Details : Sitravatinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 22, 2021
Details:
Pantoprazole is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Esophagitis.
Lead Product(s): Pantoprazole Sodium,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 29, 2021
Lead Product(s) : Pantoprazole Sodium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Pantoprazole is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Esophagitis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 29, 2021
Details:
Sandoz has shipped pantoprazole sodium for injection, 40 mg to Civica Rx to supply the hospitals it serves as part of a multiyear collaboration to help reduce supply shortages, with several other medicines on the way before the end of the year.
Lead Product(s): Pantoprazole Sodium,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Pantoprazole Sodium-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Civica Rx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 02, 2020
Lead Product(s) : Pantoprazole Sodium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Civica Rx
Deal Size : Undisclosed
Deal Type : Collaboration
Sandoz Ships First Medicine in Collaboration with Civica Rx to Supply Us Hospitals
Details : Sandoz has shipped pantoprazole sodium for injection, 40 mg to Civica Rx to supply the hospitals it serves as part of a multiyear collaboration to help reduce supply shortages, with several other medicines on the way before the end of the year.
Product Name : Pantoprazole Sodium-Generic
Product Type : Miscellaneous
Upfront Cash : Undisclosed
November 02, 2020
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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
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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.
A Zurcal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zurcal, including repackagers and relabelers. The FDA regulates Zurcal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zurcal 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 Zurcal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zurcal supplier is an individual or a company that provides Zurcal active pharmaceutical ingredient (API) or Zurcal finished formulations upon request. The Zurcal suppliers may include Zurcal API manufacturers, exporters, distributors and traders.
click here to find a list of Zurcal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zurcal DMF (Drug Master File) is a document detailing the whole manufacturing process of Zurcal active pharmaceutical ingredient (API) in detail. Different forms of Zurcal DMFs exist exist since differing nations have different regulations, such as Zurcal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zurcal DMF submitted to regulatory agencies in the US is known as a USDMF. Zurcal USDMF includes data on Zurcal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zurcal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zurcal 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 Zurcal Drug Master File in Korea (Zurcal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zurcal. The MFDS reviews the Zurcal KDMF as part of the drug registration process and uses the information provided in the Zurcal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zurcal 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 Zurcal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zurcal suppliers with KDMF on PharmaCompass.
A Zurcal CEP of the European Pharmacopoeia monograph is often referred to as a Zurcal Certificate of Suitability (COS). The purpose of a Zurcal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zurcal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zurcal to their clients by showing that a Zurcal CEP has been issued for it. The manufacturer submits a Zurcal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zurcal CEP holder for the record. Additionally, the data presented in the Zurcal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zurcal DMF.
A Zurcal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zurcal 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 Zurcal suppliers with CEP (COS) on PharmaCompass.
A Zurcal written confirmation (Zurcal WC) is an official document issued by a regulatory agency to a Zurcal manufacturer, verifying that the manufacturing facility of a Zurcal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zurcal APIs or Zurcal finished pharmaceutical products to another nation, regulatory agencies frequently require a Zurcal WC (written confirmation) as part of the regulatory process.
click here to find a list of Zurcal 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 Zurcal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zurcal 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 Zurcal 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 Zurcal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zurcal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zurcal suppliers with NDC on PharmaCompass.
Zurcal 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 Zurcal 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 Zurcal GMP manufacturer or Zurcal GMP API supplier for your needs.
A Zurcal CoA (Certificate of Analysis) is a formal document that attests to Zurcal's compliance with Zurcal specifications and serves as a tool for batch-level quality control.
Zurcal CoA mostly includes findings from lab analyses of a specific batch. For each Zurcal 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.
Zurcal may be tested according to a variety of international standards, such as European Pharmacopoeia (Zurcal EP), Zurcal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zurcal USP).
