Synopsis
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1. Esomeprazole
2. Esomeprazole Potassium
3. Esomeprazole Sodium
4. Esomeprazole Strontium
5. Esomeprazole Strontium Anhydrous
6. Nexium
7. Strontium, Esomeprazole
1. Omeprazole Magnesium
2. 161973-10-0
3. Prilosec Otc
4. H 168/68 Magnesium
5. 95382-33-5
6. Omeprazole (as Magnesium)
7. 426qfe7xlk
8. Magnesium;5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
9. Esomeprazole Magnesium Salt
10. Unii-426qfe7xlk
11. Omeprazole Magnesium [usan]
12. Omeprazole Magnesium [usan:usp]
13. Prilosec Otc (tn)
14. Esomeprazole(magnesium)
15. Omeprazole Magnesium Salt
16. Omeprazole Magnesium (usp)
17. Mls001165732
18. Schembl722792
19. Esomeprazole Magnesium (nexium)
20. Chembl1567328
21. Chebi:94401
22. H-168/68 Magnesium
23. Hms2878h13
24. Omeprazole Magnesium [vandf]
25. Mfcd06798050
26. Omeprazole Magnesium [mart.]
27. Omeprazole Magnesium [usp-rs]
28. Omeprazole Magnesium [who-dd]
29. Akos015896379
30. Akos025402081
31. Omeprazole Magnesium Salt [mi]
32. As-75082
33. Omeprazole Magnesium [orange Book]
34. Smr000550477
35. Omeprazole Magnesium [ep Monograph]
36. Omeprazole Magnesium [usp Impurity]
37. Omeprazole Magnesium [usp Monograph]
38. Ft-0657297
39. Sw220306-1
40. Talicia Component Omeprazole Magnesium
41. D05259
42. Omeprazole Magnesium Component Of Talicia
43. A810316
44. J-014249
45. Q-100195
46. Q27166253
47. 5-methoxy-1h-1,3-benzimidazol-2-yl (4-methoxy-3,5-dimethyl-2-pyridinyl)methyl Sulfoxide
48. (rs)-5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole, Magnesium Salt (2:1)
49. 5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole, Magnesium Salt
50. 5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)benzimidazole, Magnesium Salt (2:1)
51. Magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]benzimidazol-1-ide;esomeprazole Magnesium(random Configuration)
52. Magnesium(2+) 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1h-1,3-benzodiazol-1-ide 6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1h-1,3-benzodiazol-1-ide
53. Magnesium, Bis(6-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl-.kappa.o)-1h-benzimidazolato-.kappa.n3)-, (t-4)-
| Molecular Weight | 713.1 g/mol |
|---|---|
| Molecular Formula | C34H36MgN6O6S2 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 14 |
| Rotatable Bond Count | 10 |
| Exact Mass | 712.1988169 g/mol |
| Monoisotopic Mass | 712.1988169 g/mol |
| Topological Polar Surface Area | 163 Ų |
| Heavy Atom Count | 49 |
| Formal Charge | 0 |
| Complexity | 453 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 2 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
| 1 of 6 | |
|---|---|
| Drug Name | Esomeprazole magnesium |
| PubMed Health | Esomeprazole |
| Drug Classes | Gastric Acid Secretion Inhibitor, Gastrointestinal Agent |
| Drug Label | The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole... |
| Active Ingredient | Esomeprazole magnesium |
| Dosage Form | Capsule, delayed release |
| Route | oral |
| Strength | 40mg; 20mg |
| Market Status | Tentative Approval |
| Company | Ranbaxy |
| 2 of 6 | |
|---|---|
| Drug Name | Nexium |
| Drug Label | The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole... |
| Active Ingredient | Esomeprazole magnesium |
| Dosage Form | Capsule, delayed rel pellets; For suspension, delayed release |
| Route | Oral |
| Strength | eq 5mg base/packet; eq 20mg base/packet; eq 20mg base; eq 40mg base; eq 10mg base/packet; eq 40mg base/packet; eq 2.5mg base/packet |
| Market Status | Prescription |
| Company | Astrazeneca |
| 3 of 6 | |
|---|---|
| Drug Name | Omeprazole magnesium |
| Drug Label | The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole... |
| Active Ingredient | Omeprazole magnesium |
| Dosage Form | Capsule, delayed release |
| Route | Oral |
| Strength | eq 20mg base |
| Market Status | Over the Counter |
| Company | Dr Reddys Labs |
| 4 of 6 | |
|---|---|
| Drug Name | Esomeprazole magnesium |
| PubMed Health | Esomeprazole |
| Drug Classes | Gastric Acid Secretion Inhibitor, Gastrointestinal Agent |
| Drug Label | The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole... |
| Active Ingredient | Esomeprazole magnesium |
| Dosage Form | Capsule, delayed release |
| Route | oral |
| Strength | 40mg; 20mg |
| Market Status | Tentative Approval |
| Company | Ranbaxy |
| 5 of 6 | |
|---|---|
| Drug Name | Nexium |
| Drug Label | The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole... |
| Active Ingredient | Esomeprazole magnesium |
| Dosage Form | Capsule, delayed rel pellets; For suspension, delayed release |
| Route | Oral |
| Strength | eq 5mg base/packet; eq 20mg base/packet; eq 20mg base; eq 40mg base; eq 10mg base/packet; eq 40mg base/packet; eq 2.5mg base/packet |
| Market Status | Prescription |
| Company | Astrazeneca |
| 6 of 6 | |
|---|---|
| Drug Name | Omeprazole magnesium |
| Drug Label | The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole... |
| Active Ingredient | Omeprazole magnesium |
| Dosage Form | Capsule, delayed release |
| Route | Oral |
| Strength | eq 20mg base |
| Market Status | Over the Counter |
| Company | Dr Reddys Labs |
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.)
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28462
Submission : 2014-07-08
Status : Active
Type : II
Certificate Number : R1-CEP 2012-256 - Rev 02
Issue Date : 2021-06-03
Type : Chemical
Substance Number : 2372
Status : Valid
NDC Package Code : 49927-0005
Start Marketing Date : 2015-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daehan New Pharm Co., Ltd.
Registration Date : 2020-03-11
Registration Number : 20180627-127-H-339-30(4)
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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DMF Review : N/A
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DMF Number : 37233
Submission : 2022-07-01
Status : Active
Type : II
| Available Reg Filing : ASMF |
Minakem is manufacturing small molecules APIs including corticosteroids
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2021-08-10
Registration Number : 20200904-127-H-381-38(1)
Manufacturer Name : Athena Drug Delivery Solutions Pvt Ltd@[Manufacturer of Esomeprazole Magnesium Dihydrate] Glenmark Life Sciences Limited
Manufacturer Address : Plot No. A-1 to A-5, MIDC, Chemical zone, Ambernath(W), Thane 421 501 Maharashtra State, India@[Manufacturer of Esomeprazole Magnesium Dihydrate] Plot No. 3109, GIDC Industrial Estate, Ankleshwar City: Ankleshwar - 393 002, Dist: Bharuch, Gujarat State, India
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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DMF Number : 35519
Submission : 2020-12-29
Status : Active
Type : II
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-03-04
Registration Number : 20151230-127-H-290-20(4)
Manufacturer Name : Metrochem API PVT LTD
Manufacturer Address : Unit-I, Plot No. 62/C/6, Pipeline Road, Phase-I, IDA, Jeedimetla, Quthbullapur(M), Medchal(District)-500 055, Telangana State, India
Certificate Number : R1-CEP 2015-043 - Rev 01
Issue Date : 2020-12-02
Type : Chemical
Substance Number : 2787
Status : Withdrawn by Holder
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
NDC Package Code : 51014-7111
Start Marketing Date : 2014-11-11
End Marketing Date : 2025-11-30
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.
Date of Issue : 2025-07-25
Valid Till : 2028-06-04
Written Confirmation Number : WC-0043
Address of the Firm :
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USDMF
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-25
Pay. Date : 2019-10-16
DMF Number : 34026
Submission : 2019-10-04
Status : Active
Type : II
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28462
Submission : 2014-07-08
Status : Active
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37233
Submission : 2022-07-01
Status : Active
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-26
Pay. Date : 2023-04-18
DMF Number : 36556
Submission : 2021-12-24
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35400
Submission : 2020-11-28
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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DMF Review : N/A
Rev. Date :
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DMF Number : 27925
Submission : 2014-01-17
Status : Inactive
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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DMF Review : N/A
Rev. Date :
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DMF Number : 35519
Submission : 2020-12-29
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-04-21
DMF Number : 28127
Submission : 2014-03-31
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-18
Pay. Date : 2013-01-16
DMF Number : 25858
Submission : 2012-03-30
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2013-01-16
DMF Number : 23994
Submission : 2010-07-26
Status : Active
Type : II
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Esomeprazole Magnesium Trihydrate, Micronised, N...
Certificate Number : R1-CEP 2012-256 - Rev 02
Status : Valid
Issue Date : 2021-06-03
Type : Chemical
Substance Number : 2372
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Esomeprazole Magnesium Trihydrate
Certificate Number : CEP 2020-386 - Rev 02
Status : Valid
Issue Date : 2024-08-26
Type : Chemical
Substance Number : 2372
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Esomeprazole Magnesium Dihydrate
Certificate Number : CEP 2021-022 - Rev 01
Status : Valid
Issue Date : 2024-06-20
Type : Chemical
Substance Number : 2787
Esomeprazole Magnesium Dihydrate, Form A - Micro...
Certificate Number : R1-CEP 2015-043 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2020-12-02
Type : Chemical
Substance Number : 2787
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Esomeprazole Magnesium Trihydrate, EMT-2 Process
Certificate Number : R0-CEP 2023-070 - Rev 00
Status : Valid
Issue Date : 2023-06-15
Type : Chemical
Substance Number : 2372
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Esomeprazole Magnesium Trihydrate
Certificate Number : R1-CEP 2012-395 - Rev 01
Status : Valid
Issue Date : 2023-06-05
Type : Chemical
Substance Number : 2372
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Esomeprazole Magnesium Trihydrate, Process II
Certificate Number : R0-CEP 2021-243 - Rev 00
Status : Valid
Issue Date : 2022-01-03
Type : Chemical
Substance Number : 2372
Esomeprazole Magnesium Dihydrate
Certificate Number : R0-CEP 2014-158 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2016-09-13
Type : Chemical
Substance Number : 2787
Esomeprazole Magnesium Trihydrate
Certificate Number : R0-CEP 2015-008 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-05-17
Type : Chemical
Substance Number : 2372
Esomeprazole Magnesium Dihydrate
Certificate Number : R0-CEP 2016-088 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2018-02-09
Type : Chemical
Substance Number : 2787
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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
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Drugs in Development
Details:
The transaction includes Trustan, Altosec, Zuvamor, Ciavor, Grantryl and Aspen Granisetron brands. To secure uninterrupted patient access to these medicines, the parties have also signed a manufacturing and supply agreement.
Lead Product(s): Esomeprazole Magnesium,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Trustan
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Acino Pharma
Deal Size: $119.4 million Upfront Cash: Undisclosed
Deal Type: Acquisition October 22, 2021
Lead Product(s) : Esomeprazole Magnesium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Acino Pharma
Deal Size : $119.4 million
Deal Type : Acquisition
Acino Acquires Selected Aspen Brands in South Africa
Details : The transaction includes Trustan, Altosec, Zuvamor, Ciavor, Grantryl and Aspen Granisetron brands. To secure uninterrupted patient access to these medicines, the parties have also signed a manufacturing and supply agreement.
Product Name : Trustan
Product Type : Miscellaneous
Upfront Cash : Undisclosed
October 22, 2021
Details:
Esomeprazole magnesium hydrate capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Lead Product(s): Esomeprazole Magnesium,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Esomeprazole-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 14, 2024
Lead Product(s) : Esomeprazole Magnesium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Notice of Approval for Esomeprazole Capsules with New Manufacturing Plant Addition
Details : Esomeprazole magnesium hydrate capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Product Name : Esomeprazole-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 14, 2024
Details:
Esomeprazole magnesium delayed-release capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Lead Product(s): Esomeprazole Magnesium,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Nexium-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 19, 2023
Lead Product(s) : Esomeprazole Magnesium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Gets USFDA Nod for Generic Drug Used for Short-term Treatment of Heartburn
Details : Esomeprazole magnesium delayed-release capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Product Name : Nexium-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 19, 2023
Details:
INCB161734 is a drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Lead Product(s): INCB161734,Itraconazole,Rifampicin,Esomeprazole Magnesium,Famotidine
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 12, 2025
Lead Product(s) : INCB161734,Itraconazole,Rifampicin,Esomeprazole Magnesium,Famotidine
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
INCB161734 PK Study with Itraconazole, Rifampin, Acid-Reducing Agents In Healthy Adults
Details : INCB161734 is a drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
June 12, 2025
Details:
Nexium (Esomeprazole Magnesium) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Esophagitis, Peptic.
Lead Product(s): Esomeprazole Magnesium,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Nexium
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 27, 2025
Lead Product(s) : Esomeprazole Magnesium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Nexium (Esomeprazole Magnesium) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Esophagitis, Peptic.
Product Name : Nexium
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 27, 2025
Details:
Zasocitinib 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): Zasocitinib,COC,Metformin,Digoxin,Esomeprazole Magnesium
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 27, 2025
Lead Product(s) : Zasocitinib,COC,Metformin,Digoxin,Esomeprazole Magnesium
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Interaction of Zasocitinib (TAK-279) With Other Medicines in Healthy Adults
Details : Zasocitinib 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
January 27, 2025
Details:
NX-5948 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): NX-5948,Esomeprazole Magnesium
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 04, 2024
Lead Product(s) : NX-5948,Esomeprazole Magnesium
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : NX-5948 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
December 04, 2024
Details:
Nexium-Generic (esomeprazole magnesium) is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Lead Product(s): Esomeprazole Magnesium,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Nexium-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 12, 2024
Lead Product(s) : Esomeprazole Magnesium,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Glenmark gets USFDA nod to market generic drug
Details : Nexium-Generic (esomeprazole magnesium) is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.
Product Name : Nexium-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 12, 2024
Details:
Esomeprazole is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Gastroesophageal Reflux.
Lead Product(s): Esomeprazole Magnesium,Sodium Bicarbonate
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 28, 2024
Lead Product(s) : Esomeprazole Magnesium,Sodium Bicarbonate
Therapeutic Area : Gastroenterology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy and Safety of EsoDuo®
Details : Esomeprazole is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Gastroesophageal Reflux.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 28, 2024
Details:
BI 300202 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): BI 300202,Esomeprazole Magnesium
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 17, 2024
Lead Product(s) : BI 300202,Esomeprazole Magnesium
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : BI 300202 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
May 17, 2024
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Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ESOMEPRAZOLE PENSA PHARMA
Dosage Form : Gastro-Resistant Hard Capsules
Dosage Strength : 20 mg
Packaging : 14 UNITS 20 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ESOMEPRAZOLE PENSA PHARMA
Dosage Form : Gastro-Resistant Hard Capsules
Dosage Strength : 20 mg
Packaging : 14 UNITS 20 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ESOMEPRAZOLE PENSA PHARMA
Dosage Form : Gastro-Resistant Hard Capsules
Dosage Strength : 40 mg
Packaging : 14 UNITS 40 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ESOMEPRAZOLE PENSA PHARMA
Dosage Form : Gastro-Resistant Hard Capsules
Dosage Strength : 40 mg
Packaging : 14 UNITS 40 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ESOMEPRAZOLE PENSA PHARMA
Dosage Form : Gastro-Resistant Hard Capsules
Dosage Strength : 20 mg
Packaging : 28 UNITS 20 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ESOMEPRAZOLE PENSA PHARMA
Dosage Form : Gastro-Resistant Hard Capsules
Dosage Strength : 20 mg
Packaging : 28 UNITS 20 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ESOMEPRAZOLE PENSA PHARMA
Dosage Form : Gastro-Resistant Hard Capsules
Dosage Strength : 40 mg
Packaging : 28 UNITS 40 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ESOMEPRAZOLE PENSA PHARMA
Dosage Form : Gastro-Resistant Hard Capsules
Dosage Strength : 40 mg
Packaging : 28 UNITS 40 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : ESOMEPRAZOLE ARISTO
Dosage Form : Gastroresistant Capsules
Dosage Strength : 20 mg
Packaging : 14 UNITS 20 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Esomeprazol Sandoz
Dosage Form : Enteric Tablet
Dosage Strength : 20 mg
Packaging : Box of plastic with dry solvent
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 2...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 204655
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21153
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 21153
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22511
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22511
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EDQM
Omeprazole for peak identification
CAS Number : 73590-58-6
Quantity Per Vial : 10 mg
Sale Unit : 1
Order Code : Y0001042
Batch No : 2
Price (€) : 79
Storage : -20°C ± 5°C
CAS Number : 88546-55-8
Quantity Per Vial : 15 mg
Sale Unit : 1
Order Code : O0151000
Batch No : 3
Price (€) : 79
Storage : -20°C ± 5°C
CAS Number : 73590-58-6
Quantity Per Vial : 50 mg
Sale Unit : 1
Order Code : O0150000
Batch No : 5
Price (€) : 79
Storage : -20°C ± 5°C
Esomeprazole magnesium trihydrate
CAS Number : 217087-09-7
Quantity Per Vial : 5 mg
Sale Unit : 1
Order Code : Y0001028
Batch No : 2
Price (€) : 79
Storage : +5°C ± 3°C
Esomeprazole magnesium dihydrate
CAS Number : 217087-10-0
Quantity Per Vial : 15 mg
Sale Unit : 1
Order Code : Y0001660
Batch No : 1
Price (€) : 79
Storage : +5°C ± 3°C
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ABOUT THIS PAGE
13
PharmaCompass offers a list of Esomeprazole Magnesium 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 Esomeprazole Magnesium manufacturer or Esomeprazole Magnesium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Esomeprazole Magnesium manufacturer or Esomeprazole Magnesium supplier.
PharmaCompass also assists you with knowing the Esomeprazole Magnesium API Price utilized in the formulation of products. Esomeprazole Magnesium API Price is not always fixed or binding as the Esomeprazole Magnesium Price is obtained through a variety of data sources. The Esomeprazole Magnesium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nexium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexium, including repackagers and relabelers. The FDA regulates Nexium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexium 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 Nexium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nexium supplier is an individual or a company that provides Nexium active pharmaceutical ingredient (API) or Nexium finished formulations upon request. The Nexium suppliers may include Nexium API manufacturers, exporters, distributors and traders.
click here to find a list of Nexium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nexium DMF (Drug Master File) is a document detailing the whole manufacturing process of Nexium active pharmaceutical ingredient (API) in detail. Different forms of Nexium DMFs exist exist since differing nations have different regulations, such as Nexium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nexium DMF submitted to regulatory agencies in the US is known as a USDMF. Nexium USDMF includes data on Nexium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nexium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nexium suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Nexium Drug Master File in Japan (Nexium JDMF) empowers Nexium API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Nexium JDMF during the approval evaluation for pharmaceutical products. At the time of Nexium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Nexium suppliers with JDMF 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 Nexium Drug Master File in Korea (Nexium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nexium. The MFDS reviews the Nexium KDMF as part of the drug registration process and uses the information provided in the Nexium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nexium 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 Nexium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nexium suppliers with KDMF on PharmaCompass.
A Nexium CEP of the European Pharmacopoeia monograph is often referred to as a Nexium Certificate of Suitability (COS). The purpose of a Nexium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nexium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nexium to their clients by showing that a Nexium CEP has been issued for it. The manufacturer submits a Nexium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nexium CEP holder for the record. Additionally, the data presented in the Nexium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nexium DMF.
A Nexium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nexium 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 Nexium suppliers with CEP (COS) on PharmaCompass.
A Nexium written confirmation (Nexium WC) is an official document issued by a regulatory agency to a Nexium manufacturer, verifying that the manufacturing facility of a Nexium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nexium APIs or Nexium finished pharmaceutical products to another nation, regulatory agencies frequently require a Nexium WC (written confirmation) as part of the regulatory process.
click here to find a list of Nexium 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 Nexium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nexium 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 Nexium 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 Nexium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nexium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nexium suppliers with NDC on PharmaCompass.
Nexium 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 Nexium 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 Nexium GMP manufacturer or Nexium GMP API supplier for your needs.
A Nexium CoA (Certificate of Analysis) is a formal document that attests to Nexium's compliance with Nexium specifications and serves as a tool for batch-level quality control.
Nexium CoA mostly includes findings from lab analyses of a specific batch. For each Nexium 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.
Nexium may be tested according to a variety of international standards, such as European Pharmacopoeia (Nexium EP), Nexium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nexium USP).
