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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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Submission : 2014-07-08
Status : Active
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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
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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
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Substance Number : 2787
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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
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
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Esomeprazole Magnesium Dihydrate, Micronised, No...
Certificate Number : R1-CEP 2015-086 - Rev 00
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Substance Number : 2787
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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Esomeprazole Magnesium Trihydrate
Certificate Number : CEP 2022-012 - Rev 02
Status : Valid
Issue Date : 2024-12-13
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Substance Number : 2372
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Esomeprazole Magnesium Trihydrate
Certificate Number : CEP 2020-386 - Rev 02
Status : Valid
Issue Date : 2024-08-26
Type : Chemical
Substance Number : 2372
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Esomeprazole Magnesium Dihydrate
Certificate Number : CEP 2021-022 - Rev 01
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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
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Esomeprazole Magnesium Trihydrate, EMT-2 Process
Certificate Number : R0-CEP 2023-070 - Rev 00
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Type : Chemical
Substance Number : 2372
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Esomeprazole Magnesium Trihydrate
Certificate Number : R1-CEP 2012-395 - Rev 01
Status : Valid
Issue Date : 2023-06-05
Type : Chemical
Substance Number : 2372
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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 Trihydrate
Certificate Number : R0-CEP 2015-008 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-05-17
Type : Chemical
Substance Number : 2372
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Esomeprazole magnesium hydrate
Registration Number : 303MF10113
Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Mahara...
Initial Date of Registration : 2021-07-16
Latest Date of Registration : 2021-07-16
Esomeprazole magnesium hydrate
Registration Number : 303MF10137
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2021-08-20
Latest Date of Registration : 2021-08-20
Esomeprazole magnesium hydrate "Apitoria"
Registration Number : 306MF10086
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03
Esomeprazole magnesium hydrate
Registration Number : 303MF10107
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...
Initial Date of Registration : 2021-07-09
Latest Date of Registration : 2021-07-09
Esomeprazole magnesium hydrate
Registration Number : 303MF10115
Registrant's Address : No. 89 1st street, Lingbei Road, Lingchuan, Guilin Guangxi, PR China
Initial Date of Registration : 2021-07-20
Latest Date of Registration : 2021-07-20
Esomeprazole magnesium hydrate "D"
Registration Number : 301MF10050
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...
Initial Date of Registration : 2019-08-20
Latest Date of Registration : 2019-08-20
Esomeprazole magnesium hydrate
Registration Number : 303MF10042
Registrant's Address : NORTH-EAST OF DONGWAIHUAN ROAD, DONGCHENG INDUSTRIAL AREA, SHOUGUANG CITY, SHANDONG, ...
Initial Date of Registration : 2021-03-15
Latest Date of Registration : 2021-03-15
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Esomeprazole Magnesium Trihydrate Ph.Eur.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...
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Date of Issue : 2022-06-07
Valid Till : 2025-07-07
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Esomeprazole Magnesium Trihydrate IH/Ph.Eur
Date of Issue : 2022-06-07
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...
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Esomeprazole Magnesium Amorphous IH
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Date of Issue : 2022-05-26
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035
Address of the Firm : Unit-lll, Plot No. 116, Sri Venkateswara Co-operative, Industrial Estate, IDA, B...
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Esomeprazole Magnesium Trihydrate Ph. Eur.
Date of Issue : 2022-05-26
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035
Address of the Firm : Unit-lll, Plot No. 116, Sri Venkateswara Co-operative, Industrial Estate, IDA, B...
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Esomeprazole Magnesium Trihydrate Ph.Eur
Date of Issue : 2022-05-27
Valid Till : 2025-06-04
Written Confirmation Number : WC-0043
Address of the Firm : Chemical Technical Operations ? Unit V, Peddadevulapally Village, Tripuraram Man...
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Esomeprazole Magnesium Tri-Hydrate IP/Ph.Eur
Date of Issue : 2024-08-16
Valid Till : 2027-02-26
Written Confirmation Number : WC-0494
Address of the Firm : (Unit-1), Sy No 29, Tupakulagudem (V), Pochavaram Panchayat, Tallapudi (M), West...
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Esomeprazole magnesium trihydrate
Registrant Name : Pharmasolution Co., Ltd.
Registration Date : 2019-04-04
Registration Number : 20180627-127-H-339-30(1)
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Esomeprazole magnesium trihydrate
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2020-02-06
Registration Number : 20180627-127-H-339-30(3)
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Esomeprazole magnesium trihydrate
Registrant Name : 엠피크코리아(주)
Registration Date : 2019-12-24
Registration Number : 20180627-127-H-339-30(2)
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Esomeprazole magnesium trihydrate
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2010-10-29
Registration Number : 20101029-127-H-21-05
Manufacturer Name : Minakem Dunkerque Production
Manufacturer Address : 224 avenue de la Dordogne Zone d'Entreprises du Nord Gracht 59640 Dunkerque, France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Esomeprazole magnesium trihydrate
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2018-06-27
Registration Number : 20180627-127-H-339-30
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Esomeprazole magnesium trihydrate
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
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2020-09-04
Registration Number : 20200904-127-H-381-38
Manufacturer Name : Athena Drug Delivery Solutio...
Manufacturer Address : Plot No. A-1 to A-5, MIDC, Chemical zone, Ambernath(W), Thane 421 501 Maharashtra Sta...
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Esomeprazole magnesium dihydrate
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 Solutio...
Manufacturer Address : Plot No. A-1 to A-5, MIDC, Chemical zone, Ambernath(W), Thane 421 501 Maharashtra Sta...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Esomeprazole magnesium hydrate
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2015-12-30
Registration Number : 20151230-127-H-290-20
Manufacturer Name : Metrochem API PVT LTD
Manufacturer Address : Unit-I, Plot No. 62/C/6, Pipeline Road, Phase-I, IDA., Jeedimetla, Quthbullapur (M), ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Esomeprazole magnesium hydrate
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2018-11-26
Registration Number : 20151230-127-H-290-20(1)
Manufacturer Name : Metrochem API PVT LTD
Manufacturer Address : Unit-I, Plot No. 62/C/6, Pipeline Road, Phase-I, IDA., Jeedimetla, Quthbullapur (M), ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
NDC Package Code : 49927-0001
Start Marketing Date : 2009-10-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
NDC Package Code : 49927-0006
Start Marketing Date : 2015-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
NDC Package Code : 49927-0002
Start Marketing Date : 2010-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
NDC Package Code : 42765-015
Start Marketing Date : 2020-11-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
NDC Package Code : 42765-024
Start Marketing Date : 2020-12-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
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
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
NDC Package Code : 49169-1038
Start Marketing Date : 2011-06-08
End Marketing Date : 2025-12-31
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 : 55111-948
Start Marketing Date : 2012-03-30
End Marketing Date : 2026-12-31
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 : 55111-871
Start Marketing Date : 2010-07-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Average Price (USD/KGS) |
Number of Transactions |
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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
Therapeutic Area: Gastroenterology Brand Name: Trustan
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Acino Pharma
Deal Size: $119.4 million Upfront Cash: Undisclosed
Deal Type: Acquisition October 22, 2021
Lead Product(s) : Esomeprazole Magnesium
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 : Other Small Molecule
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
Therapeutic Area: Gastroenterology Brand Name: Esomeprazole-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 14, 2024
Lead Product(s) : Esomeprazole Magnesium
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
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
Therapeutic Area: Gastroenterology Brand Name: Nexium-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 19, 2023
Lead Product(s) : Esomeprazole Magnesium
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
October 19, 2023
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
Therapeutic Area: Gastroenterology Brand Name: Nexium-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 06, 2024
Lead Product(s) : Esomeprazole Magnesium
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
December 06, 2024
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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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 Esomeprazole Magnesium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole Magnesium, including repackagers and relabelers. The FDA regulates Esomeprazole Magnesium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole Magnesium 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 Esomeprazole Magnesium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esomeprazole Magnesium supplier is an individual or a company that provides Esomeprazole Magnesium active pharmaceutical ingredient (API) or Esomeprazole Magnesium finished formulations upon request. The Esomeprazole Magnesium suppliers may include Esomeprazole Magnesium API manufacturers, exporters, distributors and traders.
click here to find a list of Esomeprazole Magnesium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Esomeprazole Magnesium DMF (Drug Master File) is a document detailing the whole manufacturing process of Esomeprazole Magnesium active pharmaceutical ingredient (API) in detail. Different forms of Esomeprazole Magnesium DMFs exist exist since differing nations have different regulations, such as Esomeprazole Magnesium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Esomeprazole Magnesium DMF submitted to regulatory agencies in the US is known as a USDMF. Esomeprazole Magnesium USDMF includes data on Esomeprazole Magnesium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esomeprazole Magnesium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Esomeprazole Magnesium 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 Esomeprazole Magnesium Drug Master File in Japan (Esomeprazole Magnesium JDMF) empowers Esomeprazole Magnesium 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 Esomeprazole Magnesium JDMF during the approval evaluation for pharmaceutical products. At the time of Esomeprazole Magnesium 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 Esomeprazole Magnesium 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 Esomeprazole Magnesium Drug Master File in Korea (Esomeprazole Magnesium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Esomeprazole Magnesium. The MFDS reviews the Esomeprazole Magnesium KDMF as part of the drug registration process and uses the information provided in the Esomeprazole Magnesium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Esomeprazole Magnesium 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 Esomeprazole Magnesium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Esomeprazole Magnesium suppliers with KDMF on PharmaCompass.
A Esomeprazole Magnesium CEP of the European Pharmacopoeia monograph is often referred to as a Esomeprazole Magnesium Certificate of Suitability (COS). The purpose of a Esomeprazole Magnesium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Esomeprazole Magnesium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Esomeprazole Magnesium to their clients by showing that a Esomeprazole Magnesium CEP has been issued for it. The manufacturer submits a Esomeprazole Magnesium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Esomeprazole Magnesium CEP holder for the record. Additionally, the data presented in the Esomeprazole Magnesium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Esomeprazole Magnesium DMF.
A Esomeprazole Magnesium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Esomeprazole Magnesium 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 Esomeprazole Magnesium suppliers with CEP (COS) on PharmaCompass.
A Esomeprazole Magnesium written confirmation (Esomeprazole Magnesium WC) is an official document issued by a regulatory agency to a Esomeprazole Magnesium manufacturer, verifying that the manufacturing facility of a Esomeprazole Magnesium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Esomeprazole Magnesium APIs or Esomeprazole Magnesium finished pharmaceutical products to another nation, regulatory agencies frequently require a Esomeprazole Magnesium WC (written confirmation) as part of the regulatory process.
click here to find a list of Esomeprazole Magnesium 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 Esomeprazole Magnesium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Esomeprazole Magnesium 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 Esomeprazole Magnesium 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 Esomeprazole Magnesium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Esomeprazole Magnesium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Esomeprazole Magnesium suppliers with NDC on PharmaCompass.
Esomeprazole Magnesium 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 Esomeprazole Magnesium 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 Esomeprazole Magnesium GMP manufacturer or Esomeprazole Magnesium GMP API supplier for your needs.
A Esomeprazole Magnesium CoA (Certificate of Analysis) is a formal document that attests to Esomeprazole Magnesium's compliance with Esomeprazole Magnesium specifications and serves as a tool for batch-level quality control.
Esomeprazole Magnesium CoA mostly includes findings from lab analyses of a specific batch. For each Esomeprazole Magnesium 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.
Esomeprazole Magnesium may be tested according to a variety of international standards, such as European Pharmacopoeia (Esomeprazole Magnesium EP), Esomeprazole Magnesium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Esomeprazole Magnesium USP).
