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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 | |
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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.)
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
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Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
A Esomeprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole, including repackagers and relabelers. The FDA regulates Esomeprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esomeprazole supplier is an individual or a company that provides Esomeprazole active pharmaceutical ingredient (API) or Esomeprazole finished formulations upon request. The Esomeprazole suppliers may include Esomeprazole API manufacturers, exporters, distributors and traders.
click here to find a list of Esomeprazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Esomeprazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Esomeprazole active pharmaceutical ingredient (API) in detail. Different forms of Esomeprazole DMFs exist exist since differing nations have different regulations, such as Esomeprazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Esomeprazole DMF submitted to regulatory agencies in the US is known as a USDMF. Esomeprazole USDMF includes data on Esomeprazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esomeprazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Esomeprazole 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 Drug Master File in Japan (Esomeprazole JDMF) empowers Esomeprazole 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Esomeprazole 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 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 Drug Master File in Korea (Esomeprazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Esomeprazole. The MFDS reviews the Esomeprazole KDMF as part of the drug registration process and uses the information provided in the Esomeprazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Esomeprazole 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Esomeprazole suppliers with KDMF on PharmaCompass.
A Esomeprazole CEP of the European Pharmacopoeia monograph is often referred to as a Esomeprazole Certificate of Suitability (COS). The purpose of a Esomeprazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Esomeprazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Esomeprazole to their clients by showing that a Esomeprazole CEP has been issued for it. The manufacturer submits a Esomeprazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Esomeprazole CEP holder for the record. Additionally, the data presented in the Esomeprazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Esomeprazole DMF.
A Esomeprazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Esomeprazole 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 suppliers with CEP (COS) on PharmaCompass.
A Esomeprazole written confirmation (Esomeprazole WC) is an official document issued by a regulatory agency to a Esomeprazole manufacturer, verifying that the manufacturing facility of a Esomeprazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Esomeprazole APIs or Esomeprazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Esomeprazole WC (written confirmation) as part of the regulatory process.
click here to find a list of Esomeprazole 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Esomeprazole 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Esomeprazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Esomeprazole suppliers with NDC on PharmaCompass.
Esomeprazole 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 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 GMP manufacturer or Esomeprazole GMP API supplier for your needs.
A Esomeprazole CoA (Certificate of Analysis) is a formal document that attests to Esomeprazole's compliance with Esomeprazole specifications and serves as a tool for batch-level quality control.
Esomeprazole CoA mostly includes findings from lab analyses of a specific batch. For each Esomeprazole 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Esomeprazole EP), Esomeprazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Esomeprazole USP).
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