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