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1. H 168 68
2. H 168-68
3. H 16868
4. Magnesium, Omeprazole
5. Omeprazole
6. Omeprazole Magnesium
7. Omeprazole Sodium
8. Prilosec
9. Sodium, Omeprazole
1. Omeprazole Sodium
2. Losec Sodium
3. H 168/68 Sodium
4. 95510-70-6
5. Omeprazole Sodium [usan]
6. 161796-78-7
7. Omeprazole (as Sodium)
8. Kv03yz6qlw
9. 95510-70-6 (sodium)
10. Andra
11. Omeprazole Sodium (usan)
12. 5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)benzimidazole, Sodium Salt
13. 1h-benzimidazole, 5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-, Sodium Salt
14. (s)-omeprazole Sodium
15. Esomeprazole Sodium Salt
16. Sompraz
17. Sodium 5-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide
18. Unii-kv03yz6qlw
19. Losec Sodium (tn)
20. Esomeprazole Sodium (nexium)
21. Omeprazole Sodium [jan]
22. Chembl2105294
23. H-168/68 Sodium
24. Chebi:31934
25. Omeprazole Sodium [mart.]
26. Hms3651e16
27. Omeprazole Sodium [who-dd]
28. Bcp23377
29. Esomeprazole Sodium (nexium I.v.)
30. Ac-403
31. S5658
32. Akos024255604
33. Bcp9000660
34. Omeprazole Sodium [ep Monograph]
35. Bcp0726000228
36. Sw219428-1
37. D01207
38. Ab01274809-01
39. Q27282459
40. Sodium 6-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]-3ah-benzimidazole
1. Omeprazole Sodium Hydrate
| Molecular Weight | 367.4 g/mol |
|---|---|
| Molecular Formula | C17H18N3NaO3S |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 5 |
| Exact Mass | 367.09665690 g/mol |
| Monoisotopic Mass | 367.09665690 g/mol |
| Topological Polar Surface Area | 81.5 Ų |
| Heavy Atom Count | 25 |
| Formal Charge | 0 |
| Complexity | 459 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Esomeprazole sodium |
| Drug Label | The active ingredient in esomeprazole sodium for injection is (S)-5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1 H-benzimidazole sodium, a proton pump inhibitor that inhibits gastric acid secretion. Esomeprazole is the S-isome... |
| Active Ingredient | Esomeprazole sodium |
| Dosage Form | Injectable |
| Route | Intravenous |
| Strength | eq 20mg base/vial; eq 40mg base/vial |
| Market Status | Prescription |
| Company | Sun Pharma Global |
| 2 of 4 | |
|---|---|
| Drug Name | Nexium |
| 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 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 4 | |
|---|---|
| Drug Name | Esomeprazole sodium |
| Drug Label | The active ingredient in esomeprazole sodium for injection is (S)-5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1 H-benzimidazole sodium, a proton pump inhibitor that inhibits gastric acid secretion. Esomeprazole is the S-isome... |
| Active Ingredient | Esomeprazole sodium |
| Dosage Form | Injectable |
| Route | Intravenous |
| Strength | eq 20mg base/vial; eq 40mg base/vial |
| Market Status | Prescription |
| Company | Sun Pharma Global |
| 4 of 4 | |
|---|---|
| Drug Name | Nexium |
| 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 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 |
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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ABOUT THIS PAGE
A Omeprazole Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omeprazole Sodium, including repackagers and relabelers. The FDA regulates Omeprazole Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omeprazole Sodium 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 Omeprazole Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Omeprazole Sodium supplier is an individual or a company that provides Omeprazole Sodium active pharmaceutical ingredient (API) or Omeprazole Sodium finished formulations upon request. The Omeprazole Sodium suppliers may include Omeprazole Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Omeprazole Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Omeprazole Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Omeprazole Sodium active pharmaceutical ingredient (API) in detail. Different forms of Omeprazole Sodium DMFs exist exist since differing nations have different regulations, such as Omeprazole Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Omeprazole Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Omeprazole Sodium USDMF includes data on Omeprazole Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Omeprazole Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Omeprazole Sodium 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 Omeprazole Sodium Drug Master File in Japan (Omeprazole Sodium JDMF) empowers Omeprazole Sodium 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 Omeprazole Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Omeprazole Sodium 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 Omeprazole Sodium suppliers with JDMF on PharmaCompass.
A Omeprazole Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Omeprazole Sodium Certificate of Suitability (COS). The purpose of a Omeprazole Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Omeprazole Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Omeprazole Sodium to their clients by showing that a Omeprazole Sodium CEP has been issued for it. The manufacturer submits a Omeprazole Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Omeprazole Sodium CEP holder for the record. Additionally, the data presented in the Omeprazole Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Omeprazole Sodium DMF.
A Omeprazole Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Omeprazole Sodium 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 Omeprazole Sodium suppliers with CEP (COS) on PharmaCompass.
A Omeprazole Sodium written confirmation (Omeprazole Sodium WC) is an official document issued by a regulatory agency to a Omeprazole Sodium manufacturer, verifying that the manufacturing facility of a Omeprazole Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Omeprazole Sodium APIs or Omeprazole Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Omeprazole Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Omeprazole Sodium 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 Omeprazole Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Omeprazole Sodium 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 Omeprazole Sodium 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 Omeprazole Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Omeprazole Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Omeprazole Sodium suppliers with NDC on PharmaCompass.
Omeprazole Sodium 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 Omeprazole Sodium 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 Omeprazole Sodium GMP manufacturer or Omeprazole Sodium GMP API supplier for your needs.
A Omeprazole Sodium CoA (Certificate of Analysis) is a formal document that attests to Omeprazole Sodium's compliance with Omeprazole Sodium specifications and serves as a tool for batch-level quality control.
Omeprazole Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Omeprazole Sodium 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.
Omeprazole Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Omeprazole Sodium EP), Omeprazole Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Omeprazole Sodium USP).
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