Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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.)
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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.
GDUFA
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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
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 Dihydrate, Micronised, No...
Certificate Number : R1-CEP 2015-086 - Rev 00
Status : Valid
Issue Date : 2020-08-31
Type : Chemical
Substance Number : 2787
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Esomeprazole Magnesium Trihydrate
Certificate Number : CEP 2022-012 - Rev 02
Status : Valid
Issue Date : 2024-12-13
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 Trihydrate
Certificate Number : R0-CEP 2015-008 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-05-17
Type : Chemical
Substance Number : 2372
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
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
Related Excipient Companies
Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Chynops Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pramukh Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zeal MediPharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Doshion Polyscience
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NEWEDGE Overseas
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Coating Systems & Additives
Fillers, Diluents & Binders
Controlled & Modified Release
Solubilizers
Thickeners and Stabilizers
Direct Compression
Taste Masking
Granulation
Disintegrants & Superdisintegrants
Lubricants & Glidants
Film Formers & Plasticizers
Chewable & Orodispersible Aids
Co-Processed Excipients
Topical
Parenteral
Emulsifying Agents
Empty Capsules
Rheology Modifiers
API Stability Enhancers
Coloring Agents
Vegetarian Capsules
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
15
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 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).
