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Also known as: Omeprazole sodium, Losec sodium, H 168/68 sodium, 95510-70-6, Omeprazole sodium [usan], 161796-78-7
Molecular Formula
C17H18N3NaO3S
Molecular Weight
367.4  g/mol
InChI Key
RYXPMWYHEBGTRV-UHFFFAOYSA-N
FDA UNII
KV03YZ6QLW

Omeprazole Sodium
A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.
1 2D Structure

Omeprazole Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
2.1.2 InChI
InChI=1S/C17H18N3O3S.Na/c1-10-8-18-15(11(2)16(10)23-4)9-24(21)17-19-13-6-5-12(22-3)7-14(13)20-17;/h5-8H,9H2,1-4H3;/q-1;+1
2.1.3 InChI Key
RYXPMWYHEBGTRV-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC.[Na+]
2.2 Other Identifiers
2.2.1 UNII
KV03YZ6QLW
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.3.3 Other Synonyms

1. Omeprazole Sodium Hydrate

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 367.4 g/mol
Molecular Formula C17H18N3NaO3S
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count7
Rotatable Bond Count5
Exact Mass367.09665690 g/mol
Monoisotopic Mass367.09665690 g/mol
Topological Polar Surface Area81.5 Ų
Heavy Atom Count25
Formal Charge0
Complexity459
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameEsomeprazole sodium
Drug LabelThe 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 IngredientEsomeprazole sodium
Dosage FormInjectable
RouteIntravenous
Strengtheq 20mg base/vial; eq 40mg base/vial
Market StatusPrescription
CompanySun Pharma Global

2 of 4  
Drug NameNexium
PubMed HealthEsomeprazole
Drug ClassesGastric Acid Secretion Inhibitor, Gastrointestinal Agent
Drug LabelThe 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 IngredientEsomeprazole magnesium
Dosage FormCapsule, delayed rel pellets; For suspension, delayed release
RouteOral
Strengtheq 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 StatusPrescription
CompanyAstrazeneca

3 of 4  
Drug NameEsomeprazole sodium
Drug LabelThe 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 IngredientEsomeprazole sodium
Dosage FormInjectable
RouteIntravenous
Strengtheq 20mg base/vial; eq 40mg base/vial
Market StatusPrescription
CompanySun Pharma Global

4 of 4  
Drug NameNexium
PubMed HealthEsomeprazole
Drug ClassesGastric Acid Secretion Inhibitor, Gastrointestinal Agent
Drug LabelThe 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 IngredientEsomeprazole magnesium
Dosage FormCapsule, delayed rel pellets; For suspension, delayed release
RouteOral
Strengtheq 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 StatusPrescription
CompanyAstrazeneca

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]

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ESTATE, 11\/II-B,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741026600,"product":"OMEPRAZOLE SODIUM BP PHARMACEUTICAL RAWMATERIALS","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE SHAHJALAL ISLAMI BANK LTD,","customerCountry":"BANGLADESH","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"260","totalValueFC":"5101.8","currency":"USD","unitRateINR":22095.25,"date":"04-Mar-2025","totalValueINR":"441905","totalValueInUsd":"5101.8","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"8684274","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741113000,"product":"OMEPRAZOLE SODIUM STERILE (34% TO 38% W\/W)B.N..AOSS24057,MD.JAN-25,ED.DEC-27,B.N.AOSS24059,AOSS24060,MD.FEB-25,ED.JAN-28","address":"M-134, 2ND FLOOR","city":"NEW DELHI","supplier":"RAJASTHAN ANTIBIOTICS","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"TO THE ORDER OF","customerCountry":"INDONESIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"208","totalValueFC":"50700.4","currency":"USD","unitRateINR":17566.181920000003,"date":"05-Mar-2025","totalValueINR":"4391545.48","totalValueInUsd":"50700.4","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"8724654","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Sterile","supplierPort":"Delhi Air","supplierAddress":"M-134, 2ND FLOOR, NEW DELHI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741199400,"product":"ESOMEPRAZOLE SODIUM PHARMACEUTICAL RAW MATERIALS","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"EVA PHARMA","customerCountry":"EGYPT","quantity":"14.00","actualQuantity":"14","unit":"KGS","unitRateFc":"300","totalValueFC":"4065","currency":"USD","unitRateINR":25150.322142857145,"date":"06-Mar-2025","totalValueINR":"352104.51","totalValueInUsd":"4065","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"8759823","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741545000,"product":"ESOMEPRAZOLE SODIUM STERILE (34 % TO 38% W\/W)(AESS24009 M.NOV-24 E.OCT-27,AESS24010 M.DEC-24 E.NOV-27)","address":"M-134, 2ND FLOOR","city":"NEW DELHI","supplier":"RAJASTHAN ANTIBIOTICS","supplierCountry":"INDIA","foreign_port":"SURABAYA","customer":"TO THE ORDER OF","customerCountry":"INDONESIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"732","totalValueFC":"28901.3","currency":"USD","unitRateINR":62583.9375,"date":"10-Mar-2025","totalValueINR":"2503357.5","totalValueInUsd":"28901.3","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"8883475","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Sterile","supplierPort":"Delhi Air","supplierAddress":"M-134, 2ND FLOOR, NEW DELHI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741631400,"product":"ESOMEPRAZOLE SODIUM (IHS) STERILE LYOPHILIZED POWDER (PHARMACEUTICAL RAW MATERIAL (ALLOPATHIC) OF PHARMACEUTICAL GRADE","address":"G1-567, RIICO INDL.AREA KHUSHKHERA","city":"N\/A","supplier":"VARTIKA CHEMICALS AND PHARMACEUTICALS PRIVATE LIMI","supplierCountry":"INDIA","foreign_port":"ISLAMABAD - ISLAMABA","customer":"TO:THE ORDER OF,","customerCountry":"PAKISTAN","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"210","totalValueFC":"1789.2","currency":"USD","unitRateINR":15498,"date":"11-Mar-2025","totalValueINR":"154980","totalValueInUsd":"1789.2","indian_port":"Delhi Air","hs_no":"29333990","bill_no":"8901429","productDescription":"API","marketType":"","country":"PAKISTAN","selfForZScoreResived":"Sterile","supplierPort":"Delhi Air","supplierAddress":"G1-567, RIICO INDL.AREA KHUSHKHERA, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741717800,"product":"ESOMEPRAZOLE SODIUM FOR INJ. (LYOPHILISED STERILE BULK)","address":"304, TOWN CENTRE, ANDHERI KURLA","city":"MUMBAI \/ MAHARASHTRA","supplier":"MAC-CHEM PRODUCTS (INDIA) PVT.LTD","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER OF","customerCountry":"BANGLADESH","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"421","totalValueFC":"41010.6","currency":"USD","unitRateINR":35522.349999999999,"date":"12-Mar-2025","totalValueINR":"3552235","totalValueInUsd":"41010.6","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"8947047","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Sterile","supplierPort":"Bombay Air","supplierAddress":"304, TOWN CENTRE, ANDHERI KURLA, MUMBAI \/ MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742322600,"product":"PHARMACEUTICAL RAW MATERIAL:(SI\/EPZ\/00211224 M.DEC-24 E.NOV-27) ESOMEPRAZOLE SODIUM (STERILE)","address":"1705, 4TH FLOOR, ONKAR BHAWAN","city":"DELHI","supplier":"STERILE INDIA PVT. LTD","supplierCountry":"INDIA","foreign_port":"HANOI - NOIBAI","customer":"TO THE ORDER OF","customerCountry":"VIETNAM","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"450","totalValueFC":"8881.3","currency":"USD","unitRateINR":38464.040999999997,"date":"19-Mar-2025","totalValueINR":"769280.82","totalValueInUsd":"8881.3","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"9122189","productDescription":"API","marketType":"","country":"VIETNAM","selfForZScoreResived":"Sterile","supplierPort":"Delhi Air","supplierAddress":"1705, 4TH FLOOR, ONKAR BHAWAN, DELHI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742927400,"product":"OMEPRAZOLE SODIUM STERILE (34 % TO 38 %W\/W) BATCH NO.AOSS24062,DATE OF MFG.FEB-25,DATE OF EXP.JAN-28","address":"M-134, 2ND FLOOR","city":"NEW DELHI","supplier":"RAJASTHAN ANTIBIOTICS","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"TO THE ORDER OF","customerCountry":"INDONESIA","quantity":"170.00","actualQuantity":"170","unit":"KGS","unitRateFc":"172.7","totalValueFC":"28737.4","currency":"USD","unitRateINR":14642.131764705882,"date":"26-Mar-2025","totalValueINR":"2489162.4","totalValueInUsd":"28737.4","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"9373486","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Sterile","supplierPort":"Delhi Air","supplierAddress":"M-134, 2ND FLOOR, NEW DELHI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743100200,"product":"OMEPRAZOLE SODIUM STERILE (34% TO 38% W\/W) (B.NO. 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29-Mar-2025
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ABOUT THIS PAGE

Looking for 95510-70-6 / Omeprazole Sodium API manufacturers, exporters & distributors?

Omeprazole Sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Omeprazole Sodium 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 Omeprazole Sodium manufacturer or Omeprazole Sodium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Omeprazole Sodium manufacturer or Omeprazole Sodium supplier.

PharmaCompass also assists you with knowing the Omeprazole Sodium API Price utilized in the formulation of products. Omeprazole Sodium API Price is not always fixed or binding as the Omeprazole Sodium Price is obtained through a variety of data sources. The Omeprazole Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Omeprazole Sodium

Synonyms

Losec sodium, H 168/68 sodium, 95510-70-6, Omeprazole sodium [usan], 161796-78-7, Omeprazole (as sodium)

Cas Number

95510-70-6

Unique Ingredient Identifier (UNII)

KV03YZ6QLW

About Omeprazole Sodium

A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.

Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam Manufacturers

A Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam, including repackagers and relabelers. The FDA regulates Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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 sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam Suppliers

A Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam supplier is an individual or a company that provides Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam active pharmaceutical ingredient (API) or Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam finished formulations upon request. The Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam suppliers may include Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam API manufacturers, exporters, distributors and traders.

click here to find a list of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam USDMF

A Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam DMF (Drug Master File) is a document detailing the whole manufacturing process of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam active pharmaceutical ingredient (API) in detail. Different forms of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam DMFs exist exist since differing nations have different regulations, such as Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam DMF submitted to regulatory agencies in the US is known as a USDMF. Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam USDMF includes data on Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam suppliers with USDMF on PharmaCompass.

Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam JDMF

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 sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam Drug Master File in Japan (Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam JDMF) empowers Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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 sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam JDMF during the approval evaluation for pharmaceutical products. At the time of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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 sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam suppliers with JDMF on PharmaCompass.

Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CEP

A Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CEP of the European Pharmacopoeia monograph is often referred to as a Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam Certificate of Suitability (COS). The purpose of a Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam to their clients by showing that a Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CEP has been issued for it. The manufacturer submits a Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CEP holder for the record. Additionally, the data presented in the Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam DMF.

A Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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 sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam suppliers with CEP (COS) on PharmaCompass.

Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam WC

A Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam written confirmation (Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam WC) is an official document issued by a regulatory agency to a Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam manufacturer, verifying that the manufacturing facility of a Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam APIs or Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam finished pharmaceutical products to another nation, regulatory agencies frequently require a Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam WC (written confirmation) as part of the regulatory process.

click here to find a list of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam suppliers with Written Confirmation (WC) on PharmaCompass.

Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam GMP

Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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 sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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 sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam GMP manufacturer or Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam GMP API supplier for your needs.

Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CoA

A Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CoA (Certificate of Analysis) is a formal document that attests to Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam's compliance with Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam specifications and serves as a tool for batch-level quality control.

Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam CoA mostly includes findings from lab analyses of a specific batch. For each Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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 sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam may be tested according to a variety of international standards, such as European Pharmacopoeia (Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam EP), Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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