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1. Btamaze
2. Combactam
3. Cp 45899
4. Cp-45899
5. Cp45899
6. Penicillanic Acid Sulfone
7. Sodium, Sulbactam
8. Sulbactam
9. Sulfone, Penicillanic Acid
1. 69388-84-7
2. Sulbactam Sodium Salt
3. Sodium Sulbactam
4. Combactam
5. Sulbactam (sodium)
6. Sulbactam (as Sodium)
7. Dkq4t82ye6
8. Sodium (2s-cis)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide
9. Sodium;(2s,5r)-3,3-dimethyl-4,4,7-trioxo-4lambda6-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
10. Cp-45899-2
11. Cp-45,899-2
12. Sodium 1,1-dioxopenicillanate
13. Cp-458992
14. Sulbactam Sodium (unasyn)
15. Sodium Penicillanate 1,1-dioxide
16. Sulbactam Natrium
17. Cp 45899 Sodium Salt
18. Penicillanic Acid Dioxide Sodium Salt
19. Penicillanic Acid Sulfone Sodium Salt
20. Unii-dkq4t82ye6
21. Cp 45899-2
22. Sulbactam Sodium [usan:usp:jan]
23. Sodium (2s,5r)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate 4,4-dioxide
24. Sodium (2s-cis)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate 4,4-dioxide
25. Einecs 273-984-4
26. Cp 45899 Sodium
27. Penicillanic Acid 1,1-dioxide Sodium Salt
28. 4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylicacid, 3,3-dimethyl-7-oxo-, 4,4-dioxide, Sodium Salt, (2s,5r)- (9ci)
29. Schembl667857
30. Sulbactam Sodium [jan]
31. Sulbactam Sodium (jp17/usp)
32. Sulbactam Sodium [usan]
33. Chembl1200944
34. Sulbactam Sodium [vandf]
35. Hy-b0334a
36. Sulbactam Sodium [mart.]
37. Chebi:157785
38. Sulbactam Sodium [who-dd]
39. Dtxsid401026661
40. Hms3651h07
41. Sulbactam Sodium Salt [mi]
42. Akos015963378
43. Sulbactam Sodium [ep Impurity]
44. Sulbactam Sodium [orange Book]
45. Ccg-267009
46. Sulbactam Sodium [ep Monograph]
47. Sulbactam Sodium [usp Impurity]
48. Sulbactam Sodium [usp Monograph]
49. Ac-20083
50. Cs-0013161
51. S2551
52. Sulperazone Component Sulbactam Sodium
53. D02223
54. Sulbactam Sodium Component Of Sulperazone
55. W-104633
56. Q27276453
57. Sulbactam Sodium, Antibiotic For Culture Media Use Only
58. (2s,5r)-3,3-dimethyl-4,4,7-trioxo-4$l^{6}-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
59. (2s,5r)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-, 4,4-dioxide Sodium Salt
60. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-, 4,4-dioxide, Sodium Salt, (2s-cis)-
61. Sodium(2s-cis)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate4,4-dioxide
| Molecular Weight | 255.23 g/mol |
|---|---|
| Molecular Formula | C8H10NNaO5S |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 1 |
| Exact Mass | 255.01773788 g/mol |
| Monoisotopic Mass | 255.01773788 g/mol |
| Topological Polar Surface Area | 103 Ų |
| Heavy Atom Count | 16 |
| Formal Charge | 0 |
| Complexity | 452 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
beta-Lactamase Inhibitors
Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)
API SUPPLIERS
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16452
Submission : 2003-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19805
Submission : 2006-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19608
Submission : 2006-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14974
Submission : 2000-08-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17189
Submission : 2004-03-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22261
Submission : 2008-12-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17560
Submission : 2004-05-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16587
Submission : 2003-05-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17512
Submission : 2004-07-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16532
Submission : 2003-04-01
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Certificate Number : CEP 2007-200 - Rev 05
Status : Valid
Issue Date : 2023-11-28
Type : Chemical
Substance Number : 2209
Certificate Number : CEP 2022-441 - Rev 00
Status : Valid
Issue Date : 2024-07-01
Type : Chemical
Substance Number : 2209
Certificate Number : R1-CEP 2007-228 - Rev 03
Status : Valid
Issue Date : 2021-02-02
Type : Chemical
Substance Number : 2209
Certificate Number : CEP 2024-030 - Rev 01
Status : Valid
Issue Date : 2025-04-29
Type : Chemical
Substance Number : 2209
Certificate Number : CEP 2024-428 - Rev 00
Status : Valid
Issue Date : 2025-07-22
Type : Chemical
Substance Number : 2209
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 228MF10054
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2016-02-18
Latest Date of Registration : 2024-02-07
Japanese Pharmacopoeia Sulbactam Sodium (sterile) "Apitoria"
Registration Number : 306MF10136
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-10-16
Latest Date of Registration : 2024-10-16
Registration Number : 220MF10060
Registrant's Address : Poligono Industrial de Silvota, parcelas 22B-23 E-33192 Silvota, Llanera-Asturias (Sp...
Initial Date of Registration : 2008-02-25
Latest Date of Registration : 2021-07-09
Registration Number : 227MF10104
Registrant's Address : No. 2 Yuli Industrial Zone, Changjiang District, Jingdezhen City 333000, Jiangxi, Chi...
Initial Date of Registration : 2015-04-09
Latest Date of Registration : 2023-04-12
Japanese Pharmacopoeia Sulbactam Sodium
Registration Number : 306MF10130
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2024-09-25
Latest Date of Registration : 2024-09-25
Japanese Pharmacopoeia Sulbactam Sodium (for manufacturing only)
Registration Number : 218MF10710
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2006-08-14
Latest Date of Registration : 2019-03-29
Sulbactam Sodium (for manufacturing purposes only)
Registration Number : 219MF10293
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2007-09-10
Latest Date of Registration : 2019-03-29
Registration Number : 226MF10212
Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 0...
Initial Date of Registration : 2014-11-17
Latest Date of Registration : 2014-11-17
Registration Number : 230MF10001
Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 0...
Initial Date of Registration : 2018-01-10
Latest Date of Registration : 2018-01-10
Registration Number : 229MF10066
Registrant's Address : 161, Yeoksam-ro, Gangnam-gu, Seoul, Korea
Initial Date of Registration : 2017-03-17
Latest Date of Registration : 2017-07-31
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Date of Issue : 2022-08-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0121
Address of the Firm : Plot No. 68-70, 73-91, 95, 96, 260, 261, IDA, Pashamylaram (village), Patancheru...
Sulbactam Sodium (Sterile) Ph. Eur.
Date of Issue : 2022-08-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0121
Address of the Firm : Plot No. 68-70, 73-91, 95, 96, 260, 261, IDA, Pashamylaram (village), Patancheru...
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PharmaCompass offers a list of Sulbactam 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 Sulbactam Sodium manufacturer or Sulbactam Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sulbactam Sodium manufacturer or Sulbactam Sodium supplier.
PharmaCompass also assists you with knowing the Sulbactam Sodium API Price utilized in the formulation of products. Sulbactam Sodium API Price is not always fixed or binding as the Sulbactam Sodium Price is obtained through a variety of data sources. The Sulbactam Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Combactam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Combactam, including repackagers and relabelers. The FDA regulates Combactam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Combactam 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 Combactam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Combactam supplier is an individual or a company that provides Combactam active pharmaceutical ingredient (API) or Combactam finished formulations upon request. The Combactam suppliers may include Combactam API manufacturers, exporters, distributors and traders.
click here to find a list of Combactam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Combactam DMF (Drug Master File) is a document detailing the whole manufacturing process of Combactam active pharmaceutical ingredient (API) in detail. Different forms of Combactam DMFs exist exist since differing nations have different regulations, such as Combactam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Combactam DMF submitted to regulatory agencies in the US is known as a USDMF. Combactam USDMF includes data on Combactam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Combactam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Combactam 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 Combactam Drug Master File in Japan (Combactam JDMF) empowers Combactam 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 Combactam JDMF during the approval evaluation for pharmaceutical products. At the time of Combactam 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 Combactam 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 Combactam Drug Master File in Korea (Combactam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Combactam. The MFDS reviews the Combactam KDMF as part of the drug registration process and uses the information provided in the Combactam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Combactam 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 Combactam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Combactam suppliers with KDMF on PharmaCompass.
A Combactam CEP of the European Pharmacopoeia monograph is often referred to as a Combactam Certificate of Suitability (COS). The purpose of a Combactam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Combactam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Combactam to their clients by showing that a Combactam CEP has been issued for it. The manufacturer submits a Combactam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Combactam CEP holder for the record. Additionally, the data presented in the Combactam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Combactam DMF.
A Combactam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Combactam 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 Combactam suppliers with CEP (COS) on PharmaCompass.
A Combactam written confirmation (Combactam WC) is an official document issued by a regulatory agency to a Combactam manufacturer, verifying that the manufacturing facility of a Combactam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Combactam APIs or Combactam finished pharmaceutical products to another nation, regulatory agencies frequently require a Combactam WC (written confirmation) as part of the regulatory process.
click here to find a list of Combactam 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 Combactam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Combactam 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 Combactam 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 Combactam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Combactam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Combactam suppliers with NDC on PharmaCompass.
Combactam 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 Combactam 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 Combactam GMP manufacturer or Combactam GMP API supplier for your needs.
A Combactam CoA (Certificate of Analysis) is a formal document that attests to Combactam's compliance with Combactam specifications and serves as a tool for batch-level quality control.
Combactam CoA mostly includes findings from lab analyses of a specific batch. For each Combactam 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.
Combactam may be tested according to a variety of international standards, such as European Pharmacopoeia (Combactam EP), Combactam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Combactam USP).
