Synopsis
0
CEP/COS
0
EU WC
0
VMF
0
FDA Orange Book
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Btamaze
2. Combactam
3. Cp 45899
4. Cp-45899
5. Cp45899
6. Penicillanic Acid Sulfone
7. Sodium, Sulbactam
8. Sulbactam Sodium
9. Sulfone, Penicillanic Acid
1. 68373-14-8
2. Sulbactam Acid
3. Betamaze
4. Penicillanic Acid Sulfone
5. (2s,5r)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid 4,4-dioxide
6. Sulbactamum
7. Penicillanic Acid 1,1-dioxide
8. (2s,5r)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid 4,4-dioxide
9. Chembl403
10. Cp-45899
11. (2s,5r)-3,3-dimethyl-4,4,7-trioxo-4$l^{6}-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid
12. Cp-45,899
13. Chebi:9321
14. S4tf6i2330
15. Sulbactam (inn)
16. 68373-14-8 (free Acid)
17. Nsc-759886
18. Sulbactam 100 Microg/ml In Acetonitrile
19. Sulbactam [inn]
20. Dsstox_cid_3605
21. (2s,5r)-3,3-dimethyl-4,4,7-trioxo-4lambda6-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid
22. Dsstox_rid_77104
23. Dsstox_gsid_23605
24. 2,2-dimethyl-1,1-dioxidopenam-3alpha-carboxylic Acid
25. Cp-458992
26. Smr000387064
27. Cas-68373-14-8
28. Cp 45899
29. Sulbactam [inn:ban]
30. Sr-01000760610
31. Sulbactamum [inn-latin]
32. Mfcd00867005
33. Unii-s4tf6i2330
34. Sulbactam,(s)
35. (2s,5r)-3,3-dimethyl-4,4,7-trioxo-4?^{6}-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid
36. 0rn
37. Einecs 269-878-2
38. Sulbactam [mi]
39. Sulbactam [vandf]
40. Ncgc00159487-06
41. Sulbactam; Sulbactam Acid
42. Sulbactam [mart.]
43. Sulbactam [usp-rs]
44. Sulbactam [who-dd]
45. Schembl47781
46. Mls001048859
47. Mls001304017
48. Sodium 1,1-dioxypenicillanate
49. Dtxsid1023605
50. Gtpl10769
51. Hms2090e07
52. Hms2269a12
53. Hms3651c06
54. Hms3715b09
55. Zinc897244
56. Bcp13271
57. Ex-a2000
58. Hy-b0334
59. Tox21_113642
60. Bbl033518
61. Bdbm50021954
62. S1958
63. Stk801889
64. Akos004119988
65. Tox21_113642_1
66. Ccg-221124
67. Db09324
68. Ks-5198
69. Nsc 759886
70. (2s,5r)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptan-2-carbonsaeure 4,4-dioxid
71. Sulbactam, Analytical Reference Material
72. Ncgc00159336-02
73. Ncgc00159336-03
74. Ncgc00159336-05
75. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-, 4,4-dioxide, (2s-cis)-
76. Ac-18973
77. Bs167314
78. S0868
79. Sultamicillin Impurity A [ep Impurity]
80. C07770
81. D08533
82. Ab00698109-06
83. Ab00698109-08
84. Ab00698109_09
85. 373s148
86. A836122
87. Q423393
88. Sr-01000760610-2
89. Sr-01000760610-3
90. Brd-k44133266-001-10-0
91. Z1563146038
92. Sulbactam, European Pharmacopoeia (ep) Reference Standard
93. Sulbactam, United States Pharmacopeia (usp) Reference Standard
94. (2s,5r)-2-carboxylato-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane4,4-dioxide
95. (2s,5r)-3,3-dimethyl-4,4,7-trioxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid
96. (2s,5r)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylicacid4,4-dioxide
97. 3,3-dimethyl-4,4,7-trioxo-4lambda*6*-thia-1-aza-bicyclo[3.2.0]heptane-2-carboxylic Acid
98. Sulbactam For Peak Identification, European Pharmacopoeia (ep) Reference Standard
99. (2s,5r)-3,3-dimethyl-4,4,7-trioxo-4lambda*6*-thia-1-aza-bicyclo[3.2.0]heptane-2-carboxylic Acid
100. (2s,5r)-3,3-dimethyl-4,4,7-tris(oxidanylidene)-4$l^{6}-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid
101. (2s,5r)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo-[3.2.0]heptane-2-carboxylic Acid 4,4-dioxide
102. (2s,5r)?-?3,3-?dimethyl-?7-?oxo-?4-?thia-?1-?azabicyclo[3.2.0]?heptane-?2-?carboxylic Acid 4,4-dioxide
103. (s)-3,3-dimethyl-7-(r)-oxo-4,4-dioxo-4lambda*6*-thia-1-aza-bicyclo[3.2.0]heptane-2-carboxylic Acid
104. 3,3-dimethyl-4,4,7-trioxo-4lambda*6*-thia-1-aza-bicyclo[3.2.0]heptane-2-carboxylic Acid (sulbactam)
105. 4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-,4,4-dioxide, (2s, Cis)
106. 4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid,3,3-dimethyl-7-oxo-, 4,4-dioxide, (2s,5r)-
| Molecular Weight | 233.24 g/mol |
|---|---|
| Molecular Formula | C8H11NO5S |
| XLogP3 | -1 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 1 |
| Exact Mass | 233.03579362 g/mol |
| Monoisotopic Mass | 233.03579362 g/mol |
| Topological Polar Surface Area | 100 Ų |
| Heavy Atom Count | 15 |
| Formal Charge | 0 |
| Complexity | 446 |
| 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 | 1 |
Sulbactam is currently available in combination products with ampicillin. Within this formulation it is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Klebsiella spp. (including K. pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter spp., and Acinetobacter calcoaceticus. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae), Bacteroides spp. (including B. fragilis), and Enterobacter spp. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli, and Bacteroides spp. (including B. fragilis).
FDA Label
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.)
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01C - Beta-lactam antibacterials, penicillins
J01CG - Beta-lactamase inhibitors
J01CG01 - Sulbactam
Absorption
Peak serum concentrations are reached almost immediately following a 15-minute intravenous infusion of sulbactam + ampicillin. Mean peak serum levels for sulbactam range from 48 to 88 mcg/mL following intravenous administration of 2000 mg of ampicillin plus 1000 mg sulbactam. After an intramuscular injection of 1000 mg ampicillin plus 500 mg sulbactam, peak sulbactam serum levels ranging from 6 to 24 mcg/mL are attained.
Route of Elimination
Approximately 75 to 85% of both ampicillin and sulbactam are excreted unchanged in the urine during the first 8 hours after administration.
Volume of Distribution
Penetration of both ampicillin and sulbactam into cerebrospinal fluid in the presence of inflamed meninges has been demonstrated after IV administration.
~1 hr
Sulbactam is an irreversible inhibitor of -lactamase; by binding and inhibiting -lactamase produced by bacterial cells, sulbactam is thereby able to prevent it from reducing antibiotic activity. Although sulbactam alone possesses little useful antibacterial activity, except against the Neisseriaceae, whole organism studies have shown that sulbactam restores ampicillin activity against beta-lactamase producing strains. In particular, sulbactam has good inhibitory activity against the clinically important plasmid mediated beta-lactamases most frequently responsible for transferred drug resistance. The presence of sulbactam in formulations with ampicillin effectively extends the antibacterial spectrum of ampicillin to include many bacteria normally resistant to it and to other beta-lactam antibacterials. Thus, products with ampicillin + sulbactam possess the properties of a broad-spectrum antibacterial and a beta-lactamase inhibitor.
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
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 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]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Sulbactam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulbactam, including repackagers and relabelers. The FDA regulates Sulbactam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulbactam 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 Sulbactam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulbactam supplier is an individual or a company that provides Sulbactam active pharmaceutical ingredient (API) or Sulbactam finished formulations upon request. The Sulbactam suppliers may include Sulbactam API manufacturers, exporters, distributors and traders.
click here to find a list of Sulbactam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulbactam DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulbactam active pharmaceutical ingredient (API) in detail. Different forms of Sulbactam DMFs exist exist since differing nations have different regulations, such as Sulbactam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulbactam DMF submitted to regulatory agencies in the US is known as a USDMF. Sulbactam USDMF includes data on Sulbactam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulbactam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulbactam 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 Sulbactam Drug Master File in Japan (Sulbactam JDMF) empowers Sulbactam 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 Sulbactam JDMF during the approval evaluation for pharmaceutical products. At the time of Sulbactam 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 Sulbactam 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 Sulbactam Drug Master File in Korea (Sulbactam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sulbactam. The MFDS reviews the Sulbactam KDMF as part of the drug registration process and uses the information provided in the Sulbactam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sulbactam 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 Sulbactam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sulbactam suppliers with KDMF 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 Sulbactam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sulbactam 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 Sulbactam 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 Sulbactam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sulbactam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sulbactam suppliers with NDC on PharmaCompass.
Sulbactam 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 Sulbactam 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 Sulbactam GMP manufacturer or Sulbactam GMP API supplier for your needs.
A Sulbactam CoA (Certificate of Analysis) is a formal document that attests to Sulbactam's compliance with Sulbactam specifications and serves as a tool for batch-level quality control.
Sulbactam CoA mostly includes findings from lab analyses of a specific batch. For each Sulbactam 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.
Sulbactam may be tested according to a variety of international standards, such as European Pharmacopoeia (Sulbactam EP), Sulbactam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sulbactam USP).
LOOKING FOR A SUPPLIER?
