Synopsis
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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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GDUFA
DMF Review : Reviewed
Rev. Date : 2020-07-23
Pay. Date : 2020-05-18
DMF Number : 34192
Submission : 2020-05-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-11
Pay. Date : 2015-05-26
DMF Number : 29231
Submission : 2015-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19608
Submission : 2006-07-10
Status : Active
Type : II
Certificate Number : CEP 2007-200 - Rev 05
Issue Date : 2023-11-28
Type : Chemical
Substance Number : 2209
Status : Valid
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 :
Date of Issue : 2022-08-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0121
Address of the Firm :
NDC Package Code : 59651-944
Start Marketing Date : 2024-02-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14974
Submission : 2000-08-04
Status : Active
Type : II
Registration Number : 220MF10060
Registrant's Address : Poligono Industrial de Silvota, parcelas 22B-23 E-33192 Silvota, Llanera-Asturias (Spain)
Initial Date of Registration : 2008-02-25
Latest Date of Registration :
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 : 17189
Submission : 2004-03-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23769
Submission : 2010-05-03
Status : Inactive
Type : II
Registrant Name : Korea Chorus Co., Ltd.
Registration Date : 2013-05-22
Registration Number : 20130207-150-I-192-05(4)
Manufacturer Name : Zhuhai United Laboratories Co., Ltd.
Manufacturer Address : Sanzao Science & Technology Park, National Hi-Tech Zone, Zhuhai, Guangdong. 519040, PR China
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 : 17560
Submission : 2004-05-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22261
Submission : 2008-12-04
Status : Inactive
Type : II
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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 : 16587
Submission : 2003-05-14
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 : 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
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Average Price (USD/KGS) |
Number of Transactions |
|---|
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FDF Dossiers
Regulatory Info : RX
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Packaging :
Approval Date : 2009-12-23
Application Number : 65403
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : China
Cefoperazone Sodium; Sulbactam Sodium
Brand Name :
Dosage Form : Injection
Dosage Strength : 1G; 1G
Packaging : 2g x 10 vials/box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Regulatory Info : DISCN
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Packaging :
Approval Date : 2011-12-21
Application Number : 90653
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Packaging :
Approval Date : 2005-11-30
Application Number : 65176
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : UNASYN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Packaging :
Approval Date : 1988-11-23
Application Number : 62901
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Packaging :
Approval Date : 2006-07-25
Application Number : 65240
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Packaging :
Approval Date : 2006-07-25
Application Number : 65310
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Packaging :
Approval Date : 2014-04-07
Application Number : 202197
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : China
Cefoperazone Sodium; Sulbactam Sodium
Brand Name :
Dosage Form : Injection
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Regulatory Info : DISCN
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Packaging :
Approval Date : 2016-01-11
Application Number : 90578
Regulatory Info : DISCN
Registration Country : USA
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RLD : No
TE Code :
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date : 2010-09-20
Application Number : 90340
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date : 2010-09-20
Application Number : 90349
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code :
DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
Brand Name : XACDURO (COPACKAGED)
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date : 2023-05-23
Application Number : 216974
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date : 2011-12-21
Application Number : 90646
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date : 2011-12-21
Application Number : 90653
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date : 2005-11-25
Application Number : 65188
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date : 2005-11-29
Application Number : 65222
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date : 2006-11-27
Application Number : 65314
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date : 2007-06-29
Application Number : 65316
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code : AP
AMPICILLIN SODIUM; SULBACTAM SODIUM
Brand Name : UNASYN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date : 1993-12-10
Application Number : 50608
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
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Regulatory Info :
Registration Country : Romania
Ampicillin Sodium; Sulbactam Sodium
Brand Name : AMPIPLUS®
Dosage Form : powder for injection/I...
Dosage Strength : 1000MG; 500MG
Packaging : Box x 1 vial, Box x 25 vial, Box x 50 vial
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Romania
Packaging : Box x 1 vial, Box x 25 vial, Box x 50 vial
Regulatory Info :
Ampicillin Sodium; Sulbactam Sodium
Dosage : powder for injection/I...
Dosage Strength : 1000MG; 500MG
Brand Name : AMPIPLUS®
Approval Date :
Application Number :
Registration Country : Romania
Regulatory Info : Generic
Registration Country : Pakistan
Cefoperazone; Sulbactam Sodium
Brand Name : Sulperazone
Dosage Form : INJECTION
Dosage Strength : 1000MG; 1000MG
Packaging : 1x1vial
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Pakistan
Packaging : 1x1vial
Regulatory Info : Generic
Cefoperazone; Sulbactam Sodium
Dosage : INJECTION
Dosage Strength : 1000MG; 1000MG
Brand Name : Sulperazone
Approval Date :
Application Number :
Registration Country : Pakistan
Regulatory Info :
Registration Country : India
Cefepime Hydrochloride; Sulbactam Sodium
Brand Name : Pime-SB
Dosage Form : Injection
Dosage Strength : 1000MG; 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Cefepime Hydrochloride; Sulbactam Sodium
Dosage : Injection
Dosage Strength : 1000MG; 500MG
Brand Name : Pime-SB
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : China
Cefoperazone Sodium; Sulbactam Sodium
Brand Name :
Dosage Form : Injection
Dosage Strength : 1G; 1G
Packaging : 2g x 10 vials/box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging : 2g x 10 vials/box
Regulatory Info :
Cefoperazone Sodium; Sulbactam Sodium
Dosage : Injection
Dosage Strength : 1G; 1G
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : China
Cefoperazone Sodium; Sulbactam Sodium
Brand Name :
Dosage Form : Injection
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Cefoperazone Sodium; Sulbactam Sodium
Dosage : Injection
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : China
Cefoperazone Sodium; Sulbactam Sodium
Brand Name :
Dosage Form : Injection
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Cefoperazone Sodium; Sulbactam Sodium
Dosage : Injection
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : China
Cefoperazone Sodium; Sulbactam Sodium
Brand Name :
Dosage Form : Injection
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Cefoperazone Sodium; Sulbactam Sodium
Dosage : Injection
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : China
Ampicillin Sodium; Sulbactam Sodium
Brand Name :
Dosage Form : Injection
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Ampicillin Sodium; Sulbactam Sodium
Dosage : Injection
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : China
Ampicillin Sodium; Sulbactam Sodium
Brand Name :
Dosage Form : Injection
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Ampicillin Sodium; Sulbactam Sodium
Dosage : Injection
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 0.25GM
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 0.25GM
Brand Name :
Approval Date :
Application Number :
Registration Country : China
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Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2035-11-17
DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
US Patent Number : 10376499
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216974
Patent Use Code : U-2840
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-11-17
Patent Expiration Date : 2035-11-17
DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
US Patent Number : 9968593
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216974
Patent Use Code : U-2840
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-11-17
Patent Expiration Date : 2033-04-02
DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
US Patent Number : 9623014
Drug Substance Claim :
Drug Product Claim :
Application Number : 216974
Patent Use Code : U-2840
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-04-02
Patent Expiration Date : 2033-04-02
DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
US Patent Number : 9309245
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 216974
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-04-02
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
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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.
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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 AMPICILLIN; SULBACTAM-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMPICILLIN; SULBACTAM-1, including repackagers and relabelers. The FDA regulates AMPICILLIN; SULBACTAM-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMPICILLIN; SULBACTAM-1 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 AMPICILLIN; SULBACTAM-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AMPICILLIN; SULBACTAM-1 supplier is an individual or a company that provides AMPICILLIN; SULBACTAM-1 active pharmaceutical ingredient (API) or AMPICILLIN; SULBACTAM-1 finished formulations upon request. The AMPICILLIN; SULBACTAM-1 suppliers may include AMPICILLIN; SULBACTAM-1 API manufacturers, exporters, distributors and traders.
click here to find a list of AMPICILLIN; SULBACTAM-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AMPICILLIN; SULBACTAM-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of AMPICILLIN; SULBACTAM-1 active pharmaceutical ingredient (API) in detail. Different forms of AMPICILLIN; SULBACTAM-1 DMFs exist exist since differing nations have different regulations, such as AMPICILLIN; SULBACTAM-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AMPICILLIN; SULBACTAM-1 DMF submitted to regulatory agencies in the US is known as a USDMF. AMPICILLIN; SULBACTAM-1 USDMF includes data on AMPICILLIN; SULBACTAM-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AMPICILLIN; SULBACTAM-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 AMPICILLIN; SULBACTAM-1 Drug Master File in Japan (AMPICILLIN; SULBACTAM-1 JDMF) empowers AMPICILLIN; SULBACTAM-1 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 AMPICILLIN; SULBACTAM-1 JDMF during the approval evaluation for pharmaceutical products. At the time of AMPICILLIN; SULBACTAM-1 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a AMPICILLIN; SULBACTAM-1 Drug Master File in Korea (AMPICILLIN; SULBACTAM-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AMPICILLIN; SULBACTAM-1. The MFDS reviews the AMPICILLIN; SULBACTAM-1 KDMF as part of the drug registration process and uses the information provided in the AMPICILLIN; SULBACTAM-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a AMPICILLIN; SULBACTAM-1 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 AMPICILLIN; SULBACTAM-1 API can apply through the Korea Drug Master File (KDMF).
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A AMPICILLIN; SULBACTAM-1 CEP of the European Pharmacopoeia monograph is often referred to as a AMPICILLIN; SULBACTAM-1 Certificate of Suitability (COS). The purpose of a AMPICILLIN; SULBACTAM-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AMPICILLIN; SULBACTAM-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AMPICILLIN; SULBACTAM-1 to their clients by showing that a AMPICILLIN; SULBACTAM-1 CEP has been issued for it. The manufacturer submits a AMPICILLIN; SULBACTAM-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a AMPICILLIN; SULBACTAM-1 CEP holder for the record. Additionally, the data presented in the AMPICILLIN; SULBACTAM-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AMPICILLIN; SULBACTAM-1 DMF.
A AMPICILLIN; SULBACTAM-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AMPICILLIN; SULBACTAM-1 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A AMPICILLIN; SULBACTAM-1 written confirmation (AMPICILLIN; SULBACTAM-1 WC) is an official document issued by a regulatory agency to a AMPICILLIN; SULBACTAM-1 manufacturer, verifying that the manufacturing facility of a AMPICILLIN; SULBACTAM-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AMPICILLIN; SULBACTAM-1 APIs or AMPICILLIN; SULBACTAM-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a AMPICILLIN; SULBACTAM-1 WC (written confirmation) as part of the regulatory process.
click here to find a list of AMPICILLIN; SULBACTAM-1 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 AMPICILLIN; SULBACTAM-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for AMPICILLIN; SULBACTAM-1 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 AMPICILLIN; SULBACTAM-1 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 AMPICILLIN; SULBACTAM-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AMPICILLIN; SULBACTAM-1 NDC to their finished compounded human drug products, they may choose to do so.
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AMPICILLIN; SULBACTAM-1 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 AMPICILLIN; SULBACTAM-1 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 AMPICILLIN; SULBACTAM-1 GMP manufacturer or AMPICILLIN; SULBACTAM-1 GMP API supplier for your needs.
A AMPICILLIN; SULBACTAM-1 CoA (Certificate of Analysis) is a formal document that attests to AMPICILLIN; SULBACTAM-1's compliance with AMPICILLIN; SULBACTAM-1 specifications and serves as a tool for batch-level quality control.
AMPICILLIN; SULBACTAM-1 CoA mostly includes findings from lab analyses of a specific batch. For each AMPICILLIN; SULBACTAM-1 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.
AMPICILLIN; SULBACTAM-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (AMPICILLIN; SULBACTAM-1 EP), AMPICILLIN; SULBACTAM-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AMPICILLIN; SULBACTAM-1 USP).
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