Synopsis
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USP
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JP
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Canada
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Australia
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1. 3-((6,7-dihydro-5h-pyrazolo(1,2-a)(1,2,4)triazol-4-ium-6-yl)thio)-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo(3,2,0)hept-2-ene-2-carboxylate
2. Cli 86,815
3. Cli 86815
4. Cli-86815
5. L 627
6. L-627
7. Ljc 10627
8. Ljc-10627
9. Ljc10,627
1. 120410-24-4
2. Omegacin
3. Biapenern
4. L-627
5. Ljc-10627
6. Lj C10,627
7. Cl 186,815
8. L 627
9. Cl-186815
10. Rpx2003
11. (4r,5s,6s)-3-(6,7-dihydro-5h-pyrazolo[1,2-a][1,2,4]triazol-4-ium-6-ylsulfanyl)-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
12. Yr5u3l9zh1
13. Chebi:3089
14. Lj-c10627
15. (4r,5s,6s)-3-((6,7-dihydro-5h-pyrazolo[1,2-a][1,2,4]triazol-4-ium-6-yl)thio)-6-((r)-1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
16. 6-(((4r,5s,6s)-2-carboxy-6-((1r)-1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo(3.2.0)hept-2-en-3-yl)thio)-6,7-dihydro-5h-pyrazolo(1,2-a)-s-triazol-4-ium Hydroxide, Inner Salt
17. Biapenem [usan:inn]
18. Omegacin (tn)
19. (4r,5s,6s)-3-(6,7-dihydro-5h-pyrazolo[1,2-a][1,2,4]triazol-4-ium-6-ylthio)-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
20. (6s)-2-(6,7-dihydro-5h-pyrazolo[1,2-a][1,2,4]triazol-4-ium-6-ylsulfanyl)-6-[(1r)-1-hydroxyethyl]-1beta-methyl-2,3-didehydro-1-carbapenam-3-carboxylate
21. Biapenem;(4r,5s,6s)-3-(6,7-dihydro-5h-pyrazolo[1,2-a][1,2,4]triazol-4-ium-6-ylthio)-6-((r)-1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
22. Ljc 10627
23. Unii-yr5u3l9zh1
24. Bipenem
25. Ncgc00164551-01
26. Ljc10627
27. Cli 86815
28. Ljc10,627
29. Mfcd00864863
30. Biapenem [usan]
31. Biapenem [inn]
32. Biapenem [jan]
33. Biapenem [mi]
34. Biapenem [mart.]
35. Biapenem [who-dd]
36. Dsstox_cid_26435
37. Dsstox_rid_81612
38. Dsstox_gsid_46435
39. Schembl49242
40. Biapenem (jan/usan/inn)
41. Chembl285347
42. Biapenem, >=98% (hplc)
43. Dtxsid5046435
44. Gtpl12022
45. Ex-a4945
46. Tox21_112180
47. S1370
48. Akos025149478
49. Ccg-268031
50. Cs-2071
51. Db13028
52. Ncgc00164551-02
53. Ncgc00164551-05
54. As-14655
55. Hy-13573
56. L627
57. Cas-120410-24-4
58. D01057
59. A804499
60. Q-101421
61. Q4902548
62. (4r,5s,6s)-3-(6,7-dihydro-5h-pyrazolo[1,2-a][1,2,4]triazol-4-ium-6-ylthio)-6-((r)-1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
63. (4r,5s,6s)-3-(6,7-dihydro-5h-pyrazolo[1,2-a][1,2,4]triazol-4-ium-6-ylthio)-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
64. 5h-pyrazolo(1,2-a)(1,2,4)triazol-4-ium, 6-((2-carboxy-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo(3.2.0)hept-2-en-3-yl)thio)-6,7-dihydro-, Hydroxide, Inner Salt, (4r-(4.alpha.,5.beta.,6.beta.(r*)))-
65. 6-(((4r,5s,6s)-2-carboxy-6-((1r)-1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo(3.2.0)hept-2-en-3-yl)thio)-6,7-dihydro-5h-pyrazolo(1,2-a)(1,2,4)triazol-4-ium Inner Salt
Molecular Weight | 350.4 g/mol |
---|---|
Molecular Formula | C15H18N4O4S |
XLogP3 | 1.4 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 3 |
Exact Mass | 350.10487624 g/mol |
Monoisotopic Mass | 350.10487624 g/mol |
Topological Polar Surface Area | 128 Ų |
Heavy Atom Count | 24 |
Formal Charge | 0 |
Complexity | 609 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Anti-Infective Agents
Substances that prevent infectious agents or organisms from spreading or kill infectious agents in order to prevent the spread of infection. (See all compounds classified as Anti-Infective Agents.)
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01D - Other beta-lactam antibacterials
J01DH - Carbapenems
J01DH05 - Biapenem
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34914
Submission : 2020-06-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34914
Submission : 2020-06-16
Status : Inactive
Type : II
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Details:
BDR Pharma elevates its own standard of the wide range of critical care segment products with launch of biapenem under brand name Biapen to treat intra-abdominal, lower respiratory or complicated urinary tract infections, which will be available in the market shortly.
Lead Product(s): Biapenem
Therapeutic Area: Infections and Infectious Diseases Brand Name: Biapen
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 24, 2021
Lead Product(s) : Biapenem
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : BDR Pharma elevates its own standard of the wide range of critical care segment products with launch of biapenem under brand name Biapen to treat intra-abdominal, lower respiratory or complicated urinary tract infections, which will be available in the m...
Product Name : Biapen
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 24, 2021
CAS Number : 627-31-6
End Use API : Biapenem
About The Company : At Infinium Pharmachem Pvt. Ltd., we are well focused to Iodine chemistry & this is the only core area of ours. We are working as CRAMS, but our domain is very ...
6,7-dihydro-6-mercapto-5H-Pyrazolo[1,2- a][1,2,4]t...
CAS Number : 153851-71-9
End Use API : Biapenem
About The Company : Jiangsu Yutian Pharmaceutical Co., Ltd. is located in Dapu Pharmaceutical Zone of Lianyungang City in Jiangsu Province. It is a new and high-tech enterprise eng...
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PharmaCompass offers a list of Biapenem 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 Biapenem manufacturer or Biapenem supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Biapenem manufacturer or Biapenem supplier.
PharmaCompass also assists you with knowing the Biapenem API Price utilized in the formulation of products. Biapenem API Price is not always fixed or binding as the Biapenem Price is obtained through a variety of data sources. The Biapenem Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Biapenem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biapenem, including repackagers and relabelers. The FDA regulates Biapenem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biapenem 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 Biapenem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Biapenem supplier is an individual or a company that provides Biapenem active pharmaceutical ingredient (API) or Biapenem finished formulations upon request. The Biapenem suppliers may include Biapenem API manufacturers, exporters, distributors and traders.
click here to find a list of Biapenem suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Biapenem DMF (Drug Master File) is a document detailing the whole manufacturing process of Biapenem active pharmaceutical ingredient (API) in detail. Different forms of Biapenem DMFs exist exist since differing nations have different regulations, such as Biapenem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Biapenem DMF submitted to regulatory agencies in the US is known as a USDMF. Biapenem USDMF includes data on Biapenem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Biapenem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Biapenem suppliers with USDMF on PharmaCompass.
Biapenem 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 Biapenem 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 Biapenem GMP manufacturer or Biapenem GMP API supplier for your needs.
A Biapenem CoA (Certificate of Analysis) is a formal document that attests to Biapenem's compliance with Biapenem specifications and serves as a tool for batch-level quality control.
Biapenem CoA mostly includes findings from lab analyses of a specific batch. For each Biapenem 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.
Biapenem may be tested according to a variety of international standards, such as European Pharmacopoeia (Biapenem EP), Biapenem JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Biapenem USP).