Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
FDF
0
FDA Orange Book
0
Canada
0
Australia
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. Cilastatin Monosodium Salt
2. Cilastatin Sodium
3. Mk 0791
4. Mk 791
5. Mk-791
6. Mk0791
7. Mk791
8. Monosodium Salt, Cilastatin
9. Salt, Cilastatin Monosodium
10. Sodium, Cilastatin
1. 82009-34-5
2. Cilastatina
3. Cilastatine
4. Cilastatinum
5. Mk-791
6. Cilastatin (inn)
7. Mk0791
8. Chebi:3697
9. Cilastatin Acid
10. 141a6amn38
11. Mk 0791
12. (2z)-7-{[(2r)-2-amino-2-carboxyethyl]sulfanyl}-2-{[(1s)-2,2-dimethylcyclopropyl]formamido}hept-2-enoic Acid
13. Cilastatine [french]
14. Cilastatinum [latin]
15. Cilastatin [inn]
16. Cilastatina [spanish]
17. Cilastatin [inn:ban]
18. (z)-(s)-6-carboxy-6-[(s)-2,2-dimethylcyclopropanecarboxamido]hex-5-enyl-l-cysteine
19. (z)-7-(((r)-2-amino-2-carboxyethyl)thio)-2-((s)-2,2-dimethylcyclopropane-1-carboxamido)hept-2-enoic Acid
20. Cilastin
21. (l)-7-(2-amino-2-carboxy-ethylsulfanyl)-2-[(2,2-dimethyl-cyclopropanecarbonyl)-amino]-hept-2-enoic Acid
22. (z)-7-((r)-2-amino-2-carboxy-ethylsulfanyl)-2-[((s)-2,2-dimethyl-cyclopropanecarbonyl)-amino]-hept-2-enoic Acid
23. Ncgc00181346-01
24. Einecs 279-875-8
25. Unii-141a6amn38
26. Mk791
27. (z)-7-[(2s)-2-amino-3-hydroxy-3-oxopropyl]sulfanyl-2-[[(1s)-2,2-dimethylcyclopropanecarbonyl]amino]hept-2-enoic Acid
28. Cilastatin [mi]
29. 81129-83-1
30. Cilastatin [vandf]
31. Chembl766
32. Cilastatin [who-dd]
33. Schembl37051
34. 2-heptenoic Acid, 7-((2-amino-2-carboxyethyl)thio)-2-(((2,2-dimethylcyclopropyl)carbonyl)amino)-, (r-(r*,s*-(z)))-
35. Bidd:gt0782
36. Gtpl5166
37. Dtxsid8048238
38. Ex-a4954
39. Hy-a0166
40. Zinc4095696
41. Ac-268
42. Bdbm50367502
43. Mfcd00867379
44. Akos015962144
45. Cs-8177
46. Db01597
47. (2z)-7-{[(2r)-2-amino-2-carboxyethyl]sulfanyl}-2-({[(1s)-2,2-dimethylcyclopropyl]carbonyl}amino)hept-2-enoic Acid
48. Ds-11972
49. A16977
50. C01675
51. D07698
52. A840230
53. Q418201
54. Sr-01000781260
55. Sr-01000781260-3
56. (z)-7-[(2r)-2-azanyl-3-oxidanyl-3-oxidanylidene-propyl]sulfanyl-2-[[(1s)-2,2-dimethylcyclopropyl]carbonylamino]hept-2-enoic Acid
57. (z)-7-[[(2r)-2-amino-2-carboxyethyl]thio]-2-[[[(1s)-2,2-dimethylcyclopropyl]-oxomethyl]amino]-2-heptenoic Acid
58. 2-heptenoic Acid, 7-[[(2r)-2-amino-2-carboxyethyl]thio]-2-[[[(1s)-2,2-dimethylcyclopropyl]carbonyl]amino]-, (2z)-
| Molecular Weight | 358.5 g/mol |
|---|---|
| Molecular Formula | C16H26N2O5S |
| XLogP3 | -1 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 11 |
| Exact Mass | 358.15624311 g/mol |
| Monoisotopic Mass | 358.15624311 g/mol |
| Topological Polar Surface Area | 155 Ų |
| Heavy Atom Count | 24 |
| Formal Charge | 0 |
| Complexity | 519 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Cilastatin is indicated, in combination with [imipenem] with or without [relebactam], for the treatment of bacterial infections including respiratory, skin, bone, gynecologic, urinary tract, and intra-abdominal as well as septicemia and endocarditis.
FDA Label
Cilastatin is a chemical compound which inhibits the human enzyme dehydropeptidase. Renal Dehydropeptidase degrades the antibiotic [imipenem]. Cilastatin is therefore combined intravenously with imipenem in order to protect it from dehydropeptidase and prolong its antibacterial effect. However, cilastatin in and of itself does not have any antibacterial activity. The increased renal excretion of unchanged imipenem appears to prevent proximal tubular necrosis associated with high doses of imipenem.
Protease Inhibitors
Compounds which inhibit or antagonize biosynthesis or actions of proteases (ENDOPEPTIDASES). (See all compounds classified as Protease Inhibitors.)
Route of Elimination
Cilastatin is reported by official FDA labeling to be 70% excreted in the urine, however published literature has reported values as high as 98%.
Volume of Distribution
Cilastatin has a volume of distribution of 14.6-20.1L.
Clearance
Cilastatin has a total clearance of 0.2 L/h/kg and a renal clearance of 0.10-0.16 L/h/kg.
The half-life of cilastatin is approximately 1h.
Cilastatin is a renal dehydropeptidase-I inhibitor. Since the antibiotic, imipenem, is hydrolyzed by dehydropeptidase-I, which resides in the brush border of the renal tubule, cilastatin is administered with imipenem to block the metabolism of imipenem.
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]INTERMEDIATES SUPPLIERS
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]Europe
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 Cilastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cilastatin, including repackagers and relabelers. The FDA regulates Cilastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cilastatin 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 Cilastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cilastatin supplier is an individual or a company that provides Cilastatin active pharmaceutical ingredient (API) or Cilastatin finished formulations upon request. The Cilastatin suppliers may include Cilastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Cilastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cilastatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Cilastatin active pharmaceutical ingredient (API) in detail. Different forms of Cilastatin DMFs exist exist since differing nations have different regulations, such as Cilastatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cilastatin DMF submitted to regulatory agencies in the US is known as a USDMF. Cilastatin USDMF includes data on Cilastatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cilastatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cilastatin suppliers with USDMF 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 Cilastatin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cilastatin 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 Cilastatin 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 Cilastatin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cilastatin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cilastatin suppliers with NDC on PharmaCompass.
Cilastatin 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 Cilastatin 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 Cilastatin GMP manufacturer or Cilastatin GMP API supplier for your needs.
A Cilastatin CoA (Certificate of Analysis) is a formal document that attests to Cilastatin's compliance with Cilastatin specifications and serves as a tool for batch-level quality control.
Cilastatin CoA mostly includes findings from lab analyses of a specific batch. For each Cilastatin 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.
Cilastatin may be tested according to a variety of international standards, such as European Pharmacopoeia (Cilastatin EP), Cilastatin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cilastatin USP).
LOOKING FOR A SUPPLIER?
