Synopsis
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1. 147084-10-4
2. Lastacaft
3. R89674
4. R-89674
5. R 89674
6. 7z8o94ecsx
7. Chebi:71023
8. 11-(1-methylpiperidin-4-ylidene)-5,6-dihydroimidazo[2,1-b][3]benzazepine-3-carbaldehyde
9. Lastacaft (tn)
10. 11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5h-imidazo[2,1-b][3]benzazepine-3-carbaldehyde
11. 2-(1-methylpiperidin-4-ylidene)-4,7-diazatricyclo[8.4.0.0(3,7)]tetradeca- 1(14),3,5,10,12-pentaene-6-carbaldehyde
12. Alcaftadine [usan:inn]
13. Unii-7z8o94ecsx
14. Alcaftadina
15. Alcaftadinum
16. 5h-imidazo(2,1-b)(3)benzazepine-3-carboxaldehyde, 6,11-dihydro-11-(1-methyl-4-piperidinylidene)-
17. 5h-imidazo[2,1-b][3]benzazepine-3-carboxaldehyde, 6,11-dihydro-11-(1-methyl-4-piperidinylidene)-
18. Alcaftadine [inn]
19. Alcaftadine [jan]
20. Alcaftadine [usan]
21. Alcaftadine [vandf]
22. Alcaftadine [mart.]
23. Alcaftadine [who-dd]
24. Alcaftadine (jan/usan/inn)
25. Gtpl7587
26. Schembl1602418
27. Chembl1201747
28. Alcaftadine, >=98% (hplc)
29. (unlabelled)alcaftadine-13c-d3
30. Alcaftadine [orange Book]
31. Dtxsid80598455
32. Hms3885b12
33. Bcp04261
34. Mfcd09954106
35. S4625
36. Zinc11726211
37. Akos025402002
38. Am84429
39. Bcp9000269
40. Ccg-267551
41. Db06766
42. Ncgc00390732-04
43. 5h-imidazo[2,1-b][3]benzazepine-3-carboxaldehyde,6,11-dihydro-11-(1-methyl-4-piperidinylidene)-
44. Ac-28019
45. As-56303
46. Hy-17039
47. Bcp0726000082
48. Db-063693
49. Ft-0661472
50. A16393
51. D06552
52. Q4712900
53. 11-(1-methylpiperidin-4-ylidene)-5,6-dihydroimidazo[2,3-b][3]benzazepine-3-carbaldehyde
54. 11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5h-benzo[d]imidazo[1,2-a]azepine-3-carbaldehyde
55. 11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5h-imidazolo(2,1-b)(3)benzazepine-3-carbaldehyde
56. 2-(1-methylpiperidin-4-ylidene)-4,7-diazatricyclo[8.4.0.0^{3,7}]tetradeca-1(14),3,5,10,12-pentaene-6-carbaldehyde
57. 4-(1-methyl-piperidin-4-ylidene)-9,10-dihydro-4h-3,10a-diaza-benzo(f)azulene-1-carbaldehyde
58. 5h-imidazo(2,1-b)(3)benzazepine-3-carboxaldehyde, 6,11-dihydro-11-(1-methyl-4- Piperidinylidene)-
Molecular Weight | 307.4 g/mol |
---|---|
Molecular Formula | C19H21N3O |
XLogP3 | 1.7 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 3 |
Rotatable Bond Count | 1 |
Exact Mass | 307.168462302 g/mol |
Monoisotopic Mass | 307.168462302 g/mol |
Topological Polar Surface Area | 38.1 Ų |
Heavy Atom Count | 23 |
Formal Charge | 0 |
Complexity | 479 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Lastacaft |
PubMed Health | Alcaftadine (Into the eye) |
Drug Classes | Ophthalmologic Agent |
Drug Label | LASTACAFT is a sterile, topically administered H1 receptor antagonist containing alcaftadine for ophthalmic use. Alcaftadine is a white to yellow powder with an empirical formula of C19H21N3O and a molecular weight of 307.39. Contains: Active: alca... |
Active Ingredient | Alcaftadine |
Dosage Form | Solution/drops |
Route | Ophthalmic |
Strength | 0.25% |
Market Status | Prescription |
Company | Allergan |
2 of 2 | |
---|---|
Drug Name | Lastacaft |
PubMed Health | Alcaftadine (Into the eye) |
Drug Classes | Ophthalmologic Agent |
Drug Label | LASTACAFT is a sterile, topically administered H1 receptor antagonist containing alcaftadine for ophthalmic use. Alcaftadine is a white to yellow powder with an empirical formula of C19H21N3O and a molecular weight of 307.39. Contains: Active: alca... |
Active Ingredient | Alcaftadine |
Dosage Form | Solution/drops |
Route | Ophthalmic |
Strength | 0.25% |
Market Status | Prescription |
Company | Allergan |
For the prevention of itching associated with allergic conjunctivitis.
FDA Label
Following bilateral topical ocular administration of alcaftadine ophthalmic solution, 0.25%, the mean plasma Cmax of alcaftadine was approximately 60 pg/mL and the median Tmax occurred at 15 minutes. Plasma concentrations of alcaftadine were below the lower limit of quantification (10 pg/mL) by 3 hours after dosing. The mean Cmax of the active carboxylic acid metabolite was approximately 3 ng/mL and occurred at 1 hour after dosing. Plasma concentrations of the carboxylic acid metabolite were below the lower limit of quantification (100 pg/mL) by 12 hours after dosing.
Histamine H1 Antagonists
Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)
S - Sensory organs
S01 - Ophthalmologicals
S01G - Decongestants and antiallergics
S01GX - Other antiallergics
S01GX11 - Alcaftadine
Route of Elimination
Based on data following oral administration of alcaftadine, the carboxylic acid metabolite is primarily eliminated unchanged in the urine.
The metabolism of alcaftadine is mediated by non-CYP450 cytosolic enzymes to the active carboxylic acid metabolite.
The elimination half-life of the carboxylic acid metabolite is approximately 2 hours following topical ocular administration.
Alcaftadine is a H1 histamine receptor antagonist and inhibitor of the release of histamine from mast cells. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.
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PharmaCompass offers a list of Alcaftadine 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 Alcaftadine manufacturer or Alcaftadine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alcaftadine manufacturer or Alcaftadine supplier.
PharmaCompass also assists you with knowing the Alcaftadine API Price utilized in the formulation of products. Alcaftadine API Price is not always fixed or binding as the Alcaftadine Price is obtained through a variety of data sources. The Alcaftadine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lastacaft manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lastacaft, including repackagers and relabelers. The FDA regulates Lastacaft manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lastacaft 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 Lastacaft manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lastacaft supplier is an individual or a company that provides Lastacaft active pharmaceutical ingredient (API) or Lastacaft finished formulations upon request. The Lastacaft suppliers may include Lastacaft API manufacturers, exporters, distributors and traders.
click here to find a list of Lastacaft suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lastacaft DMF (Drug Master File) is a document detailing the whole manufacturing process of Lastacaft active pharmaceutical ingredient (API) in detail. Different forms of Lastacaft DMFs exist exist since differing nations have different regulations, such as Lastacaft USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lastacaft DMF submitted to regulatory agencies in the US is known as a USDMF. Lastacaft USDMF includes data on Lastacaft's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lastacaft USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lastacaft suppliers with USDMF 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 Lastacaft Drug Master File in Korea (Lastacaft KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lastacaft. The MFDS reviews the Lastacaft KDMF as part of the drug registration process and uses the information provided in the Lastacaft KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lastacaft 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 Lastacaft API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lastacaft suppliers with KDMF on PharmaCompass.
A Lastacaft written confirmation (Lastacaft WC) is an official document issued by a regulatory agency to a Lastacaft manufacturer, verifying that the manufacturing facility of a Lastacaft active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lastacaft APIs or Lastacaft finished pharmaceutical products to another nation, regulatory agencies frequently require a Lastacaft WC (written confirmation) as part of the regulatory process.
click here to find a list of Lastacaft 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 Lastacaft as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lastacaft 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 Lastacaft 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 Lastacaft and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lastacaft NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lastacaft suppliers with NDC on PharmaCompass.
Lastacaft 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 Lastacaft 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 Lastacaft GMP manufacturer or Lastacaft GMP API supplier for your needs.
A Lastacaft CoA (Certificate of Analysis) is a formal document that attests to Lastacaft's compliance with Lastacaft specifications and serves as a tool for batch-level quality control.
Lastacaft CoA mostly includes findings from lab analyses of a specific batch. For each Lastacaft 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.
Lastacaft may be tested according to a variety of international standards, such as European Pharmacopoeia (Lastacaft EP), Lastacaft JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lastacaft USP).