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1. 3-methyl-n-(2-oxo-2-((2,2,2-trifluoroethyl)amino)ethyl)-5-((5s)-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-4,5-dihydro-1,2-oxazol-3-yl)-2-thiophenecarboxamide
2. Credelio
1. 1369852-71-0
2. Lotilaner [inn]
3. Credelio
4. Heh4938d7k
5. Lotilaner (ema Epar: Veterinary)
6. (s)-5-[5-(3,4,5-trichlorophenyl)-5-trifluoromethyl-4,5-dihydroisoxazol-3-yl]-3-methylthiophene-2-carboxylic Acid [(2,2,2-trifluoroethyl Carbamoyl) Methyl] Amide
7. 3-methyl-n-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl]-5-[(5s)-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-4h-1,2-oxazol-3-yl]thiophene-2-carboxamide
8. 2-thiophenecarboxamide, 5-((5s)-4,5-dihydro-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-3-isoxazolyl)-3-methyl-n-(2-oxo-2-((2,2,2-trifluoroethyl)amino)ethyl)-
9. Lotilaner [usan:inn]
10. Unii-heh4938d7k
11. Lotilaner [mi]
12. Lotilaner (usan/inn)
13. Lotilaner [usan]
14. Lotilaner [green Book]
15. Chembl3707310
16. Schembl16860871
17. Dtxsid701027551
18. Ex-a3269
19. Ac-36763
20. Hy-116564
21. Cs-0065903
22. D11212
23. Q27279888
24. 3-methyi-n-(2-oxo-2-((2,2,2-trifluoroethyl)amino)ethyl)-5-((55)-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-4,5-dihydro-1,2-oxazol-3-yl)thiophene-2-carboxamide
| Molecular Weight | 596.8 g/mol |
|---|---|
| Molecular Formula | C20H14Cl3F6N3O3S |
| XLogP3 | 6.6 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 11 |
| Rotatable Bond Count | 6 |
| Exact Mass | 594.972565 g/mol |
| Monoisotopic Mass | 594.972565 g/mol |
| Topological Polar Surface Area | 108 Ų |
| Heavy Atom Count | 36 |
| Formal Charge | 0 |
| Complexity | 868 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
For the treatment of flea and tick infestations.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
* Dogs:
This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).
* Cats:
This veterinary medicinal product provides immediate and persistent killing activity for 1 month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).
QP53BE04
NDC Package Code : 46016-1360
Start Marketing Date : 2025-10-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 17205-629
Start Marketing Date : 2023-08-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]VMF Number : 6306
Submission : 2019-04-30
Status : Active
Type : II

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About the Company : Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and man...
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RLD : Yes
TE Code :
Brand Name : XDEMVY
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.25%
Approval Date : 2023-07-24
Application Number : 217603
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CREDELIO
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 56.25MG
Packaging : 01/03/2006
Approval Date :
Application Number : 2471205
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CREDELIO
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 112.5MG
Packaging : 01/03/2006
Approval Date :
Application Number : 2471213
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CREDELIO
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 225MG
Packaging : 01/03/2006
Approval Date :
Application Number : 2471248
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CREDELIO
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 450MG
Packaging : 01/03/2006
Approval Date :
Application Number : 2471221
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CREDELIO
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 900MG
Packaging :
Approval Date :
Application Number : 2471256
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CREDELIO PLUS
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 56.25MG
Packaging :
Approval Date :
Application Number : 2525674
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CREDELIO PLUS
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 112.5MG
Packaging :
Approval Date :
Application Number : 2525682
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CREDELIO PLUS
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 225MG
Packaging :
Approval Date :
Application Number : 2525690
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CREDELIO PLUS
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 450MG
Packaging :
Approval Date :
Application Number : 2525704
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CREDELIO PLUS
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 900MG
Packaging :
Approval Date :
Application Number : 2525712
Regulatory Info : Prescription
Registration Country : Canada

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Global Sales Information
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ABOUT THIS PAGE
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PharmaCompass offers a list of Lotilaner 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 Lotilaner manufacturer or Lotilaner supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lotilaner manufacturer or Lotilaner supplier.
PharmaCompass also assists you with knowing the Lotilaner API Price utilized in the formulation of products. Lotilaner API Price is not always fixed or binding as the Lotilaner Price is obtained through a variety of data sources. The Lotilaner Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lotilaner manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lotilaner, including repackagers and relabelers. The FDA regulates Lotilaner manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lotilaner 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 Lotilaner manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lotilaner supplier is an individual or a company that provides Lotilaner active pharmaceutical ingredient (API) or Lotilaner finished formulations upon request. The Lotilaner suppliers may include Lotilaner API manufacturers, exporters, distributors and traders.
click here to find a list of Lotilaner suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Lotilaner as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lotilaner 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 Lotilaner 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 Lotilaner and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lotilaner NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lotilaner suppliers with NDC on PharmaCompass.
Lotilaner 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 Lotilaner 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 Lotilaner GMP manufacturer or Lotilaner GMP API supplier for your needs.
A Lotilaner CoA (Certificate of Analysis) is a formal document that attests to Lotilaner's compliance with Lotilaner specifications and serves as a tool for batch-level quality control.
Lotilaner CoA mostly includes findings from lab analyses of a specific batch. For each Lotilaner 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.
Lotilaner may be tested according to a variety of international standards, such as European Pharmacopoeia (Lotilaner EP), Lotilaner JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lotilaner USP).