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ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: 1369852-71-0, Lotilaner [inn], Credelio, Heh4938d7k, Lotilaner (ema epar: veterinary), (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
Molecular Formula
C20H14Cl3F6N3O3S
Molecular Weight
596.8  g/mol
InChI Key
HDKWFBCPLKNOCK-SFHVURJKSA-N
FDA UNII
HEH4938D7K

Lotilaner
1 2D Structure

Lotilaner

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
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
2.1.2 InChI
InChI=1S/C20H14Cl3F6N3O3S/c1-8-2-13(36-16(8)17(34)30-6-14(33)31-7-19(24,25)26)12-5-18(35-32-12,20(27,28)29)9-3-10(21)15(23)11(22)4-9/h2-4H,5-7H2,1H3,(H,30,34)(H,31,33)/t18-/m0/s1
2.1.3 InChI Key
HDKWFBCPLKNOCK-SFHVURJKSA-N
2.1.4 Canonical SMILES
CC1=C(SC(=C1)C2=NOC(C2)(C3=CC(=C(C(=C3)Cl)Cl)Cl)C(F)(F)F)C(=O)NCC(=O)NCC(F)(F)F
2.1.5 Isomeric SMILES
CC1=C(SC(=C1)C2=NO[C@@](C2)(C3=CC(=C(C(=C3)Cl)Cl)Cl)C(F)(F)F)C(=O)NCC(=O)NCC(F)(F)F
2.2 Other Identifiers
2.2.1 UNII
HEH4938D7K
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2014-08-25
3 Chemical and Physical Properties
Molecular Weight 596.8 g/mol
Molecular Formula C20H14Cl3F6N3O3S
XLogP36.6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count11
Rotatable Bond Count6
Exact Mass594.972565 g/mol
Monoisotopic Mass594.972565 g/mol
Topological Polar Surface Area108 Ų
Heavy Atom Count36
Formal Charge0
Complexity868
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

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).


5 Pharmacology and Biochemistry
5.1 ATC Code

QP53BE04


NDC API

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01

PROCOS SpA

Italy
BIO Partnering at JPM
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PROCOS SpA

Italy
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BIO Partnering at JPM
Not Confirmed

LOTILANER

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

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02

Siegfried AG

Switzerland
BIO Partnering at JPM
Not Confirmed
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Siegfried AG

Switzerland
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BIO Partnering at JPM
Not Confirmed

LOTILANER

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

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Listed Suppliers

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01

  • fda
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  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Flag India
Digital Content Digital Content

Lotilaner

About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...

Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Biophore

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Digital Content Digital Content

Lotilaner

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

03

Seqens

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Digital Content Digital Content

Lotilaner

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...

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 manufacturing of drug substances from pre-clinical to commercial stages. Seqens offers a broad portfolio of APIs and proprietary products, along with custom solutions for healthcare, electronics, and cosmetics. With 16 industrial plants and 9 R&D centers worldwide, Seqens produces complex molecules across small- and large-scale requirements. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

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Lotilaner

About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulat...

Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulations. With 23 years of production experience, the company operates 6 GMP-compliant workshops, achieving a monthly capacity of 100 tons to meet cGMP requirements. Currently, the factory has registered 21 APIs in NMPA, filed 4 US-DMFs, and applied for 9 CEPs, while successfully passing audits by MFDS, US FDA, and global customers. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Shandong Chenghui Shuangda Pharmaceutical

05

HRV Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Digital Content Digital Content

Lotilaner

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
HRV Global Life Sciences

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Lotilaner

About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...

Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios with over 350 products, alongside tailored CDMO services. Leveraging deep expertise and diverse technologies, we deliver flexible, high-quality solutions to meet our partners’ needs. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
TAPI Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothQingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.

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Digital Content Digital Content

Lotilaner

About the Company : Sichuan Qingmu Pharmaceutical is an innovation-driven company specializing in generic APIs, advanced intermediates, and CDMO/CMO services for small-molecule drugs. Approved by US F...

Sichuan Qingmu Pharmaceutical is an innovation-driven company specializing in generic APIs, advanced intermediates, and CDMO/CMO services for small-molecule drugs. Approved by US FDA, Korea MFDS, and China NMPA, Qingmu supports global clients from early development to commercial supply, maintaining international quality standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMaithri Drugs: Dedicated to your API needs.

Flag India
Digital Content Digital Content

Lotilaner

About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...

Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, antibiotics, ARVs, CNS, and cardiovascular segments. The company operates facilities approved by US FDA, EDQM, Health Canada, and WHO-GMP, supported by multiple global DMFs and Ecovadis recognition. Backed by strong R&D, global patents, and customer-focused practices, Maithri delivers high-quality APIs with regulatory excellence. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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09

BIO Partnering at JPM
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Lotilaner

About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...

Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.
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BIO Partnering at JPM
Not Confirmed
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Lotilaner

About the Company : Alivira Animal Health Limited has emerged as India's largest and 1st Global integrated animal health company specialising in manufacturing of Active Pharmaceutical Ingredients (API...

Alivira Animal Health Limited has emerged as India's largest and 1st Global integrated animal health company specialising in manufacturing of Active Pharmaceutical Ingredients (API) and Finished Dosage Formulations (FDF).Our logotype is inspired by nature and its different forms and shapes. From a microscopic view to the skin texture, footprint of a chosen animal. The circular shape evokes the idea of protection and control. It’s a closed and perfect shape that is naturally balanced, reminiscing the brand idea “Animals source of health.
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01

TARSUS

U.S.A
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TARSUS

U.S.A
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LOTILANER

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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Canada

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LOTILANER

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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LOTILANER

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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LOTILANER

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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LOTILANER

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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05

Biotech Showcase
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LOTILANER

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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06

Biotech Showcase
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LOTILANER

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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07

Biotech Showcase
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LOTILANER

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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Biotech Showcase
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LOTILANER

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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Biotech Showcase
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LOTILANER

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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LOTILANER

Brand Name : CREDELIO PLUS

Dosage Form : TABLET (CHEWABLE)

Dosage Strength : 900MG

Packaging :

Approval Date :

Application Number : 2525712

Regulatory Info : Prescription

Registration Country : Canada

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ABOUT THIS PAGE

Looking for 1369852-71-0 / Lotilaner API manufacturers, exporters & distributors?

Lotilaner manufacturers, exporters & distributors 1

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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.

API | Excipient name

Lotilaner

Synonyms

1369852-71-0, Lotilaner [inn], Credelio, Heh4938d7k, Lotilaner (ema epar: veterinary), (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

Cas Number

1369852-71-0

Unique Ingredient Identifier (UNII)

HEH4938D7K

Lotilaner Manufacturers

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.

Lotilaner Suppliers

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.

Lotilaner NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Lotilaner API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Lotilaner CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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