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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS Certifications

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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


API SUPPLIERS

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01

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
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  • 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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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Metrochem

02

Seqens

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • 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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03

Shandong Chenghui Shuangda Pharmac...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • 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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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Shandong Chenghui Shuangda Pharmaceutical

04

HRV Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
HRV Global Life Sciences

05

TAPI Technology & API Services

Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
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  • 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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Sichuan Qingmu Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • 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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07

Maithri Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
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Virtual BoothMaithri Drugs: Dedicated to your API needs.

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08

Flax Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Siegfried AG

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Siegfried AG

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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Alivira Animal Health

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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NDC API

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Siegfried AG

Switzerland
OPRD
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Siegfried AG

Switzerland
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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 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

02

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 : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...

Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists in the development, scale-up and manufacturing of drug substances from pre-clinical to commercial stages. Seqens boasts a vast portfolio of APIs and proprietary products while also developing custom solutions and ingredients for the healthcare, electronics and cosmetics industries. It operates 16 industrial plants and 9 R&D centers worldwide. Seqens possesses technologies that enable it to produce complex molecules to meet both small- and large-scale demands.
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03

  • 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.
Shandong Chenghui Shuangda Pharmaceutical

04

HRV Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Lotilaner

About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Pharma effectively promote projects and products. HRV Pharma represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Pharma has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

05

  • 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-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
TAPI Company Banner

06

  • 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 Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing of generic APIs and ...

Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing of generic APIs and advanced intermediates, and also offer high-quality CDMO/CMO services for small-molecule drugs. Qingmu has been inspected and approved by global regulatory authorities such as the US FDA, Korea MFDS, and China NMPA, and has earned client approvals across the U.S., Europe, Japan, and China. With strong technical capabilities and a commitment to international quality standards, we support customers from early development through to commercial supply.
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07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMaithri Drugs: Dedicated to your API needs.

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Lotilaner

About the Company : Maithri Drugs Pvt. Ltd. is a trusted global partner in Active Pharmaceutical Ingredients (APIs), supplying to pharmaceutical leaders in 60+ countries. With APIs spanning antivirals...

Maithri Drugs Pvt. Ltd. is a trusted global partner in Active Pharmaceutical Ingredients (APIs), supplying to pharmaceutical leaders in 60+ countries. With APIs spanning antivirals, antibiotics, ARVs, CNS, and cardiovascular segments, we deliver innovation with reliability. Our facilities are approved by US FDA, EDQM, Health Canada, and WHO-GMP, backed by numerous global DMFs and recognition as an Ecovadis-rated company. Supported by strong R&D, global patents, and customer-centric practices, Maithri ensures world-class APIs with regulatory excellence and exceptional service.
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08

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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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09

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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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Lotilaner

About the Company : Flax Laboratories was established by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology driven bulk...

Flax Laboratories was established by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology driven bulk drugs and intermediates at competitive price. Our objective of providing the critical India advantage to both the innovator and generic pharmaceutical players in both domestic and international markets including the regulated markets.
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Drugs in Development

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Details:

The net proceeds from the offering will be used to commercialize Xdemvy (lotilaner). It is being indicated for the treatment of Demodex blepharitis.


Lead Product(s): Lotilaner,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Xdemvy

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Goldman Sachs & Co

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 12, 2025

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01

PREP
Not Confirmed
PREP
Not Confirmed

Lead Product(s) : Lotilaner,Inapplicable

Therapeutic Area : Ophthalmology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Goldman Sachs & Co

Deal Size : $100.0 million

Deal Type : Public Offering

Details : The net proceeds from the offering will be used to commercialize Xdemvy (lotilaner). It is being indicated for the treatment of Demodex blepharitis.

Product Name : Xdemvy

Product Type : Miscellaneous

Upfront Cash : Undisclosed

March 12, 2025

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Details:

The net proceeds from the offering will be used to commercialize Xdemvy (lotilaner). It is being indicated for the treatment of Demodex blepharitis.


Lead Product(s): Lotilaner,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Xdemvy

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Goldman Sachs & Co

Deal Size: $125.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 12, 2025

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02

PREP
Not Confirmed
PREP
Not Confirmed

Lead Product(s) : Lotilaner,Inapplicable

Therapeutic Area : Ophthalmology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Goldman Sachs & Co

Deal Size : $125.0 million

Deal Type : Public Offering

Details : The net proceeds from the offering will be used to commercialize Xdemvy (lotilaner). It is being indicated for the treatment of Demodex blepharitis.

Product Name : Xdemvy

Product Type : Miscellaneous

Upfront Cash : Undisclosed

March 12, 2025

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Details:

Proceeds will be used for the U.S. commercialization of Xdemy (lotilaner), designed to target and kill Demodex mites causing Demodex blepharitis.


Lead Product(s): Lotilaner,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Goldman Sachs & Co

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 29, 2024

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03

PREP
Not Confirmed
PREP
Not Confirmed

Lead Product(s) : Lotilaner,Inapplicable

Therapeutic Area : Ophthalmology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Goldman Sachs & Co

Deal Size : $100.0 million

Deal Type : Public Offering

Details : Proceeds will be used for the U.S. commercialization of Xdemy (lotilaner), designed to target and kill Demodex mites causing Demodex blepharitis.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

February 29, 2024

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Details:

TP-05 (lotilaner) is an oral, well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-Cl channels. It is being evaluated for the prevention of Lyme Disease.


Lead Product(s): Lotilaner,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 22, 2024

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04

PREP
Not Confirmed
PREP
Not Confirmed

Details : TP-05 (lotilaner) is an oral, well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-Cl channels. It is being evaluated for the prevention of Lyme Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 22, 2024

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Details:

Lotilaner is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Demodex Blepharitis.


Lead Product(s): Lotilaner,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 26, 2023

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05

PREP
Not Confirmed
PREP
Not Confirmed

Details : Lotilaner is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Demodex Blepharitis.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 26, 2023

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Details:

TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel small molecule, approved for Demodex blepharitis under the brand name Xdemvy. Now it is being evaluated as an investigational therapy for the treatment of Meibomian Gland Disease (MGD) in patients with Demodex mites.


Lead Product(s): Lotilaner,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 11, 2023

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06

PREP
Not Confirmed
PREP
Not Confirmed

Details : TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel small molecule, approved for Demodex blepharitis under the brand name Xdemvy. Now it is being evaluated as an investigational therapy for the treatment of Meibomian Gland Disease (MGD) in patients w...

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 11, 2023

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Details:

TP-03 (lotilaner) is a novel investigational therapeutic designed to resolve the signs and symptoms of Demodex blepharitis via targeting and eradicating the root cause by selectively inhibiting the GABA-Cl channels.


Lead Product(s): Lotilaner,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 30, 2023

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07

LianBio

China
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PREP
Not Confirmed

LianBio

China
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PREP
Not Confirmed

Details : TP-03 (lotilaner) is a novel investigational therapeutic designed to resolve the signs and symptoms of Demodex blepharitis via targeting and eradicating the root cause by selectively inhibiting the GABA-Cl channels.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 30, 2023

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Details:

The company intends to use the net proceeds to fund the commercial launch of Xdemvy (lotilaner) for the treatment of Demodex blepharitis in the United States and to develop its product pipeline including TP-03 for the treatment of Meibomian Gland Disease.


Lead Product(s): Lotilaner,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Goldman Sachs & Co

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering August 01, 2023

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08

PREP
Not Confirmed
PREP
Not Confirmed

Lead Product(s) : Lotilaner,Inapplicable

Therapeutic Area : Ophthalmology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Goldman Sachs & Co

Deal Size : $100.0 million

Deal Type : Public Offering

Details : The company intends to use the net proceeds to fund the commercial launch of Xdemvy (lotilaner) for the treatment of Demodex blepharitis in the United States and to develop its product pipeline including TP-03 for the treatment of Meibomian Gland Disease...

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

August 01, 2023

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Details:

The company intends to fund the commercial launch of Xdemvy (lotilaner) for the treatment of Demodex blepharitis in the United States and to develop its product pipeline including TP-03 for the treatment of Meibomian Gland Disease, or MGD, TP-04 and TP-05.


Lead Product(s): Lotilaner,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Goldman Sachs & Co

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering July 31, 2023

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PREP
Not Confirmed
PREP
Not Confirmed

Lead Product(s) : Lotilaner,Inapplicable

Therapeutic Area : Ophthalmology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Goldman Sachs & Co

Deal Size : $100.0 million

Deal Type : Public Offering

Details : The company intends to fund the commercial launch of Xdemvy (lotilaner) for the treatment of Demodex blepharitis in the United States and to develop its product pipeline including TP-03 for the treatment of Meibomian Gland Disease, or MGD, TP-04 and TP-0...

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

July 31, 2023

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Details:

Xdemvy (lotilaner ophthalmic solution), a novel prescription eye drop, is recently approved by FDA and is designed to treat demodex blepharitis by targeting and eradicating the root cause of the disease, demodex mite infestation.


Lead Product(s): Lotilaner,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 25, 2023

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Not Confirmed
PREP
Not Confirmed

Details : Xdemvy (lotilaner ophthalmic solution), a novel prescription eye drop, is recently approved by FDA and is designed to treat demodex blepharitis by targeting and eradicating the root cause of the disease, demodex mite infestation.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 25, 2023

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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

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

CAS Number : 859199-06-7

End Use API : 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 ...

Shandong Chenghui Shuangda Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

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

CAS Number : 2758907-87-6

End Use API : 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 ...

Shandong Chenghui Shuangda Pharmaceutical

03

  • fda
  • EDQM
  • WHO-GMP

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

CAS Number : 158401-00-4

End Use API : 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 ...

Shandong Chenghui Shuangda Pharmaceutical

04

Rampex Labs

India
OPRD
Not Confirmed
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Rampex Labs

India
OPRD
Not Confirmed
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CAS Number : 1171331-39-7

End Use API : Lotilaner

About The Company : We are Rampex Labs, a fully cGMP compliant pharmaceutical intermediates plant located in the outskirts of Hyderabad, India. Our company was founded in 2004 with...

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05

Rampex Labs

India
OPRD
Not Confirmed
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Rampex Labs

India
OPRD
Not Confirmed
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CAS Number : 158401-00-4

End Use API : Lotilaner

About The Company : We are Rampex Labs, a fully cGMP compliant pharmaceutical intermediates plant located in the outskirts of Hyderabad, India. Our company was founded in 2004 with...

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06

SS Pharma

India
OPRD
Not Confirmed
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SS Pharma

India
OPRD
Not Confirmed
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CAS Number : 158401-00-4

End Use API : Lotilaner

About The Company : SS Pharmaceutical develops and manufactures active pharmaceutical ingredients (APIs), registered pharma intermediates, fine chemicals and pyridine derivatives f...

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SS Pharma

India
OPRD
Not Confirmed
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SS Pharma

India
OPRD
Not Confirmed
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CAS Number : 1171331-39-7

End Use API : Lotilaner

About The Company : SS Pharmaceutical develops and manufactures active pharmaceutical ingredients (APIs), registered pharma intermediates, fine chemicals and pyridine derivatives f...

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FDF Dossiers

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01

PREP
Not Confirmed
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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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PREP
Not Confirmed
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Not Confirmed

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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03

PREP
Not Confirmed
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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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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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PREP
Not Confirmed
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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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PREP
Not Confirmed
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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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PREP
Not Confirmed
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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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PREP
Not Confirmed
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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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PREP
Not Confirmed
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Not Confirmed

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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FDA Orange Book

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01

TARSUS

U.S.A
PREP
Not Confirmed
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TARSUS

U.S.A
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Not Confirmed

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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01

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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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Organic Process R&D
Not Confirmed
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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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Luxepack
Not Confirmed
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Not Confirmed

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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Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

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

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

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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08

Luxepack
Not Confirmed
arrow
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Luxepack
Not Confirmed

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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09

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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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Organic Process R&D
Not Confirmed
arrow
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Organic Process R&D
Not Confirmed

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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Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

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01

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PREP
Not Confirmed

TARSUS

U.S.A
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PREP
Not Confirmed

LOTILANER

US Patent Number : 11690826

Drug Substance Claim :

Drug Product Claim :

Application Number : 217603

Patent Use Code : U-3674

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-12-14

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Not Confirmed

TARSUS

U.S.A
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Not Confirmed

LOTILANER

US Patent Number : 11197847

Drug Substance Claim :

Drug Product Claim :

Application Number : 217603

Patent Use Code : U-3674

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-12-14

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TARSUS

U.S.A
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Not Confirmed

LOTILANER

US Patent Number : 10835517

Drug Substance Claim :

Drug Product Claim :

Application Number : 217603

Patent Use Code : U-3674

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-12-14

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TARSUS

U.S.A
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Not Confirmed

LOTILANER

US Patent Number : 12171750

Drug Substance Claim :

Drug Product Claim :

Application Number : 217603

Patent Use Code : U-3674

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-12-14

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TARSUS

U.S.A
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Not Confirmed

LOTILANER

US Patent Number : 11752137

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 217603

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-12-14

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Not Confirmed

TARSUS

U.S.A
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Not Confirmed

LOTILANER

US Patent Number : 12213964

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 217603

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-12-14

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Not Confirmed

TARSUS

U.S.A
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Not Confirmed

LOTILANER

US Patent Number : 12364685

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 217603

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-12-14

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Not Confirmed

TARSUS

U.S.A
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PREP
Not Confirmed

LOTILANER

US Patent Number : 11690827

Drug Substance Claim :

Drug Product Claim :

Application Number : 217603

Patent Use Code : U-3674

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-12-14

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Not Confirmed

TARSUS

U.S.A
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Not Confirmed

LOTILANER

US Patent Number : 8383659

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217603

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-01-17

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ABOUT THIS PAGE

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

Lotilaner manufacturers, exporters & distributors 1

92

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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