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Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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FDA (Orange Book)

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Europe

Europe

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Australia

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South Africa

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GLOBAL SALES INFORMATION

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Data Compilation #PharmaFlow

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Chemistry

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Also known as: Gs7l1rur5i, (r)-a-1443, A-663, 1122022-03-0, Benzamide, 4-((5r)-5-(3,5-dichlorophenyl)-4,5-dihydro-5-(trifluoromethyl)-3-isoxazolyl)-2-methyl-n-(2-oxo-2-((2,2,2-trifluoroethyl)amino)ethyl)-, Unii-gs7l1rur5i
Molecular Formula
C22H17Cl2F6N3O3
Molecular Weight
556.3  g/mol
InChI Key
MLBZKOGAMRTSKP-HXUWFJFHSA-N
FDA UNII
GS7L1RUR5I

Fluralaner
1 2D Structure

Fluralaner

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[(5R)-5-(3,5-dichlorophenyl)-5-(trifluoromethyl)-4H-1,2-oxazol-3-yl]-2-methyl-N-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl]benzamide
2.1.2 InChI
InChI=1S/C22H17Cl2F6N3O3/c1-11-4-12(2-3-16(11)19(35)31-9-18(34)32-10-21(25,26)27)17-8-20(36-33-17,22(28,29)30)13-5-14(23)7-15(24)6-13/h2-7H,8-10H2,1H3,(H,31,35)(H,32,34)/t20-/m1/s1
2.1.3 InChI Key
MLBZKOGAMRTSKP-HXUWFJFHSA-N
2.1.4 Canonical SMILES
CC1=C(C=CC(=C1)C2=NOC(C2)(C3=CC(=CC(=C3)Cl)Cl)C(F)(F)F)C(=O)NCC(=O)NCC(F)(F)F
2.1.5 Isomeric SMILES
CC1=C(C=CC(=C1)C2=NO[C@](C2)(C3=CC(=CC(=C3)Cl)Cl)C(F)(F)F)C(=O)NCC(=O)NCC(F)(F)F
2.2 Other Identifiers
2.2.1 UNII
GS7L1RUR5I
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Gs7l1rur5i

2. (r)-a-1443

3. A-663

4. 1122022-03-0

5. Benzamide, 4-((5r)-5-(3,5-dichlorophenyl)-4,5-dihydro-5-(trifluoromethyl)-3-isoxazolyl)-2-methyl-n-(2-oxo-2-((2,2,2-trifluoroethyl)amino)ethyl)-

6. Unii-gs7l1rur5i

7. Schembl8515337

8. Dtxsid301101022

9. 4-[(5r)-5-(3,5-dichlorophenyl)-4,5-dihydro-5-(trifluoromethyl)-3-isoxazolyl]-2-methyl-n-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl]benzamide

2.4 Create Date
2013-04-19
3 Chemical and Physical Properties
Molecular Weight 556.3 g/mol
Molecular Formula C22H17Cl2F6N3O3
XLogP35.6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count10
Rotatable Bond Count6
Exact Mass555.0551158 g/mol
Monoisotopic Mass555.0551158 g/mol
Topological Polar Surface Area79.8 Ų
Heavy Atom Count36
Formal Charge0
Complexity846
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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01

Seqens

France

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

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

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02

Rochem International Inc

U.S.A

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Rochem

03

Suanfarma

Spain

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSuanfarma, at the Core of a Better Life.

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Suanfarma

04

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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Shandong Chenghui Shuangda Pharmaceutical

05

ChemWerth Inc

U.S.A

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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06

Sichuan Qingmu Pharmaceutical

China

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

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

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07

Enaltec Labs

India

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEnaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.

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08

BrightGene Bio-Medical Technology ...

China

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

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09

NGL Fine-Chem

India

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

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NGL Fine-Chem

India

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

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Zydus Lifesciences

India

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

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NDC API

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01

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

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FLURALANER

NDC Package Code : 82712-2003

Start Marketing Date : 2024-12-24

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (10kg/10kg)

Marketing Category : BULK INGREDIENT

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02

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FLURALANER

NDC Package Code : 52133-0048

Start Marketing Date : 2024-02-21

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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FLURALANER

NDC Package Code : 69011-0008

Start Marketing Date : 2025-04-24

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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FLURALANER

NDC Package Code : 42513-0019

Start Marketing Date : 2023-01-05

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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FLURALANER

NDC Package Code : 13612-0023

Start Marketing Date : 2021-05-17

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (10kg/10kg)

Marketing Category : BULK INGREDIENT

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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716748200,"product":"FLURALANER AS PER INVOICE INV CPLEXP2400047 BATCH NO.69322002 (CO CHINA)","address":"406,WORLD TRADE CENTRE,SAYAJIGUNJ,","city":"VADODARA GUJ.","supplier":"CENTURY PHARMACEUTICALS LTD","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"TO ORDER","customerCountry":"TURKEY","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"2200","totalValueFC":"21705.1","currency":"USD","unitRateINR":180920.85000000001,"date":"27-May-2024","totalValueINR":"1809208.5","totalValueInUsd":"21705.1","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"1188238","productDescription":"API","marketType":"","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"406,WORLD TRADE CENTRE,SAYAJIGUNJ,, VADODARA GUJ.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1665426600,"product":"FLURALANER (FOR R & D PURPOSE)","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO","supplierCountry":"CHINA","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"12000","totalValueFC":"48096.7","currency":"USD","unitRateINR":"989400","date":"11-Oct-2022","totalValueINR":"3957600","totalValueInUsd":"48096.7","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"2820049","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737570600,"product":"FLURALANER (LICENCE NUMBER: TL\/AZ\/22\/001683) FLURALANER","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"1012.4","totalValueFC":"2045.3","currency":"USD","unitRateINR":"88183.9","date":"23-Jan-2025","totalValueINR":"176367.71","totalValueInUsd":"2045.3","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"7960748","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":". NO.8 NANGANG ROAD FUQING JIANGYIN INDUSTRIAL ZONE FUZHOU CITY CHINA, , China","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738089000,"product":"FLURALANER (BATCH NO-20240901-02-01,20241001A) (R & D PURPOSE ONLY)FLURALANER (BATCH NO-20240901-02-01,20241001A)","address":"BLDG. NO.3,FLAT NO.203,","city":"NEAR VASANT VIHAR","supplier":"LASHPLUS CORP LTD","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"INTELLISCEND NDDR PRIVATE LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"2000","totalValueFC":"4040.4","currency":"USD","unitRateINR":"174200","date":"29-Jan-2025","totalValueINR":"348400","totalValueInUsd":"4040.4","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"8067666","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHENGDU","supplierAddress":"ROOM 1450 14\/F ETON TOWER8 HYSAN A VENUE CAUSEWAY BAYHONG KONG SDNF","customerAddress":"BLDG. NO.3,FLAT NO.203,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1759257000,"product":"FLURALANER FLURALANER","address":"F 43 DEOLALI PLAZA, LAM ROAD,DEOLA","city":"NASIK,MAHARASHTRA","supplier":"TAIZHOU CRENE BIOTECHNOLOGY CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"REYAANSH HEALTHCARE","customerCountry":"INDIA","quantity":"0.90","actualQuantity":"0.9","unit":"KGS","unitRateFc":"700","totalValueFC":"633.4","currency":"USD","unitRateINR":"62195","date":"01-Oct-2025","totalValueINR":"55975.5","totalValueInUsd":"633.4","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"4847564","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"ECONOMIC DEVELOPED ZONE OF TAIZHOU ZHEJIANG CHINA Guangzhou, , CHINA SDNF CHINA","customerAddress":"F 43 DEOLALI PLAZA, LAM ROAD,DEOLA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1759257000,"product":"FLURALANER FLURALANER","address":"F 43 DEOLALI PLAZA, LAM ROAD,DEOLA","city":"NASIK,MAHARASHTRA","supplier":"TAIZHOU CRENE BIOTECHNOLOGY CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"REYAANSH HEALTHCARE","customerCountry":"INDIA","quantity":"32.00","actualQuantity":"32","unit":"KGS","unitRateFc":"700","totalValueFC":"22521.6","currency":"USD","unitRateINR":"62195","date":"01-Oct-2025","totalValueINR":"1990240","totalValueInUsd":"22521.6","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"4850435","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"ECONOMIC DEVELOPED ZONE OF TAIZHOU ZHEJIANG CHINA Guangzhou, , CHINA SDNF CHINA","customerAddress":"F 43 DEOLALI PLAZA, LAM ROAD,DEOLA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1759516200,"product":"FLURALANER FLURALANER","address":"F 43 DEOLALI PLAZA, LAM ROAD,DEOLA","city":"NASIK,MAHARASHTRA","supplier":"TAIZHOU CRENE BIOTECHNOLOGY CO LTD","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"REYAANSH HEALTHCARE","customerCountry":"INDIA","quantity":"9.00","actualQuantity":"9","unit":"KGS","unitRateFc":"700","totalValueFC":"6394.8","currency":"USD","unitRateINR":"62790","date":"04-Oct-2025","totalValueINR":"565110","totalValueInUsd":"6394.8","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"4898240","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"ECONOMIC DEVELOPED ZONE OF TAIZHOU ZHEJIANG CHINA Guangzhou, , CHINA SDNF CHINA","customerAddress":"F 43 DEOLALI PLAZA, LAM ROAD,DEOLA"}]
11-Oct-2022
04-Oct-2025
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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 : 55860-35-0

End Use API : Fluralaner

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 : 1171331-39-7

End Use API : Fluralaner

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 : 130336-16-2

End Use API : Fluralaner

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

  • 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 : 864725-62-2

End Use API : Fluralaner

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

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 55860-35-0

End Use API : Fluralaner

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 130336-16-2

End Use API : Fluralaner

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 1171331-39-7

End Use API : Fluralaner

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB

08

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 55860-35-0

End Use API : Fluralaner

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

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09

Aventus Labs

India
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Aventus Labs

India
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CAS Number : 55860-35-0

End Use API : Fluralaner

About The Company : Aventus Labs is a forward-thinking pharmaceutical company committed to developing and delivering high-quality, effective healthcare solutions. With a focus on r...

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CAS Number : 864725-62-2

End Use API : Fluralaner

About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

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FDF Dossiers

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01

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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Regulatory Info :

Registration Country : India

Fluralaner

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 112.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

02

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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Regulatory Info :

Registration Country : India

Fluralaner

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

03

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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Regulatory Info :

Registration Country : India

Fluralaner

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

04

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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Regulatory Info :

Registration Country : India

Fluralaner

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

05

  • fda
  • EDQM
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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Regulatory Info :

Registration Country : India

Fluralaner

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 1400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

06

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Fluralaner; Moxidectin

Brand Name :

Dosage Form : Spot-on Solution

Dosage Strength : 280MG/1ML; 14 MG/1ML

Packaging :

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Regulatory Info :

Registration Country : China

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Fluralaner

Brand Name : Fluralaner

Dosage Form : Spot-On Solution

Dosage Strength : 280MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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08

Merck & Co

U.S.A
Global ChemShow
Not Confirmed
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Merck & Co

U.S.A
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Global ChemShow
Not Confirmed

FLURALANER

Brand Name : BRAVECTO

Dosage Form : TABLET (CHEWABLE)

Dosage Strength : 112.5MG

Packaging : 01/02/2004

Approval Date :

Application Number : 2425068

Regulatory Info : Prescription

Registration Country : Canada

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09

Merck & Co

U.S.A
Global ChemShow
Not Confirmed
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Merck & Co

U.S.A
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Global ChemShow
Not Confirmed

FLURALANER

Brand Name : BRAVECTO

Dosage Form : TABLET (CHEWABLE)

Dosage Strength : 250MG

Packaging : 01/02/2004

Approval Date :

Application Number : 2425076

Regulatory Info : Prescription

Registration Country : Canada

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10

Merck & Co

U.S.A
Global ChemShow
Not Confirmed
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Merck & Co

U.S.A
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Global ChemShow
Not Confirmed

FLURALANER

Brand Name : BRAVECTO

Dosage Form : TABLET (CHEWABLE)

Dosage Strength : 500MG

Packaging : 01/02/2004

Approval Date :

Application Number : 2425084

Regulatory Info : Prescription

Registration Country : Canada

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Looking for 1122022-03-0 / Fluralaner API manufacturers, exporters & distributors?

Fluralaner manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Fluralaner 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 Fluralaner manufacturer or Fluralaner supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluralaner manufacturer or Fluralaner supplier.

PharmaCompass also assists you with knowing the Fluralaner API Price utilized in the formulation of products. Fluralaner API Price is not always fixed or binding as the Fluralaner Price is obtained through a variety of data sources. The Fluralaner Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Fluralaner

Synonyms

Gs7l1rur5i, (r)-a-1443, A-663, 1122022-03-0, Benzamide, 4-((5r)-5-(3,5-dichlorophenyl)-4,5-dihydro-5-(trifluoromethyl)-3-isoxazolyl)-2-methyl-n-(2-oxo-2-((2,2,2-trifluoroethyl)amino)ethyl)-, Unii-gs7l1rur5i

Cas Number

1122022-03-0

Unique Ingredient Identifier (UNII)

GS7L1RUR5I

Fluralaner Manufacturers

A Fluralaner manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluralaner, including repackagers and relabelers. The FDA regulates Fluralaner manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluralaner 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 Fluralaner manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Fluralaner Suppliers

A Fluralaner supplier is an individual or a company that provides Fluralaner active pharmaceutical ingredient (API) or Fluralaner finished formulations upon request. The Fluralaner suppliers may include Fluralaner API manufacturers, exporters, distributors and traders.

click here to find a list of Fluralaner suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Fluralaner 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 Fluralaner as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Fluralaner 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 Fluralaner 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 Fluralaner and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluralaner NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Fluralaner suppliers with NDC on PharmaCompass.

Fluralaner GMP

Fluralaner 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 Fluralaner 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 Fluralaner GMP manufacturer or Fluralaner GMP API supplier for your needs.

Fluralaner CoA

A Fluralaner CoA (Certificate of Analysis) is a formal document that attests to Fluralaner's compliance with Fluralaner specifications and serves as a tool for batch-level quality control.

Fluralaner CoA mostly includes findings from lab analyses of a specific batch. For each Fluralaner 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.

Fluralaner may be tested according to a variety of international standards, such as European Pharmacopoeia (Fluralaner EP), Fluralaner JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fluralaner 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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