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Synopsis

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

API REF. PRICE (USD/KG)

MARKET PLACE

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FDF

FINISHED DOSAGE FORMULATIONS

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FDA Orange Book

FDA (Orange Book)

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Europe

Europe

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Australia

Australia

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South Africa

South Africa

0 DRUGS IN DEVELOPMENT

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

PATENTS & EXCLUSIVITIES

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US Patents

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US Exclusivities

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Health Canada Patents

DIGITAL CONTENT

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Data Compilation #PharmaFlow

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Stock Recap #PipelineProspector

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Weekly News Recap #Phispers

GLOBAL SALES INFORMATION

US Medicaid

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Annual Reports

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Finished Drug Prices

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0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

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

VMF

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Listed Suppliers

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01

Seqens

France
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  • fda
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Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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Fluralaner

About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.
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02

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

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Fluralaner

About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
Rochem

03

Suanfarma

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSuanfarma, at the Core of a Better Life.

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Fluralaner

About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...

Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical industry innovatively & sustainably. Backed by a robust global network of 12 strategically located local offices, we cater to the needs of over 400 active customers in 70+ countries. At Suanfarma we offer our CDMO capacity for fermentation & chemical synthesis projects, offering a One Stop Shop service with a solid track record, & which allows us to achieve success in the development, scaling, manufacturing, & commercialization of an API, either innovative or generic.
Suanfarma

04

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Virtual BoothShuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.

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Fluralaner

About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...

Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has 6 workshops and 9 production lines which has 100t/month production capacity.The company is committed to maintain the standards with continuous improvements to the current standards throughout the product lifecycle.The main products include local anesthetic drugs, antiviral drugs, cardiovascular and cerebrovascular drugs, antitumor drugs, gastrointestinal drugs, diabetic drugs, veterinary drugs, and CDMO products.
Shandong Chenghui Shuangda Pharmaceutical

05

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

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Fluralaner

About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...

Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.
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06

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Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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Fluralaner

About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...

Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include customized R&D as well as the production of small molecule pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) for both international and domestic pharmaceutical firms. Our capabilities span from laboratory-scale kilograms to commercial ton-scale production. Additionally, we are committed to independent research and development, as well as the production and sales of high-end pharmaceutical intermediates and API products.
Jinan Tantu Chemicals

07

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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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Fluralaner

About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...

Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Supriya follows industry standards and constantly improves to deliver quality products. Its facility is 47,000 square meters with dedicated areas for warehouse, QA, QC, R&D, production and finished products. The current capacity is 550 KL, with plans to expand to over 1000 KL by 2024. Supriya has 14 active USDMFs, 8 active CEPs, strong R&D and compliant facilities worldwide. Supriya works with innovators, generic companies, and as a CMO.
Supriya

08

BioFlorida Conference
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Fluralaner

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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Fluralaner

About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special gener...

BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FDFs with primary strategic focus on the regulated market. We have an exciting and very promising innovative pipeline including immuno-oncological therapeutic agents, orally available GLP-1RA peptides for type 2 diabetes, antibody drug conjugates for solid tumor, novel non-antibody dependent tumor targeting conjugates for brain cancer and solid tumor brain-metastasis.
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Fluralaner

About the Company : Sichuan Qingmu Pharmaceutical Co., Ltd, is a FDA approved cGMP factory in China, focusing on APIs’ production. The products are mainly Oncology APIs, Cardiovascular APIs, and Vet...

Sichuan Qingmu Pharmaceutical Co., Ltd, is a FDA approved cGMP factory in China, focusing on APIs’ production. The products are mainly Oncology APIs, Cardiovascular APIs, and Veterinary APIs, such as Bisoprolol, Dabigatran, Lenvatinib and Fluralaner with DMFs available. Some products are certified with CEP. Also with our mother factory, we can provide CDMO production from intermediates, APIs to formulations.
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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1662575400,"product":"FLURALANER IH","address":"301 3RD FLOOR ESQUARE SUBHASH ROAD VILE PARLE EAST Contac","city":"MUMBAI","supplier":"NGL FINE CHEM ","supplierCountry":"INDIA","foreign_port":"GUADALAJARA","customer":"CONSIGNEE NAME ADDRESS ","customerCountry":"MEXICO","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"15600","totalValueFC":"3419","currency":"USD","unitRateINR":1096000,"date":"08-Sep-2022","totalValueINR":"274000","totalValueInUsd":"3419","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"4055607","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"301 3RD FLOOR ESQUARE SUBHASH ROAD VILE PARLE EAST Contac, MUMBAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1651602600,"product":"FLURALANER (FOR R & D PURPOSE)","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"WISDOM PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"11000","totalValueFC":"10980.7","currency":"USD","unitRateINR":"848650","date":"04-May-2022","totalValueINR":"848650","totalValueInUsd":"10980.7","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"8542017","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":"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 PHARMACEUTICAL GROUP","supplierCountry":"CHINA","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","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"}]
04-May-2022
11-Oct-2022
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Average Price (USD/KGS)

Number of Transactions

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Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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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

  • fda
  • EDQM
  • WHO-GMP

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

  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content

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

  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content

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
  • WHO-GMP

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

Merck & Co

U.S.A
Fi Europe 2024
Not Confirmed
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Merck & Co

U.S.A
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FLURALANER

Brand Name : VITRECTO

Dosage Form : SOLUTION

Dosage Strength : 250MG/0.89ML

Packaging :

Approval Date :

Application Number : 2491737

Regulatory Info : Prescription

Registration Country : Canada

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07

Merck & Co

U.S.A
Fi Europe 2024
Not Confirmed
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Merck & Co

U.S.A
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Fi Europe 2024
Not Confirmed

FLURALANER

Brand Name : BRAVECTO ONE

Dosage Form : TABLET (CHEWABLE)

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2502224

Regulatory Info : Prescription

Registration Country : Canada

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08

Merck & Co

U.S.A
Fi Europe 2024
Not Confirmed
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Merck & Co

U.S.A
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Fi Europe 2024
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
Fi Europe 2024
Not Confirmed
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Merck & Co

U.S.A
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Fi Europe 2024
Not Confirmed

FLURALANER

Brand Name : BRAVECTO

Dosage Form : TABLET (CHEWABLE)

Dosage Strength : 1000MG

Packaging : 01/02/2004

Approval Date :

Application Number : 2425092

Regulatory Info : Prescription

Registration Country : Canada

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10

Merck & Co

U.S.A
Fi Europe 2024
Not Confirmed
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Merck & Co

U.S.A
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Fi Europe 2024
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FLURALANER

Brand Name : BRAVECTO

Dosage Form : SOLUTION

Dosage Strength : 500MG/1.79ML

Packaging :

Approval Date :

Application Number : 2454963

Regulatory Info : Prescription

Registration Country : Canada

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Canada

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BioFlorida Conference
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FLURALANER

Brand Name : VITRECTO

Dosage Form : SOLUTION

Dosage Strength : 112.5MG/0.4ML

Packaging :

Approval Date :

Application Number : 2491729

Regulatory Info : Prescription

Registration Country : Canada

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02

BioFlorida Conference
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BioFlorida Conference
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FLURALANER

Brand Name : VITRECTO

Dosage Form : SOLUTION

Dosage Strength : 250MG/0.89ML

Packaging :

Approval Date :

Application Number : 2491737

Regulatory Info : Prescription

Registration Country : Canada

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03

BioFlorida Conference
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FLURALANER

Brand Name : BRAVECTO ONE

Dosage Form : TABLET (CHEWABLE)

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 2502232

Regulatory Info : Prescription

Registration Country : Canada

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FLURALANER

Brand Name : BRAVECTO ONE

Dosage Form : TABLET (CHEWABLE)

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number : 2502240

Regulatory Info : Prescription

Registration Country : Canada

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BioFlorida Conference
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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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06

BioFlorida Conference
Not Confirmed
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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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07

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
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FLURALANER

Brand Name : BRAVECTO

Dosage Form : TABLET (CHEWABLE)

Dosage Strength : 1000MG

Packaging : 01/02/2004

Approval Date :

Application Number : 2425092

Regulatory Info : Prescription

Registration Country : Canada

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08

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
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FLURALANER

Brand Name : BRAVECTO

Dosage Form : SOLUTION

Dosage Strength : 500MG/1.79ML

Packaging :

Approval Date :

Application Number : 2454963

Regulatory Info : Prescription

Registration Country : Canada

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09

BioFlorida Conference
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FLURALANER

Brand Name : BRAVECTO

Dosage Form : SOLUTION

Dosage Strength : 1000MG/3.57ML

Packaging :

Approval Date :

Application Number : 2454971

Regulatory Info : Prescription

Registration Country : Canada

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10

BioFlorida Conference
Not Confirmed
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FLURALANER

Brand Name : BRAVECTO

Dosage Form : SOLUTION

Dosage Strength : 1400MG/5ML

Packaging :

Approval Date :

Application Number : 2454998

Regulatory Info : Prescription

Registration Country : Canada

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