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Synopsis

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ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: Veraflox, 195532-12-8, Pradofloxacin [inn], 6o0t5e048i, 8-cyano-1-cyclopropyl-7-((1s,6s)-2,8-diazabicyclo[4.3.0]nonan-8-yl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid, 8-cyano-1-cyclopropyl-6-fluoro-7-((4as,7as)-hexahydro-1h-pyrrolo[3,4-b]pyridin-6(2h)-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
Molecular Formula
C21H21FN4O3
Molecular Weight
396.4  g/mol
InChI Key
LZLXHGFNOWILIY-APPDUMDISA-N
FDA UNII
6O0T5E048I

Pradofloxacin
Pradofloxacin is a 3rd generation fluoroquinolone antibiotic developed by Bayer HealthCare AG, Animal Health GmBH. It was approved by the European Commission in April 2011 for bacterial infections in dogs and cats.
1 2D Structure

Pradofloxacin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
7-[(4aS,7aS)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-8-cyano-1-cyclopropyl-6-fluoro-4-oxoquinoline-3-carboxylic acid
2.1.2 InChI
InChI=1S/C21H21FN4O3/c22-16-6-13-18(26(12-3-4-12)9-15(20(13)27)21(28)29)14(7-23)19(16)25-8-11-2-1-5-24-17(11)10-25/h6,9,11-12,17,24H,1-5,8,10H2,(H,28,29)/t11-,17+/m0/s1
2.1.3 InChI Key
LZLXHGFNOWILIY-APPDUMDISA-N
2.1.4 Canonical SMILES
C1CC2CN(CC2NC1)C3=C(C=C4C(=C3C#N)N(C=C(C4=O)C(=O)O)C5CC5)F
2.1.5 Isomeric SMILES
C1C[C@H]2CN(C[C@H]2NC1)C3=C(C=C4C(=C3C#N)N(C=C(C4=O)C(=O)O)C5CC5)F
2.2 Other Identifiers
2.2.1 UNII
6O0T5E048I
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Veraflox

2. 195532-12-8

3. Pradofloxacin [inn]

4. 6o0t5e048i

5. 8-cyano-1-cyclopropyl-7-((1s,6s)-2,8-diazabicyclo[4.3.0]nonan-8-yl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid

6. 8-cyano-1-cyclopropyl-6-fluoro-7-((4as,7as)-hexahydro-1h-pyrrolo[3,4-b]pyridin-6(2h)-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid

7. Pudofloxacin

8. Unii-6o0t5e048i

9. Pradofloxacin [mi]

10. Schembl150884

11. Chembl1256815

12. Dtxsid60173229

13. Pradofloxacin [green Book]

14. Ex-a5917

15. Zinc3827732

16. Db11453

17. Pradofloxacin [ema Epar Veterinary]

18. A937065

19. Q15679498

20. 8-cyano-1-cyclopropyl-6-fluoro-7-((4as,7as)-octahydro-6h-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid

21. 8-cyano-1-cyclopropyl-7-((1s,6s)-2,8-diazabicyclo[4.3.0]-nonan-8-yl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid

22. 8-cyano-1-cyclopropyl-7-((1s,6s)-2,8-diazabicyclo[4.3.0]nonan-8-yl)-6-fluoro-1,4-dihydro-4-oxo-3quinolinecarboxylic Acid

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 396.4 g/mol
Molecular Formula C21H21FN4O3
XLogP30.4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count3
Exact Mass396.15976871 g/mol
Monoisotopic Mass396.15976871 g/mol
Topological Polar Surface Area96.7 Ų
Heavy Atom Count29
Formal Charge0
Complexity803
Isotope Atom Count0
Defined Atom Stereocenter Count2
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

* Dogs:

Treatment of:

- wound infections caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius);

- superficial and deep pyoderma caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius);

- acute urinary-tract infections caused by susceptible strains of Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius);

- as adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues caused by susceptible strains of anaerobic organisms, for example Porphyromonas spp. and Prevotella spp.

* Cats:

Treatment of acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).


Dogs: , Infections of the skin and soft tissues, i. e. superficial and deep pyoderma and wound infections caused by Gram-positive organisms, typically Staphylococcus spp. and Streptococcus spp. , and Gram-negative organisms such as Escherichia coli, Pseudomonas spp. and Proteus spp. , Infections of the urinary tract caused by Gram-negative bacteria such as enterobacteriaceae, e. g. Escherichia coli, Enterobacter spp. , Klebsiella spp. and Proteus spp. , Pseudomonas spp. , and Gram-positive organisms, typically Staphylococcus spp. , Infections of the gingiva and periodontal tissues caused by anaerobic organisms, for example Porphyromonas spp. , Prevotella spp. ; Fusobacterium spp. , Eikenella spp. and capnophilic bacteria such as Capnocytophaga spp. , , Cats: , Infections of the respiratory tract caused by Gram-negative organisms such as Pasteurella spp. , Escherichia coli and Pseudomonas spp. , and Gram-positive organisms such as Streptococcus spp. and Staphylococcus spp. ,


5 Pharmacology and Biochemistry
5.1 ATC Code

QJ01MA97


QJ01MA


NDC API

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01

Bayer AG

Germany

PRADOFLOXACIN

NDC Package Code : 12527-0386

Start Marketing Date : 2021-08-09

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

Company Banner

02

Bayer AG

Germany

PRADOFLOXACIN

NDC Package Code : 12527-0385

Start Marketing Date : 2021-08-09

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

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03

PEGS Boston Summit
Not Confirmed
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PRADOFLOXACIN

NDC Package Code : 66653-011

Start Marketing Date : 2024-04-30

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

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

Flag U.S.A
Digital Content Digital Content

Pradofloxacin

About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...

ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships for product development, compliance, and secure logistics. ChemWerth accesses over 500 APIs and 30 manufacturing facilities across the US, Europe, India, and China, acts as a regulatory agent for 25+ FDA-approved facilities, sells 100+ products, and operates in 38 countries. In 2020, it filed its 500th DMF with the FDA . Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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INTERMEDIATE SUPPLIERS

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CAS Number : 6228-73-5

End Use API : Pradofloxacin

About The Company : Shree Ganesh Remedies is established Since 1995 with an aim to manufacture, supply and export best quality of Pharmaceutical-intermediates, Bulk drugs and Speci...

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FDF Dossiers

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01

Bayer AG

Germany

Pradofloxacin

Brand Name : Veraflox

Dosage Form : Oral Suspension

Dosage Strength : 25mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

Company Banner

02

Bayer AG

Germany

Pradofloxacin

Brand Name : Veraflox

Dosage Form : Tablet

Dosage Strength : 120mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

Company Banner

03

Bayer AG

Germany

Pradofloxacin

Brand Name : Veraflox

Dosage Form : Tablet

Dosage Strength : 15mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

Company Banner

04

Bayer AG

Germany

Pradofloxacin

Brand Name : Veraflox

Dosage Form : Tablet

Dosage Strength : 60mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

Company Banner

05

Elanco

U.S.A
PEGS Boston Summit
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Elanco

U.S.A
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Pradofloxacin

Brand Name : Veraflox

Dosage Form : Tablet

Dosage Strength : 120mg

Packaging :

Approval Date : 12-04-2011

Application Number : 28104526609

Regulatory Info : Prescription

Registration Country : Denmark

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Elanco

U.S.A
PEGS Boston Summit
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Elanco

U.S.A
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Pradofloxacin

Brand Name : Veraflox

Dosage Form : Tablet

Dosage Strength : 15mg

Packaging :

Approval Date : 12-04-2011

Application Number : 28104526409

Regulatory Info : Prescription

Registration Country : Denmark

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Elanco

U.S.A
PEGS Boston Summit
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Elanco

U.S.A
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Not Confirmed

Pradofloxacin

Brand Name : Veraflox

Dosage Form : Oral Suspension

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 12-04-2011

Application Number : 28104526709

Regulatory Info : Prescription

Registration Country : Denmark

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08

Elanco

U.S.A
PEGS Boston Summit
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Elanco

U.S.A
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Pradofloxacin

Brand Name : Veraflox

Dosage Form : Tablet

Dosage Strength : 60mg

Packaging :

Approval Date : 12-04-2011

Application Number : 28104526509

Regulatory Info : Prescription

Registration Country : Denmark

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PEGS Boston Summit
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PRADOFLOXACIN

Brand Name : VERAFLOX

Dosage Form : SUSPENSION

Dosage Strength : 25MG/ML

Packaging : 15ML/30ML

Approval Date :

Application Number : 2436744

Regulatory Info : PRESCRIPTION

Registration Country : Canada

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PEGS Boston Summit
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PRADOFLOXACIN

Brand Name : VERAFLOX

Dosage Form : TABLET

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number : 2437392

Regulatory Info : PRESCRIPTION

Registration Country : Canada

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ABOUT THIS PAGE

Looking for 195532-12-8 / Pradofloxacin API manufacturers, exporters & distributors?

Pradofloxacin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Pradofloxacin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pradofloxacin manufacturer or Pradofloxacin supplier for your needs.

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

API | Excipient name

Pradofloxacin

Synonyms

Veraflox, 195532-12-8, Pradofloxacin [inn], 6o0t5e048i, 8-cyano-1-cyclopropyl-7-((1s,6s)-2,8-diazabicyclo[4.3.0]nonan-8-yl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid, 8-cyano-1-cyclopropyl-6-fluoro-7-((4as,7as)-hexahydro-1h-pyrrolo[3,4-b]pyridin-6(2h)-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

Cas Number

195532-12-8

Unique Ingredient Identifier (UNII)

6O0T5E048I

About Pradofloxacin

Pradofloxacin is a 3rd generation fluoroquinolone antibiotic developed by Bayer HealthCare AG, Animal Health GmBH. It was approved by the European Commission in April 2011 for bacterial infections in dogs and cats.

Pradofloxacin Manufacturers

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

Pradofloxacin Suppliers

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

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

Pradofloxacin 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 Pradofloxacin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pradofloxacin GMP

Pradofloxacin 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 Pradofloxacin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pradofloxacin GMP manufacturer or Pradofloxacin GMP API supplier for your needs.

Pradofloxacin CoA

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

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

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