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Clobazam Tablets 10mg & 20 mg (USA)

CATEGORY : Allopathy


SUB CATEGORY : Tablets


SUB SUB CATEGORY : Uncoated Tablets


STRENGTH : 10mg & 20 mg


PHARMACOPOEIAL STATUS : API official in EP /BP not in USP ; Tablet is not official in EP/BP/USP


LABEL CLAIM : Each tablet contains 10 mg or 20 mg of Clobazam


MARKET : USA




Price : ₹0.00 /
1000 Available
Add To Cart

  • General
    Application form (Hard copy and electronic format)
    Mfg.lic, -notary copies
    FSC & COPP- notary copies
    WHO GMP- notary copies
    Special Export Permission (If Applicable)
    Summary of product characteristics, labeling and package leaflet/insert-English
    Summary of product characteristics
    Labeling
    Package leaflet/insert -(Country specific language)
    Mockups and samples of trade packages (if samples of trade packages are not available – a sample in final immediate (inside) package without final labeling shall be submitted. In this case a sample in final immediate (inside) and secondary (outer) packages should be given additionally as soon as it is available. Further on, for approval of methods of quality control of the medicinal product additional samples, reference substances with batch certificate including date of production, shelf life and storage conditions could be requested. - Country Specific Language
    Summary of product characteristics approved in manufacturer/applicant country.    (specification of origin of the country)
    Environmental risk assessment including Standards of the manufacturing facility and effluents treatment details to be mentioned
  • Table of contents of module-2, module-3, module-4 and module-5
    Introduction to CTD
    General summary on quality
    DRUG SUBSTANCE (NAME, MANUFACTURER)
    General Information
    Manufacture
    Characterization
    Control of Drug Substance
    Reference Standards or Materials
    Container Closure System
    Stability
    DRUG PRODUCT (NAME, DOSAGE FORM)
    Description and Composition of the Drug Product
    Pharmaceutical Development
    Manufacture
    Control of Excipients
    Control of Drug Product
    Reference Standards or Materials
    Container Closure System
    Stability (As per country requirement)
    Review of preclinical data
    Review of clinical data
    Summary of pre-clinical data
    Introduction
    Summary of pharmacological data in text format
    Brief Summary
    Primary Pharmacodynamics
    Secondary Pharmacodynamics
    Safety Pharmacology
    Pharmacodynamic Drug Interactions
    Discussion and Conclusions
    Tables and Figures
    Summary of pharmacological data in tabular format
    Summary of pharmacokinetics data in text format
    Methods of Analysis
    Absorption
    Distribution
    Metabolism (interspecies comparison)
    Summary of pharmacokinetics data in tabular format
    Summary of toxicological data in text format
    Summary of toxicological data in tabular format
    Summary of clinical data
    Summary of biopharmaceutical studies and related analytical methods
    Summary of clinical pharmacology studies
    Summary of clinical efficacy
    Summary of clinical safety
    Copies of used literature sources
    Short reviews of individual trials
  • Table of contents
    Relevant data
    Medicinal substance (for medicinal products containing more than one medicinal substance an information should be given in full with respect to each of them)
    General information
    Name
    Structure
    General properties
    Manufacturer
    Manufacturer
    Description of manufacturing process and its control
    Control of materials
    Control of critical stages and intermediate products
    Process validation and/or its assessment
    Development of manufacturing process
    Characteristics
    Demonstration of structure and other characteristics
    Impurities
    Control of medicinal substance
    Specification
    Analytical methods
    Validation of analytical methods
    Batch analysis 3 BATCH COA (VALIDITY)
    Substantiation of specification
    Standard samples or substances 1BATCH COA (VALIDITY)
    Container/closure system
    Stability (As per country requirement)
    Summary on stability and conclusions
    Report on post-registration stability study and stability associated obligations
    Stability data
    Medicinal product
    Description and composition of the medicinal product
    Development pharmaceutics
    Constituents of the medicinal product
    Medicinal substance
    Excipients
    Medicinal product
    Development of composition
    Overages
    Physical and chemical, and biological properties
    Development of manufacturing process
    Container/closure system
    Microbiological characteristics
    Compatibility
    Manufacture
    Manufacturers
    Composition for batch
    Description of manufacturing process and process control
    Control of critical stages and intermediate products
    Process validation and/or its assessment
    Control of excipients
    Specifications
    Analytical methods
    Validation of analytical methods
    Justification of specifications
    Excipients of human and animal origin
    New excipients
    Control of medicinal product
    Specification (-s)
    Analytical methods
    Validation of analytical methods
    Batch analysis
    Characteristics of impurities
    Substantiation of specification (-s)
    Standard samples and substances
    Container/closure system
    Stability Data
    Summary and conclusions on stability studies
    Report on post-registration stability study and stability associated obligations
    Stability data
    Amendments
    Technical devices and facilities
    Safety assessment of foreign microorganisms
    New excipients
    Regional  information
    Copies of used literature sources
  • Table of contents
    Pharmacology
    Primary pharmacodynamics
    Secondary pharmacodynamics
    Safety pharmacology
    Pharmacodynamic drug interactions
    Pharmacokinetics
    Analytical methods and their validation report
    Absorption
    Distribution
    Metabolism
    Excretion
    Pharmacokinetic drug interactions (pre-clinical)
    Other pharmacokinetic studies
    Toxicology
    Toxicity after a single dose administration
    Toxicity after repeated administration
    Genotoxicity
    Carcinogenicity
    Reproductive and ontogenetic toxicity
    Local tolerance
    Other toxicity studies
    Copies of used literature sources
  • Table of contents
    List of all clinical trials in tables
    Report of clinical trials
    Reports on biopharmaceutical studies
    Reports on studies related to pharmacokinetics studies with use of human biomaterials
    Reports on pharmacokinetic studies in human beings
    Reports on pharmacokinetic studies in human beings
    Reports on efficacy and safety studies
    Reports on post-registration experience
    Samples of individual registration forms and individual lists of patients
    Copies of used literature sources
    Joint analysis and Registration
    Availability of Any Other Details : (COUNTRY SPECIFIC requirements - Except above mentioned)

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