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FDA (FOOD AND DRUG ADMINISTRATION) ORANGE BOOK:

Comprehensive global suppliers information with their contacts covering all Formulations

Key Highlights

Countries

200


Molecules

25000


Downloadable Report

Quick-Report

Instant access to global buyers info with their contacts for a specific product(s) in an excel sheet


Contact details

Finished Dosage Form (FDF) Listed Buyers Key & decision maker(s) of all buyers including name, number and email address

Verified data points

We ensure highest level of correctness & consistency of data points and contact details

The publication approved drug products with therapeutic Equivalence evaluation named as Orange Book based on drug product approved by Food and Drug Administration (FDA). It included only currently marketed prescription drug products approved by FDA through new drug applications (NDAs) and abbreviated new drug applications (ANDAs) under the provisions of Section 505 of the FD&C Act and FDA regulations at that time. In FDA Orange book listed drug must be safe and must be prove effective. It also includes therapeutic equivalence evaluation for approved multisource prescription drug product. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the domain of drug.

Data Coverage

BASIC INFO

  • Chemical Name
  • CAS No.
  • Synonyms
  • Molecular Formula
  • Molecular Weight
  • Innovator
  • Developer
  • Indication
  • Market Status
  • Segment
  • Approval Year

TECHNICAL INFO

  • Industry Application
  • End Application
  • Route Of Synthesis
  • Technology
  • Mechanism of Action

COMMERCIAL INFO

  • Global Market Size (MT)
  • Global Market Size (MUSD)
  • Average Price (USD/KG.)
  • US Drug Sales (M USD)

SUPPLIER INFO

  • No. Of Supplier
  • Supplying Volume (MT)
  • Supplier Certification
  • No. Of Country Covered
  • No. Of Suppliers Email

BUYER INFO

  • No. Of Buyer
  • Buying Volume (MT)
  • Buyer Certification
  • No. Of Country Covered
  • No. Of Buyers Email

CERTIFICATION

  • USFDA Certified Site
  • EU GMP Certified Site
  • Japan PMDA Certified Site
  • Canada Certified Site
  • India CDSCO Certified Site

PATENT

  • Patent Expiry (US)
  • Exclusivity (US)
  • SPC
  • Para IV (US)
  • Off Patent - No Generics Approved

Clinical Trial

  • United States
  • Europe
  • Japan
  • Canada
  • Korea
  • India
  • Australia & New Zealand

WARNING

  • USFDA Recall/Withdrawal
  • USFDA Warning
  • USFDA Site Inspection
  • India CDSCO Banned Drug
  • India Banned Pesticide
  • Banned Pesticide (World)
  • India NPPA
  • India NLEM
  • EU-List Under Monitoring
  • WHO Essentials Medicine

REGULATORY INFO

ACTIVE INGREDIENT

  • USDMF
  • JDMF
  • KDMF
  • CEP/COS
  • EU API Registered
  • India EU Written
  • India Import Licence
  • REACH Registration
  • FDA NDC
  • UK MHRA

FORMULATION

  • US ANDA
  • Europe Registered
  • Japan Registered
  • South Korea Registered
  • Australia Registered
  • Canada Registered
  • India Registered
  • Brazil Registered
  • South Africa Registered
  • Sri Lanka Registered
  • Philippines Registered
  • US Excipient Registered
  • Ghana Registered
  • Bangladesh Registered
  • US Veterinary Registered
  • Pakistan Registered