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.

BASIC INFO

  • Chemical Name
  • CAS No.
  • Synonyms
  • Molecular Formula
  • Molecular Weight
  • Innovator

BASIC INFO
BASIC INFO

  • Developer
  • Indication
  • Market Status
  • Segment
  • Approval Year

BASIC INFO
TECHNICAL INFO

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

APPLICATION
COMMERCIAL INFO

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

TECHNICAL INFO
SUPPLIER INFO

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

COMMERCIAL INFO
BUYER INFO

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

CLINICAL TRIAL
CLINICAL TRIAL

  • US Clinical Trial
  • EU Clinical Trial
  • Japan Clinical Trial
  • India Clinical Trial

PATENT
CLINICAL TRIAL

  • NZ and AU Clinical Trial
  • Canada Clinical Trial
  • Korea Clinical Trial

CLINICAL TRIAL
PATENT

  • Patent Expiry (US)
  • Exclusivity (US)
  • SPC
  • Para IV (US)

CLINICAL TRIAL
CERTIFICATION

  • EU GMP Certified Site
  • Buyer Certification
  • Supplier Certification
  • USFDA Certified Site
  • Japan PMDA Certified Site
  • India CDSCO Certified Site

PATENT
WARNING

  • USFDA Recall/Withdrawal
  • USFDA Warning
  • USFDA Site Inspection
  • India CDSCO Banned Drug

CERTIFICATION
WARNING

  • India Banned Pesticide
  • Banned Pesticide (World)
  • India NPPA
  • India NLEM

ALERT/WARNING

REGULATORY INFO

ACTIVE INGREDIENT

  • USDMF
  • JDMF
  • KDMF
  • CEP/COS

CLINICAL TRIAL
ACTIVE INGREDIENT

  • EU API Registered
  • India EU Written
  • India Import Licence
  • REACH Registration

PATENT
FORMULATION

  • US ANDA
  • Canada Registered
  • Australia Registered
  • Europe Registered
  • South Africa Registered

CERTIFICATION
FORMULATION

  • India Registered
  • Brazil Registered
  • Japan Registered
  • Sri Lanka Registered
  • Philippines Registered

ALERT/WARNING