cGxP Directory
GMP · GLP · GCP Intelligence Platform

Global Directory ofPharma, Biotech, Medical Devices, CROs, CDMOs, Cosmetics, Foodand other Life Sciences companies.

Comprehensive regulatory intelligence, approved drugs, licensed biologics, master files, supply shortages, and clinical trials across global life sciences enterprises.

Orange Book

Approved drug products with therapeutic equivalence evaluations.

  • Search the archive by ingredient, brand name or applicant
  • Filter and sort the whole archive in a full-screen table
  • A page per active ingredient, with its applications, patents and exclusivities
Open Orange Book

Purple Book

Licensed biological products, their biosimilars, and when their exclusivity ends.

  • Browse licensed biologics as a grid or a table
  • See which licences are biosimilar, and which are interchangeable
  • A page per licence and per biologic substance
Open Purple Book

Drug Master Files

The FDA’s quarterly list of DMFs — who filed, what for, and whether it is still active.

  • Search 41,000 filings by DMF number, holder or subject
  • Filter by type and status, with the type spelled out in full
  • Sorted numerically, so page one opens on 0, 1, 2 — not 0, 1, 10, 100
Open Drug Master Files

Drug Shortages

Every drug the FDA currently lists as in short supply, and why.

  • Search by drug, company or package NDC
  • Filter by status, availability and dosage form
  • The reason behind each shortage, and the packaging it affects
Open Drug Shortages

National Drug Code Directory

Every drug product listed with the FDA under an NDC, and the packages it ships in.

  • Search by drug, labeler, NDC or application number
  • Filter by dosage form, route, marketing category, type and DEA schedule
  • A page per NDC, with its package listings and pharmacologic class
Open National Drug Code Directory

Product Labeling

Structured Product Labeling — the prescribing information and Drug Facts panels that ship with a marketed drug.

  • Search 262,000 product labels by title or labeler
  • Narrow to the labels that carry a particular section, such as a boxed warning
  • A page per SPL lineage, with every landed section
Open Product Labeling

Drugs@FDA Applications

Every drug application the FDA has acted on — NDAs, their generic equivalents and biologics licences.

  • Search by application number or sponsor company
  • Filter by type, status and submission class
  • A page per application, with its full submission and review-document history
Open Drugs@FDA Applications

Drug Enforcement

FDA drug recalls and enforcement reports.

  • Search by recall number, firm, or product description
  • Filter by classification, status, and product type
  • A page per enforcement report
Open Drug Enforcement

Drug Adverse Events

Post-market safety reports submitted to the FDA through FAERS.

  • Search and filter reports by drug, country, and seriousness
  • Review patient reactions and suspect products for each report
  • See the source report and reporting context
Open Drug Adverse Events

Clinical Trials

Complete study protocols, recruitment statuses, phases and outcomes from ClinicalTrials.gov.

  • Search studies by NCT ID, title or sponsor
  • Filter by trial phase, recruitment status, and sponsor company
  • Detailed protocols with primary/secondary outcomes and study locations
Open Clinical Trials

Companies Directory

Comprehensive intelligence on pharmaceutical, biotech, and medtech corporations.

  • Explore company profiles, market caps, and corporate headquarters
  • 360° record view aggregating approved drugs, biologics, and clinical trials
  • Drug shortages and recall enforcement reports linked to each company
Open Companies Directory

Cosmetic Adverse Events

Reports of reactions to cosmetic products, collected by the FDA under MoCRA.

  • Search by report number or implicated product name
  • Filter by report type and reported gender
  • A page per report, with its reactions, outcomes and products
Open Cosmetic Adverse Events