
Topic
Manufacturing Capacity
Drug substance, fill-finish, CDMO bottlenecks, inspections, tech transfer, and capacity as a commercial constraint.

Deals· August 4, 2026 · 13 min read
By Ran Chen#Manufacturing Capacity#GLP-1#Manufacturing

Manufacturing· August 1, 2026 · 20 min read
FDA Warning Letters by the Numbers (2026): CDER Drug Enforcement Surge

Manufacturing· July 26, 2026 · 17 min read
FDA Drug Shortages by the Numbers: 2026 National Registry Analysis

Generics· July 25, 2026 · 21 min read
FDA Green Book by the Numbers (2026): 2,882 Approved Animal Drugs, Zoetis Leads
By Ran Chen#FDA Approval#Generics#NADA

Manufacturing· July 18, 2026 · 20 min read
MAUDE drug-delivery adverse events: insulin pumps dominate 1.39M reports

Manufacturing· July 15, 2026 · 23 min read
Sterile-Injectable Shortage Ledger: Capacity, Not Another ANDA, Is the Opening

Pricing & Access· June 24, 2026 · 26 min read
Pfizer Portfolio Dossier: Patent Cliffs, Shortages, and Recalls
By Ran Chen#Orange Book#Purple Book#FDA Approval

Generics· June 21, 2026 · 5 min read
Generic Contrast Media: Amneal's Iohexol CGT Exclusivity and Shortage Triage
By Ran Chen#Generics#Orange Book#Manufacturing Capacity

Manufacturing· June 15, 2026 · 11 min read
ADHD stimulant shortage: 222 records, 75 not fully available, 3-year median age

Manufacturing· June 14, 2026 · 10 min read