Manufacturing· September 18, 2026 · 31 min read
A Supplier COA Is Not Component Identity Testing
By Ran Chen#API Manufacturing#CDMO#CMC
Topic
Supply Chain
Pharmaceutical supply chain risk, API sourcing, CDMO oversight, serialization, and global manufacturing logistics.
Manufacturing· September 8, 2026 · 23 min read
Starter-PN Compounding Discretion Is Not an Approved Drug or 503B CGMP Waiver
Manufacturing· September 7, 2026 · 28 min read
PreCheck's Type V Facility DMF Is Not a PAI, and a CDMO Seat Does Not Transfer CGMP
By Ran Chen#Manufacturing Capacity#Manufacturing#CMC
Manufacturing· September 6, 2026 · 30 min read
Annex 1 CCS Is Not FDA's 2026 Packaging CCS, and Neither Replaces 2004 Aseptic Guidance
By Ran Chen#Manufacturing Capacity#Manufacturing#CMC
Generics· August 21, 2026 · 17 min read
The Estradiol Patch Shortage: Reading FDA's Database Against ASHP Bulletins
By Ran Chen#Supply Chain#Generics#Orange Book
Policy· August 7, 2026 · 14 min read
EUDAMED mandatory 2026: EU device database scale, actors, and MDR deadlines
By Ran Chen#Policy#Regulatory#Supply Chain
Manufacturing· August 5, 2026 · 21 min read
2026 oncology injectable shortage: ifosfamide, carboplatin & buy-and-bill
By Ran Chen#Supply Chain#Oncology#Manufacturing
Policy· July 28, 2026 · 22 min read
Trump's Generic Drug Tariff: The 2028–2029 Onshoring Timeline and US Import Exposure
By Ran Chen#Generic Drugs#Tariffs#Manufacturing
Manufacturing· July 26, 2026 · 17 min read
FDA Drug Shortages by the Numbers: 2026 National Registry Analysis
Manufacturing· July 23, 2026 · 20 min read