LATEST 03 NOV 2026 · Nanjing Hanxin · WARNING LETTER · IA 66-40 02 NOV 2026 · USV, Daman · WARNING LETTER · STERILE LINE STOPPED FOR US

This week on the Red List

Source: FDA

FDA WARNING LETTER · 02 NOV 2026

USV, Daman, India

Sterile filling line pulled from the US market. Octreotide injection (Avet) and oral generics come from the same site.

14octreotide API makers, 12 with US DMF

25injection makers

Listed in the API-FDF database today. Names and contacts are one click away.

Supply disruption tracker

The Red List

DATE	SITE	STATUS	WHAT STOPS	WHO'S IN
03 NOV 2026	Nanjing Hanxin, China	WARNING LETTERIA 66-40	APIs for sterile products and compounding	Tirzepatide23 API (15 US DMF)
29 OCT 2026	Chongqing Qiancan, China	WARNING LETTERIA 66-79	APIs shipped for US compounding	Products not named by FDA
29 OCT 2026	Tianjin Healthcare Medical, China	WARNING LETTERIA 66-79	APIs shipped for US pharmacy compounding	Products not named by FDA
16 OCT 2026	Glukem Biocare, India	EU NCR	Drug pellets (intermediates) for EU medicines	Products not named in the NCR
29 SEP 2026	Baxter, Round Lake, USA	WARNING LETTERRECALL	Premixed IV bags (Galaxy) from a shared beta-lactam building	Vancomycin17 API (12 US DMF) · 38 FDF
28 SEP 2026	OCB Pharmaceutical, Spain	EU NCRCEP SUSPENDED	All APIs from the site: nine bismuth salts	Bismuth subsalicylate7 API (0 CEP)

Analysis

Where the money moved

Case Files · 13 NOV 2026

Sandoz Settles for $469M. Teva Faces a Price-Fixing Trial in February

Read the analysis

Signals · 12 NOV

Cytarabine Shortage: A ₹330 Crore Pfizer JV Plant Is Out Until 2028

Opinion · 06 NOV

Palbociclib Drops 93% to ₹2,720. Roche’s ₹123,506 Vial Doesn’t Budge

Case Files · 03 NOV

Baxter Warning Letter Ends a $50M Cephalosporin Line With 60% Margins

Regulatory deadlines

The clock is running

30 NOV IN 16 DAYS

Medicare negotiated prices for 15 more drugs, effective 2028 Brand owners of the 2028 list, first cycle with Part B drugs

18 DEC IN 34 DAYS

BIOSECURE Act: first list of biotech companies of concern Buyers of Chinese CDMO and API services, WuXi first in line

01 JAN IN 48 DAYS

Medicare negotiated prices for 15 drugs take effect Brand owners of the 15 drugs on the 2027 list

FEB

Teva price-fixing trial Sandoz already settled for $469M

01 FEB IN 79 DAYS

Medicare picks up to 20 drugs for 2029 price cuts Brands on the list; generic and biosimilar filers on the same molecules

They're out.
Someone else makes it.

Find the replacement on API-FDF

From the files

Market WatchSugammadex Generics Wipe $353M Off Merck’s Bridion in One Quarter OpinionThe $245 Discount: Medicare Pays Up to 17× India’s Price for the Same Weight-Loss Molecule – and Calls It a Bargain RegulatoryThe Annex III Club: Why September 29 Is the Real Deadline in Pharma’s Tariff War Market WatchAntibiotic OPEC: The Shadow Cartels Monetizing the Ruins of the Strait of Hormuz Market WatchThe 21% Correction: Why Public Markets Are No Longer Buying Biotech Platforms Without Clinical Anchors Market WatchStop Searching, Start Connecting: Your Global API & FDF Hub