Gemcitabine Hydrochloride shortage — FR supply status & alternatives

Gemcitabine Hydrochloride

—

🇦🇺 AUST R 233935 · Sun Pharma ANZ Pty Ltd

In supply · Australia

Gemcitabine

In supply · 🇦🇺 Australia · short in🇫🇷 FR🇺🇸 US🇧🇪 BE🇬🇷 GR

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Gemcitabine Hydrochloride
Brand names	Gemcitabine
Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Sun Pharma ANZ Pty Ltd, Gland Pharma Limited, SANDOZ CANADA INCORPORATED
Registrations on file	13
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

16 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Low concentration risk

Arch Pharmalabs LTDDr Reddys Laboratories LTDScinopharm Taiwan LTDSun Pharmaceutical Industries LTDTapi Nl BVHetero Labs LTD+10 more

Manufacturing countries: India, Taiwan, China, Spain · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🇫🇷

France

ANSM · 8h ago

High

🇺🇸

United States

FDA · just now

Medium

🇬🇷

EOF · 1d ago

Medium

🇧🇪

FAMHP · 3mo ago

Medium

🇸🇬

Singapore

HSA-SG · 4mo ago

Resolved

Verified timeline regulator events

🇬🇷 29 Apr 2026

medium reported

🇫🇷 1 Apr 2026

high reported

🇫🇷 7 Jan 2026

high reported

🇺🇸 11 Sept 2025

medium reported

🇺🇸 11 Sept 2025

medium reported

🇧🇪 17 July 2025

medium reported

Sources official regulators

🇺🇸

FDA

verified just now

verify ↗

🇫🇷

ANSM

verified 8h ago

verify ↗

🇬🇷

EOF

verified 1d ago

verify ↗

🇧🇪

FAMHP

verified 3mo ago

verify ↗

🇸🇬

HSA-SG

verified 4mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders13 registrations · 3 MA holders

Product	Strength	Form	Market	MA holder	Status
Gemcitabine SUN gemcitabine hydrochloride	1300mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Gemcitabine SUN gemcitabine hydrochloride	1400mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Gemcitabine SUN gemcitabine hydrochloride	1500mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Gemcitabine SUN gemcitabine hydrochloride	1700mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Gemcitabine SUN gemcitabine hydrochloride	1800mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Gemcitabine SUN gemcitabine hydrochloride	1600mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Gemcitabine SUN gemcitabine hydrochloride	1900mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Gemcitabine SUN gemcitabine hydrochloride	2000mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Gemcitabine SUN gemcitabine hydrochloride	2200mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Gemcitabine SUN gemcitabine hydrochloride	1200mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
gemcitabine hydrochloride	200mg/5mL	injection	🇺🇸 US	Gland Pharma Limited	Active
gemcitabine hydrochloride	1g/25mL	injection	🇺🇸 US	Gland Pharma Limited	Active
Gemcitabine Hydrochloride For	—	solution	🇨🇦 CA	SANDOZ CANADA INCORPORATED	Active

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.