Sertraline shortage — US supply status & alternatives

Sertraline

—

🇦🇺 AUST R 321602 · Mylan Health Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA🇧🇪 BE🇬🇷 GR🌐 MY🇳🇱 NL

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$2.50DPMQ A$19.84details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Sertraline
Therapeutic category	Auto-created by CBG-MEB (Netherlands) scraper
Controlled substance	No
Marketing-authorisation holders	Mylan Health Pty Ltd, Sandoz Pty Ltd, TEVA UK LIMITED, ROSEMONT PHARMACEUTICALS LIMITED +6 more
Registrations on file	17
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$2.50

AEMP

Dispensed (DPMQ)

A$19.84

incl. fees

Pack

sertraline 50 mg tablet, 30

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$3.56

Acquisition

🇬🇧 GB

£0.96

Drug Tariff

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

15 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

Viyash Life Sciences Private LTDDr Reddys Laboratories LTDMatrix Pharmacorp Private LTDApitoria Pharma Private LTDLupin LTDTorrent Pharmaceuticals LTD+9 more

Manufacturing countries: India · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🇺🇸

United States

FDA MedWatch · 1mo ago

High

🇧🇪

FAMHP · just now

Medium

🇨🇦

Canada

HC · 2h ago

Medium

🇳🇱

Netherlands

CBG-MEB · 3h ago

Medium

🌐

NPRA · 9d ago

Medium

🇬🇷

EOF · 9d ago

Medium

Verified timeline regulator events

🇨🇦 2 Oct 2026

medium reported

🇨🇦 30 Sept 2026

medium reported

🇨🇦 23 Sept 2026

medium reported

🇨🇦 19 Sept 2026

medium reported

🇨🇦 2 Sept 2026

medium reported

🇨🇦 1 Sept 2026

medium reported

Sources official regulators

🇧🇪

FAMHP

verified just now

verify ↗

🇨🇦

verified 2h ago

verify ↗

🇳🇱

CBG-MEB

verified 3h ago

verify ↗

🌐

NPRA

verified 9d ago

verify ↗

🇬🇷

EOF

verified 9d ago

verify ↗

🇺🇸

FDA MedWatch

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders17 registrations · 10 MA holders

Product	Strength	Form	Market	MA holder	Status
ZOLOFT sertraline	100 mg	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
Blooms The Chemist	100mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
Blooms The Chemist	50mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
SERTRALINE 50 MG FILM-COATED TABLETS	50 MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
SERTRALINE 100 MG FILM-COATED TABLETS	100 MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
SERTRALINE 20MG/ML CONCENTRATE FOR ORAL SOLUTION	20MG	solution	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
SERTRALINE 150 MG FILM-COATED TABLETS	150 MG	tablet	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
SERTRALINE 200 MG FILM-COATED TABLETS	200 MG	tablet	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
SERTRALINE 50MG TABLETS	50MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
SERTRALINE 100MG TABLETS	100MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
SERTRALINE 50MG FILM-COATED TABLETS	50MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
SERTRALINE 100MG FILM-COATED TABLETS	100MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
SERTRALINE 25MG FILM-COATED TABLETS	25MG	tablet	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
SERTRALINE 50MG FILM COATED TABLETS	50MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
SERTRALINE 100MG FILM COATED TABLETS	100MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active

+2 more registrations on file

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.