Pancreatin shortage — PT supply status & alternatives

Pancreatin

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In supply · Australia

KreonKreon Os

In supply · 🇦🇺 Australia · short in🇵🇹 PT

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)	Pancreatin
Brand names	Kreon, Kreon Os
Therapeutic category	Auto-created by INFARMED — Gestão da Disponibilidade do Medicamento scraper
Controlled substance	No

Marketing-authorisation holders	VIATRIS PRODUCTS LIMITED, JAMIESON LABORATORIES LTD, GAHLER ENTERPRISES LTD., METAGENICS, INC. +3 more

Registrations on file	7

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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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

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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

1 API manufacturer

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.

Very high concentration risk

Laboratorio Opoterapico Argentino SA

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders7 registrations · 7 MA holders

Product	Strength	Form	Market	MA holder	Status
Creon Micro Pancreatin	60.12 MG	creon	🇬🇧 GB	VIATRIS PRODUCTS LIMITED	Active
Pancreatin Tab	400MG	tablet	🇨🇦 CA	JAMIESON LABORATORIES LTD	Active
Pancreatine Enzymes	—	tablet	🇨🇦 CA	GAHLER ENTERPRISES LTD.	Active
Gtf-Vitamin-Minerals & Pancreatin Tab	—	tablet	🇨🇦 CA	METAGENICS, INC.	Active
Pancreatin And Enzyme Formula -	—	tablet	🇨🇦 CA	HEALTH-WISE NUTRITION INC.	Cancelled
Pancreatinum	—	globules	🇨🇦 CA	SEROYAL INTERNATIONAL INC.	Cancelled
Mega-Zyme Pancreatin Tablets With Proteolytic Enzymes	—	tablet	🇨🇦 CA	ENZYMATIC THERAPY (CANADA) INC.	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.