Will the acetaminophen shortage crisis end?

Corepharm Bio’s ‘Coacet Tab 500mg’ gains marketing authorization…uses MFC-developed API

MFDS supports product development under Essential Medicines Supply Stabilization Program

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The shortage of acetaminophen (AAP)-based fever reducers and pain relievers during COVID-19 highlighted the necessity and urgency of domestic pharmaceutical production, or pharmaceutical localization.

Following this crisis, the Ministry of Food and Drug Safety (MFDS) conducted a research project for the stable supply of essential medicines, achieving the complete domestic production of acetaminophen from active pharmaceutical ingredient (API) to finished dosage form.

On the 10th, the MFDS approved Corepharm Bio’s ‘Coacet Tab 500mg’ (OTC).

This product is an acetaminophen tablet and represents the first approved finished drug using a domestically developed API, which was manufactured by MFC.

The Ministry of Food and Drug Safety designated acetaminophen (tablets and syrup) as a national essential drug in November 2023 and included the ingredient in its ‘National Essential Medicines Supply Stabilization Research Program’ to support the development of its manufacturing process control technologies for domestic production.

The National Essential Medicines Supply Stabilization Research Program is a KRW 5 billion initiative to develop 10 domestically manufactured essential medicines.

For the acetaminophen domestic production project, MFC was selected for the API manufacturing, and Corepharm Bio’s for the finished product.

MFC completed development of the acetaminophen API last year and finalized its DMF (Drug Master File) registration. Corepharm Bio subsequently secured regulatory approval for the finished product using this API. Previously, APIs for acetaminophen tablets were entirely dependent on overseas sources.

Analysis indicates that domestically produced acetaminophen APIs are more expensive per unit than imported alternatives, which historically made the commercialization of finished products challenging. Nevertheless, Corepharm Bio has completed receiving approval for its finished product and is in preparation for domestic market launch.

Industry observers anticipate that finished products using domestic API will require sufficient drug pricing support to ensure a stable supply. Consequently, high pricing for this product is expected to be key to ensuring a stable supply.

The Ministry of Health and Welfare decided last year to apply a 68% price premium to national essential medicines manufactured using domestically produced APIs. An industry official stated, “It's difficult to say that the development of domestic APIs will completely resolve supply instability. Continued pricing support and policy incentives are necessary to ensure companies can maintain stable production and supply.”