Celltrion Pharm gets 3-month suspension for failing to supervise aspirin manufacturing partner

The Ministry of Food and Drug Safety announced a three-month manufacturing suspension for Celltrion Pharm's Astection Enteric Coated Tablets 100mg (aspirin), effective from Feb. 27 to May 26, due to violations of the Pharmaceutical Affairs Act.

The medication is used for preventing thrombosis in conditions such as myocardial infarction, cerebral infarction, unstable angina, and in patients undergoing coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA).

It is also prescribed for reducing cardiovascular risk in high-risk patients with conditions like hypertension and diabetes.

The penalty comes after an investigation revealed lapses in the manufacturing process of Astection from Theragen Etex, the contract manufacturing organization to Celltrion Pharm, which had outsourced the production.

The oversight concerns centered around Theragen Etex's handling of materials, specifically the failure to verify and document the quantity of labels released for use in the product's packaging properly.

More specifically, Theragen Etex neglected to match the physical quantity of labels with what was documented in the packaging instructions and failed to sign off on this process, the MFDS said.