The drug regulator ordered Samsung Pharm to suspend manufacturing of hypertension drug Amonepin Tab. (ingredient: amlodipine maleate), saying the drugmaker violated the Good Manufacturing Practices (GMP).

On Friday, the Ministry of Food and Drug Safety said Samsung Pharm received a four-month suspension on the production of Amonepin Tab. from May 25 to Sept. 24.

According to the ministry, Samsung Pharm changed the raw materials and the quantity of the hypertension treatment and manufactured and released different medicines without reporting the changes to the ministry. The company also wrote a false manufacturing report of the product and failed to comply with the company’s regulations on item change management when manufacturing the product.

Amonepin Tab., a calcium channel blocker (DDB), is a prescription drug for hypertension. It is indicated for high blood pressure, fixed occlusion of the coronary artery (stable angina), or myocardial ischemia caused by vasospasm of the coronary system (dysmorphic angina).

Three months ago, Samsung Pharm received the government’s penalty because of irregularities in manufacturing quality control.

On Feb. 28, the MFDS ordered the company to recall and discard Amonepin with a particular manufacturing number because related substances exceeded the permissible level. In March, the Ministry of Health and Welfare discontinued reimbursement for Amonepin.

Separately from the Amonepin case, Samsung Pharm was suspended from manufacturing all products for three months last year due to GMP violations.

With repeated regulatory penalties on Samsung Pharm, attention is on whether the drug company would reform the manufacturing process and restore trust.

According to the company's public filing on Monday, Samsung Pharm reported 12.5 billion won ($9.8 million) sales, 400 million won operating loss, and a 1.5 billion won net loss in the first quarter.