Cinacalcet impurities spread…Huons recalls product

Following Kyowa Kirin’s product recall

Proactive measures were taken following detection of excess N-nitroso cinacalcet

Huons “Reviewing various measures such as impurity removal and reduction”

The detection of excess 'N-nitroso cinacalcet' impurity has led to the recall of the kidney drug cinacalcet hydrochloride.

 

The Ministry of Food and Drug Safety announced on the 17th that Huons’ Calcepara Tab 25 mg (cinacalcet hydrochloride) with 3 manufacturing numbers TTB201 (2025-08-16), TTB301 (2026-05-18), and TTB302 (2026-05-21) will be recalled by the manufacturer.

 

The cinacalcet hydrochloride-based formulations are used for the treatment of secondary hyperparathyroidism in patients with chronic kidney failure undergoing dialysis, and the original drug product, Regpara Tab (cinacalcet hydrochloride), was first recalled on November 20th.

 

List of approved cinacalcet drugs

In early October, an Indian drug manufacturer decided to recall the drug due to the detection of nitrosamine impurities in the cinacalcet ingredient, raising the possibility of a recall in Korea.

 

In early November, the U.S.

 

Food and Drug Administration (FDA) announced a voluntary recall on its website after nitrosamines were found to exceed the FDA's recommended daily allowable intake limit.

 

In Korea, Kyowa Kirin Korea recalled some lot numbers of two products, Regpara Tab 25mg and 75mg, due to excessive impurities detected in stability tests.

 

The source of the N-nitroso cinacalcet is believed to be the reaction between the raw materials and excipients.

 

Regpara Tab was launched in Korea in 2011 and became popular as soon as it was launched because it induces a decrease in parathyroid hormone (PTH) while reducing serum phosphorus (P), serum calcium (Ca), and Calcium-phosphorus product (CaxP) levels and it is easy to take once a day without the side effects caused by vitamin D preparations.

 

In particular, generics have been entering the market at a rapid pace since the patent expired in 2017, and there are currently 11 generics approved for cinacalcet in Korea.

 

According to the import and manufacturing performance of drugs disclosed by the Ministry of Food and Drug Safety, 2 doses of the original, Regpara, posted sales of KRW 5.8 billion at the current exchange rate.

 

Alvogen Korea's ‘Cinacet Tab,’ Daewon Pharmaceutical's Repatzin Tab,’ and Yuyu Pharmaceutical's ‘Beneph Tab’ have posted figures of more than KRW 1 billion, while Calcepara Tab, which has been recalled, has posted nearly KWR 143.1 million.

 

An MFDS official said, “Since impurities were detected in ingredients, excipients, and other components, we asked generic drug manufacturers to test whether excess N-nitroso cinacalcet were detected.

 

We plan to consider necessary measures based on the results.” In response to the manufacturer's request for temporary ease of the tolerance standard and the opinions of medical expert organizations on its medical necessity, the MFDS will reportedly take measures such as temporarily raising the impurity threshold.

 

However, manufacturers will be required to notify the agency within a month and implement a countermeasure plan for reducing impurities within 3 years.

 

Meanwhile, Huons is conducting research to ensure that products exceeding the impurity standard are not distributed.

 

It is considering various measures such as shortening the use period and removing or reducing impurities.

 

“We are conducting various studies to reduce the risk of impurities, such as reduction measures,” said a Huons representative, ”and we will complete the research and development faster than the specified period so as not to disrupt the supply for patients.”