MFDS reviews sales ban on Binex-manufactured generics

Pharmaceutical companies manufactured bulk generics through Binex Busan plant could be penalized due to Pharmaceutical Affairs Act violation

4 out of 6 Binex items manufactured through consignment deal including Amorin, Xelectin and Rofsin

The impact of the allegation on Binex manipulating the manufacturing method and active ingredient dosage in six drugs including antidiabetics and antidepressants is snowballing within the pharmaceutical industry.

 

Source confirmed South Korea’s Ministry of Food and Drug Safety (MFDS) has started reviewing administrative measure to be ordered on generics produced by Binex Busan Plant 1 as a contract manufacturing organization (CMO), which was found to have violated the Pharmaceutical Affairs Act.

 

The ministry has already ordered manufacturing and sales ban on the six products the company decided to voluntarily recall.

 

On Mar.

 

9, MFDS official explained “The ministry is reviewing the necessity and validity of ordering manufacturing and sales ban or recall on bulk generics manufactured in the same manufacturing plant as six items Binex voluntarily reported of illegal change in manufacturing method.

 

The decision in administrative measure would be officially announced promptly.” The health authority’s action would much complicate the impact the Binex incident has brought onto the South Korean pharmaceutical industry.

 

Four out of six Binex items the ministry imposed the administrative measure were generics manufactured as CMO.

 

CMO generics are drugs by a pharmaceutical company with marketing authorization and another manufacturer with production facility entrusted to manufacture the product.

 

For instance, a pharmaceutical company wins a MFDS marketing authorization on a certain generic, and signs a consignment deal with another pharmaceutical company capable of drug production to manufacture the authorized generic.

 

Basically, the products are made by the CMO, as entrusted by the authorized company, and because the generics made by the both companies are exactly the same, they are labeled as “bulk generics” or “twin drugs.” MFDS is now considering on imposing same level of administrative order as the six items on those bulk generics manufactured at Binex Busan Plant 1 under the consignment deal.

 

On Mar.

 

7, the ministry imposed administrative measure on six Binex items including antidiabetic Amorin tablet (glimepiride), antidepressant Xelectin capsule and Xelectin 10 mg capsule (fluoxetine hydrochloride), antiarthritic Daxfen tablet (dexibuprofen), anti-inflammatory Rofsin 250 mg tablet (ciprofloxacin hydrochloride) and antihypertension Cadil 1 mg tablet (doxazosin mesylate).

 

And four items—Amorin tablet, Xelectin capsule, Xelectin 10 mg capsule and Rofsin 250 mg tablet—are manufactured by Binex under consignment deals.

 

Three pharmaceutical companies, 13 companies, 15 companies and seven companies have entrusted Binex to manufacture Amorin tablet, Xelectin capsule, Xelectin 10 mg capsule and Rofsin 250 mg tablet, respectively.

 

These are twin drugs manufactured in the same production line at the Binex Busan Plant 1, where generics that accused of fabricating manufacturing method and ingredient dosage and received administrative order were manufactured.

 

As the health authority is considering on ordering sales ban and recall on the bulk generics, the pharmaceutical companies with the products would take a massive hit on their business.

 

MFDS official said, “A related department is currently reviewing the administrative measures on the bulk generics manufactured at Binex Busan Plant 1.

 

The decision has not been made, yet.

 

The on-site inspection at the Busan plant started from Mar.

 

8.

 

And when the issue is confirmed, the department would make the final decision.”