Janssen prepares to close Hyangnam plant, renewing licenses

Drops manufacturing license in Korea, inevitable break in supply

Janssen Korea is to close Hyangnam plant in 2021 and the company is speeding up the process of transferring items manufactured in Hyangnam to other facilities.

 

Apparently some of them would be transferred to other Korean manufacturing companies, whereas some would be manufactured abroad and imported to Korea.

 

As of Jan.

 

28, Korea’s Ministry of Food and Drugs Safety (MFDS) cleared Janssen Korea’s antipsychotic medicine, Invega (paliperidone) ER tablet in 3 mg, 6 mg, and 9 mg doses.

 

These items are the same items approved back in April 2010.

 

But the newly approved items would be imported to Korea, unlike the previously approved ones manufactured in Hyangnam plant.

 

Janssen Korea has preemptively notified the change to drug distribution channels in Korea and forewarned the drug supply would be suspended until coming May.

 

With the new license in Korea as an imported drug, Invega is expected to be listed for reimbursement from April.

 

UBIST reported Invega has generated 2.3 billion won in Korea for outpatient prescription last year.

 

The drug manufacturing plant is reportedly moving to Italy from Hyangnam, Korea.

 

And the global company would obtain more new drug import licenses, as Janssen has notified Jurnista SR tablet and Topamax springkle capsule would also be manufactured abroad and imported back to Korea.

 

The existing license on Invega has been returned as of passed Jan.

 

17.

 

Janssen Korea canceling the license and leaving void period in between licenses are inevitable at the moment.

 

Regardless, Invega Sustenna injection would be supplied without a break.

 

Invega Sustenna, unlike the tablet form, was approved as an imported drug in July 2010.

 

Janssen has already registered the injection’s DMF with Irish and Belgian plants as manufacturer of active ingredient paliperidone.

 

Some items are transferring to other Korean manufacturers.

 

Pain reliever Ultracet is transferred to Handok, and gastro-oesophageal reflux disease treatment Pariet is running bioequivalence test for approval to be transferred to Kolmar Korea.

 

And Tyrenol 8-hour ER tablet is highly likely to be transferred to Handok.

 

Janssen’s Hyangnam plant, built in 1983, would stop its production life of 38 years after a year.

 

As it was the center of global drug manufacturing plant in Korea, the Korean pharmaceutical industry is left with bittersweet sentiment of the plant.