Sayana and Gonal-F shortage may last longer than expected

Torem, Norpin, Lipo-A, Soxinase and Omethyl QTlet also experiencing shortage

Unstable substance supply, QC schedule change and manufacturing transfer caused shortage

Shortages in various drug products are reportedly caused by manufacturing facility changes and unstable supply of pharmaceutical substances.

 

According to pharmaceutical distribution industry sources on Aug.

 

10, Pfizer Pharmaceutical Korea, Merck Korea, Dalim Biotech and other companies have recently informed of shortages in some products.

 

Pfizer Pharmaceutical Korea notified of halting supply of an injected female contraception Sayana (104 mg/ 0.65 mL) from coming October.

 

The subcutaneous injection is currently indicated for contraception or pain from endometriosis in female patients.

 

The global company explained the unstable production delay in the manufacturing facility would prolong the shortage.

 

The final batches of supply are to be expired on May 31, 2023.

 

Merck Korea’s self-injected fertility treatment Gonal-F Pen (300/ 450/ 900 IU) would also experience temporary shortage due to delay in supply.

 

Apparently, the QC schedule in Korea was postponed.

 

Merck Korea stated, “The supply would be ceased around Aug.

 

10,” but “It would resume around second or third week of September.

 

And more accurate schedule would be notified again in late August or early September.” The importation schedule for Menarini Korea’s diuretic Torem 2.5 mg tablet has been pushed, because the company is changing the overseas manufacturing facility.

 

The supply is expected to resume from Sept.

 

4.

 

Regardless, Torem 5 mg or 10 mg tablets would be supplied normally.

 

Dalim Biotech issued a notice on temporary shortage in Norpin 20 mL injection due to reevaluation on the transferred manufacturing facility.

 

Dalim Biotech official noted, “As the company moved its manufacturing factory, the health authority has also been changed from Gyeongin Regional Office of Food and Drug Safety to Seoul Regional Office of Food and Drug Safety.

 

And the health authority requested reevaluation on Norpin,” accordingly, “The product would likely to experience temporary shortage until the Ministry of Food and Drug Safety (MFDS) completes the evaluation.” The shortage is expected to last about a month, and the normalized supply would resume from late August to early September.

 

With the manufacturing factory transfer, Dalim Biotech is also having a temporary shortage in a diabetic nephropathy treatment Lipo-A tablet 30T.

 

However, Lipo-A tablet 500T is in supply.

 

Meanwhile, Ildong Pharmaceutical’s OTC digestive Soxinase Triple tablet 300T and Korea United Pharm’s hypertriglyceridemia treatment Omethyl QTlet 2 g soft capsule are also out of stock at the moment as the companies are dealing with problems in substance supply.

 

Currently, the two companies do not have specific dates for the resumption of the product supply.