Taiwan’s FDA responds to nitrosamine impurities in Ritalin 10mg by halting imports, increasing domestic production, and tightening quality controls, as shortages ripple through the medication market until 2027.
Taiwan’s Food and Drug Administration says supply of the attention deficit hyperactivity disorder medicine Ritalin 10mg remains controlled after the manufacturer found nitrosamine impurities above the acceptable daily intake in some batches.
According to the Liberty Times report, the company has halted imports while it works to fix the problem, and the regulator said the drug should return to normal supply in February 2027. Until then, the agency said it will not release imported stock until each batch has been checked by the National Laboratories and cleared for use.
The FDA has also moved to shore up the market by asking generic manufacturers to increase imports and approving a domestic drugmaker to produce the medicine under a special arrangement. Officials said that step is meant to cover the shortage caused by the quality problem in the original product.
Lin Yi-zhu, head of the FDA’s drug division, said the health insurer has assigned a special code and set a favourable reimbursement price for the substitute product, so clinics and pharmacies should not face payment cuts for using it. That was aimed at calming fears that higher-priced alternatives might leave providers reluctant to dispense them.
Separately, the FDA said it has opened emergency calls for special imports of ifosfamide, melphalan and desferrioxamine injections because of shortages. The agency said those medicines are clinically necessary even though Taiwan’s annual demand is relatively small, so there is no commercial market large enough to support steady local supply.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
