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  • Will the Indian API cause problems?
  • by Kim, Jin-Gu | translator Hong, Ji Yeon | Oct 29, 2025 06:12am
Concerns over the impact of impurity detection in tramadol combi
NNDT impurity detected in several generic products using API sourced from India
85% of DMF from India¡¦If impurity detection expands, market restructuring is inevitable
Q3 tramadol¡¤AAP prescription sales amounted to KRW 114.9B¡¦Top-selling products likely to see benefit
An impurity issue has emerged as a major variable in the tramadol-acetaminophen combination drug market, valued at approximately KRW 150 billion annually.

Following the detection of impurities in three generic products using Indian-sourced active pharmaceutical ingredients (API), the pharmaceutical industry is watching closely for the potential expansion of the impurity issue across all API from India. In this case, the market is expected to be reorganized around products that use non-Indian sourced API.

85% of tramadol DMFs are produced in India...Concerns Over Widespread Impurity Detection

According to the Ministry of Food and Drug Safety (MFDS) on October 29, following the excess detection of the impuri
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