FDA Warns China and India API Makers of Import Refusal
The Food and Drug Administration threatened Chinese and India drug makers with import refusal in two recent warning letters. In a letter dated June 10 (here), FDA told Tianjin Zhongan Pharmaceutical of China that it needs to correct violations of…
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current good manufacturing practice (CGMP) requirements or else face an import alert on its active pharmaceutical ingredients (APIs). In a separate letter dated June 16 (here), FDA told Apotex Pharmachem India that it will continue to refuse imports of APIs from the company, also for violations of CGMP requirements.