While a raft of India's largest drugmakers have had their shipments to the U.S. banned by the FDA over quality concerns, Ipca Laboratories has decided to do that on its own.
The drugmaker reported to the Bombay stock exchange that it was halting shipments of active pharmaceutical ingredients (APIs) from a plant in Ratlam after it scored a Form 483 following an inspection by the FDA. It said it "had voluntarily decided to temporarily suspended API shipments from this manufacturing facility for the US markets till this issue is addressed." The step has broader consequences because it uses APIs from the plant to make finished drugs at plants in Silvassa and Indore.
According to Reuters, Ipca exports to the U.S., Canada, Europe and Australia, but didn't indicate it was interrupting API or drug shipments to any other markets. The company did not delineate what kinds of problems inspectors noted in the report. but said it was fully committed to resolving the issues as quckly as possible.
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The drugmaker reported to the Bombay stock exchange that it was halting shipments of active pharmaceutical ingredients (APIs) from a plant in Ratlam after it scored a Form 483 following an inspection by the FDA. It said it "had voluntarily decided to temporarily suspended API shipments from this manufacturing facility for the US markets till this issue is addressed." The step has broader consequences because it uses APIs from the plant to make finished drugs at plants in Silvassa and Indore.
According to Reuters, Ipca exports to the U.S., Canada, Europe and Australia, but didn't indicate it was interrupting API or drug shipments to any other markets. The company did not delineate what kinds of problems inspectors noted in the report. but said it was fully committed to resolving the issues as quckly as possible.
continue to read here
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