🙋‍♂️ Citizen Petition to FDA on Sitagliptin

It’s a different topic from those we have been discussing so far. I am surprised that nitrosamines should be dealt with by not only science but also business.

I added the MHLW reports of the NTTP contamination issue.

0.37ppm is consistent with 37ng/day. According to the report, root cause investigation and corrective action assessment have been completed. The company seems to have changed the manufacturing process to decrease amounts of NTTP by less than 0.37 ppm.

I understand why the detailed root causes of nitrosamine contamination have not been disclosed in case studies.

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