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Why The US FDA Requested Ranitidine Withdrawal; How Other Withdrawals Could Follow

Executive Summary

Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.

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Why The US FDA Did Not Appreciate Valisure’s Extra Measure Of Protection From Poor Quality Drugs

Unusual citations for DSCSA violations in a recent inspection report and untitled letter from the FDA provide insight into the agency's concerns about the pharmacy that second-guesses the regulatory system it oversees by testing drugs before dispensing them.

FDA’s Scandal In Waiting?

Headlines about potential carcinogens in the drug supply have been a chronic, low-level challenge for the US FDA’s reputation in recent years. A recent Congressional hearing shows how much tinder is now laid for a potential flare up into a full-on crisis in confidence in the agency.

Indian Firms Take Different Paths On Ranitidine

A double blow to ranitidine medicines  suspension in the EU and a withdrawal request in the US  has caused Indian API and formulation manufacturers to recalibrate their strategies. Amid uncertainty over future prospects for the gastrointestinal drug, Strides is considering a relaunch in the US while Solara is reassigning part of its capacity to manufacture other APIs.

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