Korean drugmaker Mezzion has filed a suit against Dr Reddy’s Laboratories (DRL) in a US court alleging that the Indian pharmaceutical company hid significant deficiencies and misrepresented compliance in its manufacturing practices.
Mezzion, which had a contract with Dr. Reddy’s to manufacture Udenafil on its behalf, is developing a treatment for erectile dysfunction.
In a statement, the company said that Dr Reddy’s repeatedly represented to Mezzion that it was compliant with FDA regulations and that it hid its misconduct from Mezzion.
The lawsuit alleges the misconduct was “the sole reason given by the US Food and Drug Administration (FDA) to deny approval” of Mezzion’s new drug application (NDA) for an erectile dysfunction drug, Udenafil.
In the suit, filed in the state of New Jersey, Mezzion seeks to “recover millions of dollars from DRL in damages for fraudulent concealment and misrepresenting its compliance”.
The FDA issued a Warning Letter to Dr Reddy's which stated that, during an FDA inspection at the Dr Reddy's facilities in India, the FDA identified numerous deviations and violations in FDA compliance.
The FDA also uncovered a previously unknown and uncontrolled "Custom QC laboratory," which engaged in a "practice of substituting repeat tests after failing results."
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