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Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
Seoul-based biotech company Mezzion Pharma has filed a suit against Dr Reddy’s Laboratories in a US court.
It has alleged the Hyderabad-based supplier had committed fraud by hiding significant deficiencies in the Current Good Manufacturing Practice, or CGMP, regulations enforced by the US health regulator.
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”.
It alleges the misconduct was “the sole reason given by the US Food and Drug Administration to deny approval” of Mezzion’s new drug application for an erectile dysfunction drug, Udenafil.
The FDA’s refusal to grant marketing approval of Mezzion’s finished drug product Udenafil has incurred delay and expenses.
The South Korean company was forced to seek new manufacturers and suppliers for Udenafil, and it is currently taking the necessary steps required to re-submit its NDA to the FDA for approval.
When asked about the suit, a DRL spokesperson said it had got no communication from Mezzion or the court in question.
“We will be able to comment when there is official intimation. We don’t want to comment on the basis of media reports,” the spokesperson clarified.
In November 2015, the FDA had issued a warning letter to DRL after an inspection at its active pharmaceutical ingredients facilities at Miryalaguda (Telangana) and Srikakulam (Andhra Pradesh), and its oncology formulation facility at Visakhapatnam (Andhra Pradesh).
The US regulator had identified numerous deviations and violations in FDA compliance.
It said it had also uncovered a previously unknown and uncontrolled custom quality control laboratory, which engaged in a “practice of substituting repeat tests after failing results”.
DRL, second largest drug manufacturer in India, is expecting the FDA to re-audit the three units during the current quarter.
Image: Anji Reddy, chairman, Dr Reddy's. Photograph: Courtesy, Dr Reddy's.
