MUMBAI: Mezzion, a South Korean drug company has filed suit on Dr Reddy’s Laboratory in New Jersey court. Mezzoin has alleged that Dr Reddy’s had committed fraud by hiding significant deficiencies in the Current Good Manufacturing Practice, or CGMP, regulations enforced by the US health regulator.
Mezzion in the filed suit stated that Dr Reddy’s has repeatedly represented itself as complaint with FDA rules and regulations, hiding its misconduct.
The company also alleged that 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, for the treatment of erectile dysfunction (ED) and for FDA’s refusal to grant marketing approval of Mezzion’s udenafil finished drug product.
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 as the company stated in a press release, “Mezzion has incurred delay and expense and was forced to seek new manufacturers and suppliers for udenafil and the udenafil finished product, and Mezzion is currently taking the necessary steps required to resubmit its udenafil NDA to the FDA for approval”, reports ET
Earlier 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).
While speaking with BS, a spokesperson said, “We will be able to comment when there is official intimation. We don’t want to comment on the basis of media reports.”
Dr. Reddy’s Laboratories is an Indian multinational pharmaceutical company based in Hyderabad, Telangana, India. Dr. Reddy’s manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.
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