South Korea’s Mezzion Pharma files suit against Dr Reddy’s in US
Mezzion alleges that Dr Reddy’s hid ‘significant deficiencies’ and misrepresented compliance with the US FDA cGMP practices regarding the udenafil drug
New Delhi: South Korean firm Mezzion Pharma Co. Ltd has filed a suit against Dr Reddy’s Laboratories Ltd in the US alleging that the Indian company hid “significant deficiencies” and misrepresented compliance with the US Food and Drug Administration (FDA) cGMP practices.
Hyderabad-based Dr Reddy’s has, however, said it is yet to receive any “legal papers”.
Mezzion said it is seeking “millions of dollars in damages for fraud, fraudulent concealment and other counts”.
“Mezzion has filed a suit for damages against Dr Reddy’s in New Jersey State Court alleging that Dr Reddy’s committed fraud relating to Dr Reddy’s hiding significant deficiencies in its Food and Drug Administration (FDA) cGMP practices, and misrepresenting its compliance to Mezzion,” the South Korean firm said in a statement.
Mezzion, which used to be a customer of Dr Reddy’s, said it “has incurred delay and expense and was forced to seek new manufacturers and suppliers for udenafil and the udenafil finished product”. The company is currently taking the necessary steps required to resubmit its udenafil NDA to the FDA for approval, Mezzion added.
In a BSE filing, Dr Reddy’s said: “As of now the company has not been served with any legal papers or legal process in the matter refereed to in Mezzion’s press release.”
The suit also states that Dr Reddy’s misconduct was the sole reason given by the FDA to deny approval to Mezzion’s new drug application (NDA) for 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 this suit filed with the New Jersey State Court, Mezzion seeks to recover from Dr Reddy’s millions of dollars in damages for fraud, fraudulent concealment and other counts,” Mezzion said. In 2015, Dr Reddy’s had received a warning letter from the US Food and Drug Administration (USFDA) for two of its active pharma ingredients (API) manufacturing plants and a formulation facility located in Andhra Pradesh and Telangana.