31 January 2017 | News | By BioSpectrum Bureau
South Korea's Mezzion Pharma files lawsuit against India's Dr Reddy's laboratories
Mezzion said it is seeking "millions of dollars in damages for fraud, fraudulent concealment and other counts"
Singapore: South Korean pharmaceutical firm Mezzion Pharma has filed a suit against India's 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.
This recent law suit has further added pressure on the company which is already reeling under the pressure of warning letters from the FDA. Dr Reddy's received a warning letter from the U.S. FDA in November 2015 at three of its facilities for violations of the the regulator's current good manufacturing practice (cGMP) standards.
Dr Reddy's Laboratories Ltd. will defend itself against Mezzion Pharma Co Ltd.'s claims against the company, the pharmaceutical major told BloombergQuint in emailed response. The company said that sait 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.
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.