Dr Reddy’s To Defend Itself Against Fraud Allegations Made By Korean Firm Mezzion

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. South Korean company Mezzion Pharma has filed a suit against Dr Reddy’s in a New Jersey state court (U.S.), seeking millions of dollars in damages, it said in a media statement.

Mezzion Pharma has alleged that Dr Reddy's fraudulently hid its manufacturing compliance issues from the company, as result of which the U.S. drug regulator rejected the South Korean company’s new drug application for its erectile dysfunction treatment, udenafil.

In an emailed response to BloombergQuint, Dr Reddy’s said it has not been served with any legal papers by Mezzion Pharma so far.

The November 2015 warning letters to three Dr Reddy’s facilities forced Mezzion Pharma to to shift its API (Active Pharmaceutical Ingredients) source, hence delaying its opportunity in udenafil, the South Korean pharmaceutical said.

It was also forced it to seek new suppliers for udenafil, leading to further delay and added expense, the company added.

Mezzion Pharma is preparing to resubmit its udenafil new drug application (NDA) to the U.S. Food And Drug Administration (U.S. FDA) for approval, said Bloomberg, citing the company’s January 24 media statement.

This adds to Dr Reddy’s woes which is already reeling under pressure due to regulatory action on three of its facilities in India and intense pricing pressure for its key products in the U.S. 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.