SEOUL, Korea, Jan. 24, 2017 /PRNewswire/ -- 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 suit notes that Dr. Reddy's repeatedly represented to Mezzion that it was compliant with FDA regulations, and that it hid its misconduct from Mezzion. The suit also states that Dr. Reddy's misconduct was the sole reason given by the FDA to deny approval of 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. As a result, 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.
The FDA issued a Warning Letter to Dr. Reddy's which states that, during an FDA inspection at the Dr. Reddy's facilities in India, the FDA identified numerous deviations and violations in FDA compliance, and also uncovered a previously unknown and uncontrolled "Custom QC laboratory" (CQC), which engaged in a "practice of substituting repeat tests after failing results."
As a result, the FDA, in the Warning Letter, advised Dr Reddy's that:
"At Dr. Reddy's Laboratories Limited CTO Units VI and V facilities, we identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs). At Dr. Reddy's Laboratories Limited Unit-VII facility, we found significant violations of CGMP regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.
These deviations and violations cause your APIs and finished drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 351(a)(2)(B). The methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP."
The complete Warning Letter is available on the FDA's website.
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 Pharma Co. Ltd.
Mezzion Pharma is a publicly-listed biotech company in Korea focusing on the development of new drugs.
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of the Company.
Mr. Won Geun KIM
Tel: +82 2 560 8008
Email: [email protected]
SOURCE Mezzion Pharma Co. Ltd.