Warning Letter Against Lantech For Violating FDA Rules

Warning Letter Against Lantech For Violating FDA Rules

Introduction

On August 8, 2019, The Food and Drug Administration of U.S. issued a warning letter to Hyderabad-based Lantech Pharmaceuticals Limited after finding that the company failed to investigate complaints related to the blood pressure medicine Valsartan.

In December 2018, Lantech Pharmaceuticals was notified by their customer firm that the solvent recovered by the company contained the potential mutagenic impurities, N-Nitrosodiethylamine (NDEA) which resulted in cancer. A year after, concerns related to cancer-causing impurities found in samples of Valsartan were raised in the US.

The letter stated that the company failed to investigate and resolve complaints raised by its customer firm that used its contract solvent recovery services to make the valsartan active pharmaceutical ingredient (API). This included their failure in investigating the solvent that contained N-Nitrosodimethylamine (NDMA), a cancer-causing impurity found in samples collected from equipment used by the company to recover the solvents. The company acted as a solvent recovery facility for other companies that manufacture API used in Valsartan, a generic version of Diovan.

Valsartan claims are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.