Dive Brief:
- A plant owned by Indian drugmaker Lupin appeared to pass muster with the Food and Drug Administration following the completion of a current good manufacturing practice (cGMP) inspection. The company was left with just one observation, which it characterized as a procedural deficiency.
- The inspection at the Tarapur facility in India was conducted between August 27 and 31, 2018, by three FDA investigators, Lupin said.
- In addition, Lupin's manufacturing process for valsartan was judged to be free of the NDMA impurity that has affected a number of other foreign manufacturers producing the heart drug.
Dive Insight:
Regulatory authorities in the U.S. and EU have issued a number of safety alerts regarding NMDA impurities in valsartan API created by foreign drug manufacturers. The positive findings at Lupin's Tarapur facility are one good sign, as regulators check through the drug supply chain.
The FDA concluded the manufacturing processes for Lupin's valsartan, losartan and irbesartan bulk products were "safe with no chance of presence of the NDMA impurity in the APIs."
The Tarapur plant has mostly seemed to stay on the right side of the FDA's ledger. According to FDA records, the facility has had three inspections over the last decade: one in 2009, one in 2012 and one in 2015. Each resulted in a "voluntary action indicated" classification, which means the agency found objectionable conditions but chose not to recommend regulatory action.
More concerning for Lupin, however, was a November 2017 warning letter from the FDA, which tore into two of the company's other Indian facilities.
The warning letter cited failure to investigate when APIs and finished products were out-of-specification. Regulators claimed the company repeated tests until they met standards, or in some cases blamed laboratory errors without properly investigating them. There were repeated failures at both sites, and the FDA demanded immediate and comprehensive assessments of global manufacturing operations to ensure that products met FDA requirements at all of Lupin's production facilities.