Lupin hit with more regulatory challenges
No details of the observations made at the Indore, India, site have been released. The Indian drugmaker stated that it is working towards addressing the observations.
Lupin has faced a number of regulatory issues over the past few months.
Most recently, the company recalled 42 lots of its antibiotic, Ceftriaxone, after contaminant was found in the vials.
In December 2018, Lupin received 22 observations across three of its facilities at its Mandideep campus, after an inspection by the US Food and Drug Administration (FDA) in late November.
At the time, Lupin stated that the observations were “largely procedural in nature,” after the FDA identified gaps in the facility’s aseptic processing areas of its active pharmaceutical ingredient (API) manufacturing block.
However, the FDA did give Lupin the all clear for the company’s manufacturing process for its ‘sartan’, despite discovering one “procedural deficiency.”
Valsartan, losartan, and irbesartan are all APIs that have been making headlines after a carcinogen, N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) had been found to contaminate certain medicines.
During the FDA’s inspection for NDMA and NDEA contaminants, it did observe a procedural deficiency at the company’s site in Tarpur, India, which encompasses 14 manufacturing plants and five solvent recovery blocks.
