The Financial Times reported yesterday that Boehringer-Ingelheim and Roche have both had to recall drugs in the U.S. and Europe within the past few weeks due to manufacturing quality issues.
Roche recalled its HIV treatment, Viracept, in Europe and some developing nations a few weeks ago because the drug contained chemical impurities, and higher than normal levels of methane sulfonic acid ethylester.
B-I's recall of its pet arthritis drug, Synoquin, is particularly interesting, since it was reportedly motivated by a competitor, the Nutraceuticals supplier Vet Plus. Vet Plus ran lab tests on the B-I product which found that it contained less than the required amount of active ingredient.
...More arguments for use of process analytical technologies during manufacturing.
But, as competition in the industry intensifies, could more companies adapt Vet Plus' "guerilla" pharma marketing strategy? Analyze the competitor's product, then publicize any quality problems discovered... cGMPs as marketing tool...
