Teva plant in Israel cited by FDA, expands in Americas
pharmafile | February 8, 2011 | News story | Manufacturing and Production | Corporacion Infarmasa, FDA, Peru, Teva, Teva Pharmaceutical, generics, generics manufacturing, manufacturing compliance
A manufacturing facility in Jerusalem operated by Teva Pharmaceutical failed to pass muster in an FDA inspection, prompting a warning letter.
The plant manufactures solid oral dosage forms and was inspected by the FDA in September 2010.
In keeping with a lot of FDA warning letters of late, the issues highlighted include not only deviations from Good Manufacturing Practice, but also problems with quality control processes and oversight.
Teva responded to the regulator’s initial concerns in October but this was judged to not be sufficiently robust, prompting the official warning letter, which carries the usual clause that a failure to address the problems could lead to withheld FDA approval for products made at the plant.
Teva said it was working hard to resolve the situation at the Jerusalem site, which manufactures generic versions of Bristol-Myers Squibb’s Glucovance (glyburide and metformin) and Sanofi-Aventis’ sleeping disorder treatment Ambien (zolpidem).
A report in the Globes newspaper citing Citi analyst John Boris indicated that combined sales of the aforementioned products were less than $40 million, and the problems will not affect Teva’s upcoming generic version of Eli Lilly’s blockbuster antipsychotic Zyprexa (olanzapine) because that is made at a different facility.
Teva also received a warning letter last year for its US plant in Irvine, California, which resulted this year in the decision to lay off around 200 staff at the shuttered unit.
Peruvian acquisition
Meanwhile, Teva looks set to expand its operations in Latin America after agreeing to buy Peruvian company Corporación Infarmasa for an undisclosed sum.
The latter operates a number of manufacturing facilities and sells around 500 different generic medicines, mainly corticosteroids, antihistamines, analgesics and antibiotics. The Peruvian pharmaceutical market is expected to be worth around $1.8 billion in 2015, according to Teva.
Phil Taylor
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