The value proposition generated through two sites specialized in freeze drying is
unique, from manufacturing process optimization to producing freeze dried
characterized and documented vials, allowing our clients to diff erentiate on their
own markets. We recently invested 7 million euros to increase capacity in our Spanish site targeting specialization in freeze dried and F&F sterile products compliant
with new GMP Annex 1. We can offer a capacity of 30 million vials. Synerlab has a
dedicated center of excellence with 15 freeze driers and laboratory
equipment to simulate cycles, with QBD expertise mastering the entire
cold chain. We developed the capability to install new capacities in less
than 12 months. Recently, we got FDA approval for one of our major API product.
Following an audit of the manufacturing process by the US authorities,
we obtained prior approval to manufacture commercial lots for US
patients. One crucial fact is that we obtained this authorizati on
in 3 months, which usually takes at least 12 months.
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