TBD-Biodiscovery operates in compliance with EU-GMP standards. Our quality system and processes are regularly audited by the authorities and our customers. Please find our GMP certificate here. (link)
Our production facility is located in the Tartu Biotechnology Park.
In total we have three GMP qualified production areas, equipped with reactors 20-150 L with total capacity of 600 L and special equipment for hydrogenation (up to 50 bar) and distillation.
This means we are focused on small scale manufacturing of products with complicated chemistry and high added value. Those can be niche generics, API for orphan drugs or original compounds (NCE). The annual volumes of commercial batches can be 20 to 200 kg (this depends on the process).
Packaging is carried out in the class D cleanroom.