TBD-Biodiscovery operates in compliance with EU-GMP standards. Our quality system and processes were audited many times by the authorities and our customers. Please find our GMP certificate here.
Our production facilities are 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 so called 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). Production of commercial batches can be carried away up to annual volumes of 20-200 kg (this depends on the process).
Packaging is carried out in the class D cleanroom.