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Suven passes US FDA inspection, secures CNS product patents

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/filmfoto)
(Image: Getty/filmfoto)
Suven Life Sciences has completed a US FDA renewal inspection at its Pashamylaram-based facility, which manufactures and supplies APIs, intermediates, and formulations.

Following a successful inspection and subsequent review, the facility was found compliant with regards to current good manufacturing processes (cGMP).

The US Food and Drug Administration (FDA) has determined inspection classification of this facility as “no action indicated (NAI), according to the contract development and manufacturing organization (CDMO).

To date, the facility has filed 19 drug master files (DMF) and five abbreviated new drug applications (ANDA).

Suven's drug discovery program is focused on discovering, developing and commercializing CNS therapies through the use of G-protein-coupled receptors (GPCR) targets.

The company currently has four clinical-stage compounds and nine internally-discovered therapeutic drug candidates in various stages of preclinical development.

In related news, Suven today announced that is has secured product patents in Australia, Eurasia, and Europe.

The patent covers its class of selective 5-HT4 compounds being developed for the treatment of cognitive impairment associated with neurodegenerative disorders.

“We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally,"​ said Venkat Jasti, Suven CEO, in a statement.

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