QUALITY ASSURANCE

APIs with full regulatory compliance!


 

In Farmhispania we deliver the highest purity APIs with full regulatory compliance.

Our manufacturing plant is regularly visited and audited by customers. Working under strict cGMP guidelines, we are regularly audited by the Spanish and European Health Authorities and by the USA FDA.

Worldwide Health Authorities' requests are stricter day by day, our QA / Regulatory Affairs department is up to date with the latest guidelines (CTD DMFs, LoAs, MRPs, deficiency letters, etc...) providing full support to our customers. We have filed our DMFs with major world Health Authorities. CEP have also been granted to Farmhispania.

Our QA Dept. supervises the overall process  and analytical validation plan.

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