Committed to Good Manufacturing Practices

As LUPI is responsible for the research and production of Active Pharmaceutical Ingredients (API), its Regulatory Affairs Department has been committed for many years to comply with all relevant Good Manufacturing Practices requirements from health authorities worldwide. 


For the safety and efficacy of the pharmaceutical products
Regulatories stem from the desire of governments to protect public health by monitoring the pharmaceutical industry. On the other hand, companies that research and produce drugs, veterinary products, pesticides, parapharmaceuticals and cosmetics want their products to be in line with current safety regulations.


As a manufacturer of Active Pharmaceutical Ingredients, LUPI offers an extensive experience and excellent inspection records with all major regulatory bodies, among them the Italian Agenzia Italiana del Farmaco (AIFA), the US Food and Drug Administration (FDA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the Korean Food and Drug Administration (KFDA).


High quality dossiers (DMFs) are filed and maintained worldwide and documentation is prepared in coordination with customers. A qualified, punctual service on technical and regulatory matters addresses and supports customer’s and Authorities’ needs in a timely and accurate manner.

Excellent inspection records, since 1972
As the above infographic synthesize, LUPI’s commitment to Good Manufacturing Practices has resulted in regular and excellent inspection records in the last forty years.