Sites and Contacts

Gropello, Italy

Overview

Our site in Gropello, Italy develops and manufactures small molecule APIs, with a focus on steroid chemistry, from grams to tons – supporting all the phases of your drug’s lifecycle.

With a team of more than 150 employees, the site provides 300 cubic meters of vessel capacity, manufacturing more than 200 tons of steroids a year.

Working with our team at Gropello provides you access to classic small molecules capabilities, crystallization expertise, milling, enzymatic reaction, and sterilization know-how.

The site also features a wide range of flexible manufacturing facilities including kilo scale, pilot scale and large scale commercial production plants.

Site Details

• Six commercial scale production units including a dedicated sterile steroids production building and an anticancer and High Potent Substance production unit.
  • A multipurpose area for steroid production with a reactor capacity of 46 cubic meters
  • Progestinic steroid manufacturing departments with a total capacity of 27 cubic meters
  • Dedicated sterile steroids manufacturing units with a dissolution capacity of 1.500 liters; two crystallization units with a capacity of 1.000 and 3.500 liters respectively
  • A reserved production section for High Potency Substances, fully computerized, with capacity reactors ranging from 135 liters through to 1.000 liters. The glove boxes used meet class 100’000 or ≥0.1 µm cleanroom requirements
  • A department entirely dedicated to the production of antineoplastic (anticancer) APIs. The department is fully computerized and equipped with reactors varying in capacity from 5 to 200 liters. The unit is ideal for processing highly active antineoplastic that fall into exposure Class 4 according to the Occupational Exposure Band classification
• cGMP pilot plant
• Analytical laboratories
• Strong regulatory history, the most recent inspections listed:
  • AIFA (Italy), regularly, 2019
  • FDA (US), regularly, 2017
  • Russian Ministry of Health, 2019
  • KFDA (Korea), 2011
  • The company is ISO 9001 and ISO 14001 certified
  • weekly customer audits

Other important facts

We take in pride in our long, regulatory track record; with the most recent site inspection in December 2018 by the US FDA resulted in ‘No Action Indicated’ outcome.

Please click here to find out about our Policy of prevention of major accidents.