Sites and Contacts
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.
- 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
- a 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
Please click here to find out about our Policy of prevention of major accidents