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    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
    • 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

    Address

    Farmabios SPA
    Via Pavia 1
    27027 Gropello Cairoli (PV)
    ITALY

    Contact
    Tel: +39 0382 8191
    Fax: +39 0382 815886