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Pierfrancesco Morosini, CEOIcrom is certified by a vast array of global pharma authorization bodies such as the European IMA, USFDA, and Japanese PDMA in reviewing and producing APIs for pharma companies. An agile firm, Icrom implements a lean management system that facilitates faster delivery of safe and stable molecules and compounds depending on the stage of a drug clinical trial program. The company’s ability to rapidly transform its operations to match a client’s changing requirements assures full transparency between pharma companies and regulators.
Its team of scientists uses the latest innovative technologies such as LC-MS equipment, pilot reactors and parallel synthesis to optimize the production of required APIs.
“We take into account all the local and international regulatory needs from the start of project to avoid any altercations that may delay the clinical product development and release,” says Pierfrancesco Morosini, CEO at Icrom.![]()
We offer CMO and CDMO capabilities from grams to tons under GMP regulations and use modern technology and state of the art equipment in compliance with the most-strict regulatory requirements
The company has opened an operational facility that houses its new and improved quality control lab and unit. In addition, it has added a warehouse three times larger than its existing center that has the latest protection and inventory management systems for molecule and compound storage. “We offer CMO and CDMO capabilities from grams to tons under GMP regulations and use modern technology and state of the art equipment in compliance with the most-strict regulatory requirements,” says Morosini.
With tailor-made chemical processes that match the quality and regulatory requirements, Icrom’s clients can release their finished medical products to market on time. For one client, the CMO and CDMO services provider assisted them in overcoming the formulation of an ingredient according to the original patent and in sterile conditions. In doing so, Icrom delivered a sterilized API with a high level of purity and ready for inducement in the intended drug product. In another instance, Icrom enabled a pharma company to avoid any patent infringement by designing a specific impurity pattern for a niche API.
As clinical trials become increasingly burdensome due to chemistry or regulatory requirement, Icrom continues to follow its clients on a day-to-day basis during their drug discovery and development operations. The company has established a network of pharmaceutical services with select centers of excellence for those applications and offerings that are not part of its own portfolio. “We want to be a one-stop-boutique that offers unparalleled CMO and CDMO services to develop special pharmaceutical products,” concludes Morosini.
Company
Icrom Srl
Management
Pierfrancesco Morosini, CEO
Description
ICROM is an Italian company specialized in the GMP manufacturing and in contract manufacturing of active pharmaceutical ingredients (APIs) and relevant intermediates. Our classical products belong to antipsychotic area and more recently to the one of high-potency anticancer drugs. ICROM operations are based on a 40 years experience in applying its own technologies as well as the technologies developed by its sister company FAR-CHEMICAL, Inc. to serve worlwide pharmaceutical outsourcing