ICROM S.p.A.

Italy

https://www.icrom.com/

Drug Substance

Analytical & Bioanalytical Services

Regulatory, Tech Transfer & Support Services

Contract Research Organization

Chemistry, Manufacturing and Controls

Company Overview

About

ICROM S.p.A. is an Italian custom API development and manufacturing company based in Concorezzo (MB), specializing in custom development, custom manufacturing, and APIs for specialty drugs. The company operates under cGMP with inspections by AIFA, USFDA, PMDA, and KFDA, and holds Drug Master Files in all major regulatory markets. ICROM recently acquired Holodiag and has a subsidiary Proxis.

Key Expertise

custom API synthesis, specialty drug APIs, GMP intermediates, diagnostic pharmaceutical dyes, highly potent API handling

Therapeutic Areas

CNS (Central Nervous System)

Metabolic Disease

Oncology

Quick Facts

HQ:Italy

Capabilities & Services

Core Capabilities

Small Molecule API
API Manufacturing
Process Development

Production Scales

Lab Scale

Pilot Scale

Phase I Clinical Trials

Phase II

Clinical

Commercial Scale

Annual Capacity

Small Batch / R&D (< 100 kg/year)

Medium Clinical (100 - 1,000 kg/year)

Commercial (1,000 - 10,000 kg/year)

Markets Served

Europe

Manufacturing Facilities

1 site worldwide

ICROM S.p.A. - Italy Facility

Italy

View on Map

Site Capabilities

Gene Therapy

Cell Therapy

mRNA

Certifications

KFDA (South Korea)

Korea Food and Drug Administration

FDA Registration

U.S. Food and Drug Administration

EMA GMP Certificate

European Medicines Agency

PMDA (Japan Pharmaceuticals and Medical Devices Agency)

Pharmaceuticals and Medical Devices Agency

Customer Reviews

No reviews available yet.

Company Documents

No documents available.

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