CHEMICAL-SYNTHETIC SERVICES in Europe
European CDMO Specialized in Steroids, Hormones & HPAPI
About the plant
Steroid has been operating in Italy for over 70 years in the production of HPAPIs, both for generic and innovator. It acts as API manufacturer and CDMO service provider.
Beyond that, its excellent reputation derives from its diverse international experienced management team, its strong regulatory track record (inspected by worldwide regulatory agencies), its obsessive attention to quality and respect for the rules, its production capacity´s availability, its flexibility and prompt response and its financial strength and stable ownership structure.
Steroid has a wide range of technologies installed and chemical skills, enabling it to perform - among the others - hazardous reactions, hydrogenations, cryogenic reactions. Company’s processes are OEB6 compliant. Steroid is in fact - since years - specialized in manufacturing high potent small molecules.
Certifications
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- French Service-Public (CIR)
- ECOVADIS
- World Health Organization (GMP / HACCP)
- TGA (Australia GMP)
- ANVISA (Brazil B-GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- COFEPRIS
- MHRA (UK GMP)
- TITCK (Turkish Health Authorities)
Activity
- CHEMICAL-SYNTHETIC, SERVICES, RSM (Raw Starting Materials), Intermediates, API (Active Pharmaceutical Ingredients) manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: 1, 2, 3, 4
- Therapeutic areas: (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system
- Markets: COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), MFDS (South Korea), Turkish Health Authorities
Batch Size / Reactor
- Small, Medium, Large, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L
Services
- Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Analytical methods development, Analytical methods validation, Release testing of raw materials, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Safety studies, Solid form selection, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis
