CHEMICAL-SYNTHETIC NUTRACEUTICALS in Europe
Our fully GMP-compliant and FDA-inspected facility based at Settala (20min close to Milan) specializes in complex APIs and high-potent compounds up to OEB 6, supported by a team of 500 professionals,...
About the plant
Headquartered in Milan (Italy), Indena is the leading company dedicated to the identification, development and production of high quality active principles for use in the pharmaceutical industry.
Backed up by a century of experience, 4 production sites and over 1000 high-skilled staff, the company invested a significant amount of its annual turnover in research and technological expansions, making CDMO activities the key to its success and a priority in Indena’s strategic vision.
Custom services and strong partnerships with clients have been a company focus since the very beginning and, thanks to a meticulous activity done over the last 30 years, nowadays those represent one of the Indena’s key strengths.
Our fully GMP-compliant and FDA-inspected facility based at Settala (20min close to Milan) specializes in complex APIs and high-potent compounds up to OEB 6, supported by a team of 500 professionals, including 70 dedicated to R&D.
Today, Indena manufactures 12 commercial HPAPIs from different origin: synthetic, semi-synthetic and fermentation molecules. This positioning has been achieved thanks to Indena capacity to handle HPAPI with an OEL from 1 Microgram /m3 to 1 ng/m3; the onsite availability of complementary technologies such as GMP microbial fermentation/biotransformation, synthesis and extraction capabilities and its qualified and cohesive CDMO team. Moreover, with over 30 years’ experience in the spray drying from organic solvents, Indena has expanded and upgraded its mid- and large-scale spray dryers.
These represent Indena’s major technological pillars securing customized solutions to its partners.
Products and Services:
- HPAPI development & manufacturing (down to an OEL of 1 ng/m3), including ADC payloads
- Fermentation of HPAPI and complex APIs
- Complex API development & manufacturing
- Chromatography services
- Spray drying from organic solvents, also in presence of excipients.
Target Audience:
Indena is looking to connect with biotech and pharma companies that are looking for a CDMO partner for their HPAPIs and complex API small molecules to support for clinical trials (phase I, II and III) and commercialization.
Compliance
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- NMPA (China GMP)
- ANVISA (Brazil B-GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- 9001
- 14001
- 45001
- 22000 (Food)
Activity
- CHEMICAL-SYNTHETIC, NUTRACEUTICALS, Intermediates, Fine Chemicals, 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: N/A
- BSL: N/A
- Therapeutic areas: N/A
- Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), 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, 5,000 - 10,000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, DMF (Drug Master File) preparation and submission, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, OSD (Oral Solid Doses) manufacturing, Safety studies, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis, Extractables & Leachables, Stability tests, Identity, Content, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Particle size (LD), Crystal form, Residual solvents (GC-MS), Elemental impurities / Metals (ICP-MS), Nitrosamines (HPLC-MS/MS), Endotoxins (LAL), Microbiology
