Fine Chemicals

Angelini Fine Chemicals

Angelini pharmaceutical’s chemical plant is located in Aprilia (LT-Italy).
The plant is specialized in:
  • manufacturing of active pharmaceutical ingredients and advanced intermediates
  • contract manufacturing
  • custom synthesis for major international pharmaceutical companies as well as the Biotech Virtual pharmaceutical sector.
Some of the plant’s main commercial products include: benzydamine, trazodone, metaxalone, oxolamine, bendazac l-lysine, acamprosate, dapiprazole and ibopamine.
The site includes a classified Kilo lab and a smaller Manufacturing Plant where small quantities of API are manufactured prior to the large scale production phase.
Moreover, a new technology based on microflow reactors has been implemented, which is able to provide increased production yields, higher product quality, faster product time to market.
The Fine Chemicals plant operates in compliance with all international standards and regulations and is regularly inspected by the main Regulatory Authorities.
Safeguarding of the environment is one of the priorities of Angelini Fine Chemicals. In keeping up with European and international standards, Angelini Fine Chemicals plant utilizes the most up-to-date technologies and management tools for the treatment of waste waters, the recovery of solvents, the monitoring of gas emissions.

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Manufacturing Facilities

Multipurpose Manufacturing Plants
3 MANUFACTURING MULTIPURPOSE FACILITIES WITH:
  • Reactors ranging from 800 to 6000 lt volume
  • 140,000 lt of total glass lined and stainless steel (AISI 316 and 304) reactor capacity
  • Operation conditions -10°C to + 250°C
  • Solvent recovery
  • Stainless steel, glass lined or ebonized pressure filters and centrifuges

1 MANUFACTURING MULTIPURPOSE PLANT FOR SMALLER BATCH SIZE BATCHES WITH:
  • 4 glass lined and stainless steel reactors ranging from 250 to 800 lt capacity
  • 1 glass reactor (600 lt)
  • 1 glass lined dryer- filter (500 lt)
  • Distributed process control systems (DCS)
  • Operative conditions: -20°C to +250°C

1 PRODUCTION MULTIPURPOSE LABORATORY:
In 2011 a new laboratory in “classified environment” (Class C) was built for the production of API for sterile pharmaceutical products

FINISHING BULK FACILITIES:
  • 7 fluid bed and rotary vacuum dryers; finished bulk APIs dryer in clean room
  • Separated finishing areas for micronizing, blending and sieving operations in clean rooms

Analytical R&D and QC Services
  • Titrimetric, potentiometric
  • Gravimetric
  • Elemental analysis (C, H, N, S)
  • Chromatography (TLC, HPLC, GC)
  • Capillary electrophoresis
  • Spectrophotometry UV/VIS and FT-IR
  • Nuclear Magnetic Resonance for 1H and 13C
  • Mass spectrometry (CC, LC coupled with APCI) and electrospray interfaces
  • Differential scanning calorimetry (polymorphism and purity studies)
  • Melting/boiling point equipment (Bùchi, Mettler, Kofler)
  • Particle size measurement (Sonic Sifter, Malvern Mastersizer)
  • METAMORPH® image analyzer
  • Environment chambers for ICH
  • Stability conditions
  • Computerized QC data processing

Environmental Capabilities
  • Physicochemical and Biological WW Plant
  • Contract WW treatment Process R&D Capabilities

Process R&D Capabilities
  • Organic synthesis laboratories operating up to 20 lt volume
  • Micronization equipment
  • Auto-Mate H.E.L. (calorimeter for Hazard Evaluation)
  • Microflow reactors

Regulatory
  • AIFA inspected since 1975
  • FDA inspected since 1979
  • PMDA inspected since 2009
  • Validation master plans
  • Process validations
  • ICH stability studies
  • DMF preparation and filing

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Process Technology

Angelini Fine Chemicals has substantial experience in process development and industrial manufacturing of fine chemicals.
The following reactions are currently per formed in Angelini Fine Chemicals production plant:
  • High temperature reactions (up to 250°c)
  • Solvent free reactions (melted substances)
  • Complex heterocycles synthesis
  • Condensations
  • Phase-transfer catalysis
  • Hydrogen peroxide chemistry (metal catalyst)
  • Hydrazine chemistry and handling
  • Reductions (activated borohydrides, vitride, iron, zinc, hydrazine, sulfites, dithionite)
  • Oxidations
  • Chiral chemistry
  • Diazotization and nitrosation (sodium nitrite)
  • Chlorination and halide exchange (thionyl and sulfuryl chloride, bromide exchange)
  • Silylation (tmcs, hmds, bsa)
  • Acylation, amidation,Esterification and hydrolysis
  • Friedel-craft reactions
  • C-alkylation, n-alkylation, o-alkylation and arylation
  • Aliphatic and aromatic nucleophilic substitution
  • Aldol condensations
  • Ring closure and aromatization

Angelini Fine Chemicals - Download the brochure

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