Archimica at a Glance - Strengths
We provide quality products and services, consistently, reliably responsibly and continuously applying
some of the world’s most difficult to handle chemical technologies.
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Experience with the Most Challenging Reagents, Reactions and Substance Classes Known.
Made in
Europe
Agile Capacity
Availability
Premium Client
Attention
Highly Flexible Manufacturing
and Development
History Lodi Site
Archimica’s Evolution – 75 Years of Continuity of Supply into the World´s Pharmaceutical Market.
1947
Foundation of Istituto Chemioterapico Italiano (I.C.I.)
1984
Foundation of Prime European Therapeuticals S.p.A (Euticals)
2008
Mandarin Capital Partners becomes majority Euticals shareholder
2012
Clessidra, an Italian Financial Fund becomes majority Euticals shareholder
2016
AMRI acquired Euticals Group
2019
Effective August 1, Livia acquires Lodi site, and brands it Archimica S.p.A.
Products
APIs/GMP Building Block – Process Development and Manufacturing.
From Clinical to Large Commercial Scale for the Innovative and Generic Industry.
APIs, GMP Building blocks, Reagents
Customers are relying on Archimica’s Products and Services for Quality Medicine Worldwide.
All Therapeutic Classes. All Substance Classes (including Anticancer APIs)
11
Active Products
24
Active Drug Master Files in 39 Countries
200
Active Customers
50
Supplied Countries Worldwide
Generic API Portfolio - Active Pharmaceutical Ingredient
- Cytarabine
- Glycerophosphoryl-Choline (GPC)
- Glycerophosphorylethanolamine (GPE)
- Hydroxyurea
- Mianserin Hydrochloride
- Oxcarbazepine
- Pyridine/Sulfur Trioxide
- Sucralfate
- Sucrose Octasulfate Sodium/Potassium salt
- Hydralazine hydrochloride
- Sulfathiazole
- Dihydralazine sulfate
- Amtolmetin Guacil
- Aurothiomalate Sodium
- Azanidazole
- Bromfenac
- Capecitabine
- Citicoline
- Diacereine
- Disopyramide
- Fludarabine
- Iodocasein
- Lithium Carbonate
- Pentetrazole
- Pirenzepine Dihydrochloride
- Sulfapyridine
- Thenfadil
- Tolmetin
- Vidarabine
Technologies & Plant
Staff
58%
PRODUCTION
22%
QUALITY
10%
MAINTENANCE
10%
SALES & ADMINISTRATION
Plant
Manufacturing Overview
Reactor Capacity Supported by a Vast Range of Sophisticated Ancillary Technology:
Reactor Volume: About 250 m3 (stainless steel and glass line).
Temperature Range: -20 to 160°.
Pressure Range: 10 mbar to 6 bar.
Reactor Volume Range: 50 to 10.000 liters.
Dryers: Fluid bed dryer, agitated vacuum pan dryer, vacuum horizontal agitated dryer, vacuum double cone dryer, Planex® dryer, tray dryer.
Centrifuges/Filters
Filters: Filter Presses – Filter Dryers – Pressure Filters
Centrifuges: Vertical Axis top discharge, Vertical Axis Bottom Discharge, Horizontal Axis Peeler.
Ancillary Equipment: Sieves – Ultra Filters, Ion Exchange Chromatography Columns.
Products plant list
F1 – QC Laboratory
F2A – Multi-Purpose Plant
F3A – Raw Materials, Intermediates and APIs warehouse
F3B – Finishing & Drying Plant (ISO 8, controlled environment)
F5A – Hydroxyurea Plant
F5B – Multi-Purpose Plant
F5C – Cytarabine Plant
F6A – Sucralfate Plant
F6B – Sulfamidics Plant
F7 – Multi-Purpose Plant
F8 – Utilities
Tech
Main differentiators
Highly flexible and broad permit for all technologies, reagents and solvents.
Broad range of extraordinary hazardous chemistry and chemicals processable in large scale:
solvents, including chlorinated and toxic solvents;
Strong acids including phosphorous oxychloride, chlorosulfonicacid, hydrofluoric acid;
Highly flammable, highly corrosive, explosive chemicals.
Residual thermal oxidizer allowing trace gas contamination removal, all waste gas streams.
Seveso guideline compliant.
Own on-site waste water treatment, backed by external partners.
Solvent recovery and tank farms.
Differentiators - Technology specialities
Large Scale Deacylated Phospholipids production (GPC, GPE)
Large Scale Use of Pyridine as reagent or solvent, as well as pyridine-SO3 complex handling.
Cytostatics manufacturing/drying: Nucleosides.
Heterocyclic chemistry: Pyridines, Piperazines, Quinoxalines, Quinolones, Quinazolinones, Benzofuranes.
Chromatographic purification with ionic resins.
Micronization (third party partners).
Up to OEB4 Potency Level.
Differentiators - Reagents & Solvents
Chlorosulfonic acid
Sulfur trioxide
Pyridine
Ethylene oxide
Triphosgene
Hydrazine, Azides, Diphenyl-phosphorylazide, Acetyl Nitrate
Halogen chemistry:
Fluorine, chlorine, bromine, iodine
Hydrofluoric acid
Chlorine, chlorinating agents
Bromine, brominating agents (NBS, dibromohydantoin, phosphorous bromides)
Methylene diiodide, methyliodide, iodoform, TMSOZ
Safety
Safety
IPPC-based Authorization.
Integrated Pollution Prevention and Control.
Highly flexible and broad permit for all technologies, reagents and solvents.
Compliance with IED Directive 2010/75/UE.
Best Available Technology.
Compliance with Directive 105/15 2012/18/EU.
Seveso Directive.
Prevention and Control of On-Shore Major Accident Hazards involving Dangerous Substances.
Quality System, Inspections, Certificates
Quality System Based on EU GMP part II, ICH Q7.
Quality Processes Handled via TrackwiseTM.Deviations, Out-of-Specifications (OOS), CAPA, Change Control.
US/EU Drug Master Files. 24 Active Drug Master Files in 39 Countries and 4 active CEP.
API Registration Form: AMA -50/2020
GMP Certificate (Human): IT- API/104/H/2020
GMP Certificate (Veterinary): NBF/31/2020V
FEI Number 3002874947
DUNS Number 429351620
US-FDA
Last inspection April 2017
AIFA
Last Inspection December 2021
KFDA (Korea)
Last inspection October 2011
Veterinary Ministry of Health
Last inspection June 2019
Procurement
Archimica is continuously strengthening its Suppliers base.
Please contact our Procurement Department using our contact form below if you want to be part of our Archimica journey.
News
Discover our latest news and articles about
products, research and services.
ChemOutsourcing Sep 8-9, 2022 Parsippany, NJ
Archimica will be exhibiting at ChemOutsourcing Parsippany, New Jersey Hilton from 8 - 9 September 2022. Schedule a meeting with our team at : contact@archimica.comRead more
Hydralazine Hydrochloride, API Grade
Hydralazine Hydrochloride is a highly effective drug use in treatment of severe hypertension and congestive heart failure. It is proven since many years mainly as second line and/or important partRead more
L-α-Glycerophosphoryl-ethanolamine (GPE), Synthesis Grade
L-α-Glycerophosphoryl-ethanolamine, Synthesis Grade (GPE SG, see also Archimica´s API grade [Alpha-glycerylphosphorylethanolamine (GPE)] ) is a valuable advanced intermediate for the synthesis of lipids and antifungals. The high potential as intermediateRead moreArchimica July Press Release Expansion of Multi-Purpose Manufacturing Capacity
July 22, 2021 Archimica announces completion of its 1,2 Mio. Euro Investment Expansion of its Multi-Purpose Manufacturing Capacity on CPHI North America Archimica has started the operation of its expandedRead moreArchimica Press Release Laboratory Expansion May 2021
25 May 2021 Archimica invests 1,3 Mio. Euro in Expansion of Process Development Capacity Archimica has started the operation of its expanded development laboratories at its Lodi (Italy) site. ARead more
Alpha-glycerylphosphorylethanolamine (GPE)
Alpha-glycerylphosphorylethanolamine (GPE) is a precursor of phospholipids (PLs) and and the acetylcholine neurotransmitter. Brain aging involves changes in the lipid membrane composition that lead to a decrease in membrane excitabilityRead more
OXCARBAZEPINE API
Oxcarbazepine is an important drug in treatment of epilepsy and related disorders. It is successfully applied to patients globally in a wide variety of presentations. Recent more stringent quality requirementsRead more
Contacts
GPS coordinates
Latitude: 45 °19’ 25,3“ N
Longitude: 9°27’ 57,7’’ E
The site is located in Northern Italy in Lombardia about 30 km South of Milano and Linate airport. Access to the facility is the motorway A1 Milano-Bologna and the route SS9 Via Emilia.
Site address
Viale Milano 86,
26900 Lodi (LO) Italy
Phone: +39 0371 49021
Fax: +39 0371 610019
Email: contact@archimica.com
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