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.

Archimica Plant Lodi

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

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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.

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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