SPECIALIZATIONActivitiesSOLUBLE ORAL POWDERSMEDICATED PRE-MIXESDOUGHSINTRARUMINAL DEVICEQUALITY CONTROL LABORATORYCONTACTS

FC FRANCE SAS is a CDMO
(Contract Development and Manufacturing Organization)

Specialised in:

The research

The development

The adjustment

The manufacture

The purchase

The sale

The packaging

The storage

The marketing

of veterinary pharmaceutical products, as well as all the products in relations with the medical field, in all forms.

Administrative approvals and registrations:
ANSES / GMP Approval: V 0594/81DDPP Approval: αFR95355023
897 891 370 – RCS PontoiseSIRET: 897 891 370 00024
Intra-community VAT: FR30897891370

ACTIVITIES

MEDICINAL & NON-MEDICINAL FOOD SUPPLEMENT PRODUCTS

Preparazione orale non sterile:

Soluble oral powder (SOP)

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Medicated pre-mix (MP)

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Liquid (solution/suspension)

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Dough 

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Intraruminal device (BOLUS)

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Secondary packaging

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SOLUBLE ORAL POWDERS (SOP)

Production equipment

3 mixers: 600 l, 2000 l, 3000 l

Packaging equipment

5 pieces of equipment for 10 g to 25 kg packages

Main types of packaging

-Sachets: 10 g to 1 kg
-Sacks: 5 kg to 25 kg
-Pots: 50 g to 1 kg
-Buckets: 2 – 3 kg

MEDICATED PRE-MIXES (MP)

Production equipment

1 carousel of pre-mixes – Lot size 1000-2000 kg

Packaging equipment

1 bagging line

Main types of packaging

-Sacks: 5 kg to 25 kg

LIQUIDS (SOLUTIONS / SUSPENSION)

Production equipment

3 mixing vats: 1500 l to 4000 l

Packaging equipment

5 pieces of equipment for the main packages

Main types of packaging

-Flasks / Drums: 50 ml to 10 l
-Sticks: 4 ml to 10 ml
-Bulk: IBC (intermediate bulk container) 1000 l

DOUGHS

Production equipment

1 mixing vat: 1000 l

Packaging equipment

1 piece of equipment for the main packages

Main types of packaging

Tubes: 300-400 g

INTRARUMINAL DEVICE

Production equipment

1 injection press
1 lamination cabin

Packaging equipment

1 Bolus Intra R equipment in tube

QUALITY CONTROL LABORATORY

Chromatography analysis unit

Principal analyses: Identification, dosages and search for related substances
3 liquid chromatography devices (HPLC) and
1 chromatography device in the gaseous phase (CPG)

Chemical physics analysis unit

Principal analyses:
Dosages (potentiometry, UV spectrophotometry and burette)
Identifications (thin-layer chromatography, IR spectroscopy, moisture content, refraction index, etc.)
Techniques: Karl-Fisher, densitometry, pH-metry, spectrophotometry, etc.

Microbiological analysis unit

Principal analyses:
Dosage
Microbial contamination
Search for pathogens

Control unit of the Printed Packaging Items

Sample Library

Agreements & Administration

• ANSES / GMP Agreement: V 0594/81
• DDPP Agreement: αFR95355023
• 897 891 370 – RCS Pontoise
• SIRET: 897 891 370 00024
• TVA Intracommunautaire: FR30897891370

Activities – Oral Powder

• Manufacturing equipments
  • 3 mixing tanks
    • 600L, 2000L, 3000L
    • Packaging equipments
  • 5 primary packaging equipments
    • 10g to 25kg
    • Packaging: Sachets, bags, pots, buckets

Activities – Paste

• Non-pharmaceutical dedicated area
  • Manufacturing equipments
    • 1 mixing tanks
      • 1000L
      • Packaging equipments
    • 1 primary packaging equipment
      • Tubes: 300-400g

Activities

• FC France is a CDMO specialized in the development, manufacturing and packaging of veterinary product
• Non-sterile orale form
  • Soluble oral powder form
  • Liquid (soution/suspension) form
  • Paste form
  • Secondary packaging

Activities – Liquid

• Manufacturing equipments
  • 4 mixing tanks
    • 1500L to 4000L
    • Packaging equipments
  • 5 primary packaging equipments
    • Bottles: 50mL to 10L
    • Sticks: 4-8mL

QUALITY CONTROL OBJECTIVES

• Carrying out checks on all the batches, ranging from the received raw materials to the finished product, in addition to the intermediate levels and packaging items.
• Monitoring the corresponding environmental conditions.
• Ensuring the specifications are met: raw materials, intermediate levels, finished products and packaging items.
• Updating techniques and regulations.

QC LABORATORY

• Raw material checks
• • Over 100 products corresponding to more than 800 batches
  • Analytical checks of the finished products
  • Oral powders
  • Liquids and pastes
  • Premixes
• Packaging item (AC) and printed packaging item (ACI) checks
  • Finished product and raw material sample library

QC PHYSCHEM LABORATORY

• Chromatography analysis unit
  • Main analyses: Related substance identifications, assays and research
  • 3 liquid chromatographs (HPLC) and
  • 1 gas chromatograph (CPG)

• Chemical analysis unit
  • Main analyses:
    • Assays (potentiometry, UV spectrophotometry and burettes)
    • Identifications (CCM, IR, water content, refractive index, etc.)
  • Techniques: Karl Fischer, densimetry, pH-metry, spectrophotometry, etc.

MICROBIOLOGY QC LABORATORY

• Main analyses
  • Assay
  • Microbial contamination
  • Pathogen research

Team

Friulchem S.P.A. – Disma Giovanni Mazzola

PRESIDENT

Biagio Giugliano

GENERAL MANAGER – COO & CFO

Pierre Reynaud De La Gardette

GENERAL MANAGER – OPERATION MANAGER

Marc Feron

QA MANAGER

Friulchem spa

 

Magny-en-Vexin site location

FC France SAS is located 50 km from Paris

Address:
8-10 Rue des Aulnaies 95420 Magny-en-Vexin FRANCE