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FCA

 

Key Facts

Employees: more than 400
General Manager: Mr. Jean-Michel Martinet

Pharmaceutical activities
SKUs: more than 200
Markets: 35
Regulatory: European Local Authorities, FDA, ANVISA, ANSES
GDUFA: registered
Development: transfers, lyo cycle optimisation

API activities
Active Pharmaceutical Ingredients (CEP, DMF): 17
Regulatory: European Local Authorities, FDA, ANSES, PMDA
Development: yes

Sterile Dosage Forms Capacity (units per year)

Valdepharm has welcomed a major investment in 2015-2016 with 2 new lyophilisators of 35 sqm reaching now more than 160 sqm of capacity and a new pre-filled syringes (PFS) line.
Disposable bags handling allows to increase flexibility or to perform more efficiently clinical batches.
A specific know-how in handling viscous solution and suspension has also been developed.

Vials (lyo): more than 50 Mio units
Pre-filled syringes (PFS) : more than 25 Mio units
Ampoules: more than 15 Mio units

Sterile and non-sterile pharmaceutical ingredients

Reactor Capacity: 120 cubic meters
Glass-lined reactors: 20, from 400 to 10,000 L
Hastelloy reactors: 2, from 4,000 to 8,000 L
Filter dryers: 10 up to 6 sqm (incl. 316 L)
Centrifuges: 2 Hastelloy
Micronization: Yes, including aseptic
Milling: Impact and Airjet Mills

Location

 

 

API

  • Estradiol
  • Norethindrone
  • Trazodone
  • Trenbolone
  • Chlormadinone

Equipment & Technologies

  • Aseptic crystalization
  • Steroid handling
  • Hastelloy reactors
  • Hastelloy centrifuges
  • Aseptic micronization
  • Impact and airjet mill

Reactions

  • Epoxidation
  • Baeyer Villiger
  • Vilsmeier-Haack
  • Halogenation
  • Organometallics
  • Phosphorylation
  • Reduction

Pharmaceutical Sterile Dosage Forms

  • Freezed dried vials
  • Liquid vials
  • Pre-Filled Syringes (PFS)
  • Ampoules
  • Disposable bags handling
  • Controlled substances

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