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With operations in 11 countries, Fareva provides services on a local, regional and global level.

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Valdepharm

A state-of-the-art FDA approved site, dedicated to Active Pharmaceutical Ingredients (API) with vast experience in aseptic and steroids. Valdepharm also manufactures injectable sterile products for human and animal health

 

Key Facts

Employees: more than 500
General Manager: Mr. Franck Savignard

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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