Contact SAFC   Extranet
SAFC Global
 

SAFC® Arklow Facility

Commercial Scale API Manufacturing

SAFC Arklow, Ireland is the company’s primary center for cGMP production of commercial and generic APIs and commercial scale advanced intermediates.

>> Arklow Facility

The 64,000 m3 complex supports customers with expertise in:

  New process evaluation
  Process development and validation
  Technology transfer
  Large-scale simulated moving bed (SMB) chromatography unit for
chiral separation
SAFC Pharma – Arklow



Capabilities Overview
Fully validated cGMP site for commercial-scale API manufacturing, facility features four separate plants, and has a total reactor capacity of over 94,000 L.

  cGMP, FDA and IMB inspected
  14 glass-lined reactors (250-8,000 L)
  6 stainless steel reactors (4,000-8,000 L)
  3 centrifuges (1 stainless steel, 2 Hastelloy®)
  8 stainless steel high vacuum distillation units (200-6,000 L), stainless steel filter dryer
  Hastelloy® filter dryer, stainless steel fluidized bed dryer, glass tumbler dryer (4,000 L)
  Vacuum tray drying oven (200 kg)
  Controlled environment sieving, delumping and packaging

Arklow Pipeline
  Current Product List
SAFC Arklow has the expertise to manufacture custom and generic APIs, to the highest level of quality.

  Amitriptyline hydrochloride USP/BP/EP
  Acepromazine maleate USP/BP Vet
  Brompheniramine maleate USP29/BP/EP
  Butoconazole nitrate USP
  Clomipramine hydrochloride USP/BP/EP
  4-Chloro-N-methyl-piperidine
  Diethylcarbamazine citrate USP/BP/EP
  Doxylamine succinate USP/BP/EP
  Nortriptyline hydrochloride USP/BP/EP
  Orphenadrine citrate USP/BP/EP
  Promethazine hydrochloride USP/BP/EP
  Lofepramine hydrochloride BP/EP

Core Technologies
  Alkylation
  Esterification
  Ester Condensation
  Reduction
  Suzuki Coupling
  Core Competencies
  Large-scale SMB chromatography capabilities
  High vacuum fractional distillation
  Salt formation - crystallization
  Powder handling - milling and sieving
  Grignard chemistry