Arklow, Ireland

The Arklow Contract Manufacturing Site is located in Arklow, Ireland and encompasses 93,000 m². There are four production plants within this cGMP FDA and IMB inspected site focused on the commercial scale production of custom and generic APIs.

  • New process evaluation
  • Process development and validation
  • Technology transfer
  • Commercial key intermediate and API production
  • Solvent recycling

For more information, view the Arklow facility insert (PDF).

Core Technologies

  • Alkylation N and O
  • Esterification
  • Ester Condensation
  • Reduction
  • Suzuki Coupling
  • Grignard Chemistry
  • Simulated Moving Bed (SMB) purification
  • Natural product extractions

Core Competencies

  • Large-scale SMB chromatography capabilities for chiral separation
  • SMB Technology Overview
  • High vacuum fractional distillation
  • Salt formation – crystallization
  • Powder handling – milling and sieving
  • API custom synthesis
  • Advanced Key API Intermediates

Capabilities/Equipment Overview

  • 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®)
  • Licosept LC-450 SMB unit
  • 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

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 hydrochloride BP/EP
  • Promethazine hydrochloride USP/BP/EP
  • Lofepramine hydrochloride BP/EP

Virtual Tours

cGMP Manufacturing

Contact Facility

Facility Address:
Vale Road
Arklow, CO Wicklow, Ireland
Tel: 353-402-20335
Fax: 353-402-31147

Certificates & Documents

ISO 14001 Certificate (PDF)

FDA Registration #3002807302

cGMP to Title 21 CFR Part 210/211

ICHQ7a and EU cGMPs (Vol 4, Part 2)

Request a Site Audit

Reach out directly to our team here to process / schedule your site audit.