Generic Products

SAFC has the expertise to manufacture generic APIs, high purity excipients and advanced intermediates to the highest level of quality. Either customer specific or for the open market, they are produced for various therapeutic areas:

Anticholinergics
Anti-Depressants
Anti-Emetics
Anti-Histamines

Antipsychotics
Muscle Relaxants
Sedatives

Vasodilators
Veterinary Anthelmintics
Veterinary Tranquilizers

Core Production Technologies

  • API manufacturing and purification
  • Extensive processing equipment  
  • State of the art fractional distillation equipment
  • Large scale continuous chromotography (SMB)

Quality Control & Compliance

  • General capabilities in quality and regulatory support
  • Various analytical capabilities
  • Regulatory filing support

Process Technology

  • Process development
  • Tech transfer
  • Supervision of pilot batches
  • Process validation
  • Reference standards synthesis

Generic Products

All items are manufactured at the Arklow facility and available for immediate shipment globally.

Product Name  Compliance Packaging
Acepromazine Maleate • Conforms to the USP, EP and BP specifications
• CTD and US DMF available
Flexible packing 1-25 kgs in fiberboard drums
Amitriptyline Hydrochloride • Conforms to the USP, EP and BP specifications
• CTD and US DMF available
Flexible packing 1-25 kgs in fiberboard drums
Benzyl Alcohol • Conforms to the USP EP and JP specifications
• CEP and US DMF available
• Manufactured and tested fully to cGMPs and ICH Q7
Flexible packing 1-10 kgs in HDPE drums
Brompheniramine Maleate • Conforms to the USP, EP and BP specifications
• CTD and US DMF available
Flexible packing 1-25 kgs in fiberboard drums
Butoconazole Nitrate USP • Conforms to the USP, EP and BP specifications
• CTD and US DMF available
Flexible packing 1-25 kgs in fiberboard drums
Clomipramine Hydrochloride • Conforms to the USP, EP and BP specifications
• CTD and US DMF available
Flexible packing 1-25 kgs in fiberboard drums
Diethylcarbamazine Citrate • Conforms to the USP, EP and BP specifications
• CTD and US DMF available
Flexible packing 1-25 kgs in fiberboard drums
Doxylamine Succinate • Conforms to the USP, EP and BP specifications
• Certificate of Suitability (COS) and US DMF available
Flexible packing 1-25 kgs in fiberboard drums
Lofepramine Hydrochloride • Conforms to EP and BP specifications
• CTD available
Flexible packing 1-25 kgs in fiberboard drums
Nortriptyline Hydrochloride • Conforms to the USP, EP and BP specifications
• CTD and US DMF available
Flexible packing 1-25 kgs in fiberboard drums
Promethazine Hydrochloride • Conforms to the USP, EP and BP specifications
• CTD and US DMF available
Flexible packing 1-25 kgs in fiberboard drums
Sodium Benzoate • Conforms to the USP and EP specifications
• CEP and US DMF available
• Manufactured and tested fully to cGMPs and ICH Q7
Flexible packing 1-25 kgs in HDPE drums
4-Chloro-N-methyl-piperidine N/A Flexible packing 5-200 kgs in mild steel or plastic drums
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