The Arklow 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 that are responsible for the commercial scale production of custom and generic API's.
| SAFC Arklow: Pilot and commercial scale manufacturing of both Generic and Custom APIs and Intermediates |
What our technologies can provide for you
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API custom synthesis |
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Generic APIs to USP/EP/BP pharmacopoeil specification |
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Intermediates, including Advanced Intermediates |
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cGMP FDA and IMB Inspected |
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Commercial scale chiral separation |
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Method Transfer and Validation to ICH guidleines |
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Simulated Moving Bed (SMB) Chromatographic Unit (Licosep 6-450) |
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High Vacuum Distillation |
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Salt Formation |
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Powder Handling |
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Grignard Chemistry |
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ISO 14001 Certificate
1.3meg pdf |
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FDA Registration #3002807302 |
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cGMP to Title 21 CFR Part 210/211 |
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ICHQ7a and EU cGMPs
(Vol 4, Part 2) |
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