The new Directive 2004/27/EC determines that pharmaceutical companies manufacturing API (Active Pharmaceutical Ingredients) must select starting material suppliers who guarantee GMP compliance.

 

To date, esco has made all necessary changes to existing installations and quality systems to ensure their compliance with the ICH Q7A, as per the note regarding APIs in part II, volume 4, on the manufacturing of medication products.

 

API-NaCl™, pyrogen free, is ideally suited for applications such as parenteral dosage forms and peritoneal dialysis solutions.

 

Product Information:

API-NaCl Pharmacopoeia Grade API Sodium Chloride, pyrogen free,
e.g. dosage forms for enteral and parenteral nutrition and peritoneal dialysis solutions

API-NaCl™ is available in 25kg and 50kg paper bags with PE coated inliners as well as in 1000kg bigbags.