Ethanol for the pharmaceutical industry
The ethanol that meets international pharmacopoeia standards and is GMP-certified.
PharmEthyl® is designed to meet the most stringent pharmaceutical applications requiring ethanol as an active substance, excipient or solvent. PharmEthyl® products are obtained exclusively from raw materials produced in France, entirely traceable and GM-free. Production takes place in distilleries certified as compliant with ISO 9001, ISO 14001 and ISO 50001. PharmEthyl® also offers an unequalled degree of safety and controllability, and guarantees conformity to the regulations and expectations of the pharmaceutical industry and biotechnology.
Setting unexcelled standards
PharmEthyl® sets the standard for the use of alcohol as Raw Material for Pharmaceutical Applications (MRIP)]: as active principle, excipient, solvent and more. It assures conformity to four international requirement categories:
– PharmEthyl® EP: European Pharmacopoeia
– PharmEthyl® USP: American Pharmacopoeia
– PharmEthyl® ChP: Chinese Pharmacopoeia
– PharmEthyl® GMP: conforms to best practice for the manufacture of active substances. The PharmEthyl® GMP range offers an ethanol produced exclusively in Cristalco factories; these are all “Best Practice” certified and subject to regular inspection by local national medicines authorities (France’s ANSM).
When you choose PharmEthyl® you obtain comprehensive quality standards, from the classic to the most specialised (BSE/TSE, allergenic, ICH Q3C, ICH Q3D, etc). Obtained from sustainable agricultural raw materials, PharmEthyl® products are guaranteed GM-free and Kosher.
In the case of the GMP guarantee, a special bulk cleansing procedure incorporating a UV tanker test takes place before loading to eliminate the risk of contamination.
Cristalco is committed to providing a carefully-tailored service for each of our customers, whether packaging is in bulk (30,000 litres) or in smaller quantities (from 500 litres to 1000 litres). Our alcohols are delivered by road, river or sea, assuring you of a rapid response.