Dow Attains Certificate of Suitability (CEP) Designation for CARBOWAX™ SENTRY™ PEG 3350 and 4000 Products
The Dow Chemical Company has received Certification of Suitability (CEP) from the European Directorate for the Quality of Medicines Agency for its line of CARBOWAX™ SENTRY™ Polyethylene Glycols (PEGs).
The solid grades of CARBOWAX™ SENTRY™ PEG 3350 and 4000 attained CEP authorization on September 29, 2006 for use in PEG based laxative and colonic lavage applications. This CEP offers an attractive alternative to Dow’s country specific European Drug Master Files (DMF) which require API customers to file country-by-country as they expand their products’ marketing authorizations into additional European Union (EU) countries. The certification provides Dow with an EU-wide registration which was granted upon review and approval of Dow’s CARBOWAX™ SENTRY™ PEG 3350/4000 CEP dossier.
“As the world leader in pharmaceutical grade PEG’s, we do everything possible to make the use of these materials as easy as possible, and that includes the reduction of paper work this designation helps facilitate,” said Frank Cosmi, Dow’s global business director for Polyglycols and Surfactants. “We are very pleased to have earned this designation. Our commitment to the quality and purity guidelines required by the European Pharmacopoeia (EP) will help to facilitate further growth for our customers in Europe.”
This designation comes at the same time Dow plans to expand its manufacturing capacity for CARBOWAX™ SENTRY™ PEGs at its St. Charles, Louisiana plant by approximately 30% before the end of 2008.
The European Directorate is one of the major institutions involved in the regulation and quality control of medicinal products authorized for use in Europe, and oversees the European Pharmacopoeia (EP). The EP contains monographs/standards for nearly 2,000 active pharmaceuticals and other ingredients used to prepare medicines in Europe. All medicines sold in the 36 Member States of the European Pharmacopoeia must comply with these compendial standards in order to be authorized for use in Europe.
Dow is a diversified chemical company that harnesses the power of innovation, science and technology to constantly improve what is essential to human progress. The Company offers a broad range of products and services to customers in more than 175 countries, helping them to provide everything from fresh water, food and pharmaceuticals to paints, packaging and personal care products. Built on a commitment to its principles of sustainability, Dow has annual sales of $49 billion and employs 43,000 people worldwide. References to “Dow” or the “Company” mean The Dow Chemical Company and its consolidated subsidiaries unless otherwise expressly noted.
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