PCAS : Glycopyrrolate

Longjumeau, April 9th, 2014

PCAS is glad to announce that it was granted a Certification of suitability (CEP) to the Monographs of the European Pharmacopoeia for the production of Glycopyrrolate, also known as Glycopyrronium bromide, by the European Directorate for the Quality of Medicines (EDQM).

Glycopyrrolate is an old and well known muscarinic antagonist that is finding a new life because novel formulation devices are enabling improved medicines for the treatment of chronic obstructive pulmonary disease (COPD).

PCAS is the only European producer of Glycopyrrolate listed as having a CEP certificate; this certification comes to complete the American Drug Master File (US DMF) filed by PCAS with the FDA (Food and Drug Administration) on 2005 for Glycopyrrolate.

The new certification is another confirmation of the respect to quality production and strong compliance of PCAS production sites to European and international Pharmaceutical production standards known as Good Manufacturing Practices (GMP).

This event reinforces PCAS position as an Active Pharmaceutical Ingredients (APIs) supplier having worldwide regulatory filing capacity to support our customer's product development. This position is confirmed by the regular audit by several National authorities of PCAS production sites in support of the large number of products on the market and also of new product launches.

PCAS multi-clients catalogue of APIs lists more than 40 APIs produced in our four GMP compliant production sites. On the regulatory side, the products of the catalogue counts 29 US DMF, 25 European DMF, 15 European CEPs, 10 Japanese DMFs, 10 Canadian DMF among others successful regulatory filings including several new dossiers in progress in China.

Next date: 2014 Shareholder's Meeting,
at 10 a.m. on Wednesday, April 23, 2014 in Longjumeau

Founded in 1962, PCAS is an international fine and specialty chemicals group (165 million € net sales in 2013)  that shares an ambition for excellence with its customers, which primarily include market-leading international groups. PCAS designs and delivers the best industrial solutions for its customers' specific expectations. These various expectations all share a common demand for safety, quality, competitiveness, innovation and sustainability. PCAS also develops ranges of proprietary products based on intellectual property.