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Authorities extend CEP certification for HAPILA’s Estriol estrogen API

 

Recently the EDQM (European Directorate for the Quality of Medicines & Health Care, headquarters in Strasbourg) renewed the Certificate of suitability of Monographs of the European Pharmacopoeia (CEP) for the active pharmaceutical ingredient Estriol, micronised Ph. Eur. manufactured at HAPILA site (R1-CEP 2013-277). The Estriol, micronized was first certificated in 2015 and is widely used as a medication, primarily in hormone therapy for women with menopausal symptoms.

Regulatory support

The CEP certificate confirms that HAPILA’s Estriol quality corresponds to the quality described in the corresponding monograph of the European Pharmacopoeia. This is a basic element required for marketing authorization submissions by pharmaceutical manufacturers seeking to use Estriol as an API.

HAPILA and distribution partner Transo-Pharm Handels-GmbH will continue to provide each Estriol customer with a valid copy of the certificate as part of its basic regulatory support, making it easier to deploy Estriol as a API in pharmaceutical products brought to market.

International marketing  

Dr. Uwe Müller, HAPILA’s CEO, commented: “The EDQM certificate CEP is recognized by all 38 Member States of the European Pharmacopoeia Convention and a number of other countries, extending far beyond the EU.”

“This renewed certification therefore confirms that HAPILA is able to act as an expert and responsible development partner for customers worldwide,” said Dr. Müller.

“To obtain CEP certification from the EDQM, manufacturers are required to submit detailed description of the manufacturing process and a full impurity profile. The granted CEP certifies that the active substance is adequately controlled by means of the monograph of the Ph. Eur. This uniform control system simplifies trade in pharmaceutical active substances, as pharmaceutical companies and pharmaceutical authorities can rely on the CEP for marketing authorizations worldwide,” he explained.