Authorities extend CEP certification for HAPILA’s Estriol estrogen API

Gera, Germany: – High-potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) has confirmed that its estrogen agonist Estriol has been recertificated for quality and suitability as an active pharmaceutical ingredient (API).

HAPILA’s micronized Estriol was first certificated in 2015 and is widely used as a medication, primarily in hormone therapy for women with menopausal symptoms. The European Directorate for the Quality of Medicines & Health Care (EDQM) has now issued a renewed Certification of suitability of Monographs of the European Pharmacopoeia (CEP) Certificate for Estriol as an API, micronized and manufactured at HAPILA’s cGMP production facility in Gera, central Germany.

Regulatory support

The CEP certificate No. R1-CEP 2013-277 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 CEP certificate 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.

About HAPILA GmbH

HAPILA GmbH is a Contract developer and manufacturer (CDMO) that provides high-value services to pharma, biotech and fine chemicals client companies in the development and GMP manufacture of active pharmaceutical ingredients (APIs).

HAPILA is an independent company with particular experience in GMP-related development and GMP manufacturing, offering full regulated service for API (CEP, ASMF, IMPD Drug Substance) to very high scientific and quality assurance (QA) levels.

It supports the development and manufacture of drug products with sophisticated processes and in-depth experience in the API value-creation chain from synthesis through purification to particle design.

The company’s mission is to supply exclusive products of highest quality, potency and safety in compliance with GMP, occupational safety and environmental protection guidelines. All HAPILA teamwork is focused on product quality and customer satisfaction.

All HAPILA chemical synthesis including chemical-physical tests for in-process controls and release testing are carried out in-house at its GMP certified plants and laboratories at Gera, Thuringia, in east-central Germany.

When combined with purification and particle design, HAPILA’s chemical synthesis services cover the complete API value-creation chain, enabling it to be a highly efficient bridge-builder between API production and pharmaceutical end-use.

Further information at: https://www.hapila.de/en/home.html

Resources

Click on Estriol product sheet for more information.