CEP Revision extends HAPILA Estriol API retest period to 60 months

Gera, Germany: – High-potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) has welcomed a further revision of the Certification of suitability of Monographs of the European Pharmacopoeia (CEP) for Estriol that extends the minimum shelf life of this innovative API to five years.

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 revised CEP certificate (R1-CEP 2013-277 Rev 01) that extends the retest period for Estriol up to 60 months.

GMP standards

The CEP 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.

Estriol is micronized and manufactured at HAPILA’s Gera production facility in central Germany to cGMP standards.

HAPILA and distribution partner Transo-Pharm Handels GmbH  can 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 certified ingredient in pharmaceutical products brought to market.

Customer benefits

Dr. Steffen Wittmann, Head of HAPILA’s Quality Unit (QA/QC), commented: “This CEP revision is very welcome as it extends possibilities for our customers to use our API without additional testing.”

“Extension of the Estriol retest period greatly eases production planning processes for pharmaceutical customers providing significantly longer handling and storage times for this valuable API. This will both allow them to be more flexible in production processes and save them money on retests,” noted CEO Dr. Uwe Müller.

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 cGMP 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 (IMPD, ASMF) to very high scientific and quality assurance (QA) levels.

It supports the development and manufacture of drug products with patented 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 and environmental protection guidelines. All HAPILA teamwork is focused on product quality and customer satisfaction.

All HAPILA chemical synthesis is carried out at in-house at its GMP certified laboratories and pilot plants 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.

For more information, visit: https://www.hapila.de/en

Resources

Click on Estriol product sheet for more information.
Click on EDQM Monograph 01203 for certification details.