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CEP Revision extends HAPILA Estriol API retest period to 60 months

[Translate to Englisch:] Molekularstruktur von Estriol

23 June 2022

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

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.

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.