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Authorities confirm cGMP status for HAPILA’s Estriol estrogen API manufacturing
High-potency active ingredient specialist HAPILA GmbH (HAPILA) has received regulatory confirmation that its manufacturing facility for innovative estrogen agonist API Estriol complies with Good Manufacturing Practice (cGMP) standards.
Regulatory approval has been certified by Germany’s TLV Thüringer Landesamt für Verbraucherschutz (Thuringian State Office for Consumer Protection).
GMP certificates were awarded following a series of successful official TLV inspections and the plant will be re-inspected for every single API manufactured in strict rotation, usually every three years. Inspections focus on manufacturing activities, physical plants and facilities, quality control, and stability data programs.
The cGMP status for Estriol joins further HAPILA GMP certificates for other APIs for market supply and for a clinical development project (Phase 2).
Estriol development and manufacturing
HAPILA’s micronized Estriol was first certificated in 2013 by TLV and is widely used as a medication, primarily in hormone therapy for women with menopausal symptoms.
Confirmation of cGMP status follows a decision by the European Directorate for the Quality of Medicines & Health Care (EDQM) to issue a renewed Certification of suitability of Monographs of the European Pharmacopoeia (CEP) Certificate for Estriol as an API, micronized and manufactured at HAPILA’s Gera cGMP production facility in central Germany.
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, the basic requirement for marketing authorization submissions by pharmaceutical manufacturers seeking to use Estriol as an API.
HAPILA’s distribution partner Transo-Pharm Handels GmbH will continue to provide each Estriol customer with a valid copy of all relevant certificates as part of its basic regulatory support, making it easier to deploy Estriol as a certified ingredient in pharmaceutical products brought to market.