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Authorities confirm cGMP status for HAPILA’s Estriol estrogen API manufacturing
Gera, Germany: – 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.
HAPILA CEO Dr. Uwe Müller commented: “Confirmation of GMP compliance for Estriol is further confirmation that HAPILA can act as a highly competent long-term partner for API development and advanced manufacturing for pharma companies performing own drug development as well as generic companies, SME’s and start-ups developing new drugs who need to access API experience in the field of small molecule therapies.”
“In short, HAPILA is able not only to undertake complete synthesis development for an API but also fulfill all requirements for GMP-manufacturing of a highly sophisticated active ingredient according to the Guideline of Good Manufacturing Practice, Part II – API (Manufacturing, Verification and Release).”
“Apart from experience in GMP-related development and GMP manufacturing, HAPILA as an independent company can also offer a highly agile service that includes a full IMPD and ASMF regulated service for APIs, and very high scientific and QA-level expertise,” Dr. Müller added.
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 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
Click on HAPILA Quality Management (QM) System for further information.