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HAPILA gains ISO certification and FDA approval

news-releasesHAPILA GmbH
October 4th 2019

Gera, Germany: – High-potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) has passed two further significant milestones to ensure a high quality level for its offered services and products.

The TÜV Thüringen e.V. (Technical Supervision Association Thuringia) has granted the central German-based manufacturer DIN ISO certification for its Integrated Management System.

This allows HAPILA to be qualified as meeting the standards DIN EN ISO 9001:2015 for Quality management systems (QMS), as well as DIN EN ISO 14001:2015 Environmental management systems (EMS) and DIN ISO 45001:2018 Occupational Health & Safety (OHS) management systems.

FDA inspection

This achievement came shortly after HAPILA passed its first in-house GMP inspection by US Food & Drug Administration (FDA) for compliance with general cGMP requirements of bulk drug finished substances used for pharmacy compounding.

As well as its current EU GMP certifications for five active pharmaceutical ingredients, HAPILA is now conformed as US audited as being GMP compliant.

Integrated Management System

The DIN ISO certification covers HAPILA’s GMP compliant development, manufacturing and distribution of active pharmaceutical ingredients (APIs) as well as reference substances and API for In-vitro- diagnostic products, medical products and/or clinical samples.

Three TÜV inspectors carried out the audit over two days during July 2019, focusing on the main ISO quality management principles: customer focus, leadership, human engagement, process approach, improvement, evidence-based decision making and relationships management. HAPILA passed with no deviations. Further annual surveillance audits will verify continued effectiveness and adequacy of installed procedures and systems.

HAPILA CEO, Dr. Uwe Müller, commented: “With this new certification, we are now able to combine the GMP requirements of the EU Guideline of Good Manufacturing Practice, Part II for API manufacturing, verification and release with the requirements of the international management system standards ISO 9001, 14001 and 45001 in one Integrated Management System that can control all processes within the company.”

Continuous improvement

“In this way we can meet the needs of customers who may not require cGMP manufacturing but definitely demand high levels of assured quality, especially when it comes to reference substances and APIs for In-vitro– diagnostic products,” said Dr. Müller

He confirmed that HAPILA’s strategy was to work for continuous improvement of its management systems to ensure high process reliability under compliance with legal and regulatory requirements, as well as furthering employee development and training together with the highest health, safety and environmental (HSE) standards. All of these are vital for customer confidence.

Customer confidence

“Many customers are directed to place orders for goods and services only with suppliers who have a certified management system, whatever detailed regulatory issues apply,” noted Dr. Müller.

“The API manufacturing that forms the core of our business are primarily covered by EU GMP Guideline Part II but now customers can be sure that even projects that do not require such a regulated environment will be handled according to defined high quality standards,” he added.


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 syntheses are carried out in-house at its GMP certified laboratories at Gera, 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.

Notes on regulations

For the purposes of Germany’s AMWHV Arzneimittel und Wirkstoffherstellungsverordnung (Ordinance on Manufacture of Medicinal Products and Active Pharmaceutical Ingredients) and the EU GMP Guideline Part II, HAPILA is defined as producing, testing, storing, packaging and commercializing active pharmaceutical ingredients.

The conformity of manufacturing according to GMP requirements is specifically certified by the competent federal supervisory authority TLV Thüringer Landesamt für Verbraucherschutz (Thuringian State Office for Consumer Protection). In addition, HAPILA is regularly audited by its customers for their specific APIs.

Other activities carried out at HAPILA concern the development, manufacture and sale of reference substances and active ingredients for in vitro diagnostic products, medical devices and clinical samples.

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