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News and press releases from HAPILA

Planning for new GMP production facilities

HAPILA is ramping up its production capacity with two new GMP plants now in its manufacturing pipeline. The concept design is almost complete and includes a 240 m2 area for new GMP production facilities with a capacity of up to...[more]

HAPILA extends production capacity

HAPILA GmbH (HAPILA) has extended its production capabilities by installation of another pilot plant. The new plant has already delivered first outputs of the innovative API BTZ043 used for tuberculosis (TB) treatment. These...[more]

Authorities extend CEP certification for HAPILA’s Estriol estrogen API

Recently the EDQM (European Directorate for the Quality of Medicines & Health Care, headquarters in Strasbourg) renewed the Certificate of suitability of Monographs of the European Pharmacopoeia (CEP) for the active...[more]

Anti Tuberculosis Agent BTZ-043 commences Clinical Phase II

Since mid-November TB patients have been treated for the first time with the new substance BTZ-043 in Cape Town, South Africa. The study is being conducted in the PanACEA consortium in collaboration with the TASK Applied Science...[more]

HAPILA showcases advanced API synthesis expertise at CPhI Worldwide Frankfurt

HAPILA GmbH will again be an innovative presence at the huge CPhI Worldwide pharmaceutical fair, showcasing its abilities to develop drug substances at every step of the value chain. We will be an exhibitor in the API zone of the...[more]

HAPILA gains DIN ISO certification

HAPILA GmbH has passed a further significant milestone to ensure a high quality level for their offered services and products. The TÜV Thüringen e.V. (Technical Supervision Association Thuringia) has granted a DIN ISO...[more]

FDA Inspection Successfully Passed

In 2019 HAPILA GmbH had the first in-house GMP inspection by the American Health Authority FDA lasting several days. During this inspection our company was checked for compliance with the USFDA requirements ("facility for...[more]

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