<ul><li>Size of the site: 12,000 m² (total floor area) </li><li>Production: 3,506 m²</li><li>Packaging: 3,966 m² </li><li>Goods receipt and storage: 3,240 m² </li><li>Analytics: 877 m² </li><li>Formulation development/ clinical trials: 200 m² </li><li>FTE: 414 </li><li>Shifts: 15/5</li></ul>

<ul><li>Production of Solids<ul><li>Tablets</li><li>Powder and granules</li><li>Hardcapsules</li><li>Film coated tablets</li></ul></li><li>Semisolids<ul><li>Gels</li><li>Creams</li><li>Pastes</li><li>Ointments </li></ul></li><li>Non sterile Liquids<ul><li>Solutions</li><li>Suspensions</li></ul></li><li>OEB 1-5, incl. narcotics and hormones</li><li>Quality service</li></ul>

<ul><li>Handling of cytotoxic / cytostatic and high potent solid dosage forms</li><li>Fully cGMP compliant analytical and pharmaceutical development</li><li>Manufacture of clinical trial material and small-scale commercial production</li><li>Project management and corporate activities (e.g. RFQ, R&amp;D sales, IP &amp; portfolio management)</li><li>Technolgy transfer</li><li>Lifecycle management</li></ul>

<ul><li>Tablets (blister)</li><li>Tablets (bottles)</li><li>Liquids in bottles</li><li>Semisolids in bottles</li><li>Tubes</li><li>Dispensers</li><li>Integrated serialization &amp; aggregation</li></ul>

<ul><li>Manufacturing licenses<ul><li>EU GMP </li></ul></li><li>Non EU-GMP certificates<ul><li>US FDA </li><li>ANVISA </li><li>Belarusian Health Authority</li><li>Japanese FDA</li><li>Kenyan Health Authority</li><li>MFDS (Korea)</li><li>Russian MoH </li><li>FDA Saudi Arabia </li><li>Turkish MoH</li><li>Uganda MoH </li></ul></li></ul>

<ul><li>Rx</li><li>OTC</li><li>Food Supplements</li><li>COSM</li></ul>

Technologies

<ul><li>Equipment:<ul><li>7 tablet presses</li><li>3 capsule fillers (Hard Shell)</li><li>2 fluid bed granulators</li><li>6 drying ovens</li><li>4 roller compactors</li><li>4 large scale mixing &amp; homogenization vessels for SEL</li></ul></li></ul>
<ul><li>Coating<ul><li>3 film coating suites</li></ul></li><li>Packaging<ul><li>7 blister lines</li><li>5 bottle filling lines</li><li>5 filling lines for semisolids</li><li>2 filling lines for liquids</li></ul></li></ul>
<ul><li>Quality Control<ul><li>19 HPLC</li><li>5 Disso-tester</li><li>Franz-Zelle</li><li>2 RAMAN spectrometers</li><li>Own microbiological lab</li><li>several stabilities chamber</li></ul></li></ul>

Products

<ul><li>Anesthetics</li><li>Antidiarrheals, intestinal antiinflammatory / antiinfective agents</li><li>Antigout preparations</li><li>Anti-inflammatory and antirheumatic products</li><li>Antineoplastic agents</li><li>Anti-parkinson drugs</li><li>Antiprotozoals</li><li>Cardiac therapy</li><li>Corticosteroids for systemic use</li><li>Corticosteroids for topical use</li><li>Cytostatics / Cytotoxics</li><li>Digestives, including enzymes</li><li>Diuretics</li><li>Drugs for acid related disorders</li><li>Drugs for functional gastrointestinal disorders</li><li>Emollients and protectives</li><li>Endocrine therapy</li><li>Gynecological antiinfectives and antiseptics</li><li>Immunosuppressants</li><li>Preparations for treatment of wounds and ulcers</li><li>Psycholeptics</li><li>Sex hormones and modulators of the genital system</li><li>Stomatological preparations</li></ul>

Regensburg

The Aenova Group site in Regensburg with its special environment is one of the leading HPAPI development, production and packaging facilities for high potent solids.

The Aenova site in Regensburg has special expertise in the field of customized development, production and packaging of highly potent...

Regensburg - Aenova Group

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Tablet press Regensburg Aenova

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Facts

Location Regensburg, Germany 
Competence Center high potent solids (oncology) – conventional solids - specialty semisolids & liquids
BU Solids

The Aenova Group site in Regensburg with its special environment is one of the leading HPAPI development, production and packaging facilities for high potent solids: 

<ul><li>Capsules, tablets and film coated tablets</li><li>From small to large scale (0,5 to 500kg)</li><li> Covering complete lifecyle from development to commercial supply for Capsules, Tablets &amp; Film Coated Tablets</li></ul>
The Aenova site in Regensburg is a state-of-the-art facility paired with high flexibility.
Strategic expansions will enable the site's production capacity to double within the next years.

PM Aenova RGB New Press EN vf HP

Aenova increases capacity for tablet production in the area of highly potent, hormone-containing active ingredients

02/02/2021 - Aenova increases capacity at Regensburg site to almost 1m. tablets per hour

Regensburg, 02.02.2021

Aenova expands production of highly potent oncology drugs (up to OEB 5) with new tablet press. The fully automatic, online and process integrated control significantly increases process efficiency and enhances safety and product quality. This will enable the output of tablets for cytostatics, immunosuppressants and hormone-containing preparations at the Regensburg site to be increased to almost 1 million tablets per hour.

In COVID-19 times: Haupt Pharma Amareg produces disinfectant for
the city of Regensburg

In COVID-19 times: Haupt Pharma Amareg produces disinfectant for the city of Regensburg

Regensburg, 03.06.2020

Haupt Pharma Amareg GmbH, a member of the Aenova Group, has been supporting the city of Regensburg with disinfectants since the beginning of the Corona crisis. Since March 2020, 12,000 liters have already been delivered.

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Jan Kengelbach

Ralf Schuler

Michael Ammann

Tim Bauer

Christine Beck

Florent Bordet

Dr. Macniell Esua

Dr. Mike Schäfers

Dr. Mike Schaefers

Roel de Nobel

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