<ul><li>Land area: 75,000 m²</li><li>Production: 8,000 m² </li><li>Pharmaceutical services: 2,400 m² </li><li>Analytics: 1,300 m² </li><li>Warehouse &amp; distribution: 8,300 m² </li><li>FTE: 478 </li><li>Shifts: 15/5</li></ul>

<ul><li>Production of Solids<ul><li>Powders and granules</li><li>Tablets</li><li>Film-coated tablets</li><li>Sugar-coated tablets</li></ul></li><li>Production of Semisolids<ul><li>Suppositories</li><li>Rectal suspensions</li></ul></li><li>Production of Steriles<ul><li>Terminally sterilized solutions</li><li>Aseptically manufactured solutions</li><li>Aseptically manufactured suspensions</li><li>Aseptically filled powders</li><li>Lyophilisations</li></ul></li><li>OEB 1-3</li><li>Quality services </li></ul>

<ul><li>Clinical trials manufacturing</li><li>Clinical trials packaging / distribution </li><li>Galenical development, scaling up </li><li>Development validation of analytical methods </li><li>Handling of narcotic drugs</li></ul>

<ul><li>Sterile forms<ul><li>Blisters</li><li>Bottles</li></ul></li><li>Sterile forms<ul><li>Ampoules</li><li>Vials</li></ul></li><li>Semisolid forms<ul><li>Blisters</li></ul></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>Russian MoH</li><li>Libyan MoH</li></ul></li></ul>

Technologies

Manufacturing Solids
<ul><li>Granulation<ul><li>3 high shear mixers (100-600 l) </li><li>2 fluid bed dryers (250 kg)</li><li>1 drying ovens (200 kg)</li><li>2 roller compactor (100-200 kg/h)</li><li>4 container blenders (10-1000 kg)</li></ul></li><li>Compression <ul><li>6 rotary tablet presses </li><li>3 Fette 1200</li><li>1 Fette 2090</li><li>1 Fette 2200</li><li>1 Korsch XL400 </li></ul></li></ul>
<ul><li>Coating<ul><li>4 drum coater (200 – 300 kg)</li><li>12 coating pans (120 kg)</li></ul></li></ul>
Manufacturing Sterile Technologies
<ul><li>Lyophilisation<ul><li>OPG / Klee</li></ul></li><li>Autoclaves <ul><li>3 Belimed</li></ul></li><li>Vessels (5-1200l)</li><li>Filling lines <ul><li>3 Compact lines for ampoules (1 – 20 ml)</li><li>Filling machine for sealed ampoules (1 – 10 ml)</li><li>Filling line for vials / powder (8H, 6R, 20R dumpy)</li><li>Filling line for vials / liquid (2R, 6R, 8R, 10R, 20R, 20R dumpy)</li></ul></li></ul>
Packaging
<ul><li>Sterile technologies<ul><li>3 ampoule packaging lines </li><li>3 labelling machines (for ampoules and vials)</li></ul></li></ul>
<ul><li>Inspection machines<ul><li>3 Eisai / particle-inspection (1 – 20 ml)</li><li>3 crack-inspection (1 – 50 ml)</li><li>1 particle inspection (50 ml)</li><li>1 Seidenader inspection (1-20 ml) </li></ul></li></ul>
<ul><li>Solid forms<ul><li>5 blister lines </li><li>1 bottle filling line</li></ul></li></ul>
<ul><li>Suppositories<ul><li>1 suppository filling and packaging line</li></ul></li></ul>
Quality Control
<ul><li>HPLC</li><li>GC</li><li>Photometer</li><li>Atomic absorption</li><li>RAMAN spectroscopy</li><li>NIR spectroscopy</li><li>Polarimeter</li><li>Refractometer</li><li>Conductivity</li><li>TOC</li><li>Dissolution tester</li><li>Disintegration tester</li><li>Titration</li><li>Microbiology lab</li><li>Stability chambers</li></ul>

Gronau Production Overview

Production Overview

Products

<ul><li>Agents acting on the renin </li><li>All other therapeutic products </li><li>Analgesics </li><li>Antianemic preparations </li><li>Antibacterials for systemic use </li><li>Antidiarrheals, intestinal antiinflammatory / antiinfective agents </li><li>Antiepileptics </li><li>Antihemorrhagics </li><li>Antihistamines for systemic use </li><li>Antihypertensives </li><li>Anti-inflammatory and antirheumatic products </li><li>Anti-parkinson drugs </li><li>Antiprotozoals</li><li>Antiseptics and disinfectants </li><li>Beta blocking agents </li><li>Bile and liver therapy </li><li>Blood substitutes and perfusion solutions </li><li>Cardiac therapy </li><li>Corticosteroids for systemic use </li><li>Corticosteroids, dermatological preparations </li><li>Cough and cold preparations </li><li>Drugs for functional gastrointestinal disorders </li><li>Gynecological antiinfectives and antiseptics </li><li>Laxatives </li><li>Mineral supplements </li><li>Other respiratory system products </li><li>Pituitary and hypothalamic hormones and analoques </li><li>Psychoanaleptics </li><li>Psycholeptics </li><li>Stomatological preparations </li><li>Topical products for joint and muscular pain </li><li>Urologicals </li><li>Vitamins</li></ul>

Gronau

The Aenova site in Gronau has special expertise in the development, production and packaging of tablets, suppositories and sterile liquids.

Gronau - Aenova Group

employees

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square meter

Filling Gronau Aenova

Testing vials Gronau Aenova

Development Alzheimer Gronau Aenova

Tablet press Gronau Aenova

Packaging filling plugs Gronau Aenova

Exterior view Gronau Aenova

Facts

Location Gronau, Germany 
Competence Center lyophilized steriles and conventional solids
BU Semisolids & Liquids

The Aenova site in Gronau has special expertise in the development, production and packaging of tablets, suppositories and sterile liquids. The site can look back on more than 100 years of history in the field of pharmaceutical production and development. The Gronau site manufactures solid forms, sterile forms, suppositories and rectal suspensions, packaged in blisters, bottles, ampoules and vials and offers quality services such as analytical &amp; microbiological testing; stability studies according to ICH guidelines, development and testing of packaging components, PQR as well as galenical &amp; analytical development; manufacturing / packaging / distribution of clinical studies, handling of narcotics (approval).

PR Aenova Gronau Sterile Filling Optical Control WP

Capacity increase of sterile production to 100 million ampoules and vials at Aenova's Gronau site

26/03/2021 - Capacity increase of sterile production to 100 million ampoules and vials

Gronau, 26.03.2021

<ul><li>Aenova starts up the new RABS filling line for ampoules from 1 ml to 5ml.</li><li>This is supplemented by fully automatic optical inspection and a new packaging line.</li><li>This will enable the Gronau site to produce around 100 million ampoules and vials per year. This corresponds to a capacity increase for sterile liquids of around 7%.</li></ul>
The production and filling of sterile products requires the highest level of safety and quality. Market demand for production capacity in the sterile field has also increased significantly in recent years and has been further boosted by the filling requirements of COVID19 vaccines. At its Gronau site, Aenova, a leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, has now significantly increased its ampoule capacities. With the new ampoule filling and closing line, the sixth sterile line at the Gronau site, a new fully automatic optical control line and a likewise new packaging line, a total of more than 100 million ampoules and vials can now be produced per year. Aenova's strategy is aimed at significantly expanding capacity and optimizing supply availability at several of the Group's sites.
Read more! 
<figure><img src="https://next.aenova-group.com/content/_medium/Aenova_cleaning_and_depyrogenation_ampoules_2.JPG" alt="New sterile filling line Aenova Gronau" /><figcaption>With the new sterile filling line, a total of 100 million ampoules and vials can be produced per year at Aenova in Gronau; here the cleaning and depyrogenation area. </figcaption></figure>

Haupt Pharma Wülfing modernizes the building for pharmaceutical development

Gronau, 03.08.2020

In pharmaceutical development and production, quality and safety are the central issues. This naturally also applies to buildings and their infrastructure. Haupt Pharma Wülfing GmbH, a member of the Aenova Group with over 4,300 employees worldwide and around 450 employees in Gronau, has now put the modernized development building back into operation.

Auf einen Blick

At a glance

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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