<ul><li>Penicillin Sterile<ul><li>Powder for injection</li><li>Liquid in vials</li><li>Suspensions in plastic syringes or PFS</li></ul></li><li>Cephalosporin sterile<ul><li>Powder for injection</li><li>Suspensions in plastic syringes</li></ul></li><li>Conventional sterile<ul><li>Liquid in vials / PFS</li></ul></li><li>Penicillin oral solids<ul><li>Tablets</li><li>Capsules</li><li>Dry powders</li></ul></li><li>Conventional oral solids<ul><li>Tablets</li><li>Capsules</li><li>Dry powders</li></ul></li><li>Oral solids parasiticides tablets</li><li>Quality and regulatory services</li><li>OEB 1-3</li><li>Quality services </li></ul>

<ul><li>Technology transfer</li><li>Project management</li><li>Analytical methods</li><li>Stability studies (ICH program)</li><li>Engineering service</li><li>Process validation/qualification</li><li>Product development</li><li>Regulatory support</li><li>Testing and EU batch release</li><li>Dossier writing and update</li><li>Artwork development</li></ul>

<ul><li>Full capabilities for:<ul><li>Plastic syringes</li><li>PFS</li><li>Vials</li><li>Bottles</li><li>Blisters</li><li>Sachets</li></ul></li><li>Repackaging activities</li><li>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>SFDA </li><li>Russian Health Authorities</li><li>Turkish Health Authorities</li></ul></li></ul>

Technologies

<h5>Equipment</h5>
<ul><li>Mixer: 5 bin tumbler, 1 Rotomix</li><li>Granulation<ul><li>1 high shear granulation &amp; microwave vacuum drying</li><li>1 granulation (low shear and dry)</li><li>1 Fluid bed dryer (40 to 60 kg/batch)</li></ul></li><li>Compressing: 9 tableting machines</li><li>Capsule filling: 2 machines</li><li>7 sterile mixers</li><li>9 autoclaves</li><li>5 coating Pans</li><li>Fill&amp;Finish Suite for PFS and Vials</li></ul>
<div>Packaging</div>
<ul><li>6 blistering lines</li><li>3 strips packaging</li><li>1 pouching line</li><li>4 bottle filling lines</li><li>4 sterile vial filling lines</li><li>3 syringe filling lines</li><li>2 PFS</li><li>4 secondary packaging lines</li></ul>
<div> </div>
<div>Quality Control</div>
<ul><li>18 HPLC systems</li><li>1 UPLC system</li><li>1 dissolution test system </li><li>2 gas chromatographs</li><li>1 content uniformity test system</li><li>6 citration system</li><li>1 particle size analyzer</li><li>2 FTIR spectrophotometers</li><li>12 stability chambers</li><li>12 incubation chambers</li><li>1 NIR spectrophotometer</li><li>1 UV spectrophotometer</li><li>1 XRay spectrophotometer</li><li>1 fluorine spectrophotometer</li><li>1 Micro-organism identification system</li><li>1 Cinetic chromo-genic endotoxin identification</li><li>1 Previ color gram</li><li>2 (Trinity &amp; Combistat) microbiological assay</li></ul>

Latina Production Overview

Production Overview

Products

<ul><li>Anthelmintics</li><li>Antibacterials for intramammary use</li><li>Antibacterials for systemic use</li><li>Antibiotics and chemotherapeutics for dermatological use</li><li>Antifungals for dermatological use</li><li>Anti-inflammatory and antirheumatic products</li><li>Combination of antibacterials for intramammary use</li><li>Drugs for acid related disorders</li><li>Endectocides</li><li>Lipid modifying agents</li><li>Otologicals</li><li>Psychoanaleptics </li></ul>

Codice Etico

<a href="https://www.aenova-group.com/content/Codice_Etico_Haupt_Latina.pdf" target="_blank" rel="noreferrer noopener">Codice Etico Aenova Latina (Haupt Pharma Latina Srl)</a>

Latina

The Aenova site in Latina produces and distributes pharmaceutical products over the world for human and veterinary use.

Haupt Pharma Latina S.r.l. A Socio Unico produces and distributes pharmaceutical products. The company offers antibiotics including...

Latina - Aenova Group

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Sterile bottles Latina Aenova

New sterile area Aenova Latina

Tablet press Latina Aenova

Steriles Latina Aenova

Beta lactams Latina Aenova

Quality control syringes Latina Aenova

Packaging line Latina Aenova

Exterior view Latina Aenova

Aenova Site Latina Sterile Area

Facts

Location Latina, Italy
Competence Center animal health products and sterile technologies
BU Semisolids & Liquids

The Aenova site in Latina produces and distributes pharmaceutical products over the world for human and veterinary use. Covered business segments are
<ul><li>F&F of Biologics and Small Molecules</li><li>Betalactam Sterile Fillings</li><li>Penicillins Oral Solids </li><li>Conventional Oral Solids</li><li>Oral Solid Parasiticides</li></ul>
With many strategic investments we enhance capacity and capabilities in the site, e.g. with the new Fill&Finish Suite for PFS and Vials for small molecules API up to OEB-3 and large molecules Biologics up to BSL-2. The site in Latina is one of the largest production facilities of the Aenova Group.

Aenova site in Latina, Italy, among the winners of the Premio Industria Felix

01/12/2021 - Aenova among the winners of the Premio Industria Felix

Latina, 01/12/2021

The Premio Industria Felix was awarded to the 160 best Italian companies by industry on Nov. 25, 2021 in Rome. The Aenova site in Latina, Haupt Pharma Latina S.r.l., is among the award winners. The award was presented in a ceremony at the University Luiss Guido Carli in Rome. Industria Felix recognizes the success of Italian excellence and pays particular attention to sustainability and growth. We are very pleased to be among the award winners and to see our work recognized in such an illustrious environment. You can read more here (article in Italian). <a href="https://www.ansa.it/pressrelease/economia/2021/11/30/il-premio-industria-felix-a-160-top-imprese-italiane-_578567a3-7b7c-4b10-a02f-6eb6821ce5c4.html" target="_blank">Here you can read more</a> (article in Italian language).
<figure><img src="https://www.aenova-group.com/content/navigation/_medium/gruppo-chimiche-e-farma.jpg" data-image="543271" alt="Premio Industria Felix award ceremony in the &quot;Chemicals & Pharmaceuticals&quot; category"><figcaption>Premio Industria Felix award ceremony in the "Chemicals & Pharmaceuticals" category (Foto: IFM)</figcaption></figure>

New Video: The New Sterile Area with Fill & Finish of Biologics at Aenova Latina site

23/11/2021 - New video: the brandnew fill&finish area Aenova Latina

Latina, 23/11/2021

Aenova has significantly expanded its sterile fill and finish capacity at its Italian site in Latina. The new state-of-the-art aseptic production area features a completely new high-speed flexible line for vials and prefilled syringes (PFS) as well as a brand new compounding area. This area provides capacity for more than 80 million vials and over 180 million prefilled syringes, targeting vaccines and biologics. Further capacity expansions to a total of up to four high-speed filling lines are also being planned.
Get the newest insights! Watch <a href="https://www.aenova-group.com/content/company/sites/latina/bildgalerie/Aenova_Latina_Sterile_Area_Imagefilm.mp4">the video here</a>. 
<figure><a href="https://youtu.be/ZScUPc-DV0g" target="_blank"><img src="https://www.aenova-group.com/content/navigation/_medium/New_sterile_area_Aenova_Latina_2.jpg" data-image="541925" alt="New Fill&Finish Line in Latina"></a><figcaption>New sterile area at Aenova Latina site</figcaption></figure>

PM Aenova Neuer Sterilbereich

New sterile Fill and Finish area for vials and prefilled syringes at Aenova

19/10/2021 - New sterile Fill and Finish area for vials and prefilled syringes at Aenova

Latina, 19/10/2021

Aenova has significantly expanded its sterile fill and finish capacity at its Italian site in Latina. The new state-of-the-art aseptic production area features a completely new high-speed flexible line for vials and prefilled syringes (PFS) as well as a brand new compounding area. This area provides capacity for more than 80 million vials and over 180 million prefilled syringes, targeting vaccines and biologics. Further capacity expansions to a total of up to four high-speed filling lines are also being planned.
This first high speed flexible line can process both vials and PFS products in the preferred formats of 0.5 to 10 ml for prefilled syringes and 2 to 10 ml for ready-to-use vials. Quality control, packaging and labelling, including serialisation, complete the scope of supply. "With this expansion of our aseptic offering, Aenova becomes a Premier Solution Partner for sterile technologies," said Florent Bordet, Senior Vice President of Aenova's Sterile &amp; Liquid Business Unit.
The Aenova site in Latina, one of the largest production sites of the Aenova Group with around 600 employees, produces and distributes pharmaceutical products worldwide. Different buildings in the facility allows to be in the market with a broad site portfolio which includes injectable and oral solids for conventional medicines. "We are very proud that with the new sterile filling line we will be able to make a major contribution to the global supply of vaccines and high-value biologics like recombinant proteins or monoclonal antibodies " explains Paolo Abbate, Managing Director of Haupt Pharma Latina S.r.l., a member of the Aenova Group.
"Aenova is thus positioning itself as a provider of differentiated technologies with development and high-volume production capacities for small molecules as well as biologics," explains Jan Kengelbach, CEO of Aenova Group. "With an investment volume of around 16 million euros, the Latina plant is one of the larger investment projects that the Aenova Group is currently rolling out," adds Jan Kengelbach.Meet Aenova at CPhI worldwide from 09 to 11 November 2021 at Fiera Milano, Italy, at booth 2C20, hall 2. <figure><img src="https://www.aenova-group.com/content/navigation/_medium/New_sterile_area_Aenova_Latina_2.jpg" alt="New sterile area in Latina" /><figcaption>Sterile production at Aenova, site Latina: fill&amp;finish of biopharmaceuticals like COVID-vaccines. (Photo: Aenova).</figcaption></figure>

PR Aenova Latina new injectable vials

Aenova significantly expands capacity for Fill&Finish of Vaccines and Biologics

07/05/2021 - Aenova significantly expands capacity for Fill&Finish of Vaccines and Biologics

Latina, 07/05/2021

In order to expand its fill and finish capacity for the production of Biologics and especially BSL1 and BSL2 vaccines against the SARS-CoV-2 virus, the Aenova Group is currently building a new sterile production area at its site in Latina, Italy. With an investment volume of more than 16 million euros, the focus is on a new "Fill and Finish" area for vials and prefilled syringes (PFS) with high-speed filling lines including compounding. The first line to be installed has a capacity of more than 80 million vials (glass and plastic) and over 180 million prefilled syringes per year. Aenova is also planning a phased capacity expansion of this new area with up to three additional high-speed filling lines.
As one of the world's leading contract developer and manufacturer, Aenova has many years of experience in the production of sterile injectables - from pre-filled syringes and ampoules to liquid vials, lyophilized vials and aseptic powder vials (powder filling in vials), also for biological preparations and Bio Safety Level 1 and 2 (BSL) vaccines such as mRNA, DNA, viral vectors, protein subunits, virus-like particles and inactivated vaccines. The new sterile area is based on state-of-the-art technology: the aseptic filling process is fully automated, the multi-purpose machine can process vials as well as PFS products in the preferred formats 0.5 to 10 ml for prefilled syringes and 2 ml to 10 ml for ready-to-use vials. Quality control, packaging and labeling, including serialization, complete the scope of supply. "This investment is a major step in positioning Aenova as a provider of differentiated technologies, development and high-volume manufacturing capabilities for small molecules and biologics," explains Jan Kengelbach, CEO of Aenova Group. “With this expansion in large volume vials and pre-filled syringes to complement its existing offering in ampoules, liquid and lyophilized vials, Aenova is becoming a Premier Solution Partner for sterile technologies”, says Florent Bordet, SVP Sterile &amp; Liquid Business Unit. The Aenova site in Latina, one of the largest production facilities in the Aenova Group with around 600 employees, produces and distributes pharmaceutical products for human and animal health worldwide. This new sterile offering will complement a broad site portfolio in human and animal health that includes oral solids for conventional drugs, injectables and oral solids for beta-lactam antibiotics and chewable tablets for parasiticide compounds. "We are very proud that we, as Aenova Group, will now be able to contribute greatly to the containment of the pandemic in the future," explains Paolo Abbate, Managing Director of Haupt Pharma Latina S.r.l., Member of the Aenova Group.
<figure style="float:left;width:400px;max-width:400px;margin-left:10px;margin-right:10px;"><img src="https://www.aenova-group.com/content/navigation/_medium/Aenova_Filling_Aseptic_Injections_Latina.png" alt="Sterile production at Aenova, site Latina" /><figcaption>Sterile production at Aenova, site Latina: fill&amp;finish of biopharmaceuticals like COVID-vaccines. (Photo: © Marchesini Group).</figcaption></figure>

COVID: new aseptic filling line at Aenova in Latina (IT)

01/03/2021 - New filling line for vaccines at Aenova in Latina

With the new aseptic filling line at Aenova in Latina we link to an article in the Italian press (teaser in English see below):
<a href="https://www.ilsole24ore.com/art/vaccini-infialamento-e-produzione-ecco-aziende-che-possono-farlo-italia-AD3x2VLB" target="_blank" rel="noreferrer noopener">Vaccini, infialamento e produzione: ecco le aziende che possono farlo in Italia - Il Sole 24 ORE</a> 
Haupt Pharma of Latina is preparing the conversion of a department
"This is an investment of over 15 million euros - explains the managing director Paolo Abbate - which will allow us to fill up medicines in liquid form, starting with vaccines. On the front of the fight against Covid we will be able to inflate both vaccines with adenovirus such as that of Astrazeneca and with messenger RNA such as that of Pfizer and Moderna ". 
Haupt Pharma Latina is member of the Aenova Group.

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