<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>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><li>more coming</li></ul>

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

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Aenova Site Latina Sterile Area

Facts

Location Latina, Italy
Competence Center animal health products and sterile technologies

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 and large molecules Biologics. The site in Latina is one of the largest production facilities of the Aenova Group.

Aenova expert article on "Optimising the pre-filled syringe filling process"

31/07/2024 - Aenova expert article on "Optimising the pre-filled syringe filling process"

Latina, 31/07/2024

In recent years, the market demand for user-friendly injectable delivery systems has increased. 
The development of Prefilled Syringes (PFS) has piqued substantial interest in the industry, primarily due to its unique advantages. PFS, designed for self-administration, offers rapid injection efficiency and unparalleled dosing accuracy, making it a game changer in the field of injectable delivery systems. Among the currently available fill-and-finish technologies, peristaltic pump dosing and single-use filling assemblies have attracted attention as clean technologies that allow gentle product transfer and minimize shear stress on formulation. For this study, conducted at the Aenova Group’s Latina site in collaboration with the Pharmacy Department of “G. D’Annunzio” University (Chieti-Pescara), a custom-designed, single-use filling assembly made of ePTFE and silicon was utilized. This innovative assembly, chosen to minimize operator handling and connection in an aseptic environment, is high-temperature resistant, can be cleaned in place (CIP) and sterilized in place (SIP) and is resistant to mechanical stress with minimal spallation phenomenon. These features significantly contribute to its practicality and effectiveness in PFS manufacturing. The quality of the filling profile is critical to ensure dosing accuracy. Therefore, the study’s scope was to understand the influence of the filling line parameters and the geometry of the filling assembly on the filling profile and dosing accuracy. A design of experiments approach was applied, and a capability analysis was performed to evaluate statistical process control. An optimal combination of the best possible filling profile and filling speed sustainable for business purposes was identified, providing valuable insight into the challenges of PFS manufacturing. The results obtained by Aenova, set a benchmark for fill-and-finish manufacturing processes. They show that the configuration and type of materials identified can be a viable alternative for the production of biological injectables whose active ingredients are susceptible to gamma radiated materials or exposure to high levels of hydrogen peroxides. This finding ensures filling stability for extended production runs, providing crucial information for the industry. Aenova is a global leading Contract Development and Manufacturing Organization with a Competence Center for sterile technologies at its site in Latina, Italy.
The study on the topic "Optimizing the Prefilled Syringe Filling Process for Biological Molecules Using Innovative Single-Use Technologies: A Design of Experiments Approach" is published in the current issue of the renowned magazine “Pharmaceutical Manufacturing and Packaging Sourcer – Parenteral Technology Supplement 2024”.
With credits to: Pharmaceutical Manufacturing and Packing Sourcer, Parenteral Technology Supplement 2024, pages 37-41. © Samedan Ltd.
<a href="https://www.aenova-group.com/content/Aenova_Fill-and-Finish-study-on-optimized-filling-process_Parenteral-Tech-Supp-2024.pdf">Aenova Fill and Finish study on optimized filling process Parenteral Tech Supp 2024</a> 
<figure><img src="https://www.aenova-group.com/content/_medium/Aenova_Latina_PFS.jpg" data-image="565951" alt="Aenova Latina PFS"><figcaption>Manufacturing of pre-filled syringes at the Aenova Latina site</figcaption></figure>

Aenova Latina site and Edison Next strengthen partnership by continuing the energy transition

27/07/2023 - Aenova Latina and Edison Next strengthen partnership

Milan / Latina, 27/07/2023

<h5>New photovoltaic plant of more than 1 MW</h5>
Edison Next, an Edison Group company that accompanies customers and territories on their path to decarbonization and energy transition, and Haupt Pharma Latina, member of the Aenova Group, that is among the world leaders in the pharmaceutical field, take another important step along the road to decarbonization of the Borgo San Michele production site in Latina, which, with 600 employees and 40,000 square meters of floor space, is one of the largest in the entire Aenova Group and is located in an area considered the pharmaceutical hub of Lazio. Specifically, Edison Next, under a 15-year contract signed with Aenova, will be responsible for the design, installation, maintenance and operation of a new 1.135 MW solar tracking photovoltaic plant to be installed on the ground within the production perimeter of the Latina site. The plant, which will be commissioned by the end of the year, will be capable of producing more than 2,000 MWh per year. The new photovoltaic plant, built under a PPA (Power Purchase Agreement) formula, will have an area covering about 4,800 square meters and will consist of 10 inverters and more than 1,800 modules, mounted on solar tracking support structures with a north-south orientation. "The construction of this photovoltaic plant represents a further step in the path begun a few years ago together with Aenova with the aim of improving the sustainability and energy autonomy of the Latina site," says Marco Steardo Director of Industry at Edison Next. "Photovoltaics represent a strategic resource for the energy transition of companies. It is a well-established and mature technology that can ensure immediate benefits in terms of, both environmental impact and energy cost reduction. In fact, self-producing renewable energy also means increasing one's independence from the grid by decreasing one's exposure to price volatility." "Environmental sustainability combined with economic levers are the key to our future, as a company, as a relationship with our territory. We have a responsibility to improve year after year and to look to future generations," says Paolo Abbate, managing director of Haupt Pharma Latina, member of the Aenova Group. "The partnership with Edison Next is a virtuous example of how common goals can make Europe and our customers create synergies and bring competitiveness. It is a positive model to be replicated on many other challenges of innovation and technological improvement." The share of self-consumption of renewable electricity produced by the photovoltaic system built by Edison Next will be about 80%. The remaining portion that is not self-consumed will be fed into the grid. This plant represents a new piece in the journey that Edison Next and Aenova began together almost a decade ago with the goal of increasing energy independence and decreasing the environmental impact of the Latina site. This photovoltaic plant will make it possible to meet 23 percent of the plant's electricity needs, taken to date from the grid, through renewable sources and, adding to other energy solutions already implemented by Edison Next, will make it possible by the end of the year to meet a substantial portion of the site's energy needs through self-generation. The result will be an estimated reduction in atmospheric emissions of 746 tons of CO2 per year.(1) (1) Total avoided emissions are equal to the difference between emissions for thermoelectric production from fossil sources and emissions for production from photovoltaics (equal to 0). Emissions from thermoelectric production are calculated by multiplying the expected electricity production by the emission factor of the Italian thermoelectric fleet as defined in ISPRA environmental reports.
<figure><img src="https://www.aenova-group.com/content/news/_medium/Aenova_Latina_Site.jpg" data-image="558218" alt="Aenova Latina site in Italy"><figcaption>Aenova Latina site in Italy (Photo: Aenova)</figcaption></figure>

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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