Aprilia (LT), 22 February – Angelini Fine Chemicals is the Business Unit of Angelini Pharma SpA, specialized in the production of active pharmaceutical ingredients (APIs) and a leader in Italy in third-party contract manufacturing (CDMO), has increased its focus on the production of high-potent active pharmaceutical ingredients (HPAPIs). The company has in fact implemented a new area of its plant in Aprilia (LT), in Lazio- Italy, with the aim of expanding its HPAPI R&D and manufacturing capacity, strengthening its portfolio for CDMO services for its current and future customers.
The new area covers approximately 120 square meters and will allow the management of HPAPI production activities in two different laboratories with batch size 0.25-5+ kg. The expansion of the plant is part of an investment of € 4,000,000 started in 2017. An area dedicated to HPAPI is added to the 3 existing laboratories dedicated to development activities for the CDMO and generic API area. The new suite includes two new areas for the separate and simultaneous management of different products.
The global pandemic has not affected the production of active ingredients, especially HPAPI used mainly in drugs and oncological treatments. According to the latest report from Transparency Market Research (TMR), the global high potent active ingredients (HPAPI) market was valued at $ 17.46 billion in 2018 with CAGR more than 8.7% from 2019 to 2027.
“High potent active ingredients will become more and more central in the world of the pharmaceutical industry,especially in the post-pandemic period in which, due to Covid-19, cancer screening has been delayed and waiting lists have lengthened – comments Giovanni De Filippo, Fine Chemicals Sales & BD Head – We believe that the expansion of our plant is timely, as it will allow us to increase the number of HPAPI programs and, even more, thanks to a “fully-integrated” strategy we will be able to follow the entire development of the molecule, from research to industrial production within our factory, optimizing time and resources “.
The increasingly important presence of high potent active ingredients and the continuous development of this sector makes it necessary to adapt production sites to ensure maximum safety in the management of molecules. It is for this reason that Angelini Fine Chemicals, in recent years, has invested in technological platforms of the highest level able to handle these products, with high standards, and to guarantee the maximum safety of its specialists. All laboratories allow the maximum containment of high potent molecules, guaranteeing workers the highest safety standard: an occupational exposure band (OEB5) that does not exceed the exposure limit of 0.1 µg / m3.
The constantly growing company also renovated its offices and chemical research and development laboratories on November 2020 to offer increasingly integrated solutions: starting from the analysis, research and development phase, passing through the scale-up and test phase. of production, up to the real industrial production destined to the final markets.
Angelini Fine Chemicals
Since 1967, Angelini Fine Chemicals is at the forefront of research, development and cGMP manufacturing of Adv. IMs., APIs and HPAPIs for Company brand business and its pharmaceutical customers & partners. Located in the industrial outskirts of Aprilia (Southern Rome Area, Italy), with 70.000 m2 cGMP manufacturing facility and cutting-edge R&D labs, Angelini Fine Chemicals is housing a wide reaction technology portfolio and scale-up capabilities to meeting small molecule outsourcing needs of pharmaceutical industry – from Proof-of-Concept to early-stage clinical lots run until cGMP commercial manufacturing, from 1-1000+kg up to MT scale.
Our continuous programs of investments in R&D and novel chemical technologies (such as Flow Chemistry and High Containment API), coupled with our 50 years of industrial chemistry experience, make Angelini Fine Chemicals an attractive and trustworthy CDMO partner on relying for expedite R&D pipeline development-to-market.
Within our manufacturing size we produce more than 300 tons of APIs for year (40% under CDMO activities).
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