The Campoverde plant mainly supplies the active ingredients used in the preparation of the various pharmaceutical specialties produced by the company, but is also an established independent producer of a number of active and intermediate ingredients for the pharmaceutical industry internationally.
It is one of the most important producers in the world of verapamil HCl, phenytoin, papaverine HCl, dimenhydrinate, tribenoside and manidipine. Other pharmaceutical chemicals are produced on behalf of important pharmaceutical companies. The facility was one of the first European plants to be inspected by the American Food and Drug Administration. The United States is one of the main markets for its production, second only to Europe.
The Campoverde site covers a surface area of 380,000 sq. m. with an installed area of 35,000 sq. m., and produces approximately 650 metric tonnes per year of finished goods with approximately 5,000 metric tonnes of semifinished goods handled internally each year. High-tech systems are employed for the management of particularly delicate processes such as the reactions which employ cyanides, high pressure hydrogenations, methylations, chloromethylations or those which involve substances which require very stringent safety measures.
Investments have been made to enhance the technological and production capacity of the plant which over the years has resulted in the installation of 12 new reactors and a latest generation three stage distillation unit. To these, over the last two years, 9 more reactors were added, four for the production of lercanidipine, five for the production of tribesonide and in 2018 a new anti-acid filter was installed for the isolation of solid products.
A vast range of technologies, skills and expertise in the field of organic synthesis is employed which allow it to quickly and effectively study new processes for the production of active ingredients, from their synthesis to purification and finishing, through the various research stages, scale up and final industrialization.
The Research and Development laboratories are fitted with the latest equipment together with an extremely versatile pilot plant equipped for the small scale production, in accordance with cGMP (current Good Manufacturing Practices), of active ingredients.
In 2016 a high containment HP-API pharmaceutical isolator (glove box) was installed in the plant’s research laboratories.
The plant operates in compliance with current Good Manufacturing Practices (cGMP) and is regularly inspected by external verifying authorities such as AIFA (Agenzia Italiana del Farmaco), FDA (Food and Drug Administration), ANVISA (the Brazilian agency), PMDA (the Japanese ministry of health), KFDA (Korean Food and Drug Administration).
The plant’s environmental management system is certified according to the UNI EN ISO 14001:2004:2015 standards by Det Norske Veritas Italia (DNV), an internationally accredited body, and is inspected on an annual basis.
Technical capabilities at Recordati manufacturing site:
| Expertise in hazardous and highly toxic chemicals handling: | sodium cyanide, phosphorus oxychloride, bromine, formaldehyde, bis-chloromethylether, methylbromide, dimethylsulfate, other H350 (former R45), liquid ammonia, peroxyacids |
| Reductions: | Catalytic hydrogenation (homogeneous and heterogeneous), metal hydrides (NaBH4, LiAIH4), Raney Nickel, hydrogen transfer |
| Asymmetric reactions: | Transition metal catalysts, racemate resolution, use of chiral building blocks. |
| Oxidations: | Peroxyacids, bichromate, other inorganic salts, dehydrogenations. |
| Reactions under special conditions: | high-temperature reactions (+250°C) high-pressure reactions (10-100 bar) |
| Purifications: | Extractions, crystallizations, distillations (in batch and continuous) |
| Solid state: | Polymorph studies Polymorph detection & characterization Particle size studies & management |