Campoverde di Aprilia (Latina, Italy)
The Campoverde chemical plant manufactures several active and intermediate ingredients for the international pharmaceutical industry. It is among the most important producers in the world of Verapamil HCl, Dimenhydrinate, Tribenoside, Manidipine 2HCl and Papaverine HCl. Other pharmaceutical chemicals are produced on behalf of important pharmaceutical companies. The Campoverde chemical plant also supplies active ingredients used in the preparation of the various pharmaceutical specialties produced by the company.
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 approximately 335,000 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 cyanurations, high pressure hydrogenations, dehydrogenations, methylations, chlorine methylations, halogenations or others requiring very stringent safety measures.
Investments have been made to enhance the technological and production capacity of the plant which over the last 8 years has resulted in the installation of more than 20 new reactors, a latest generation three stage distillation unit, 2 thin film evaporations, 2 anti-acid filters for the isolation of solid products and an anti-acid dryer.
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 such as a high containment HP-API pharmaceutical isolator (glove box) and a micro reactor for the development of new continuous production processes. An extremely versatile pilot plant equipped for the small scale production of active ingredients, in accordance with cGMP (current Good Manufacturing Practices), is available.
The plant operates in compliance with current Good Manufacturing Practices (cGMP) regulations, the application of which 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 14001:2015 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 with classification H350, liquid ammonia, hydrogen, hydrogen halides, peroxyacids |
| Reductions: | Catalytic hydrogenations (homogeneous and heterogeneous systems), reactions with metal hydrides |
| Asymmetric reactions: | Transition metal catalysts, racemate resolution, use of chiral building blocks. |
| Oxidations: | Reactions with dichromates and 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 study & characterization Particle size studies & control |