When you consider where to have your cGMP materials made, there are many choices to go along with the many questions that you may have. At Flamma, we know that the ability to provide a reliable supply chain for the necessary raw materials and advanced intermediates is the key to our mutual success.
At our state-of-the-art cGMP production facilities, we provide the expertise needed for a trouble free production. This includes providing all relevant documents, from validation to a DMF.
These are just a few key factors that make Flamma a trusted, cost-effective manufacturing partner that has the capacity to deliver your projects.
For smaller projects, we use our cGMP Pilot Plant yet have the ability to manufacture large amounts using our cGMP Production Plant.
cGMP Production Plant
For example, our Chignolo Production Plant was originally built in 1994 but was upgraded in 2007. The addition led to a new department dedicated to the last steps involved in the production and drying of API. This facility is one of the most modern facilities in Italy.
Our facility is regularly inspected by regulatory agencies (FDA, Italian Ministry of Health -AIFA) as well as customers.
With a capacity of ~120 m3 and 26 reactor vessels ranging from 3,000 L to 8,000 L (~800 gal to ~2,100 gal) to choose from, Flamma’s Chignolo site is well equipped to move any size project forward.
The addition of Flamma Isso give Flamma 250 m3 of capacity between the two Italian sites. This gives Flamma more flexibility for their current and future customers than others.
R&D and cGMP Pilot Plant
Our Chignolo Pilot Plant was built in 2003. It is constantly maintained and improved to suit our customers and their needs.
Supported by our strong process R&D group, our pilot plant has a capacity of ~4.6 m3 (~1,200 gal). We can use a variety of reactor vessels that range from 150 to 1,600 L (~40 to 400 gal) to fit the chemistry required prior to moving to production scale. Smart use of a pilot plant can alleviate scale-up production problems.