Flamma
The Fully Integrated CDMO

Many Contract Development and Manufacturing Organizations (CDMOs) have increasingly become owned by Private Equity (PE) groups in recent years. The ownership is constantly changing in the background every 3-5 years unbeknownst to most as the PE looks for their profit. As drug development and manufacturing timelines continue to grow, a stable ownership at a CDMO can be of great value. This is where Flamma, with experience dating back to its beginning in 1950, is different. The company is a privately-held, family owned business.

As a fully integrated small molecule CDMO, the Flamma Group offers a unique opportunity to accelerate development of small molecules. With the ability to leverage FDA inspected cGMP Italian production facilities along with its fully-owned Chinese facility and its US cGMP site, Flamma provides a stable, secure supply chain for Active Pharmaceutical Ingredients (APIs), New Chemical Entities (NCEs), Registered Starting Materials (RSMs) and Key Intermediates.

The consolidation in the CDMO space has left a void for many looking for CMC services. Flamma is a well-respected and highly regarded CDMO that is able to service customers with difficult and challenging projects often, but not always, involving high-value amino acids. “What separates us, as our customers say, is the refreshing way that we go about forming a true partnership,” says Kenneth N. Drew, Ph.D., the VP at Flamma USA. “We offer clients a fair price, realistic timeline, and materials delivered in spec and on time. While this sounds simple, it is increasingly difficult for many CDMOs.”

With the recent explosion of small peptide drugs, Flamma has been the go-to CDMO for those looking to move away from solid-phase syntheses as they investigate more cost effective solution-phase options for their drugs. Flamma USA offers CMC services for early-stage drug development (pre-IND tox material followed by small scale GMP material). “Flamma USA offers an easy entry point into the Flamma Group. We often work alongside Flamma Honkai (China) to help move the project along more quickly,” mentions Drew.

Reshoring has been a topic of conversation as many rethink procurement and sourcing strategies. Flamma USA provides the potential to reshore drugs of low volume whereas Flamma Italy can handle larger volumes of both APIs, RSMs and intermediates.

The ability to simplify the supply chain and pass these savings along to the customer is a strength of Flamma that makes them viable as a secondary API supplier. For instance, for a recent API, the original CDMO supplier not only was charging $2X/kg but was imposing a reservation fee, claiming that they could not guarantee the delivery without receiving the fee. They also were trying to lock the customer into a long-term supply agreement where the original CDMO was guaranteed 70 percent of this API’s business moving forward.

Flamma was able to offer the API for $X/kg. This 50 percent cost savings allowed the customer to realize that the current supplier was only interested in their bottom line and not a true partnership. Such instances of consistent, transparent communication over the years have allowed Flamma to work with many other customers to find a common ground that is benficial for both sides. “Why would any company lock themselves into long term, one-sided supply agreements with anyone is unbelievable to me. Ask yourself why your CDMO is asking for guarantees and onesided supply agreements. Perhaps it is time to realize Flamma is a CDMO that strives to better work with you as a true partner in developing your API,” concludes Drew.