The supplier of specialty substances and formulation options for the pharmaceutical and private care industries has validated the manufacturing of eight substances at its Lufkin, Texas facility.
In concrete phrases, three pharmaceutical excipients and 5 beauty substances [1] have achieved manufacturing equivalency, marking a key milestone within the firm’s technique to increase regional manufacturing whereas making certain constant high quality and dependable provide worldwide.
Formally inaugurated in September 2025, Gattefossé’s first manufacturing unit in North America has already achieved the EXCiPACT® certification (GMP) for pharmaceutical merchandise and EFfCI certification for private care merchandise.
Every validation is supported by an entire technical equivalence file, together with analytical validation, stability knowledge, and regulatory documentation to make sure seamless integration into clients’ growth and commercialization packages.
“The validation of our first substances at our Lufkin facility is a significant achievement for our portfolio. Collectively, these eight excipients present formulators with dependable options to handle right this moment’s formulation challenges. By localizing the manufacturing of essential lipid-based excipients, we’re instantly answering our companions’ want for provide chain resilience and reliable home sourcing in an more and more unpredictable world market,” explains Ben Blinder, Chief Working Officer at Gattefossé USA.
By establishing large-scale oleochemical manufacturing in america, Gattefossé intends to increase its capabilities whereas serving to its clients navigate present provide chain challenges.
The Lufkin web site is supported by Gattefossé’s world community of Technical Facilities of Excellence, situated in america (Paramus, New Jersey), France, India, and China.
