The certificate awarded by the non-profit organization EXCiPACT attests that adhesives are manufactured and distributed as pharmaceutical excipients at the Henkel facilities in Salisbury and Drogenbos in accordance with EXCiPACT’s guidelines for good manufacturing practice (GMP) and good distribution practice (GDP). EXCiPACT offers an independent, high-quality certification system specifically for this area of the pharmaceutical industry. It is accepted by all important stakeholders, including the EU, the US Food and Drug Administration and the British Medicines and Healthcare products Regulatory Agency (MHRA).
Mar 26, 2024 Düsseldorf / Germany
Quality that sticks around: Henkel facilities receive EXCiPACT certificate as suppliers of pharmaceutical excipients
Two facilities, one commitment to quality: With more than 60 years of experience in polymerization Henkel Adhesive Technologies is a leading global provider of acrylic polymers for transdermal drug delivery. This comprehensive know-how has now been recognized with a quality seal for the second time. Henkel’s Salisbury, North Carolina, facility in the United States has now received the EXCiPACT certificate. The company’s Drogenbos site in Belgium has been EXCiPACT-certified since 2021.
Both Henkel facilities specialize in the production of pressure-sensitive adhesives (PSAs) and polyisobutylene (PIB). PSAs are used in the administration of drugs via transdermal patches. PIB is used to produce medical adhesives for the treatment of wounds, drug coatings and packaging materials for pharmaceuticals. Henkel Adhesive Technologies offers a broad range of more than 25 excipients for the pharmaceutical industry. The acrylic adhesives Duro-Tak and Gelva are used in over 50 approved patches that are sold worldwide. They are skin-friendly, exhibit good adhesion and also offer the desired solubility characteristics for a wide range of drugs.
“For many years now, we have been an active member of IPEC-Americas, an association that develops quality, safety and functionality standards for the pharmaceutical industry. The EXCiPACT certificate sends another strong signal to our customers that we are meeting the standards required by the pharmaceutical industry,” says Nilhan Savant Kayaci, Global Director of Drug Delivery Polymers at Henkel. “Our goal here is to further strengthen our customers’ trust in Henkel. The EXCiPACT certificate highlights our leading role in the production of excipients and our commitment to manufacturing high-quality products.”
Salisbury and Drogenbos serve North America and Europe, the dominant markets of the pharmaceutical industry. “Production capacities at both facilities are currently able to meet the global demand for pressure-sensitive adhesives in accordance with IPEC-GMP guidelines. Looking forward, we aim to expand the business to other regions such as the Asia-Pacific region as well,” says Vijay Ramachandran, Vice President Key Accounts North America at Henkel Adhesive Technologies.
Two Henkel facilities in Salisbury, North Carolina, USA, and Drogenbos, Belgium, specializing in the production of pressure-sensitive adhesives (PSAs) and polyisobutylene (PIB), have received EXCiPACT certification.
The certificate attests that adhesives are manufactured and distributed as pharmaceutical excipients in accordance with EXCiPACT’s 2021 guidelines for good manufacturing practice (GMP) and good distribution practice (GDP).
