12.02.2016, 13:28
Ashland's manufacturing plant in Calvert City, Kentucky, is first U. S. excipient facility to receive EXCiPACT certification
OREANDA-NEWS. Ashland (NYSE: ASH) today announced that its Calvert City, Kentucky, facility has earned EXCiPACTTM certification for Good Manufacturing Practice (GMP). Its scope covers the manufacturing, testing and packaging of polyvinylpyrrolidone (PVP) and polyvinylpolypyrrolidone (PVPP) used as pharmaceutical excipients. According to EXCiPACT, the certifying body, this is the first U.S. excipient facility to receive certification.
Ashland has established a goal of having all of its global pharmaceutical excipient facilities certified by 2017. A leader in excipients, Ashland supplies both cellulosic and polyvinylpyrrolidone polymers to the pharmaceutical industry, along with dedicated technical expertise and support.
“This achievement reflects Ashland’s commitment to providing high-quality products and services to our customers,” said Annie Tannhauser, vice president global product regulatory and quality, Ashland. “As an industry leader, we are always challenging ourselves to be the best in the products we produce and the quality approach we use to do so.”
“The transparency and global reach of this certification program will further patient safety through consistent, global quality standards,” noted Deneen Law, global pharmaceutical marketing and innovation director, Ashland.
ExcipientFest, held in Baltimore in 2013, marked the launch of EXCiPACTTM , an independent, globally recognized certification scheme for excipient suppliers in the United States and has expanded to the global standard. Since both the U.S. Food and Drug Administration and the European Medicines Agency require that excipient suppliers be qualified by drug producers, EXCiPACTTM certification reduces the amount of time, resources and dollars associated with responding to audit requests. Multiple drug customer audit requests can be answered through one successful EXCiPACTTM audit confirming that an excipient complies with current GMP and GDP requirements.
About Ashland Specialty Ingredients
Ashland Specialty Ingredients is the leading global producer of cellulose ethers and a global leader in vinyl pyrrolidones. It offers industry-leading products, technologies and resources for solving formulation and Ashland’s EXCiPACT Certificate 2 product-performance challenges. Using natural, synthetic and semisynthetic polymers derived from plant and seed extract, cellulose ethers, vinyl pyrrolidones and acrylic polymers, as well as polyester and polyurethane-based adhesives, Specialty Ingredients offers comprehensive and innovative solutions for today's demanding consumer and industrial applications. Key customers include: pharmaceutical companies; makers of personal care products, food and beverages; manufacturers of paint, coatings and construction materials; packaging and converting; and oilfield service companies.
About Ashland
Ashland Inc. (NYSE: ASH) is a global leader in providing specialty chemical solutions to customers in a wide range of consumer and industrial markets, including adhesives, architectural coatings, automotive, construction, energy, food and beverage, personal care and pharmaceutical. Through our three business units – Ashland Specialty Ingredients, Ashland Performance Materials and Valvoline – we use good chemistry to make great things happen for customers in more than 100 countries.
Ashland has established a goal of having all of its global pharmaceutical excipient facilities certified by 2017. A leader in excipients, Ashland supplies both cellulosic and polyvinylpyrrolidone polymers to the pharmaceutical industry, along with dedicated technical expertise and support.
“This achievement reflects Ashland’s commitment to providing high-quality products and services to our customers,” said Annie Tannhauser, vice president global product regulatory and quality, Ashland. “As an industry leader, we are always challenging ourselves to be the best in the products we produce and the quality approach we use to do so.”
“The transparency and global reach of this certification program will further patient safety through consistent, global quality standards,” noted Deneen Law, global pharmaceutical marketing and innovation director, Ashland.
ExcipientFest, held in Baltimore in 2013, marked the launch of EXCiPACTTM , an independent, globally recognized certification scheme for excipient suppliers in the United States and has expanded to the global standard. Since both the U.S. Food and Drug Administration and the European Medicines Agency require that excipient suppliers be qualified by drug producers, EXCiPACTTM certification reduces the amount of time, resources and dollars associated with responding to audit requests. Multiple drug customer audit requests can be answered through one successful EXCiPACTTM audit confirming that an excipient complies with current GMP and GDP requirements.
About Ashland Specialty Ingredients
Ashland Specialty Ingredients is the leading global producer of cellulose ethers and a global leader in vinyl pyrrolidones. It offers industry-leading products, technologies and resources for solving formulation and Ashland’s EXCiPACT Certificate 2 product-performance challenges. Using natural, synthetic and semisynthetic polymers derived from plant and seed extract, cellulose ethers, vinyl pyrrolidones and acrylic polymers, as well as polyester and polyurethane-based adhesives, Specialty Ingredients offers comprehensive and innovative solutions for today's demanding consumer and industrial applications. Key customers include: pharmaceutical companies; makers of personal care products, food and beverages; manufacturers of paint, coatings and construction materials; packaging and converting; and oilfield service companies.
About Ashland
Ashland Inc. (NYSE: ASH) is a global leader in providing specialty chemical solutions to customers in a wide range of consumer and industrial markets, including adhesives, architectural coatings, automotive, construction, energy, food and beverage, personal care and pharmaceutical. Through our three business units – Ashland Specialty Ingredients, Ashland Performance Materials and Valvoline – we use good chemistry to make great things happen for customers in more than 100 countries.
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