February 17, 2016 - Dalton Pharma Services, a leader in the manufacture and development of cGMP Active Pharmaceutical Ingredients (APIs) is pleased to announce that it has self-identified with the United States Food and Drug Administration (USFDA) under the Generic Drug User Fee Amendment of 2012 (GDUFA). As required by GDUFA, the company has self-identified as an API manufacturing, testing and packaging facility and is now on FDA's list of registered facilities for 2016.
Dalton manufactures innovative, complex and specialized APIs for low volume generic products. In the near future, Dalton is anticipating a pre-approval inspection (PAI) by the FDA. A PAI includes a systematic review of the manufacturing facility, and product file, for products in the last stages of the approval process. Peter Pekos, President and CEO of Dalton commented: "As the supply chain for API's has become Globalized a harmonized approach to safety and security of supply has been, and continues to be, a high priority. GDUFA is an important regulatory measure designed to deal with this challenge by ensuring that all sites that produce API's sold into the USA are identified and registered. We are pleased to be in compliance with it."
The rapid globalization of the drug supply chain has challenged regulators in their efforts to keep track of where API's and their starting materials are manufactured. Manufacturers play a key role in ensuring that all aspects of API production is carried out compliantly and with traceability.
Health Canada licences and inspects API manufacturing sites regularly under the Drug Establishment Licencing Program. Dalton is a licensed and inspected manufacturer of API's in Canada according to GUI-0104. Compliance with these regulations ensure the overall quality and consistency of APIs, and the subsequent finished dosage form.
The Generic Drug User Fee is mandatory for all facilities that manufacture both finished drug products and active pharmaceutical ingredients used in generic drugs. Under GDUFA, FDA can deem all generic drug products, including active pharmaceutical ingredients, manufactured in facilities that have not self-identified as misbranded and all such products can be denied entry into the US market. According to the FDA's website, GDUFA "will enhance global supply chain safety by requiring that generic drug facilities and sites around the world use a self-identification process to include the source of all materials used in the manufacturing of generic drugs". GDUFA is designed to speed access to the public of safe and effective generic drugs and reduce costs to the industry. For a complete 2016 list of self-identified generic drug facilities, sites and organization companies under GDUFA for 2016 please visit: http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm352238.htm
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a leading cGMP contract service provider of integrated chemistry, drug development and API and dosage form manufacturing services to the pharmaceutical and biotechnology industries. Dalton provides expertise in medicinal chemistry, process development and reaction optimization, as well as formulation development, analytical testing and development, and cGMP manufacturing including cGMP API production and cGMP Sterile Filling Services. Dalton brings nearly 30 years of experience to every customer project, at virtually any stage of development or commercialization. To learn more about Dalton's capabilities please visit http://www.dalton.com
Peter Pekos - President & CEO
Dalton Pharma Services