cGMP

Isotec has the scientific and regulatory expertise to meet your cGMP product needs. Isotec manufactures chemicals such as Urea-¹³C, UBT Grade (603430) and Octanoic acid-1-^13C, OBT Grade (605840) used as Active Pharmaceutical Ingredients (APIs) under the jurisdiction of the FDA and following cGMP and ICH guidelines for APIs. Our Production Team is experienced in all phases of the pharmaceutical lifecycle from process development through routine manufacture of established bulk APIs. Isotec's Analytical Group has developed and validated stability-indicating assays, isotopic analyses and impurity profiles to meet our customer's requirements. We also perform stability studies following ICH guidelines. Our QA Team has the knowledge and expertise to fulfill your regulatory needs at all development stages. Isotec maintains DMFs for urea-¹³C, UBT in over 15 countries and regularly provides documentation to support our customers' regulatory filings.