SpecGx LLC has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. The company intends to import specific drugs, including Tapentadol and Thebaine, for manufacturing purposes to create Active Pharmaceutical Ingredients. This notice allows registered manufacturers and other stakeholders to submit comments or request a hearing about this application by April 25, 2025. Approval for import will be strictly for manufacturing purposes and not for importing finished drug forms for sale.
Simple Explanation
SpecGx LLC wants permission from the government to bring in special ingredients from other countries to make medicine, but not to sell the medicine itself. People who make medicine or are interested can say what they think about this by a certain date.