US government gets permanent injunction against Deltex Pharmaceuticals

The US District Court for the Southern District of Texas has entered a consent decree of permanent injunction against privately-held US contract drug manufacturer Deltex Pharmaceuticals of Rosenberg, Texas, its president Kabir Ahmed and vice president, Mohidur Khan.

The consent decree permanently prohibits/stops the company, Mr Ahmed and Mr Khan from manufacturing and distributing drug products until Deltex’ manufacturing operations and products are in compliance with federal law and the terms of the consent decree, the Food and Drug Administration announced yesterday.

Deltex is a contract manufacturer and distributor of prescription and over-the-counter (OTC) drug products. The government’s complaint, filed by the US Department of Justice, detailed violations of the Federal Food, Drug and Cosmetic Act involving manufacturing and distributing unapproved, adulterated and misbranded drugs. Specifically, Deltex failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products and failed to comply with current good manufacturing practice (cGMP) requirements.