Dr. Paul Lohmann’s production unit was finalized in March 2017, allowing the manufacturer to comply with quality and regulatory requirements, and satisfy increasing volume demands for minerals in parenteral applications.
Endotoxins or pyrogens are lipopolysaccharides, outer membrane components of Gram-negative bacteria. During decomposition or metabolism, these bacteria release lipopolysaccharides, which are toxic. Parenteral-induced quantities as low as 0.1ng/kg of bodyweight can cause various immune reactions including fever, inflammation and sickness in humans and animals. To avoid this, the manufacture of products for parenteral administration requires particular caution; it is subject to specific regulatory requirements and is regulated by Chapter 2.6.14 of the European Pharmacopoeia (PhEur).
Pharmaceutical manufacturers of preparations for infusion or injection are obliged to observe special regulations specified by the relevant pharmacopoeia and good manufacturing practices
Customers can seamlessly integrate Dr. Paul Lohmann products, which are low in endotoxins, into their process chain for the manufacture of parenteral dosage forms. Low-endotoxin mineral compounds can be used for the production of the following pharmaceutical forms and routes of administration:
Dr. Paul Lohmann’s low in endotoxins production line was finalized successfully in March 2017. The production site is GMP and DIN EN ISO 9001:2015-certified, and LAL tests are performed according to PhEur.
Dr. Paul Lohmann GmbH KG
Company name: Dr. Paul Lohmann GmbH KG