Capsules

Roxlor provides their customers products and customer service that strive to be the best in the world. Because of this belief, our capsules undergo rigorous inspection procedures.

Capsules undergo a continuous series of visual inspections which are performed in accordance with AFNOR procedures. Capsule tolerances are tightly controlled to reach excellent consistency of product and subsequent performance in capsule filling machines.

A Quality Insurance system has been set up to be preventive and not curative. In accordance with the article L. 5311-2 of the code of the public health, the company is submitted to the control of the agency French of Sanitary Security of the Health Products (AFSSAPS). We work according to our manual quality, in conformity with the BPF norms (GMP) and have been certified following the ISO 9001/2000 norms.

We are also FDA approved. Our DMF number is 14656

With every delivery we provide our customers a bulletin of physico-chemical and bacteriological analyses in conformity with the requirements of the European Pharmacopoeia.

Gelatin

Since 1999, ROXLOR has exclusively utilized bovine or fish skin gelatin, opposed to alternatives made from bone in order to provide our customers with a better, safer product.

Our raw materials are submitted to a systematic review in our QC laboratory. At the time of every delivery, we require a veterinary certificate and a bulletin of analyses attesting a complete conformity to the texts of the European Pharmacopoeia and in particular concerning the relative precautions in the BSE. In spite of the absence of transmission risk of the BSE by vector gelatin, we constantly conform to the new European instructions to guarantee you a sure product.

Our requirements follow the evolution of the regulation and we are held aware of their modifications, in particular those concerning the relative precautions to the products including a transmission risk of agents BSE.

Lately, following the two resolutions adopted by the Committee of Public Health of the Council of Europe AP-CSP (99) 10.12.99 and AP-CSP (99) 22.12.99 structural on the application of the guideline 1999/82/CE "Setting up of a process of certification of the products of animal origin including TSE risks", we asked our suppliers to make the necessary steps to provide us gelatin benefiting from a conformity certificate to the European Pharmacopoeia.

Our plant is in conformity with the regulation of April 15, 2001 fixing the sanitary conditions for the preparation of gelatin destined to the human consumption. We apply this regulation, even for the capsules destined to the pharmaceutical industry, which is not YET covered under this regulation.