Quality
Good Manufacturing Practices
We hold operating licenses and certificates of good manufacturing and distribution practices in each country where we operate, endorsed by our Quality Assurance systems, in compliance with and in most cases exceeding local regulations.
Our Awards and Achievements
In Mexico, our manufacturing site’s Quality Assurance system has the ISO 9001 Certificate, as well as the operating license and certificate of Good Manufacturing Practices issued by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).
This establishes Stendhal as a company with high compliance standards at a global level, distinguished for its:
- Market knowledge
- Cold chain storage systems
- Facilities and processes certified by COFEPRIS NOM-059-SA1-2015
- ISO 9001:2015 Certificate
- 24/7 Pharmacovigilance platform
- Business conduct and integrity
Stendhal Facilities
Our facilities focus on the manufacturing and primary packaging of oral solids, and secondary packaging of various dosage forms.
The facilities boast a certificate of Good Manufacturing Practices issued by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), as well as the ISO 9001-2015 Certificate, with which we guarantee not only regulatory compliance, but also the correct management of a consistent and constantly improving quality system.
Manufacturing of secondary packaging for medication
We offer manufacturing services for the secondary packaging of oral solids, injectables, and cold chain medications to national and international customers in the pharmaceutical industry. For this, we have specialized areas, equipment, processes, and qualified personnel to meet requirements with the highest quality standards and a customer service approach.
Laboratories
Our facility boasts a physicochemical control laboratory for finished product release, stability testing, analytical transfers, and validation and critical system analyses, as well as a microbiological control laboratory to monitor finished products, raw materials, packaging materials, purified water, and environmental controls.
Warehouse
Our warehouse facilities are intended for the reception, storage, stocking and shipment processes of raw materials, packaging materials, semi-finished products, and finished products, all in full regulatory compliance and managed in our ERP (SAP).
