Stendhal has a facility for the manufacturing and primary packaging of oral solids and secondary packaging of various pharmaceutical forms; this site complies with national and international regulations.
The site has a certificate of Good Manufacturing Practices issued by the Federal Commission for Protection against Sanitary Risks (COFEPRIS), as well as the ISO 9001-2015 certification, which guarantees not only our regulatory compliance, but also proper management of a cohesive and constantly improving quality assurance system.
Certificate of Good Manufacturing Practices No. CAS/12944/2021.
ISO 9001:2015 Certificate
The Stendhal Site currently offers its services for the manufacturing of secondary packaging for oral solids, injectable products, and cold chain medicinal products to national and international clients in the pharmaceutical industry. We have the necessary space, equipment, processes, and qualified personnel, held to the strictest standards to ensure compliance, as well as a customer service approach.
Our Technology Transfer and Validation departments allow us to fully comply with any client processes we may receive.
We have an onsite physicochemical control laboratory for the release of finished products, stability analysis, analytical transfers, and validation and critical system analysis, as well as a microbiological control laboratory for the analysis of finished products, raw materials, packaging materials, purified water, and environmental control.
We have warehouse facilities to manage the reception, storage, order fulfillment and shipping processes of raw materials, packaging materials, and semi-finished and finished products; our facilities comply with regulations and are managed by our ERP (SAP).