GEROPHARM has successfully passed Cuba’s GMP audit

GEROPHARM received a certificate of compliance with GMP international quality standard from CECMED, the national regulatory body of Cuba. The certificate is recognised by many countries of Latin America, which will facilitate export development in this region.

GMP (Good Manufacturing Practice) standard is a system of regulations and rules regarding medicinal product manufacturing. The certificate confirms the compliance with good manufacturing practices of two GEROPHARM plants: in Pushkin (St. Petersburg) and in Obolensk (Moscow Region). CECMED has certified the following manufacturing processes: biosynthesis, purification, filling of solutions and suspensions, packaging, labelling and quality control of products.

GEROPHARM received GMP compliance certificate for the first time in 2021, and it has been successfully updated. The new document is valid until February 2027.

Cuba’s national regulatory body, CECMED, has extensive expertise in the registration and audit of medicinal products, and Cuba’s GMP is a recognised Latin American confirmation of product quality as well as a reliable manufacturer evidence.

Diabetes mellitus is a major issue in Latin America. According to IDF Diabetes Atlas 2021, the number of people with diabetes in the region is more than 32 million, and it keeps growing. The projected number of patients by 2045 is 49 million.

“CECMED inspectors have assessed the manufacturing procedures and confirmed the high level of GMP standards in the product manufacturing and quality control. The new certificate covers all forms of human insulin and its analogues produced by the company, as well as the first Russian analogue of Ozempic®: Semavic®,” Petr Rodionov, GEROPHARM Chief Executive Officer says.

Reference

CECMED is a Centre for State Control of Medicines, Equipment and Medical Devices of Cuba.

GEROPHARM is a national manufacturer of biotechnological products ensuring the medicinal safety of Russia. The company is engaged in full-cycle manufacture of medicinal products, invests in technological development and creation of modern pharmaceutical infrastructure. GEROPHARM exports its products to 13 countries worldwide: all CIS countries, Mongolia, Venezuela, Morocco.