LABORATORIOS SAVAL

A. Plant in Chile

SAVAL S.A.’s production facilities in Chile have been designed in accordance with the Food and Drug Administration (FDA) International Society of Pharmaceutical Engineering (ISPE) guidelines, which are applied in the US and other developed countries, as well as in accordance with the World Health Organization (WHO) guidelines and the International Organization for Standardization (ISO) 14644 series.

Our current Production Plant in Chile, located in Renca to the north of Santiago, was founded in 1967. From 2007 to 2011 we developed a large modernization project that included 18,000 m² of new facilities, in addition to the incorporation of new technologies.

Different dosage forms are developed and produced in our Plant, where there are two modern buildings for this purpose. One of the buildings, with an area of 13,800 m², is intended for the production of Solid products: tablets, film-coated tablets, dispersible tablets, capsules, powder for suspension; Liquid Products: syrups, suspensions, oral drops; Semisolid Products: skin creams and gels, suppositories; and Sterile Products such as ophthalmic products (eye drops, ointments and ophthalmic gels). The second building, completely separate from the other one of 2,100 m², is intended exclusively for the production of solid Penicillins: tablets, film-coated tablets, dispersible tablets, powders for suspension.

All the Company's Quality Control and Research & Development operations are carried out in our modern 1,600 m² facilities, including processes such as analysis and inspection of supplies and products, technology transfer, design and development of new formulations, process validation, among others.

In addition, we have an authorized center for conducting in vitro bioequivalence studies of our SAVAL products, allowing us to demonstrate that their efficacy is comparable to the reference product.

Likewise, in an adjoining land, SAVAL S.A. has a modern Distribution and storage Center for raw materials with a total area of 15,000 m² for the development of all its logistics operations in Chile and distribution of SAVAL products to the 13 Latin American and Central American countries where we are present. Our distribution center has high standards of technology that allow us to distribute approximately 3 million units per month of products for national sales, export sales, and promotional plans.

The design basis for our facilities relies on international standards, such as: ISPE / FDA / GMP / WHO / ISO 14644, which allow:

• Closed manufacturing processes and compliance with GMP standards for preventing cross-contamination.
• Efficient design of facilities, according to the ISPE requirements for facility and process validation in compliance with Quality Assurance guidelines.
• Modernization of Production Technologies.
• Environmental conditions, including air quality, controlled throughout the plant (air conditioning or HVAC), using modern equipment and state-of-the-art computer systems.
• Purified Water (PW), Water for Injection (WFI) and Pure Steam (PS) Generation and Distribution Systems.
• Compressed Air and Nitrogen Generation and Distribution Systems, and other support services.
• Segmentation of the Plant according to environmental air quality, as per WHO classification (Grade A, Grade B, Grade C and Grade D).
• Administration of all logistics, production, and quality activities through the SAP/R3 tool, in addition to the integrated use of barcode and radio frequency (RF) technologies, which ensures the correct storage and subsequent distribution of our products.

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Quality Certifications

SAVAL S.A. is certified by the Chilean Public Health Institute (ISP, for its acronym in Spanish) in compliance with the World Health Organization Good Manufacturing Practice (GMP) guidelines.
FHCLL2 , Supplies and Drugs (DIGEMID, for its acronym in Spanish) of Peru, in compliance with the World Health Organization (WHO) Good Manufacturing Practice (GMP) guidelines.

B. Plant in Costa Rica

At the beginning of 2023, SAVAL Costa Rica S.A. was founded and acquired a new production plant in the province of Cartago, Costa Rica. Our new plant has an area of 9,000 m², in which solid products such as tablets, capsules and powder for suspension and liquid products such as syrups, suspensions, drops are produced. The facilities also include Quality Control and Research & Development laboratories and a pilot plant, as well as all operation service and support areas, including its own distribution center.

All logistics, production, and quality activities are managed through the SAP/R3 tool, facilitating its integration to the operation in Chile. Also, this operation has a high level of maturity in using information technologies to support the operational efficiency plan management in the areas of production, engineering, and laboratories.

This new plant meets the highest quality standard and is GMP-certified. It was remodeled in 2018 to improve its regulatory compliance in accordance with WHO guidelines and the Central American Technical Regulation (RTCA, acronym in Spanish). The plant located at Cartago has a high growth potential for infrastructure, with pharmaceutical technology equipment similar to that in the plant of Chile, which will allow SAVAL to increase production output from 45 to 75 million units per year.

Lastly and most importantly, this operation led to the incorporation of 150 individuals to the company, highly qualified personnel committed to support current operation and develop new projects and products to supply SAVAL quality medicines across the region.

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Quality Certifications

SAVAL Costa Rica S.A. plant is certified by the Ministry of Health of Costa Rica regarding compliance with Good Manufacturing Practice (GMP) guidelines issued by the World Health Organization, according to the RTCA, Central American Technical Regulation for Pharmaceutical Products, Medicines for Human Use and Good Manufacturing Practices for the Pharmaceutical Industry.