Signifies the first major step towards the application process for the certification of its

Mango ED oral dissolvable products by Mexico's health governing agency, COFEPRIS

Dallas, Texas, April 12, 2024 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ:MGRX) ("MangoRx" or the "Company"), a company focused on developing, marketing, and selling a variety of men's health and wellness products in the area of erectile dysfunction (ED), hair growth and hormone replacement therapies is excited to announce that its subsidiary, MangoRx Mexico S.A. de C.V. ("MangoRx Mexico"), has secured and executed a technical agreement with Emifarma S.A. de C.V ("Emifarma") for the initial stages of development and testing (Bioequivalence and Accelerated Stability, required to obtain registry from COFEPRIS) of the Company's Mango ED products intended for the Mexican and Latin American markets.

Founded in 1998 by a group of pharmaceutical professionals with experience in Development, Production and Quality, Emifarma is a Mexican company that employs more than 100 workers and has 4 plants that specialize in: Hormonal, Injectable, Additive and Oral Solid (tablet and powdered) products where they serve as a manufacturing partner for some of the most relevant pharmaceutical companies both domestically and internationally, operating in Mexico. Emifarma is Certified for Good manufacturing Practices (GMP) by the following organizations: COFEPRIS, INVIMA, Ministry of Health of the Republic of Peru.

"This marks an enormous milestone for MangoRx as this signifies the most crucial first step in our highly anticipated planned expansion into the Mexican and Latin American markets," noted Jacob Cohen, MangoRx's Co-Founder and CEO, who continued, "As we had noted earlier upon our announcement of this growth initiative, establishing a pharmaceutical manufacturing partner was the catalyst necessary to begin product development for testing as required for the application and certification with the Comisión Federal para la Protección contra Riesgos Sanitarios ("COFEPRIS"). Assuming such approval is obtained, we expect to be able to start marketing and selling our Mango ED products to the more than 40,000 pharmacies, retail outlets, and convenience stores across Mexico."

In addition, achieving the COFEPRIS certification is anticipated to offer additional advantages for further expanding sales of MangoRx products internationally into other large and growing Latin American markets that offer ED medications as OTC products. Specifically, COFEPRIS is recognized in the following additional countries: Columbia, Ecuador, El Salvador, Chile, Costa Rica and Panama.

Efi Karchmer, President of MangoRx Mexico stated, "after visiting, interviewing, and negotiating with many different pharmaceutical manufacturing companies over the past several months, we are very excited about our decision to partner with Emifarma in this endeavor. Each of Emifarma's facilities has its own warehousing of both raw materials and finished products, a dedicated quality lab as well as full capability for packaging such as blisters, packets, envelopes, and secondary packaging such as boxes, bags, pouches, and trays which gives them a lot of flexibility and along with their proactiveness and out of the box thinking makes them an ideal partner. We have no doubt that Emifarma will be able to provide us with the production, manufacturing, and quality that we need as we work to scale our business in the Mexico and other Latin American countries."

According to a recent market study and analysis report conducted by Groupo Knobloch, the estimated annual market size in Mexico for ED pharmaceutical products is USD $216 million with approximately 24 million units sold annually, which market is estimated to be growing at a rate of 4% per year at an average sales price of USD $8.50 per unit.