Mangoceuticals Subsidiary, MangoRx Mexico, Executes Technical Agreement with Mexican Pharmaceutical Manufacturer for Initial Development and Production of its Mango Erectile Dysfunction (ED) Products

Rhea-AI Summary

Mangoceuticals, Inc. (NASDAQ: MGRX) announces a technical agreement with Emifarma S.A. de C.V for the development and testing of Mango ED products for the Mexican and Latin American markets. This marks a significant step towards obtaining certification from COFEPRIS, opening doors for expansion into multiple markets.

Insights

Pharmaceutical Industry Analyst

The partnership between Mangoceuticals, Inc. and Emifarma S.A. de C.V for the development and testing of Mango ED products is a strategic move that could have significant implications for Mangoceuticals' market penetration and revenue growth, particularly in the Mexican and Latin American markets. By securing a technical agreement with a reputable manufacturing partner that is certified for Good Manufacturing Practices (GMP) by COFEPRIS and other health agencies, Mangoceuticals is demonstrating a commitment to quality and regulatory compliance, which is essential in the pharmaceutical industry.

The approval process by COFEPRIS is not only a regulatory hurdle but also a quality assurance measure that can build consumer trust in Mango ED products. If approved, the product's availability in over 40,000 pharmacies and retail outlets could substantially increase the company's distribution channels and sales volumes. However, the pharmaceutical market in Latin America is competitive, with strict regulations and varying consumer preferences. The success of Mango ED's market entry will depend on effective marketing strategies, competitive pricing and navigating the complex regulatory environment.

Market Research Analyst

Entering the erectile dysfunction (ED) medication market in Mexico and Latin America could be promising for Mangoceuticals due to the prevalence of ED in these regions and the cultural openness to OTC medications for this condition. The partnership with Emifarma could provide Mangoceuticals with an established manufacturing infrastructure and local expertise, which are critical when entering a new market. This move could also diversify Mangoceuticals' revenue streams and reduce its dependence on existing markets.

However, the company must consider the competitive landscape, including the presence of generic ED medications and other international brands. Additionally, consumer behavior and brand loyalty in the pharmaceutical sector can be challenging to shift, especially for a new entrant. Mangoceuticals will need to invest in market research to understand the local consumer behavior and preferences to tailor their marketing and product positioning strategies accordingly.

Regulatory Affairs Specialist

Obtaining certification from COFEPRIS is a critical step for Mangoceuticals to ensure compliance with Mexican health regulations. COFEPRIS's recognition in other Latin American countries can streamline the process for Mangoceuticals to enter additional markets, leveraging the certification to gain faster access. However, the company must navigate each country's unique regulatory landscape, as mutual recognition does not equate to automatic approval.

Moreover, the bioequivalence and stability testing required by COFEPRIS are rigorous processes that ensure the product's quality, safety and efficacy. These tests can be resource-intensive and time-consuming, but they are necessary to meet the standards set forth by the regulatory body. Mangoceuticals must manage this process efficiently to avoid delays in product launch and additional costs that could impact the company's financial projections and investor expectations.

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.

About MangoRx

MangoRx is focused on developing a variety of men's health and wellness products and services via a secure telemedicine platform. To date, the Company has identified men's wellness telemedicine services and products as a growing sector and especially related to the area of erectile dysfunction (ED), hair growth and hormone replacement therapies. Interested consumers can use MangoRx’s telemedicine platform for a smooth experience. Prescription requests will be reviewed by a physician and, if approved, fulfilled and discreetly shipped through MangoRx’s partner compounding pharmacy and right to the patient’s doorstep. To learn more about MangoRx’s mission and other products, please visit www.MangoRx.com or on social media @Mango.Rx.

Cautionary Note Regarding Forward-Looking Statements

Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws, including within the meaning of the Private Securities Litigation Reform Act of 1995 ("forward-looking statements"). These forward-looking statements represent the Company's current expectations or beliefs concerning future events and can generally be identified using statements that include words such as "estimate," "expects," "project," "believe," "anticipate," "intend," "plan," "foresee," "forecast," "likely," "will," "target" or similar words or phrases. These forward-looking statements are subject to risks, uncertainties and other factors, many of which are outside of the Company's control which could cause actual results to differ materially from the results expressed or implied in the forward-looking statements, including, but not limited to; our ability to obtain Comisión Federal para la Protección contra Riesgos Sanitarios for our ED product in Mexico, the costs thereof and timing associated therewith; our ability to obtain additional funding and generate revenues to support our operations; risks associated with our ED product which have not been, and will not be, approved by the U.S. Food and Drug Administration ("FDA") and have not had the benefit of the FDA's clinical trial protocol which seeks to prevent the possibility of serious patient injury and death; risks that the FDA may determine that the compounding of our planned products does not fall within the exemption from the Federal Food, Drug, and Cosmetic Act ("FFDCA Act") provided by Section 503A; risks associated with related party relationships and agreements; the effect of data security breaches, malicious code and/or hackers; competition and our ability to create a well-known brand name; changes in consumer tastes and preferences; material changes and/or terminations of our relationships with key parties; significant product returns from customers, product liability, recalls and litigation associated with tainted products or products found to cause health issues; our ability to innovate, expand our offerings and compete against competitors which may have greater resources; our significant reliance on related party transactions; the projected size of the potential market for our technologies and products; risks related to the fact that our Chairman and Chief Executive Officer, Jacob D. Cohen has significant voting control over the Company; risks related to the significant number of shares in the public float, our share volume, the effect of sales of a significant number of shares in the marketplace, and the fact that the majority of our shareholders paid less for their shares than the public offering price of our common stock in our recent initial public offering; dilution caused by recent offerings; the fact that we have a significant number of outstanding warrants to purchase shares of common stock at $1.00 per share, the resale of which underlying shares have been registered under the Securities Act of 1933, as amended; our ability to build and maintain our brand; cybersecurity, information systems and fraud risks and problems with our websites; changes in, and our compliance with, rules and regulations affecting our operations, sales, marketing and/or our products; shipping, production or manufacturing delays; regulations we are required to comply with in connection with our operations, manufacturing, labeling and shipping; our dependency on third-parties to prescribe and compound our ED product; our ability to establish or maintain relations and/or relationships with third-parties; potential safety risks associated with our Mango ED product, including the use of ingredients, combination of such ingredients and the dosages thereof; the effects of changing rates of inflation and interest rates, and economic downturns, including potential recessions, as well as macroeconomic, geopolitical, health and industry trends, pandemics, acts of war (including the ongoing Ukraine/Russian conflict and war in Israel) and other large-scale crises; our ability to protect intellectual property rights; our ability to attract and retain key personnel to manage our business effectively; our ability to maintain the listing of our common stock on the Nasdaq Capital Market, including our current non-compliance with Nasdaq’s continued listing standards; overhang which may reduce the value of our common stock; volatility in the trading price of our common stock; and general consumer sentiment and economic conditions that may affect levels of discretionary customer purchases of the Company's products, including potential recessions and global economic slowdowns. Although we believe that our plans, intentions and expectations reflected in or suggested by the forward-looking statements we make in this release are reasonable, we provide no assurance that these plans, intentions or expectations will be achieved. Consequently, you should not consider any such list to be a complete set of all potential risks and uncertainties.

More information on potential factors that could affect the Company's financial results is included from time to time in the "Cautionary Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's filings with the SEC, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. These filings are available at www.sec.gov and at our website at https://www.mangoceuticals.com/sec-filings. All subsequent written and oral forward-looking statements attributable to the Company or any person acting on behalf of the Company are expressly qualified in their entirety by the cautionary statements referenced above. Other unknown or unpredictable factors also could have material adverse effects on the Company's future results. The forward-looking statements included in this press release are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and takes no obligation to update or correct information prepared by third parties that are not paid for by the Company. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

Follow Mangoceuticals and MangoRx on social media:

https://www.instagram.com/mango.rx
https://twitter.com/Mangoceuticals
https://www.facebook.com/MangoRxOfficial

FOR PUBLIC RELATIONS

Lucky Break Public Relations
Sahra Simpson
Sahra@luckybreakpr.com
(323) 602-0091 ext. 704

FOR INVESTOR RELATIONS

Mangoceuticals Investor Relations
Email: investors@mangorx.com

SOURCE: Mangoceuticals Inc.

FAQ

What is the significance of the technical agreement between MangoRx Mexico and Emifarma for Mango ED products?

The agreement signifies a crucial step in the certification process for Mango ED products in Mexico and Latin America, facilitating market expansion.

Who is Emifarma S.A. de C.V and what role do they play in the development of Mango ED products?

Emifarma is a Mexican pharmaceutical company specializing in various product types. They are MangoRx's manufacturing partner for the initial stages of product development and testing.

What benefits does obtaining COFEPRIS certification offer MangoRx?

COFEPRIS certification allows MangoRx to market and sell their Mango ED products in Mexico, with the potential for further expansion into other Latin American markets where COFEPRIS is recognized.

Which markets are targeted for the distribution of Mango ED products?

The Mexican and Latin American markets, with plans to reach pharmacies, retail outlets, and convenience stores across Mexico.

Who is Jacob Cohen and what is his role in MangoRx?

Jacob Cohen is the Co-Founder and CEO of MangoRx, overseeing the company's growth initiatives and expansion plans.

What are the potential future markets for MangoRx products beyond Mexico?

Countries like Columbia, Ecuador, El Salvador, Chile, Costa Rica, and Panama are potential markets for MangoRx products once COFEPRIS certification is obtained.