Immune Therapeutics Receives Approval for Lodonalâ„˘ from the Dominican Republicâ€™s Ministry of Health and Social Assistance
ORLANDO, Fla., Feb. 02, 2017 (GLOBE NEWSWIRE) — Immune Therapeutics, Inc. (OTCQB:IMUN), a global specialty pharmaceutical company dedicated to advancing the science of affordable, non-toxic therapies in Emerging Markets, announced today that the Dominican Republicâ€™s Ministry of Health and Social Assistance has issued a Certificate of Pharmaceutical Product (COPP) for Lodonalâ„˘ (Naltrexone). This certificate grants approval for the manufacturing and export of LodonalTM for the treatment of HIV/AIDS, opportunistic infections, inflammatory disease and cancer in the dosages specified in the filings.
The approval of Lodonalâ„˘ (Naltrexone) was supported by a vast array of research including dossier, certificate of analysis, stability reports, pharmacology and toxicology reports as well as clinical data from several Phase II multi-center, randomized studies. The results of these studies and documents showed patients treated with LodonalTM reported significant improvements when compared with patients receiving placebo.
â€śWe are thrilled with this certification as we are now only one step away of seeing all of our hard work come to fruition,â€ť said Noreen Griffin, CEO of Immune Therapeutics. â€śBefore selling into the Nigerian market, we required three main approvals: We received our Drug Approval last year; our Certificate of Pharmaceutical Product which was announced today; and our final approval which is the Marketing Approval from Nigeria.â€ť
â€śThe Certificate of Pharmaceutical Product is not just required for Nigeria,â€ť Ms. Griffin continued. â€śIt is the cornerstone for exportation into any of the other countries we are engaged in. This certificate is required to follow the World Health Organization format as it provides quality assurance for the pharmaceutical products (LodonalTM) and the facility (Acromax). As we push forward in Nigeria, we are simultaneously leveraging the successful clinical trial results and NAFDAC approval to expedite the approval and distribution into other nations devastated by HIV/AIDS including Malawi, Equatorial Guinea and Senegal.â€ť
About Immune Therapeutics, Inc.
Immune Therapeutics, Inc. (OTCQB:IMUN) is a biotechnology company working to combat chronic, life-threatening diseases through the activation and modulation of the bodyâ€™s immune system using its patented immunotherapies with a focus of providing such therapies in emerging nations. Its products and immunotherapy technologies are designed to harness the power of the immune system to improve the treatment of cancer, infections such as HIV/AIDS, chronic inflammatory and autoimmune diseases.
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