CanaFarma Hemp Products Corp. announced that it is developing a bioequivalent material to Hydroxychloroquine with PharmOps, a private FDA approved pharmaceutical company. On April 24th, 2020, CanaFarma signed a Letter of Intent to acquire PharmOps Ltd., and it’s its cGMP (current Good Manufacturing Practices) licensed facility in New Jersey to produce pharmaceutical and nutraceutical products.
Today, as due diligence continues on the acquisition, the two companies are working together to develop this bioequivalent material to Hydroxychloroquine.
Fast Track to Complete Abbreviated New Drug Application
To create this bioequivalent material, CanaFarma will use its expertise in Cannabinoids, along with an identified application program interface (API) source, for its water-soluble materials and fast track through the Abbreviated New Drug Application (“ANDA”), a 6-month stability test as required by the FDA. The parties have also contracted with the supplier of API material to produce a batch of the bioequivalent material and initiate safety studies right away.
The Abbreviated New Drug Application is submitted to the FDA for the review and hopeful approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, and lower-cost alternative to the brand-name drug it references.
Hydroxychloroquine Used to Fight COVID-19
The FDA, via the EUA, has allowed for a more streamlined approval process of certain drugs due to Covid-19 Pandemic. One such drug that has been widely publicized is Hydroxychloroquine, approved in the 1940s for Malaria under the Trade name of PlaquenilTM. Although this product is already available on the market as a generic version as 200 mg Tablets manufactured by Mylan, Sandoz, Teva and Watson, its recent publicity of being used prophylactically in combination with Azithromycin to ward off the Covid-19 virus has created an acute shortage for all patients, including those that are using this product as an immuno-suppressant. Furthermore, although there is some controversy as to its effectiveness in the fight against Covid-19, there have been reports of healthcare professionals either taking it or hoarding it. President Trump has been a strong advocate of the product and recently sent 2 billion doses of Hydroxychloroquine to Brazil to assist in its fight against the deadly virus.
Medical Countermeasures Used to Fight Infectious ‘CBRN’ Threats
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow these unapproved medical products and its uses to be utilized in an emergency. During these public health emergencies, like COVID-19, medical countermeasures (“MCMs”) may be used to treat or prevent serious and life-threatening diseases or conditions caused by emerging chemical, biological, radiological, nuclear (CBRN) infectious disease threats, like pandemic influenza. These medical Countermeasures are medical products such as drugs, vaccines, diagnostic tests, and other medical equipment and supplies, used to respond to emergencies when there are no adequate, approved, and available alternatives. The Emergency Use Authorization authority allows the FDA to help strengthen the Nation’s public health protections against CBRN threats, making Medical Countermeasures available needed during public health emergencies.
The Company is not making any express or implied claims that it will be successful in developing its proposed product, nor that its proposed product will have the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.
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