What makes something pharmaceutical grade
The phrase, which has served as the fuel for a considerable amount of industry chatter, is built upon the notion that there are standards for manufacturing dietary supplements that are comparable to pharmaceutical manufacturing standards. The question becomes: Are there any facts supporting this buzz-creating idea of "pharmaceutical grade" supplement manufacturing? The answer might surprise you In reality, the understanding of "Pharmaceutical Grade" Manufacturing that has permeated the dietary supplement industry is nothing if not misleading.
Supplement manufacturers and contract manufacturers who boast "pharmaceutical grade" capabilities are likely misinformed as to how the term can and cannot be applied to dietary supplements. Let's take a look at what pharmaceutical-grade manufacturing really means — keeping in mind the fact that "pharmaceutical grade" can only be used in the context of the pharmaceutical industry, never for the dietary supplement industry.
Within the pharmaceutical industry all drugs, even those that don't require a prescription, must undergo a rigorous approval process that's unique to the pharmaceutical industry. The Food and Drug Administration FDA makes sure that every new drug goes through a series of controlled clinical trials in order to demonstrate both safety and efficacy for its intended use.
Only if the drug meets the FDA's standards of approval is it made available to the public. Along with meeting the FDA's standards during clinical trials, a drug company must also have a unique monograph.
Not unlike an industrial recipe, a monograph describes the exact procedure for making a drug, including specifications for raw materials, to ensure that the identity and efficacy of the drug are consistently maintained.
The United States Pharmacopeia and The Formulary USP—NF is a book of public pharmacopeial standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements. As we've established, dietary supplements are not drugs, and as a result, they are not held to the same manufacturing practices.
Instead, dietary supplements and other nutraceuticals are subject to their own unique set of cGMPs current good manufacturing practices that have been established by the FDA. Ultimately, these GMPs have been applied to all domestic and foreign companies that manufacture, package, label or hold, test, perform quality control, pack, or distribute dietary supplements for sale in the United States.
The FDA has been strict in enforcing these cGMPs, actively auditing supplement manufacturers, and taking action against those who have failed to comply with federally issued warning letters.
Often, liquid supplements have flavors added to them, but that would deem them non-pharmaceutical grade. Capsules tend to be the more popular form of supplement, because the capsules hide the taste of the pure ingredients, and they are easily administered.
Instead, think about what is not there. Pharma grade supplements ensure that nothing is hidden from the label. They are pure, trustworthy and made from the finest ingredients. Manufacturers cannot get by with lower quality ingredients, because only high quality ingredients are pure in form. Producing something at such a pristine quality comes at an extra cost. However, this cost never should make a manufacturer hesitate, because they produce such a better supplement.
A pharma grade supplement is an investment for the manufacturer, as well as treatment for the consumer. By providing better supplements, more people will trust the brand, especially because they are more effective. Those that have chosen to manufacture and provide pharma grade supplements never express any regret over the added cost, because they know that they are doing better for the consumer. Despite the benefits, very few companies choose to make products at such a high standard.
Many of these companies all point to the same studies but seldom use the actual ingredients from these studies in their products. Often, this is because Clinical Studies use ingredients that are extremely high quality, made to ensure their study will collect accurate data but are very expensive or difficult to source due to being patented by a Biopharma company.
This is where SwissRX's spare-no-expense approach really makes a difference. They source the exact ingredients used in the Clinical Studies regardless of cost. They go to each patent holder and negotiate a sourcing arrangement often exclusively. The result for the athlete is a supplement that is of the utmost purity, bioavailability, and effectiveness. What is Pharmaceutical Grade and why you will never go back SwissRX's obsession with ingredient quality. Increased bioavailability is a major benefit of pharmaceutical grade supplements, which are often made with patented technology.
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