WHY DO WE USE THE WORD PHARMACEUTICAL?
For more than 35 years Biotics Research has been a primary manufacturer of leading edge dietary supplements.
Every product is manufactured in our fully licensed, FDA approved pharmaceutical and CDC licensed genetics and toxicology testing laboratory.
Biotics is licensed by the United States Center for Disease Control and the FDA as both a manufacturer and distributor of pharmaceuticals.
As such all products have an NDC (National Drug Code) number and are listed in the FDA Drug Registration and Listing database- a level of quality control that is above and beyond that required by third party issuers of GMP certificates.
Biotics Research is fully licensed by the FDA to manufacture pharmaceuticals, as such the level of quality control, raw material testing, chemical laboratories, and manufacturing operating procedures are far superior to just a licensed food manufacture which are better known as makers of dietary supplements . No other dietary supplement company in the industry can make this claim.
Commonly, dietary supplement companies use terms like “GMP (good manufacturing policy’s) certified” to promote the quality of their products.
The truth of the matter is, the only GMPs that count are those implemented by the government and no independent issuer of “GMP certificates” meet the proposed federal US FDS GMP standards for dietary supplements, nor does the FDA recognize these independent certifications.
Lastly, the manufacturing that Biotics Research practices, far exceeds those of the so called ‘independent certification’ practices and more closely resemble those of drug GMPs mandated by federal and state agencies.
Features of an ‘In-House’ manufacture
As a primary manufacture of pharmaceuticals and dietary supplements, all products are made in the Biotics Research laboratory- including capsules, tablets, liquids and powders. Thus Biotics has control of the ENTIRE manufacturing process from start to finish. All products, including gel capsules, are tested for contaminants, peroxide levels, and heavy metals. Botanicals are identified via their biological identity through the photochemical laboratory.
Why is this important? Companies that out-source their manufacturing purchase products made by contract manufacturers, who bid against each-other to get the deal. Quality is compromised to keep the cost low so that the manufacturer will get the bid.
As a primary manufacture, the selection of raw materials is based on quality, not cost.
The use of harsh chemical solvents such as chloroform, hexane is common practice in the material processing of dietary supplements. Biotics Research uses natural organic acids commonly found in the body when processing raw materials.
Excipient binders and fillers are commonly using in the pharmaceutical and dietary supplement industry, often times comprising up to 40% of the finished product. This is typically listed as “other ingredients” and includes unhealthy compounds like titanium dioxide, microcrystalline cellulose, stearic acid, silicon dioxide, calcium silicate, hydrogenated soybean oil encapsulate, croscarmellose sodium, maltodextrin, hypromellose, polyethylene glycol and carrageenan.
At Biotics Research the tableting base is a ‘vegetable culture’ made of dehydrated vegetable material which dissolves readily and is rich in phytochemicals. Biotics does use some natural excpients that are required for processing such as vegetable source stearic acid and magnesium stearate.
Biotics routinely performs dissolution tests on tablets and capsules to ensure the product will disintegrate within a specific period of time and for adequate absorption and utilization in the body.
The scientists at Biotics Research are some of the most highly skilled in the industry. The have equipment that test for product and ingredient identity, potency, biological activity, microbiolological and chemical contaminants and stability. They routinely employ methods such as HPLC, ICP, TLC, IR and FT-IR, gel electrophoresis, and UV spec among others.
As part of the GMPs at Biotics Research, they tests all incoming raw materials, in-process products, finished products, and performs testing to validate processes and ensures that at the time of the expiration date all ingredients are active and efficacious.