About XCAP

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.

QUALITY CONTROL
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.

PRODUCT SAFETY:
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.

Product Disintegration:
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.

Manufacturing Equipment:
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.

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