Honso pharma products are developed and marketed according to FDA guidelines. "The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. The term "medical foods" does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality. Medical foods are only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food."
According to the FDA, "Medical foods must comply with all applicable requirements for the manufacture of foods, including the Current Good Manufacturing Practices regulations (21 CFR part 110), Registration of Food Facilities requirements (21 CFR part 1 Subpart H) and, if applicable, the Low Acid Canned Food regulations (21 CFR part 113) and Emergency Permit Control regulations (21 CFR part 108). Ingredients used in medical foods must be approved food additives or a food additive that is the subject of an exemption for investigation use (21 U.S.C. 321 and 348), if the ingredients are not generally Recognized as Safe (GRAS).Over the years Honso Pharma has become synonymous with high quality medicines that we brought to market , our innovative and effective formulas are now available around the globe...
The quality and efficacy of each of our product lines is backed by extensive scientific research, which we make available to our clients in the form of research studies and clinical data. These products are strictly regulated to meet the rigorous testing standards for TCM medicine. But, beyond this Honso Pharma formulas are pharmaceutical-grade formulas in world, therefore no allowance for error is given. We have built our company's reputation on guaranteeing the quality of every Honso Pharma product.
Our products are manufactured under one of the highest quality standards in the world. We use only the highest-grade materials and all of our formulas are processed under perfected techniques to ensure maximum quality, efficacy and safety. The quality control is performed under the scrutiny of Ministry of Health and Welfare.
Herbal constituents are monitored at two levels: qualitatively on individual herbs by Thin Layer Chromatography (TLC), and quantitatively on active constituents by High Performance Liquid Chromatography (HPLC). Every lot of the Honso Pharma professional granular products, capsules & tablets is routinely tested for heavy metals, purity, and microbial contaminant. All testing results come in the form of a Certificate of Analysis, which is accessible to all customers.
According to Importing GMP guideline, other tests are performed to assurance consistency of herbal species. First Honso Pharma identify where the plant are grown and harvested and chooses the specific method of preparation based on tissue and cell morphology, and differentiates it from similar raw herbs. Then Honso Pharma performs the extract content test to determine the content of ingredients soluble in water, absolute ethanol or ether as overall content of the active ingredients. The loss-of-drying test is performed to determine water content in the raw herbs as confirmation of proper production procedures and storage stability. A total ash test is done to determine inorganic content in the raw herbs. The acid-insoluble ash is tested to identify the amount of earth and sand attached to the raw herbs.