Tradafertil is a multi-ingredient nutraceutical formulation containing Myo-Inositol, Tribulus terrestris extract, Ecklonia bicyclis extract and a water-soluble chitosan oligosaccharide ingredient. It is formulated as a combination of botanical, algal and nutritional ingredients rather than as a single chemical compound. The product is associated with nutritional and antioxidant support in male fertility-focused supplement formulations. The official Tradapharma product information identifies these four principal components.
MEDIOCON INC can present Tradafertil as a specialized nutraceutical formulation/raw-material product for qualified dietary-supplement applications. Because this is a blend, it should not be treated like a conventional API with one CAS number, molecular formula or molecular weight. Each constituent has its own chemical identity, while the finished blend is characterized by its composition and specification.
Published product information reports a formulation containing Myo-Inositol, Tribulus terrestris standardized to 90% saponins, Ecklonia bicyclis dry extract and Biovis/chitosan-derived material. One current product listing reports, per two tablets, 1,000 mg Myo-Inositol, 300 mg Tribulus terrestris extract, 200 mg Ecklonia bicyclis extract and 150 mg Biovis/glucosamine. These values describe the marketed finished product and should not automatically be entered as MEDIOCON's raw-material specification unless your supplied grade matches them.
Tradafertil has also been evaluated in a clinical study involving men with previously diagnosed infertility. The study investigated a formulation containing Myo-Inositol, Tribulus terrestris, Ecklonia bicyclis and Biovis over 90 days and reported changes in selected semen parameters and sperm DNA fragmentation. These findings should be described as research findings rather than as a guarantee of fertility improvement for individual users.
For Indian regulatory context, FSSAI records list Tradafertil (blend of Tribulus terrestris, alga Ecklonia bicyclis, chitosan oligosaccharide and myoinositol) under application 51/Std/PA/FSSAI/2018, dated 4 October 2018. The FSSAI record identifies SunDyota Numandis Probioceuticals Pvt. Ltd. in Ahmedabad in connection with that application.
Because Tradafertil is a blend, several of your normal API specification fields are not scientifically appropriate.
| CMS Field | Exact Entry |
|---|---|
| Appearance | As per approved finished-product specification |
| Identification | Conforms to identification of declared botanical, algal and nutritional components |
| Assay (HPLC) | Component-specific analytical method; not applicable as a single-compound HPLC assay |
| Loss on Drying | As per approved product specification |
| Residue on Ignition | As per approved product specification |
| Heavy Metals | Complies with applicable regulatory/product-specific limits |
| pH (1% Solution) | Product-specific / formulation dependent |
| Individual Impurity | Not applicable as a single-compound impurity parameter |
| Total Impurities | Controlled according to approved finished-product specification |
| Water Content | As per approved product specification |
| Specific Rotation | Not applicable to complete blend |
| Melting Point | Not applicable to complete blend |
| Solubility | Formulation dependent; not applicable as a single-compound parameter |
Myo-Inositol is a naturally occurring cyclic polyol and one of the principal nutritional components of the Tradafertil formulation. The referenced marketed formulation contains 1,000 mg per two tablets.
Tribulus terrestris is a botanical ingredient containing steroidal saponins. The marketed Tradafertil formulation specifies Tribulus terrestris standardized to 90% saponins.
Ecklonia bicyclis is a brown marine alga used as a source of marine polyphenolic compounds. It forms one of the principal botanical/marine components of the formulation.
The formulation uses a water-soluble chitosan-derived oligosaccharide component. Published product information describes the ingredient as Biovis/glucosamine-related material, so the exact ingredient nomenclature should be matched to the commercial specification you are supplying.
Tradafertil-type formulations may be positioned as:
Avoid presenting the product as a pharmaceutical treatment or as a guaranteed treatment for infertility.
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Tradafertil (Blend of Tribulus terrestris, Ecklonia bicyclis, Chitosan Oligosaccharide & Myo-Inositol) Manufacturer & Supplier in India | MEDIOCON INC and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Tradafertil (Blend of Tribulus terrestris, Ecklonia bicyclis, Chitosan Oligosaccharide & Myo-Inositol) Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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