n as CECT 8638.
TBMUNE / Nyaditum resae is not a conventional purified chemical ingredient. Published product-development literature describes Nyaditum resae as a galenic preparation containing heat-killed Mycobacterium manresensis. Because the organisms are heat-killed, the preparation is fundamentally different from a live probiotic or viable bacterial culture.
MEDIOCON INC can present Mycobacterium manresensis as a specialized microbial raw material/product for qualified nutraceutical and food-supplement applications, subject to the applicable regulatory status and product specification. Historical scientific literature describes Nyaditum resae as a food supplement and reports oral administration of heat-killed M. manresensis in controlled clinical studies.
Published clinical research evaluated Nyaditum resae in adults using oral administration for 14 consecutive days. The preparation was supplied in drinkable vials in one early trial and later research also describes capsule administration. The investigated preparations contained defined quantities of heat-killed bacilli, rather than a conventional milligram-based botanical extract.
The available research has investigated immunological responses and tolerability, including changes in regulatory T-cell responses. Importantly, this research should not be converted into a claim that TBMUNE/Nyaditum resae prevents, treats or cures tuberculosis. Product claims should follow the applicable regulatory authorization and current evidence.
For this product, the more meaningful specifications are:
Published studies provide the following useful reference information:
| Parameter | Reference Information |
|---|---|
| Organism | Mycobacterium manresensis |
| Species Group | M. fortuitum complex |
| Deposit | CECT 8638 |
| Status | Heat-killed / non-viable in Nyaditum resae |
| Product Name | Nyaditum resae® |
| Alternative Product Name | TBMUNE / TBMune |
| Administration | Oral |
| Clinical Study Duration | 14 days in early studies |
| Preparation Forms Described | Drinkable vials and capsules |
| Reference Biological Quantity | Studies investigated approximately 10⁴–10⁵ heat-killed bacilli per dose; formulation-specific |
| Vehicle/Excipient | Product-specific; mannitol was used as placebo/excipient in one study |
The early randomized trial evaluated 10⁴ and 10⁵ heat-killed bacilli and administered the preparation daily for 14 days. A later study describes a capsule containing approximately 10³·⁵ heat-killed bacilli. These are study-specific formulations and should not be entered as your commercial specification without a matching COA/product dossier.
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Mycobacterium manresensis (TBMUNE / Nyaditum resae) 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 Mycobacterium manresensis (TBMUNE / Nyaditum resae) 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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