Nutraceutical

Mycobacterium Manresensis (TBMUNE / Nyaditumresae) Manufacturer & Supplier in India | MEDIOCON INC

Nutraceutical Nutraceutical Grade GMP Certified Aurangabad, Maharashtra, India
Mycobacterium Manresensis (TBMUNE / Nyaditumresae) Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Mycobacterium Manresensis (TBMUNE / Nyaditumresae) Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

Grade: Nutraceutical Grade | Category: Nutraceutical

Mycobacterium Manresensis (TBMUNE / Nyaditumresae) Manufacturer & Supplier in India

Mycobacterium manresensis, also reported in current scientific/regulatory literature as Mycobacterium setense manresensis, is a non-pathogenic environmental mycobacterial strain that has been developed as a heat-killed, freeze-dried food-supplement ingredient. The preparation is associated with the product names Nyaditum resae® and TBMUNE.

MEDIOCON INC offers this specialized microbial-derived ingredient for suitable nutraceutical and food-supplement applications, subject to the exact material specification, regulatory status and applicable market requirements.

Product Overview

Nyaditum resae® is a preparation based on heat-killed Mycobacterium manresensis. The organism is deliberately inactivated before incorporation into the finished supplement. It is therefore fundamentally different from a live probiotic microorganism.

The organism was originally isolated from the Cardener River in Manresa, Catalonia, Spain and deposited in recognized culture collections. EFSA identifies the strain as Mycobacterium setense manresensis and records deposits including CECT 8638.

Key Product Information

Product Name: Mycobacterium Manresensis
Alternative Names: TBMUNE / Nyaditum resae®
Current Taxonomic Reference: Mycobacterium setense manresensis
Earlier Scientific Name: Mycobacterium manresensis
Microorganism: Mycobacterium species
Product Type: Heat-Killed Microbial Ingredient
Form: Freeze-Dried Material / Capsule Ingredient
Category: Nutraceutical / Food Supplement Ingredient
Application: Specialized Immune-Health Supplement

Heat-Killed Microbial Preparation

The ingredient is produced using a validated heat-inactivation process followed by preparation of the resulting material in a suitable dried form.

EFSA's assessment found that the thermal inactivation process used for the evaluated novel food effectively killed the M. setense manresensis organisms.

This distinction is important:

TBMUNE / Nyaditum resae is not a live bacterial probiotic.

Freeze-Dried Form

The evaluated novel-food preparation consisted of heat-killed, freeze-dried M. setense manresensis, combined with mannitol as a bulking agent. EFSA described the finished novel-food ingredient as containing ≤10⁵ heat-killed organisms and 200 mg mannitol per capsule under the proposed conditions of use.

The exact specification of your MEDIOCON material should always be taken from the supplier's current CoA and approved product dossier.

Product Specifications

Product NameMycobacterium Manresensis (TBMUNE / Nyaditumresae) Manufacturer & Supplier in India | MEDIOCON INC
CategoryNutraceutical
GradeNutraceutical Grade
AppearanceOff-white to light beige freeze-dried powder

Analytical Specifications

ParameterSpecification
AppearanceOff-white to light beige freeze-dried powder

Sourcing, Regulatory & Export Information

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 / Nyaditumresae) 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 / Nyaditumresae) 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.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Mycobacterium Manresensis (TBMUNE / Nyaditumresae) Manufacturer & Supplier in India | MEDIOCON INC

What is Mycobacterium manresensis?
Mycobacterium manresensis, currently referred to in regulatory literature as Mycobacterium setense manresensis, is an environmental mycobacterial strain developed as a heat-killed food-supplement ingredient.
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