Nutraceutical

Active Metabolites Extract of Bacillus subtilis B-2335 Manufacturer in India | Mediocon Inc.

Nutraceutical Nutraceutical GMP Certified Aurangabad, Maharashtra, India
Active Metabolites Extract of Bacillus subtilis B-2335 Manufacturer in India | Mediocon Inc. — Mediocon Inc
Active Metabolites Extract of Bacillus subtilis B-2335 Manufacturer in India | Mediocon Inc.

Product Overview

Grade: Nutraceutical | Category: Nutraceutical

Active Metabolites Extract of Bacillus subtilis B-2335 Manufacturer and Supplier in India

Product Overview

Active Metabolites Extract of Bacillus subtilis Strain 3 (B-2335) is a biological fermentation-derived ingredient associated with specialised pharmaceutical and nutraceutical formulations. It is obtained from a defined strain of Bacillus subtilis, a bacterial species used in a variety of fermentation and biotechnology processes.

The product described by PRG Pharma under the name Bactistatin is manufactured through fermentation of Bacillus subtilis strain 3 (B-2335), followed by extraction and drying of the cell-free culture medium. This approach produces a metabolite-containing preparation rather than a conventional live bacterial probiotic. Confirm that the product offered under this listing uses the same strain, process and specifications before associating it with Bactistatin.

Microbial Source and Production Process

The source organism is Bacillus subtilis, with strain identification B-2335. The strain designation is important because different bacterial strains can produce different metabolite profiles and are not automatically interchangeable.

The described manufacturing process involves controlled microbial cultivation, separation of the cell-free culture medium, extraction and drying. The final material's composition depends on the fermentation conditions, culture medium, downstream processing and quality-control methods.

The phrase “active metabolites extract” does not identify every individual compound present. Buyers should request the manufacturer's description of the metabolite profile, analytical methods, process controls and batch-release criteria.

Key Product Characteristics

The ingredient is distinguished by its specified microbial source and fermentation-derived origin. Its identity and quality should be established through documented strain traceability, validated production controls and a batch-specific certificate of analysis.

Physical form, appearance, moisture, assay, microbiological quality and storage requirements depend on the manufacturer's actual specification. These details should not be inferred from the product name alone.

Potential Applications

Pharmaceutical Formulations

The Bactistatin product information identifies the active-metabolite extract within a pharmaceutical product context. Any pharmaceutical application must be supported by the exact product's authorisation, applicable quality standards and approved labelling.

Nutraceutical Formulations

The ingredient may be considered for nutraceutical applications where its identity, specification and permitted use are established. The intended formulation, dose, safety information and product claims must be supported by appropriate evidence and comply with local regulations.

Research and Product Development

The defined microbial strain and fermentation-derived composition may be relevant to research, formulation development and analytical studies. Researchers should obtain suitable documentation describing the source strain, production process and material characteristics.

Difference Between a Metabolite Extract and a Live Probiotic

A live probiotic product contains viable microorganisms intended to provide a specified benefit when administered in adequate amounts. A cell-free metabolite extract is produced by processing fermentation material to obtain compounds from the culture medium; it should not automatically be described as containing live Bacillus subtilis cells.

The presence or absence of viable organisms must be confirmed through the manufacturing process and appropriate microbiological testing. Do not label this product as a live probiotic or as a sterile preparation without supporting documentation.

Quality Assurance and Technical Documentation

Before purchasing Active Metabolites Extract of Bacillus subtilis B-2335, buyers should request the current technical data sheet (TDS), certificate of analysis (CoA), safety data sheet (SDS), microbial strain identification information, manufacturing-process description and applicable regulatory documents.

Relevant quality checks may include identity, appearance, moisture, specified metabolite markers where applicable, microbial limits, testing for viable organisms, contaminants and stability. The exact parameters and acceptance limits should be based on the manufacturer's approved specification.

Regulatory Compliance

Regulatory status depends on the precise product, applicant, intended use, formulation and destination market. Historical application records for a similarly named ingredient should not be treated as proof that every product containing this extract is approved.

For commercial supply in India, verify the current authorisation and product-specific conditions with the relevant regulatory authority. Avoid unsupported claims about treating gastrointestinal disorders, restoring intestinal flora, correcting dysbiosis or providing other medical benefits.

Storage and Handling

Store the product in its original sealed packaging under the manufacturer's documented conditions. Protect it from moisture, contamination and unsuitable temperatures. Follow the current shelf-life, transport and handling instructions for the exact grade.

Enquire About Active Metabolites Extract of Bacillus subtilis B-2335

Contact Mediocon Inc. to enquire about product identity, grade, technical specifications, quality documentation, packaging and availability. Request the current manufacturer documentation to confirm that the supplied material matches your intended formulation and regulatory requirements.

Product Specifications

Product NameActive Metabolites Extract of Bacillus subtilis B-2335 Manufacturer in India | Mediocon Inc.
CategoryNutraceutical
GradeNutraceutical

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 Active Metabolites Extract of Bacillus subtilis B-2335 Manufacturer in India | Mediocon Inc. and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Active Metabolites Extract of Bacillus subtilis B-2335 Manufacturer 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 — Active Metabolites Extract of Bacillus subtilis B-2335 Manufacturer in India | Mediocon Inc.

1. What is Active Metabolites Extract of Bacillus subtilis B-2335?
It is a fermentation-derived ingredient associated with a specified strain of Bacillus subtilis. Its exact composition and intended use depend on the manufacturer's product specification.
2. What is B-2335?
B-2335 is the strain designation stated in the product name. Strain identity should be supported by the manufacturer's traceability and identification documentation.
3. How is the extract produced?
The Bactistatin product information describes fermentation followed by extraction and drying of the cell-free culture medium. Confirm the same production process for the exact material being supplied.
4. Is this product a live probiotic?
It is described as a metabolite extract rather than a conventional live bacterial preparation. The presence or absence of viable organisms must be verified through manufacturing documentation and microbiological testing.
5. What is the CAS number of this extract?
A verified CAS number for the complete extract has not been established. Do not assign a number without reliable documentation for the exact product.
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