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Sterile injectables · Contract manufacturing in India

Lactobacillus 100 Million, Racecadotril 10 mg, Saccharomyces Boulardii 2.5 Billion CFU Injectable suspension

Request manufacturing feasibility

Discuss third-party manufacturing of Lactobacillus 100 Million, Racecadotril 10 mg, Saccharomyces Boulardii 2.5 Billion CFU Injectable suspension with Walter Healthcare, India. Share your target market, required container count and fill volume, packaging and launch timeline for a product-specific quotation.

Catalogue reference
WH-1790
Composition and strength
Lactobacillus 100 Million, Racecadotril 10 mg, Saccharomyces Boulardii 2.5 Billion CFU
Dosage form
Injectable suspension
Indicative administration route
Parenteral
Therapeutic navigation area
Gastroenterology & hepatology
Pharmacological class
Antidiarrhoeal
Manufacturing stream
Non-beta-lactam

Catalogue details support an initial B2B discussion. Walter confirms the applicable unit, current licence scope, formula, target market and commercial feasibility before making a commitment.

Catalogue identity under review

Confirm the product identity.

These notes use the catalogue composition and presentation to frame a technical discussion. They are planning considerations, not tested properties or clinical findings for this product.

A matching clinical reference has not yet been verified for this page. Drug-specific mechanisms and human pharmacokinetic values remain open for review.

About these development notes and source limitations ↗

Resolve the catalogue identity first

Listed presentation: Injectable suspension.

The ingredient wording and injectable presentation need confirmation against the original product document. Compare the full composition, ingredient form and presentation with the source document before defining technical or clinical content for this entry.

Keep the original and confirmed wording together

Catalogue record: WH-1790.

A useful review record retains the original entry, the proposed clarification and the document that supports it. Resolve any salt-equivalence, strength or route difference explicitly, then reassess the formulation and its references using the confirmed identity.

Suggested starting point

Prioritise identity confirmation before a formulation-development brief. The present listing remains under review.

Discuss this product brief

Manufacturing & packaging brief

Plan the injectable-suspension presentation.

Use this preparation guide for Lactobacillus 100 Million, Racecadotril 10 mg, Saccharomyces Boulardii 2.5 Billion CFU Injectable suspension. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Identify the intended route, concentration, fill volume and suspension characteristics in the technical specification. Do not substitute a solution presentation in the brief.

Quality & technical transfer

Request a product-specific review of suspension controls, sterile processing, applicable release tests and container-closure integrity. Provide the available development or transfer evidence.

Review the technical documents

Packaging configuration

Describe the proposed container and closure and any administration accessory. Compatibility and delivery requirements need review for the actual suspension.

Explore packaging options

Details to confirm for this record

Full composition
Keep all named components and their individual amounts together in the specification. Ingredient substitutions, omissions and changed ratios require a separate formula and permission review.
Concentration and pack size
The record does not state a complete concentration basis. Confirm the amount per volume or weight before a specification, label or quotation is finalised; no denominator has been assumed here.

Quantities, MOQ & lead time

For Lactobacillus 100 Million, Racecadotril 10 mg, Saccharomyces Boulardii 2.5 Billion CFU Injectable suspension (WH-1790), state the container count and fill volume, target market and reorder forecast. MOQ and lead time depend on the assessed formula, process, components, testing and project readiness; request those terms in writing.

Discuss this manufacturing brief

Explore the context

Build the right manufacturing brief.

Dosage-form capabilitiesSterile injectablesTherapeutic navigationGastroenterology & hepatologyFull catalogueSearch other compositions

Related catalogue records

Grouped by catalogue navigation labels, not by therapeutic interchangeability or clinical recommendation.

Common questions

Before you request a quotation.

Lactobacillus 100 Million, Racecadotril 10 mg, Saccharomyces Boulardii 2.5 Billion CFU Injectable suspension

What is listed in the catalogue?

The catalogue lists Lactobacillus 100 Million, Racecadotril 10 mg, Saccharomyces Boulardii 2.5 Billion CFU as injectable suspension in its gastroenterology & hepatology navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Lactobacillus 100 Million, Racecadotril 10 mg, Saccharomyces Boulardii 2.5 Billion CFU Injectable suspension. The team reviews the applicable product permission and unit, formulation and equipment fit, testing, packaging and production schedule before confirming the manufacturing scope in writing. Request the relevant product and facility documents with your enquiry.

What do I need for a quotation?

Share the exact composition and strength, injectable suspension presentation, target market, initial quantity, preferred pack and timing. Identify whether this is a new product, development brief or transfer.

The quotation must confirm MOQ, inclusions, prerequisites and lead time for the proposed product and site.

What is needed for Indian and export markets?

For India, share the intended brand or institutional supply requirement, pack sizes, initial order quantity and artwork needs for Lactobacillus 100 Million, Racecadotril 10 mg, Saccharomyces Boulardii 2.5 Billion CFU Injectable suspension. Confirm the applicable product permission, manufacturing unit and labelling requirements with the team.

For export, identify each destination country, proposed pack, language and registration or dossier requirements. Ask which product-specific quality and stability documents are available. Container compatibility and destination-market requirements need review; a catalogue record does not establish export registration or a shelf-life commitment.

How do I submit my enquiry?

Use the product-specific enquiry button to carry this composition and dosage form into the form. After a successful submission, a receipt reference confirms that your brief has been saved for review. Use the RFQ checklist to prepare the remaining details.

Technical document review

Which documents can I ask Walter to review?

Ask about manufacturing and packing records, specifications, analytical methods, Certificates of Analysis (COA), stability evidence, the Process Validation Protocol (PVP) and Process Validation Report (PVR). The wider checklist below covers supplier qualification, technical transfer and ongoing supply.

View the full document checklist 14 review areas
Site, licence and audit scope
Manufacturing licence, applicable product permissions, GMP certificates, Site Master File, supplier-qualification questionnaire and relevant audit responses.
Manufacturing, packing and batch release
Master Formula Record (MFR), master packing instructions, Batch Manufacturing Record (BMR), Batch Packing Record (BPR), reconciliation and authorised release records.
Process validation and continued verification
Process Validation Protocol (PVP), Process Validation Report (PVR), process performance qualification documents and continued process verification trends.
Equipment, facilities and utilities
Validation Master Plan (VMP), user requirements, DQ/IQ/OQ/PQ records, calibration and maintenance evidence for relevant equipment and utilities.
Cleaning, carryover and hold times
Cleaning Validation Protocol (CVP), Cleaning Validation Report (CVR), residue limits, recovery studies and applicable clean, dirty and process hold-time studies.
Specifications and analytical evidence
Specifications, Method of Analysis (MOA), Standard Testing Procedure (STP), Certificates of Analysis (COA), analytical validation, verification and method-transfer records.
Stability, packaging and transport
Stability protocols/reports, ongoing stability commitments, pack specifications, approved artwork, compatibility and applicable packaging or transport studies.
Development and technology transfer
Development report, technology-transfer protocol/report, gap assessment, control strategy, critical quality attributes and critical process parameters.
Quality reviews, investigations and changes
Product Quality Review (PQR) / Annual Product Review (APR), deviations, CAPA, change control, OOS/OOT trends, complaints, recalls and relevant SOP/training records.
Material suppliers and impurity risks
API/excipient supplier qualification, traceability, material COAs, relevant origin declarations and impurity risk assessments with supporting tests.
Sterile-product evidence, where applicable
Contamination Control Strategy (CCS), media-fill/aseptic simulation reports, sterilisation and filtration validation, environmental monitoring, sterility/endotoxin and container-closure integrity evidence.
Computerised systems and data integrity
Computerised-system validation, access controls, audit-trail review, backup/restore checks and relevant data-integrity procedures.
Market-specific regulatory support
Applicable dossier sections, API master-file/CEP support, bioequivalence or biowaiver evidence and Certificate of a Pharmaceutical Product (CPP/CoPP), where required and available.
Quality agreement and access arrangements
Quality/technical agreement covering responsibilities, release, changes, subcontracting, investigations, complaints, recalls, audits and document access.

Agree the list for the exact product, site, process, pack, market and project stage. QA confirms what exists, applies and may be shared; some records may require an NDA, redaction or controlled review. See document definitions and review guidance.

Important qualification

This B2B catalogue record is not proof of current approval or confirmation that Lactobacillus 100 Million, Racecadotril 10 mg, Saccharomyces Boulardii 2.5 Billion CFU Injectable suspension is available for sale. It is not prescribing information or patient advice. Any Drugs Rules status, current approval, exemption, applicable unit, licence scope, formulation, claims, brand use, destination-market registration and commercial feasibility require documentary verification and Walter's written confirmation. Read the full regulatory disclaimer.

Composition and classification are taken from Walter's product catalogue. The manufacturing guide helps buyers prepare a technical brief. Clinical references, where shown, describe the cited product and study. Manufacturing guide updated .