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Oral solids · Contract manufacturing in India

L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg Tablets

Request manufacturing feasibility

Discuss third-party manufacturing of L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg Tablets with Walter Healthcare, India. Share your target market, required tablet count and finished-pack count, packaging and launch timeline for a product-specific quotation.

Catalogue reference
WH-0914
Composition and strength
L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg
Dosage form
Tablets
Indicative administration route
Oral
Therapeutic navigation area
Gastroenterology & hepatology
Pharmacological class
Gastrointestinal agent
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.

Clinical reference

Mechanism and pharmacokinetics.

Explore the published evidence for the ingredients in L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg Tablets. Each reference identifies its source formulation and study context. Ingredient studies describe the named reference product; they do not establish the pharmacokinetics, clinical suitability or bioequivalence of this finished formulation.

How to read our product information and sources ↗

Additional ingredient references still to be verified: L-Ornithine L-Aspartate. The references below cover only the named ingredients.

Ingredient-level reference

Pancreatin (gastro-resistant reference)

Reference for: Pancreatin. Source presentation: GASTRO-RESISTANT GRANULES. Source route: oral.

The cited studies use delayed-release gastro-resistant granules. The catalogue entry has a different or unspecified release description; these study values do not establish its absorption profile.

Human pharmacokinetic measurements are not provided by this reference. The specific evidence limitation is explained below.

Mechanism of action

The referenced porcine pancreatin supplies lipase, amylase and protease activity. Its acid-resistant coating releases enzymes in the small intestine, where they break down dietary fats, starches and proteins. Enzyme activity units and pancreatin mass are distinct measures.

Pharmacokinetics

The label states that conventional pharmacokinetic data are unavailable because the enzymes act locally in the gastrointestinal tract and are subsequently digested. A systemic absorption percentage or plasma half-life should not be invented for this preparation. The gastro-resistant delivery findings do not demonstrate equal enzyme activity or performance for an unspecified tablet.

Ingredient-level summary of the cited reference product. Study formulation, route, strength and population govern interpretation; these data do not establish pharmacokinetics or bioequivalence for Walter's formulation or fixed combination.

Source: Creon Micro 60.12 mg gastro-resistant granules: SmPC, sections 5.1–5.2

Reference accessed .

Editorial development perspective

What deserves attention in this formulation.

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.

The clinical references on this page cover only their named ingredients. These development notes do not resolve the remaining clinical-reference gaps.

About these development notes and source limitations ↗

Balance tablet performance and processability

Listed presentation: Tablets.

Use early development batches to compare blend flow, compression behaviour, tablet strength and the appropriate release test. A harder tablet or a faster disintegration result is not, by itself, a complete product specification. Set priorities around the intended presentation, then check that the chosen process can reproduce them at the proposed scale.

Separate enzyme quantity from activity

Catalogue wording: “Pancreatin”.

Request the relevant activity-unit definition, assay conditions and raw-material specification alongside any mass stated in the catalogue. For an enzyme blend, identify which activities the specification will measure. Assess activity retention through the proposed process and storage programme; a milligram figure should not be treated as a complete activity specification.

Translate the listed strength into a quantitative formula

Strength expressions in this entry include “150 mg”, “100 mg”.

Tie every stated ingredient amount to its intended dosage unit or measure, then distinguish that declared amount from the quantity of raw material needed for a batch. Record any assay or equivalence calculation in the formula. This gives development, purchasing and artwork teams the same strength definition without assigning a patient dose from the catalogue.

Suggested starting point

A practical starting point is to separate enzyme quantity from activity. For this tablets brief, agree the target characteristics and a short set of measurable development questions before comparing prototypes or supplier proposals. Keep unresolved clinical claims outside the product specification until supporting evidence is available.

Discuss this product brief

Manufacturing & packaging brief

Plan the tablet presentation.

Use this preparation guide for L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg Tablets. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Define release type, coating, scoring and any reference-product requirements. Keep each strength and presentation as a separate item in the brief.

Quality & technical transfer

Agree the product specification, analytical methods and applicable dissolution or disintegration requirements. Identify the formula and process information available for transfer.

Review the technical documents

Packaging configuration

Compare the proposed blister, strip or bottle with the formulation and its protection requirements. Specify tablets per primary pack and primary packs per carton.

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.

Quantities, MOQ & lead time

For L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg Tablets, state the tablet count and finished-pack count, 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 capabilitiesOral solidsTherapeutic 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.

L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg Tablets

What is listed in the catalogue?

The catalogue lists L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg as tablets in its gastroenterology & hepatology navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg Tablets. 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, tablets 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 L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg Tablets. 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 L-Ornithine L-Aspartate 150 mg, Pancreatin 100 mg Tablets 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 .