WalterHealthcareRequest a quote

Oral solids · Contract manufacturing in India

Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg Hard-gelatin capsules

Request manufacturing feasibility

Discuss third-party manufacturing of Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg Hard-gelatin capsules with Walter Healthcare, India. Share your target market, required capsule count and finished-pack count, packaging and launch timeline for a product-specific quotation.

Catalogue reference
WH-4857
Composition and strength
Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg
Dosage form
Hard-gelatin capsules
Indicative administration route
Oral
Therapeutic navigation area
Nutrition & supportive care
Pharmacological class
Amino acid / metabolic nutritional supplement + Mineral supplement
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 Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg Hard-gelatin capsules. 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: Copper Sulphate Pentahydrate; L-Isoleucine; L-Leucine; L-Lysine Mono Hcl; L-Methionine; L-Phenylalanine; L-Threonine; L-Tryptophan; L-Valine; Light Magnesium Oxide. The references below cover only the named ingredients.

Nutrient reference

Selenium

Reference for: Selenium. Source presentation: oral nutrient reference. Source route: oral.

Biological role

Selenium is incorporated into selenoproteins including glutathione peroxidases and thioredoxin reductases. These proteins contribute to thyroid-hormone metabolism and protection against oxidative damage.

Absorption and disposition

Absorbed organic and inorganic selenium is metabolized toward an intermediate used to synthesize selenocysteine. A substantial body pool is in skeletal muscle. Urinary excretion is the main mechanism maintaining balance; excretion through feces and lungs also increases at high intake. This general physiology does not establish equal bioavailability among selenium compounds.

Nutrient-level summary from NIH. Absorption and disposition describe general oral nutritional physiology, not a pharmacokinetic or bioequivalence study of this finished product.

Source: NIH Office of Dietary Supplements: Selenium

Reference accessed .

Nutrient reference

Manganese

Reference for: Manganese Sulphate Monohydrate. Source presentation: oral nutrient reference. Source route: oral.

Biological role

Manganese is a cofactor for enzymes including manganese superoxide dismutase, arginase and pyruvate carboxylase. These functions connect manganese to nutrient metabolism, antioxidant defense and bone formation.

Absorption and disposition

Manganese is absorbed in the small intestine by active transport, with possible diffusion at high intakes. After absorption, most circulating manganese binds to transferrin, albumin or alpha-2-macroglobulin. The cited nutrient review does not establish a plasma half-life or bioavailability for this finished product.

Nutrient-level summary from NIH. Absorption and disposition describe general oral nutritional physiology, not a pharmacokinetic or bioequivalence study of this finished product.

Source: NIH Office of Dietary Supplements: Manganese

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 ↗

Develop the fill and capsule shell together

Listed presentation: Hard-gelatin capsules.

Review the proposed fill density and flow alongside capsule size, fill-weight consistency and shell compatibility. If granules or pellets are proposed, define their role before choosing the filling process. A capsule size selected from fill weight alone can overlook the behaviour of the actual blend and its storage requirements.

Carry the exact ingredient form into development

Catalogue wording: “Sulphate”.

Use the named ingredient form when requesting material specifications and comparing possible suppliers. Resolve assay, water-content and strength-equivalence conventions before converting a formula into batch quantities. A similarly named salt or hydrate should be assessed as a distinct material choice rather than introduced through a naming shortcut.

Resolve the amount-per-container or concentration basis

Strength expressions in this entry include “1.0 mg”, “5.9 mg”, “18.3 mg”, “25.0 mg”, “18.4 mg”, with further amounts in the full composition.

Clarify whether each stated amount applies to a complete container, a defined volume or a defined weight. Put the agreed denominator beside the ingredient quantity before comparing formula costs or designing a label. Keep the finished fill size as a separate field so that changing the pack does not silently change the intended specification.

Suggested starting point

A practical starting point is to carry the exact ingredient form into development. For this hard-gelatin capsules 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 hard-capsule presentation.

Use this preparation guide for Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg Hard-gelatin capsules. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Confirm the fill type, shell material, capsule size and printing requirements. Distinguish powder, granule and pellet fills where relevant to the proposed formulation.

Quality & technical transfer

Request review of the fill specification, shell compatibility, analytical methods and applicable release testing. Identify any established formula or transfer package.

Review the technical documents

Packaging configuration

Specify capsules per blister or bottle, the proposed barrier material and carton configuration. Include shell and print requirements in the quotation scope.

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.
Salt and strength wording
Confirm whether the stated amount refers to the named salt, hydrate or equivalent active moiety. Use the agreed expression consistently in the specification, quotation and artwork.
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 Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg Hard-gelatin capsules (WH-4857), state the capsule 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 navigationNutrition & supportive careFull 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.

Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg Hard-gelatin capsules

What is listed in the catalogue?

The catalogue lists Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg as hard-gelatin capsules in its nutrition & supportive care navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg Hard-gelatin capsules. 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, hard-gelatin capsules 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 Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg Hard-gelatin capsules. 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 Copper Sulphate Pentahydrate 1.0 mg, L-Isoleucine 5.9 mg, L-Leucine 18.3 mg, L-Lysine Mono Hcl 25.0 mg, L-Methionine 18.4 mg, L-Phenylalanine 5.0 mg, L-Threonine 8.3 mg, L-Tryptophan 10.1 mg, L-Valine 6.7 mg, Light Magnesium Oxide 30.0 mg, Manganese Sulphate Monohydrate 4.0 mg, Selenium 75.0 mcg Hard-gelatin capsules 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 .