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Oral solids · Contract manufacturing enquiry

L-Methyl Folate Calcium 1 mg, Methylcobalamin 1500 mcg, Pyridoxal-5-Phosphate 5 mg Tablets

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Discuss third-party manufacturing with Walter Healthcare, India. Confirm the formulation, tablet presentation, packaging and project requirements for a product-specific quotation.

Catalogue reference
WH-0912
Composition and strength
L-Methyl Folate Calcium 1 mg, Methylcobalamin 1500 mcg, Pyridoxal-5-Phosphate 5 mg
Dosage form
Tablets
Indicative administration route
Oral
Therapeutic navigation area
Nutrition & supportive care
Pharmacological class
Haematinic & nutritional 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 L-Methyl Folate Calcium 1 mg, Methylcobalamin 1500 mcg, Pyridoxal-5-Phosphate 5 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 ↗

Nutrient reference

Vitamin B12

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

Biological role

Vitamin B12 supplies cofactors for methionine synthase and methylmalonyl-CoA mutase. These reactions support methionine formation and conversion of methylmalonyl-CoA to succinyl-CoA. B12 is involved in DNA synthesis, red-cell formation and nervous-system function.

Absorption and disposition

Free B12 combines with intrinsic factor and is taken up in the distal ileum. Absorption becomes less efficient as the dose exceeds intrinsic-factor capacity; the NIH review reports about 2% absorption at 500 micrograms and 1.3% at 1,000 micrograms. Cyanocobalamin and hydroxocobalamin are converted into active cobalamin forms. These are oral nutrient data, not injectable-product pharmacokinetics.

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: Vitamin B12

Reference accessed .

Nutrient reference

Vitamin B6

Reference for: Pyridoxal-5-Phosphate. Source presentation: oral nutrient reference. Source route: oral.

Biological role

Pyridoxal phosphate and pyridoxamine phosphate are active vitamin B6 coenzymes involved in amino-acid metabolism. B6 also contributes to neurotransmitter synthesis, glycogen metabolism and hemoglobin formation.

Absorption and disposition

Vitamin B6 is absorbed in the jejunum. Phosphorylated forms are dephosphorylated before free B6 enters by passive diffusion. The NIH review describes similar absorption from foods and supplements; much of a large pharmacological dose is rapidly eliminated in urine. This physiology does not supply a measured half-life for this formulation.

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: Vitamin B6

Reference accessed .

Nutrient reference

Folate

Reference for: L-Methyl Folate Calcium. Source presentation: oral nutrient reference. Source route: oral.

Biological role

Folate coenzymes transfer single-carbon units during DNA and RNA synthesis and amino-acid metabolism. Folate-dependent reactions include homocysteine conversion to methionine and thymidylate formation required for cell division.

Absorption and disposition

Food folates are converted to monoglutamates before intestinal absorption. Folic acid undergoes reduction and conversion to active folate forms; 5-methyltetrahydrofolate is the main plasma form. Supplemental folic acid has estimated bioavailability of about 85% with food and nearly 100% fasting. These percentages should not be transferred to a different folate form or fixed combination.

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: Folate

Reference accessed .

Manufacturing & packaging brief

Plan the tablet presentation.

Use this preparation guide for L-Methyl Folate Calcium 1 mg, Methylcobalamin 1500 mcg, Pyridoxal-5-Phosphate 5 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.
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.

Quantities, MOQ & lead time

For L-Methyl Folate Calcium 1 mg, Methylcobalamin 1500 mcg… Tablets (WH-0912), 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.

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Explore the context

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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.

L-Methyl Folate Calcium 1 mg, Methylcobalamin 1500 mcg, Pyridoxal-5-Phosphate 5 mg Tablets

What is listed in the catalogue?

The catalogue lists L-Methyl Folate Calcium 1 mg, Methylcobalamin 1500 mcg, Pyridoxal-5-Phosphate 5 mg as tablets in its nutrition & supportive care navigation area and non-beta-lactam manufacturing stream.

Is manufacturing availability confirmed?

No. Walter checks current facility permissions, formulation and equipment fit, testing, packaging and target-market requirements before written confirmation.

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.

Can I change the pack or target market?

Include each proposed pack and country in the enquiry. Container compatibility, artwork, supporting stability evidence, permission scope and destination requirements need review for the requested configuration.

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-Methyl Folate Calcium 1 mg, Methylcobalamin 1500 mcg, Pyridoxal-5-Phosphate 5 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 .