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Oral solids · Contract manufacturing in India

Alpha Lipoic Acid 100 mg, Methylcobalamin 750 mcg Hard-gelatin capsules

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Discuss third-party manufacturing of Alpha Lipoic Acid 100 mg, Methylcobalamin 750 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-2171
Composition and strength
Alpha Lipoic Acid 100 mg, Methylcobalamin 750 mcg
Dosage form
Hard-gelatin capsules
Indicative administration route
Oral
Therapeutic navigation area
Nutrition & supportive care
Pharmacological class
Haematinic & nutritional supplement
Manufacturing stream
Non-beta-lactam
BCS class
Class II (mixed)

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 Alpha Lipoic Acid 100 mg, Methylcobalamin 750 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 ↗

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 .

Ingredient-level reference

Alpha-lipoic acid (thioctic acid)

Reference for: Alpha Lipoic Acid. Source presentation: FILM-COATED TABLET. Source route: oral.

Mechanism of action

Alpha-lipoic acid is a coenzyme in mitochondrial multienzyme complexes. The reference also describes antioxidant biochemical effects and experimental findings in diabetic nerve models; these do not establish that every supplement or combination produces the same clinical benefit.

Pharmacokinetics

After a 600 mg oral tablet, the reference reports rapid absorption, a peak at approximately 0.3–0.5 hours and a plasma half-life of 20–30 minutes. Metabolism includes oxidative chain shortening and sulfur methylation. Only small quantities of unchanged substance appear in human urine. The high urinary recovery percentages reported in animal experiments are not presented here as human elimination data.

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: Austria BASG: Thioctacid 600 mg film-coated tablets, sections 5.1–5.2

Reference accessed .

Manufacturing & packaging brief

Plan the hard-capsule presentation.

Use this preparation guide for Alpha Lipoic Acid 100 mg, Methylcobalamin 750 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.
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 Alpha Lipoic Acid 100 mg, Methylcobalamin 750 mcg Hard-gelatin capsules, 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.

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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.

Alpha Lipoic Acid 100 mg, Methylcobalamin 750 mcg Hard-gelatin capsules

What is listed in the catalogue?

The catalogue lists Alpha Lipoic Acid 100 mg, Methylcobalamin 750 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 Alpha Lipoic Acid 100 mg, Methylcobalamin 750 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 Alpha Lipoic Acid 100 mg, Methylcobalamin 750 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 Alpha Lipoic Acid 100 mg, Methylcobalamin 750 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 .