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Oral solids · Contract manufacturing in India

Alfacalcidol 0.25 mcg, Calcium Citrate 1000 mg Tablets

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Discuss third-party manufacturing of Alfacalcidol 0.25 mcg, Calcium Citrate 1000 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-2642
Composition and strength
Alfacalcidol 0.25 mcg, Calcium Citrate 1000 mg
Dosage form
Tablets
Indicative administration route
Oral
Therapeutic navigation area
Nutrition & supportive care
Pharmacological class
Vitamin D / vitamin D analogue + 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 Alfacalcidol 0.25 mcg, Calcium Citrate 1000 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

Calcium

Reference for: Calcium Citrate. Source presentation: oral nutrient reference. Source route: oral.

Biological role

Calcium provides the mineral structure of bone and teeth. Ionized calcium also participates in muscle contraction, nerve signaling, blood coagulation and hormone secretion.

Absorption and disposition

Intestinal uptake occurs by vitamin-D-dependent active transport and passive diffusion. The absorbed fraction depends on intake and formulation. Calcium carbonate is more dependent on gastric acid than calcium citrate. Most body calcium is held in the skeleton, which is continually remodeled and acts as a reservoir. These nutrient data do not establish this product's bioavailability.

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: Calcium

Reference accessed .

Ingredient-level reference

Alfacalcidol

Reference for: Alfacalcidol. Source presentation: SOFT CAPSULE. Source route: oral.

Mechanism of action

Alfacalcidol is rapidly converted in the liver to 1,25-dihydroxyvitamin D, which regulates calcium and phosphate metabolism. This conversion bypasses the impaired renal activation step described in the reference.

Pharmacokinetics

The reference describes passive, nearly complete absorption in the small intestine and rapid hepatic activation. It reports an alfacalcidol half-life of approximately 4 hours, while the pharmacological effect lasts 3–5 days. These are distinct measures: duration of effect should not be treated as the plasma elimination half-life. Exposure and calcium response require interpretation in the clinical context of vitamin-D treatment.

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: Alfacalcidol 1 microgram soft capsules: SmPC, sections 5.1–5.2

Reference accessed .

Manufacturing & packaging brief

Plan the tablet presentation.

Use this preparation guide for Alfacalcidol 0.25 mcg, Calcium Citrate 1000 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.

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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 Alfacalcidol 0.25 mcg, Calcium Citrate 1000 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.

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Explore the context

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Related catalogue records

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

Common questions

Before you request a quotation.

Alfacalcidol 0.25 mcg, Calcium Citrate 1000 mg Tablets

What is listed in the catalogue?

The catalogue lists Alfacalcidol 0.25 mcg, Calcium Citrate 1000 mg as tablets in its nutrition & supportive care navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Alfacalcidol 0.25 mcg, Calcium Citrate 1000 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 Alfacalcidol 0.25 mcg, Calcium Citrate 1000 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 Alfacalcidol 0.25 mcg, Calcium Citrate 1000 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 .