Oral solids · Contract manufacturing in India

Dipyridamole 12.5 mg · Tablets

Discuss third-party manufacturing of Dipyridamole 12.5 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-3412
Composition and strength: Dipyridamole 12.5 mg
Dosage form: Tablets
Indicative administration route: Oral
Therapeutic navigation area: Haematology & thrombosis
Pharmacological class: Antiplatelet
Manufacturing stream: Non-beta-lactam
BCS class: Class II

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 Dipyridamole 12.5 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 ↗

Prescribing-label excerpts

Dipyridamole

Reference for: Dipyridamole. Source presentation: tablet. Source route: oral.

Mechanism of action

Dipyridamole inhibits the uptake of adenosine into platelets, endothelial cells and erythrocytes in vitro and in vivo; the inhibition occurs in a dose-dependent manner at therapeutic concentrations (0.5 mcg/mL to 1.9 mcg/mL). This inhibition results in an increase in local concentrations of adenosine which acts on the platelet A2-receptor thereby stimulating platelet adenylate cyclase and increasing platelet cyclic-3',5'-adenosine monophosphate (cAMP) levels. Via this mechanism, platelet aggregation is inhibited in response to various stimuli such as platelet activating factor (PAF), collagen and adenosine diphosphate (ADP).

Dipyridamole inhibits phosphodiesterase (PDE) in various tissues. While the inhibition of cAMP-PDE is weak, therapeutic levels of dipyridamole inhibit cyclic-3',5'-guanosine monophosphate-PDE (cGMP-PDE), thereby augmenting the increase in cGMP produced by EDRF (endothelium-derived relaxing factor, now identified as nitric oxide).

Pharmacokinetics

Following an oral dose of dipyridamole tablets, the average time to peak concentration is about 75 minutes. The decline in plasma concentration following a dose of dipyridamole tablets fits a two-compartment model. The alpha half-life (the initial decline following peak concentration) is approximately 40 minutes. The beta half-life (the terminal decline in plasma concentration) is approximately 10 hours. Dipyridamole is highly bound to plasma proteins. It is metabolized in the liver where it is conjugated as a glucuronide and excreted with the bile.

Selected passages from the cited U.S. prescribing label. The studies concern the source product and populations named in each passage; they do not establish Walter-product bioequivalence, an approved indication, or the kinetics of another fixed combination. Tables and the full prescribing information remain available in the source.

Source: DailyMed: Dipyridamole — tablet

Reference accessed 2026-10-06. Label revision: 2026-04-15.

Manufacturing & packaging brief

Plan the tablet presentation.

Use this preparation guide for Dipyridamole 12.5 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.

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Details to confirm for this record

Exact presentation: Use “Dipyridamole 12.5 mg Tablets” consistently in the brief. Specify coating, release, grade or other presentation requirements explicitly where the catalogue does not define them.

Quantities, MOQ & lead time

For Dipyridamole 12.5 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 solids Therapeutic navigationHaematology & thrombosis Full catalogueSearch other compositions

Common questions

Before you request a quotation.

Dipyridamole 12.5 mg Tablets

What is listed in the catalogue?

The catalogue lists Dipyridamole 12.5 mg as tablets in its haematology & thrombosis navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Dipyridamole 12.5 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 Dipyridamole 12.5 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 Dipyridamole 12.5 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 8 October 2026.