Oral solids · Contract manufacturing in India

Mirtazapine 15 mg · Tablets

Discuss third-party manufacturing of Mirtazapine 15 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-1056
Composition and strength: Mirtazapine 15 mg
Dosage form: Tablets
Indicative administration route: Oral
Therapeutic navigation area: Neurology & psychiatry
Pharmacological class: Antidepressant
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 Mirtazapine 15 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

Mirtazapine

Reference for: Mirtazapine. Source presentation: tablet, film coated. Source route: oral.

Mechanism of action

The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic α 2-adrenergic inhibitory autoreceptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.

Pharmacokinetics

Plasma levels of mirtazapine are linearly related to dose over a dose range of 15 to 80 mg (1.78 times the maximum recommended dose). Steady state plasma levels of mirtazapine are attained within 5 days, with about 50% accumulation (accumulation ratio = 1.5). The (–) enantiomer has an elimination half-life that is approximately twice as long as the (+) enantiomer and therefore achieves plasma levels that are about 3 times as high as that of the (+) enantiomer.

Mirtazapine has an absolute bioavailability of about 50% following oral administration. Peak plasma concentrations of mirtazapine are reached within about 2 hours post dose.

Mirtazapine is approximately 85% bound to plasma proteins over a concentration range of 0.01 to 10 mcg/mL.

Mirtazapine has a half-life of about 20 to 40 hours following oral administration of mirtazapine tablets.

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: Mirtazapine — tablet, film coated

Reference accessed 2026-10-06. Label revision: 2026-09-04.

Manufacturing & packaging brief

Plan the tablet presentation.

Use this preparation guide for Mirtazapine 15 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

Exact presentation: Use “Mirtazapine 15 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 Mirtazapine 15 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 navigationNeurology & psychiatry Full catalogueSearch other compositions

Common questions

Before you request a quotation.

Mirtazapine 15 mg Tablets

What is listed in the catalogue?

The catalogue lists Mirtazapine 15 mg as tablets in its neurology & psychiatry navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Mirtazapine 15 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 Mirtazapine 15 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 Mirtazapine 15 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.