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Topicals & local formats · Contract manufacturing in India

Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v Eye drops

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Discuss third-party manufacturing of Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v Eye drops with Walter Healthcare, India. Share your target market, required container count and fill volume, packaging and launch timeline for a product-specific quotation.

Catalogue reference
WH-5688
Composition and strength
Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v
Dosage form
Eye drops
Indicative administration route
Ophthalmic
Therapeutic navigation area
Ophthalmology & ENT
Pharmacological class
H1 antihistamine
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 Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v Eye drops. 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 ↗

Additional ingredient references still to be verified: Benzalkonium Chloride. The references below cover only the named ingredients.

Prescribing-label excerpts

Olopatadine Hydrochloride

Reference for: Olopatadine Hcl. Source presentation: solution/ drops. Source route: ophthalmic.

Mechanism of action

Olopatadine is a mast cell stabilizer and a histamine H1 antagonist. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.

Pharmacokinetics

Systemic bioavailability data upon topical ocular administration of olopatadine hydrochloride ophthalmic solution USP, 0.2% are not available. Following topical ocular administration of olopatadine 0.15% ophthalmic solution in man, olopatadine was shown to have a low systemic exposure.

Two studies in normal volunteers (totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay (< 0.5 ng/mL). Samples in which olopatadine was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The elimination half-life in plasma following oral dosing was 8 to 12 hours, and elimination was predominantly through renal excretion. Approximately 60 – 70 % of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.

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: Olopatadine Hydrochloride — solution/ drops

Reference accessed . Label revision: 2019-05-07.

Editorial development perspective

What deserves attention in this formulation.

These notes use the catalogue composition and presentation to frame a technical discussion. They are planning considerations, not tested properties or clinical findings for this product.

The clinical references on this page cover only their named ingredients. These development notes do not resolve the remaining clinical-reference gaps.

About these development notes and source limitations ↗

Evaluate formulation and ocular delivery together

Listed presentation: Eye drops.

Specify whether the proposed eye-drop formula is a solution, suspension or another defined system, then review pH, osmolality, viscosity and particulate considerations as applicable. Include drop delivery and the container in development work. A preservative named in the composition does not, by itself, establish a supported multidose use period.

Carry the exact ingredient form into development

Catalogue wording: “Hcl”.

Use the named ingredient form when requesting material specifications and comparing possible suppliers. Resolve assay, water-content and strength-equivalence conventions before converting a formula into batch quantities. A similarly named salt or hydrate should be assessed as a distinct material choice rather than introduced through a naming shortcut.

Translate the listed strength into a quantitative formula

Strength expressions in this entry include “0.015%”, “0.7%”.

Tie every stated ingredient amount to its intended dosage unit or measure, then distinguish that declared amount from the quantity of raw material needed for a batch. Record any assay or equivalence calculation in the formula. This gives development, purchasing and artwork teams the same strength definition without assigning a patient dose from the catalogue.

Suggested starting point

A practical starting point is to carry the exact ingredient form into development. For this eye drops brief, agree the target characteristics and a short set of measurable development questions before comparing prototypes or supplier proposals. Keep unresolved clinical claims outside the product specification until supporting evidence is available.

Discuss this product brief

Manufacturing & packaging brief

Plan the eye-drop presentation.

Use this preparation guide for Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v Eye drops. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Identify this as an ophthalmic presentation, with concentration, fill volume and single-dose or multidose requirements. Confirm product and facility scope for the exact formulation.

Quality & technical transfer

Request review of sterile-product requirements, applicable analytical and particulate tests, delivery accuracy and container-closure integrity. Preservative and in-use requirements depend on the formulation and pack.

Review the technical documents

Packaging configuration

Describe the ophthalmic container, tip, closure and tamper evidence. Ask for the complete delivery system and supported in-use period to be assessed together.

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.
Concentration and pack size
The record includes a concentration or percentage expression. Confirm its complete basis, then specify the finished fill volume or weight separately. Do not treat pack size as the strength.

Quantities, MOQ & lead time

For Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v Eye drops, state the container count and fill volume, 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 capabilitiesTopicals & local formatsTherapeutic navigationOphthalmology & ENTFull 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.

Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v Eye drops

What is listed in the catalogue?

The catalogue lists Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v as eye drops in its ophthalmology & ent navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v Eye drops. 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, eye drops 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 Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v Eye drops. 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 Benzalkonium Chloride 0.015% w/v, Olopatadine Hcl 0.7% w/v Eye drops 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 .