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Sterile injectables · Contract manufacturing in India

Etofylline 84.7 mg, Theophylline 25.3 mg Liquid injectables

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Discuss third-party manufacturing of Etofylline 84.7 mg, Theophylline 25.3 mg Liquid injectables 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-1867
Composition and strength
Etofylline 84.7 mg, Theophylline 25.3 mg
Dosage form
Liquid injectables
Indicative administration route
Parenteral
Therapeutic navigation area
Respiratory & allergy
Pharmacological class
Bronchodilator
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 Etofylline 84.7 mg, Theophylline 25.3 mg Liquid injectables. 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: Theophylline. The references below cover only the named ingredients.

Published human study

Etofylline (human pharmacokinetic study)

Reference for: Etofylline. Source presentation: 200 MG ORAL / INTRAVENOUS STUDY. Source route: oral; intravenous.

This summary describes the published study and its limitations. It does not establish a complete mechanism of action or pharmacokinetic profile for this finished product.

Human pharmacokinetic study

A 1981 crossover study in healthy volunteers compared single 200 mg oral and intravenous etofylline doses. Etofylline is an N-7-substituted theophylline derivative that did not release theophylline in the reported experiments. Following intravenous administration, the terminal phase had a half-life of 4.1 hours and approximately 20% was excreted unchanged in urine. Oral absorption was rapid but incomplete, with estimated bioavailability near 80%. These findings concern the studied single doses, not sustained-release products or etofylline/theophylline combinations. The investigators did not establish pharmacodynamic effectiveness, so the study cannot supply a verified molecular mechanism or therapeutic-benefit claim.

Summary of the cited original human study, based on its published abstract. Findings are limited to the tested doses, formulations and volunteers; they do not establish bioequivalence or clinical effectiveness for Walter's product.

Source: Zuidema et al., 1981: etofylline oral/intravenous crossover study; PubMed abstract

Reference accessed .

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 ↗

Define the sterile presentation before process selection

Listed presentation: Liquid injectables.

The development discussion should settle the intended route, vehicle, concentration and container before choosing a sterile-processing strategy. Assess formulation–container compatibility and the relevant physical and microbiological controls together. Whether filtration or another process is suitable is a technical decision for the actual product, not an inference from the ingredient name.

Resolve the amount-per-container or concentration basis

Strength expressions in this entry include “84.7 mg”, “25.3 mg”.

Clarify whether each stated amount applies to a complete container, a defined volume or a defined weight. Put the agreed denominator beside the ingredient quantity before comparing formula costs or designing a label. Keep the finished fill size as a separate field so that changing the pack does not silently change the intended specification.

Suggested starting point

A practical starting point is to resolve the amount-per-container or concentration basis. For this liquid injectables 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 liquid-injectable presentation.

Use this preparation guide for Etofylline 84.7 mg, Theophylline 25.3 mg Liquid injectables. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Confirm concentration, fill volume, route and whether the proposed container is single-dose or multidose. Identify the formulation and transfer information available.

Quality & technical transfer

Ask for review of the sterile-process strategy, applicable sterility, endotoxin and particulate controls, analytical methods and container-closure integrity requirements.

Review the technical documents

Packaging configuration

Specify ampoule, vial or other proposed container, contact materials, closure and secondary pack. Confirm equipment and facility fit for that configuration.

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 Etofylline 84.7 mg, Theophylline 25.3 mg Liquid injectables, 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 capabilitiesSterile injectablesTherapeutic navigationRespiratory & allergyFull 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.

Etofylline 84.7 mg, Theophylline 25.3 mg Liquid injectables

What is listed in the catalogue?

The catalogue lists Etofylline 84.7 mg, Theophylline 25.3 mg as liquid injectables in its respiratory & allergy navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Etofylline 84.7 mg, Theophylline 25.3 mg Liquid injectables. 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, liquid injectables 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 Etofylline 84.7 mg, Theophylline 25.3 mg Liquid injectables. 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 Etofylline 84.7 mg, Theophylline 25.3 mg Liquid injectables 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 .