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Sterile injectables · Contract manufacturing enquiry

Amoxycillin 2000 mg, Sulbactam 1000 mg Dry-powder injectables

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Discuss third-party manufacturing with Walter Healthcare, India. Confirm the formulation, dry-powder injectable presentation, packaging and project requirements for a product-specific quotation.

Catalogue reference
WH-2087
Composition and strength
Amoxycillin 2000 mg, Sulbactam 1000 mg
Dosage form
Dry-powder injectables
Indicative administration route
Parenteral
Therapeutic navigation area
Anti-infectives
Pharmacological class
Antimicrobial agent
Manufacturing stream
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 Amoxycillin 2000 mg, Sulbactam 1000 mg Dry-powder 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 ↗

Ingredient-level reference

Amoxicillin (injection reference)

Reference for: Amoxycillin. Source presentation: POWDER FOR INJECTION. Source route: intravenous; intramuscular.

Mechanism of action

Amoxicillin inhibits penicillin-binding proteins involved in bacterial peptidoglycan synthesis. The weakened cell wall can lead to bacterial lysis. Beta-lactamases can inactivate amoxicillin, so this mechanism does not establish activity against resistant organisms.

Pharmacokinetics

The injection reference reports about 18% plasma protein binding and an apparent distribution volume of 0.3–0.4 L/kg. Elimination is predominantly renal, with a mean half-life near 1 hour in healthy subjects. In the cited 500 mg intravenous bolus study, the measured half-life was 1.07 hours. Reduced renal function decreases clearance. These findings do not characterize the addition of clavulanate or sulbactam.

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: Amoxicillin 500 mg injection: SmPC, sections 5.1–5.2

Reference accessed .

Ingredient-level reference

Sulbactam (combination-study reference)

Reference for: Sulbactam. Source presentation: SULBACTAM / CEFOPERAZONE INJECTION. Source route: intravenous; intramuscular.

Mechanism of action

Sulbactam irreversibly inhibits susceptible beta-lactamases, helping protect a co-administered beta-lactam antibiotic from enzymatic degradation. This effect depends on the enzyme and organism involved.

Pharmacokinetics

In the cited sulbactam/cefoperazone injection studies, the mean sulbactam half-life was about 1 hour and roughly 84% of its dose was eliminated through the kidneys. Sulbactam clearance correlated with renal function and its half-life increased substantially in patients without functional kidneys. These are explicitly combination-study data and do not characterize every sulbactam partner, ratio or formulation.

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: Pfizer: Sulperazon product information, sulbactam component

Reference accessed .

Manufacturing & packaging brief

Plan the dry-powder injectable presentation.

Use this preparation guide for Amoxycillin 2000 mg, Sulbactam 1000 mg Dry-powder injectables. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Define the amount per container, salt-equivalence wording, route and proposed reconstitution presentation. Confirm the production route; a dry-powder listing alone does not establish lyophilisation.

Quality & technical transfer

Request 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

Provide vial size, stopper, seal and carton requirements. Identify any diluent and administration accessory separately, including their specifications and supply responsibilities.

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.
Manufacturing stream
The catalogue assigns this record to the beta-lactam stream. Request review of the proposed unit, product-family scope and applicable segregation arrangements before selecting a manufacturing site.

Quantities, MOQ & lead time

For Amoxycillin 2000 mg, Sulbactam 1000 mg Dry-powder injectables, state the vial count and amount per vial, 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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Dosage-form capabilitiesSterile injectablesTherapeutic navigationAnti-infectivesFull 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.

Amoxycillin 2000 mg, Sulbactam 1000 mg Dry-powder injectables

What is listed in the catalogue?

The catalogue lists Amoxycillin 2000 mg, Sulbactam 1000 mg as dry-powder injectables in its anti-infectives navigation area and beta-lactam manufacturing stream.

Is manufacturing availability confirmed?

No. Walter checks current facility permissions, formulation and equipment fit, testing, packaging and target-market requirements before written confirmation.

What do I need for a quotation?

Share the exact composition and strength, dry-powder 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.

Can I change the pack or target market?

Include each proposed pack and country in the enquiry. Container compatibility, artwork, supporting stability evidence, permission scope and destination requirements need review for the requested configuration.

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 Amoxycillin 2000 mg, Sulbactam 1000 mg Dry-powder 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 .