Piperacillin & Tazobactam USP 4.5 gm

In the modern clinical setting, managing serious bacterial infections—particularly those caused by resistant and hospital-acquired pathogens—requires powerful and reliable antibiotic therapy. One of the most frequently used and clinically trusted combinations is Piperacillin & Tazobactam 4.5 gm, a broad-spectrum β-lactam/β-lactamase inhibitor combination.

BluepillExpress is proud to offer third-party and contract manufacturing of Piperacillin & Tazobactam USP 4.5 gm, produced in WHO-GMP-certified injectable units using high-quality APIs and advanced aseptic technology. This life-saving antibiotic is in high demand globally for use in ICUs, surgical wards, emergency rooms, and hospital outpatient care, and BluepillExpress is your reliable partner for quality, scalability, and regulatory compliance.

Product Overview

Product Name:
Piperacillin and Tazobactam for Injection USP 4.5 gm

Formulation:
Sterile Lyophilized Powder for Reconstitution

Strength:

• Piperacillin Sodium equivalent to 4 gm
• Tazobactam Sodium equivalent to 0.5 gm

Dosage Form:
Single-use vial

Route of Administration:
Intravenous (IV) infusion or slow IV bolus

Packaging Options:

• Single-use vial with or without water for injection (WFI)
• Mono-carton with printed insert leaflet
• Bulk packs or hospital use packs available on request

Pharmacological Profile

Piperacillin

Piperacillin is a broad-spectrum, β-lactam, ureidopenicillin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). It is highly effective against a wide range of Gram-positive and Gram-negative bacteria, including Pseudomonas aeruginosa.

Tazobactam

Tazobactam is a β-lactamase inhibitor that protects piperacillin from degradation by β-lactamase enzymes, especially extended-spectrum β-lactamases (ESBLs), produced by resistant bacterial strains.

This combination enhances antibacterial coverage and helps in the treatment of complex, polymicrobial, and hospital-acquired infections.

Mechanism of Action

Piperacillin inhibits the final step in bacterial cell wall synthesis by binding to penicillin-binding proteins, leading to cell lysis. Tazobactam binds irreversibly to β-lactamases, enzymes that would otherwise inactivate piperacillin. The combination thus restores and broadens the efficacy of piperacillin against β-lactamase-producing organisms.

Therapeutic Indications

Piperacillin & Tazobactam 4.5 gm is indicated for the treatment of moderate to severe infections caused by susceptible strains of microorganisms. Clinical uses include:

• Hospital-acquired and ventilator-associated pneumonia
• Intra-abdominal infections
• Complicated skin and soft tissue infections
• Urinary tract infections (including pyelonephritis)
• Gynecological infections (e.g., pelvic inflammatory disease)
• Febrile neutropenia (in combination with aminoglycosides)
• Sepsis and bloodstream infections
• Postoperative and surgical site infections
• Empirical therapy for suspected polymicrobial infections

Dosage and Administration

Usual Adult Dose:
4.5 gm every 6–8 hours administered by intravenous infusion over 30 minutes.
Doses should be adjusted in patients with renal impairment or those undergoing dialysis.

Reconstitution Instructions:
Reconstitute with appropriate volume of sterile water for injection. Shake well until a clear solution is obtained. For IV infusion, dilute further with compatible IV fluids (e.g., 0.9% sodium chloride or dextrose solutions).

Storage:
Store the dry powder below 25°C, protected from light and moisture. Reconstituted solution should be used within specified time as per insert.

Advantages of Piperacillin & Tazobactam Combination

• Broad-spectrum bactericidal activity
• Covers both aerobic and anaerobic organisms
• Effective against β-lactamase-producing pathogens
• Suitable for empirical and definitive therapy
• Widely recommended in hospital protocols and ICU treatment regimens
• Safe profile with predictable pharmacokinetics

Why Choose BluepillExpress for Third-Party Manufacturing?

1. WHO-GMP and ISO-Certified Injectable Manufacturing Units

BluepillExpress manufactures high-quality injectables under strict compliance with WHO-GMP and ISO 9001:2015 standards, ensuring global export-readiness.

2. State-of-the-Art Sterile Production Infrastructure

Our facilities include:

• Dedicated cleanrooms for injectables
• Lyophilization (freeze-drying) capabilities
• Advanced dry powder filling lines
• Sterilized vial washing and sealing machinery
• Automated inspection and labeling systems

3. Regulatory Documentation and Export Support

We provide comprehensive documentation including:

• Certificate of Analysis (COA)
• Batch Manufacturing Records (BMR)
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate
• Technical dossiers (CTD format on request)
• Stability data and sterility reports
• Regulatory assistance for product registration

4. Global Export Experience

We have a robust export network across:

• Africa (Nigeria, Ghana, Kenya, Uganda)
• Asia (India, Vietnam, Sri Lanka, Philippines)
• CIS Countries (Uzbekistan, Kazakhstan, Tajikistan)
• Latin America (Peru, Bolivia, Ecuador)
• Middle East and GCC Nations
• Regulatory-ready markets (EU, UK, and US market pathways available)

We also support language-specific packaging and custom branding for private-label clients.

Product Quality and Assurance

BluepillExpress implements a robust quality assurance and control system covering:

• API and excipient testing
• In-process quality control during manufacturing
• Finished product testing (assay, sterility, pH, reconstitution time, particulate matter)
• Environmental monitoring of aseptic zones
• Stability studies as per ICH guidelines

Each product batch is tested for compliance with USP and pharmacopoeial standards before release.

Packaging and Labeling Options

We provide a wide range of customizable packaging solutions:

• Flip-off sealed vials
• Mono cartons with product information leaflet
• Inclusion of sterile water ampoules on request
• Hospital-use bulk packs or individual cartons
• Multilingual labeling (English, French, Arabic, Spanish, Russian)
• Private labeling with brand name, logo, and QR coding (serialization compliant)

Clinical Relevance and Demand

With rising concerns about multidrug-resistant organisms and increased ICU admissions globally, the demand for broad-spectrum combination antibiotics like Piperacillin & Tazobactam has grown rapidly.

The product is recommended in most national and international treatment protocols, including by:

• WHO
• Infectious Diseases Society of America (IDSA)
• Indian Council of Medical Research (ICMR)
• National Institute for Health and Care Excellence (NICE)

This injectable is often the first-line choice for empirical therapy in critically ill patients and is stocked in public and private hospital formularies around the world.

Contract Manufacturing Process at BluepillExpress

We follow a streamlined and transparent contract manufacturing protocol:

Step 1: Project Onboarding & NDA
An NDA is signed to protect intellectual property and confidentiality.

Step 2: Formulation & Quotation
We review client requirements and share detailed formulation specs, MOQs, and pricing.

Step 3: Sample Production & Approval
Pilot batches are produced and sent for evaluation. Adjustments are made per feedback.

Step 4: Commercial Production
Upon approval, full-scale manufacturing begins in aseptic conditions, followed by QA testing.

Step 5: Packaging, Documentation & Delivery
The product is packed, labeled, and dispatched with the full documentation kit for domestic or export use.

Opportunities for Distributors, Hospitals, and Government Procurement

BluepillExpress supports:

• Hospital and tender-based supply programs
• Ministry of Health partnerships
• Private-label distributors looking to expand critical care offerings
• Generic brand owners launching under their own trademark
• NGOs and institutional buyers operating in developing countries

Our large-scale capacity and compliance-driven approach make us ideal for high-volume and time-sensitive supply chains.

Conclusion

Piperacillin & Tazobactam USP 4.5 gm is a clinically essential, life-saving antibiotic used in the treatment of serious and resistant infections. With rising bacterial resistance and an increase in ICU and surgical admissions, demand for this injectable continues to grow in both developing and developed countries.

BluepillExpress is a trusted third-party manufacturing partner offering regulatory-approved, high-quality sterile injectables to pharmaceutical brands, hospital suppliers, and institutional buyers worldwide. Backed by scientific expertise, compliance, and a global footprint, we ensure that your product reaches the market on time, within budget, and at international standards.

Whether you’re launching a generic brand, supplying government hospitals, or expanding your export portfolio, we invite you to partner with BluepillExpress for the contract manufacturing of Piperacillin & Tazobactam 4.5 gm.