Piperacillin-Tazobactam

Description

1. Product Overview

Piperacillin-Tazobactam is a fixed-dose combination antibacterial API (8:1 ratio), indicated for moderate-to-severe nosocomial and community-acquired infections, including complicated intra-abdominal, skin, and respiratory tract infections. Its primary industrial use is in parenteral antibiotic manufacturing for hospitals and pharmaceutical formulators. The key value proposition is enhanced efficacy against beta-lactamase-producing organisms, reducing polypharmacy risks. Strategically, this product is critical in global antimicrobial resistance (AMR) response frameworks, positioning buyers for regulatory-aligned, high-demand supply.

2. Key Specifications & Technical Characteristics

• Chemical composition: Piperacillin sodium (8 parts) + Tazobactam sodium (1 part) – sterile, crystalline blend

• Purity level: ≥98.5% (HPLC, anhydrous basis); residual solvents conform to ICH Q3C

• Physical characteristics: White to off-white sterile powder; particle size D90 ≤ 250 µm; bulk density 0.4–0.6 g/mL

• Packaging options: 10 kg sterile multi-layer PE bags inside aluminum-lined drums; or 25 kg fiber drums with desiccant

• Shelf life: 36 months when stored at 2–8°C; stability-tested per ICH guidelines

3. Core Industrial Applications

• Primary industries: Injectable generic drug manufacturing, hospital compounding pharmacies, and government tender suppliers for essential antibiotics.

• Specific use cases: Large-scale production of IV bags and vials for ICU pneumonia, sepsis, and febrile neutropenia.

• Why it performs better: The fixed 8:1 ratio eliminates separate tazobactam sourcing and blending variability, reducing manufacturing QC reject rates by up to 12% compared to loose API blending.

• Cost advantage: Higher stability at room temperature for up to 30 days in transit vs. standard 7 days for branded equivalents, lowering cold-chain logistics expenditure.

4. Competitive Advantages

• Quality consistency: Batch-to-batch impurity profile variation <0.15% (n=200 batches); compliant with USP, EP, and WHO prequalification standards.

• Supply reliability: Dual manufacturing sites (Asia, EU) with 6-month rolling forecast capacity; 98.5% on-time-in-full (OTIF) track record.

• Logistics capability: Validated passive cold-chain shippers supporting -20°C to 40°C excursions during last-mile delivery.

• Sustainability: Transitioning to 30% recycled-content drums and solvent recovery processes reducing carbon footprint by 22% per MT.

• Technical support: Full DMF access, stability study reports, and vendor audit support within 48 hours of NDA execution.

5. Commercial & Supply Information

• Minimum order quantity (MOQ): 20 kg

• BULK 20MT: Available for 12-month supply agreements with volumetric discounts

• Loading capacity (MT per 20FT container): 9.6 MT (standard palletized drums)