Piperacillin-tazobactam — Indian WHO-GMP supply for NHS critical-care and GCC ICU formularies.
Broad-spectrum ureidopenicillin plus beta-lactamase inhibitor — the single most-prescribed empirical antibiotic in adult critical care globally. 2.25g and 4.5g lyophilised vials from Indian WHO-GMP facilities, with antimicrobial stewardship documentation for AWaRe Watch class compliance, vancomycin co-administration AKI warning, and pharmacokinetic dosing material (extended-infusion vs intermittent) on the pre-dispatch pack.
Multiple WHO-GMP partner lines · 2.25g and 4.5g lyophilised vials · CTD dossier on file · WHO PQ pathway supported · AWaRe Watch antibiotic class.
Active ingredient
Piperacillin sodium (a ureidopenicillin) combined with tazobactam sodium (a sulfone beta-lactamase inhibitor) in fixed 8:1 ratio. Mechanism: piperacillin binds penicillin-binding proteins (PBP-3, PBP-1) inhibiting cell-wall transpeptidation; tazobactam covalently inhibits class A and some class C beta-lactamases (TEM, SHV, CTX-M), restoring piperacillin activity against beta-lactamase-producing Gram-negatives. The combination is anti-pseudomonal: in-vitro susceptibility breakpoints per EUCAST / CLSI specify ≤16/4 mg/L for Pseudomonas.
Strengths stocked
2.25g (2g pip + 0.25g tazo) for paediatric and renal-impaired adult dosing. 4.5g (4g pip + 0.5g tazo) for standard adult ICU dosing — the high-volume tender line. Reconstitute with 10ml or 20ml sterile water for injection respectively, then further dilute in 0.9% NaCl, 5% glucose, or compatible IV fluids to 50-150 mg/ml for slow IV infusion (≥30 min standard, 4-hour extended infusion for severe/Pseudomonas-targeted regimens).
Indications
Hospital-acquired pneumonia (HAP/VAP); complicated intra-abdominal infections; complicated SSTI; complicated UTI / pyelonephritis; febrile neutropenia (single-agent or with vancomycin for MRSA cover); empirical sepsis; AECOPD with Pseudomonas risk; CF pulmonary exacerbation. WHO AWaRe Watch — surveillance-critical, dispensed against antimicrobial stewardship oversight. Standard dosing 4.5g IV every 6-8 hours.
Storage
Lyophilised vials at 15-25°C, protected from light and moisture. Reconstituted product stable 24 hours at 2-8°C; further-diluted infusion 24 hours at 2-8°C or 4-6 hours at room temperature in 0.9% NaCl. Lactated Ringer's solution is NOT compatible — calcium precipitates the formulation. Standard ambient-temperature dispatch lane; cold-chain not required.
Shelf life
24 months from manufacture; minimum 18 months at dispatch. Or we won't ship it.
Pack format
Single vial per carton, hospital pack. Type-I clear glass vial, halobutyl rubber stopper, aluminium seal with flip-off cap. Outer carton and leaflet in destination-regulator language. AWaRe Watch antibiotic stewardship label, vancomycin-AKI co-administration warning, and extended-infusion pharmacokinetic dosing guidance prominently set.
Hospital pharmacies, ICUs and tender desks across thirty markets.
India is our origin. We do not sell into the Indian market. Piperacillin-tazobactam is exported only.
United Kingdom
Piperacillin-tazobactam is core NHS critical-care formulary stock — every adult ICU and major teaching trust holds it as the empirical broad-spectrum antibiotic of first choice. Pip-tazo has been on the MHRA shortage register multiple times (most notably 2017-2018 global supply disruption and intermittent post-2020 events); the MHRA Specials / named-patient import route is well-trodden for this molecule — see MHRA Specials. Antimicrobial stewardship documentation included for hospital pharmacy committee approval and BSAC/UKHSA AMR surveillance reporting.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH ICU-formulary tender awards (NUPCO and Saudi MoH for KSA — King Faisal Specialist Hospital and SEHA ICU programmes are major buyers; MoHAP, DHA and DOH Abu Dhabi for UAE; Kuwait MoH Central Drug Store with strong military medical service demand; MoPH Qatar including Hamad Medical Corporation; MoH Oman; NHRA Bahrain) and hospital pharmacy purchase orders. SFDA, MoHAP and GCC central registration supported with a full CTD dossier.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda
Public-sector hospital tenders (NAFDAC-registered for Nigeria, KEMSA + MEDS for Kenya, FDA Ghana + Central Medical Stores, SAHPRA-registered for South Africa, EFDA + EPSS for Ethiopia, TMDA + MSD for Tanzania, NDA + NMS for Uganda) and teaching-hospital ICU supply. WHO Prequalification supported for Global Fund (sepsis-treatment commodity grants — pip-tazo + vancomycin combination is a standard sepsis-treatment commodity bundle) and Africa CDC qualification. AMR Stewardship Programme alignment is part of the standard tender documentation.
Germany, France, Brazil, Mexico, Philippines
Supply via licensed importers under §72 AMG (Germany), ANSM equivalent (France), ANVISA (Brazil), COFEPRIS (Mexico), FDA Philippines, with Qualified Person (QP) certification on EU arrival. CTD dossier and CoPP prepared for BfArM, ANSM, ANVISA, COFEPRIS and FDA Philippines recognition.
Extended infusion, vancomycin-AKI co-administration, renal dosing — pip-tazo is everyday but high-volume use means the safety items repeat.
Standard adult dose is 4.5g IV every 6-8 hours; for severe Pseudomonas infections, extended 4-hour infusion of 4.5g every 6-8 hours achieves higher %fT>MIC and is supported by current sepsis guidelines (SCCM, IDSA). Renal dose adjustment is mandatory: CrCl 20-40 ml/min → 4.5g every 8h, CrCl <20 ml/min → 2.25g every 8h, haemodialysis → 2.25g every 12h with supplemental dose post-dialysis. Loading dose is not reduced for renal impairment (only maintenance is). Therapeutic drug monitoring in critical care (target piperacillin trough 4× MIC for severe Pseudomonas) is increasingly standard in tertiary ICUs. Vancomycin co-administration AKI risk is the major prescribing trap — the pip-tazo + vancomycin combination has consistently been associated with elevated AKI rates compared to vancomycin + cefepime; current SCCM and SAFER-MED guidance recommends cefepime as the preferred Gram-negative partner when concurrent vancomycin is needed for MRSA cover, unless specific Gram-negative susceptibility justifies pip-tazo. Hypersensitivity: penicillin allergy is contraindicated; cross-reactivity with cephalosporins is real but typically mild (cefepime is the most-cross-reactive). Anaphylaxis is rare but documented. Lactated Ringer's diluent is incompatible — calcium precipitates the formulation; use 0.9% NaCl or 5% glucose. False-positive Aspergillus galactomannan ELISA is documented with pip-tazo therapy — flag in haematology / oncology patients on antifungal-screening protocols. Hypokalaemia (renal potassium loss), thrombocytopenia (immune-mediated, rare) and hepatotoxicity are PSUR-priority adverse events. Pip-tazo does not cover MRSA, VRE, Stenotrophomonas, atypical respiratory pathogens (Legionella, Mycoplasma, Chlamydia), or fungal infections — clinical decision-support should always pair pip-tazo with a culture-driven narrowing strategy.
The documentation pack a regulator actually asks for.
Piperacillin-tazobactam is a WHO EML core-list AWaRe Watch antibiotic and WHO PQ-listed. Our role is manufacturer-facing — we sit between the Indian WHO-GMP facility and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary included. Antimicrobial Stewardship Programme alignment documented for AWaRe Watch compliance. Combination-product dossier covers identity + potency of each component (piperacillin and tazobactam separately) and the fixed 8:1 ratio.
CoA and MoA, per batch
HPLC assay of piperacillin and tazobactam separately (each ≥98%), related substances (piperacillin penicilloic acid, tazobactam open-form per Ph.Eur./USP), water content (Karl Fischer), pH on reconstitution, sterility, bacterial endotoxin (≤0.06 EU/mg total beta-lactam), particulate matter — signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Notarised copies included in the shipping pack. WHO-PQ certificate available for Global Fund and Africa CDC tender qualification.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards (MHRA SmPC style for the UK, MoH style for GCC, SAHPRA for South Africa, BfArM for Germany). AWaRe Watch antibiotic stewardship label, renal dose adjustment table, extended-infusion pharmacokinetic dosing guidance, vancomycin-AKI co-administration warning and Lactated Ringer's incompatibility flag prominently set. Artwork QC before print, not after.
Temperature control
Pre-shipment validation on each shipper configuration. Pip-tazo lyophilised vial ships at 15-25°C ambient; the integrity-critical factors are container closure (sterile lyophilised product), moisture exclusion, and protection from light. Reconstituted product is cold-chain at the hospital end (24h at 2-8°C); pre-reconstitution dispatch is room-temperature.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. Vancomycin-co-administration AKI events, severe hypersensitivity reactions, hypokalaemia, thrombocytopenia, hepatotoxicity, and Aspergillus galactomannan false-positive episodes remain the PSUR priority signals for this molecule. AMR Stewardship Programme surveillance reporting included for AWaRe Watch compliance.
ICU-grade Gram+, Gram- and AMR coverage.
Pip-tazo rarely sits alone in critical care — it's paired with vancomycin (MRSA cover, AKI risk noted), aminoglycosides (Pseudomonas synergy in CF) or antifungals (galactomannan-screening flag).
Vancomycin
Glycopeptide, MRSA cover. 500mg and 1g lyophilised vials. Note: AKI risk with pip-tazo co-admin.
Meropenem
Carbapenem, broad-spectrum Gram+/Gram-/anaerobe — escalation post-pip-tazo failure. 500mg / 1g.
Metronidazole
Anti-anaerobe nitroimidazole — rarely needed when pip-tazo on board (anaerobe coverage built-in).
All anti-infectives →
180+ anti-infective SKUs: beta-lactams, glycopeptides, aminoglycosides, fluoroquinolones, antifungals, antivirals.
Anesthesia / ICU →
Critical-care molecules — paralytics, sedatives, antiemetics, vasopressors.
Vaccines →
Public-sector and tender vaccine supply — DPT, MMR, BCG, conjugates.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (2.25g or 4.5g), vial count, destination, NHS hospital pharmacy / GCC ICU tender / African public-sector / Global Fund sepsis-commodity grant / NGO supply, target delivery. Flag if AMR Stewardship Programme documentation, extended-infusion PK dosing material, or MHRA shortage-cover documentation is needed.
- We route to the right line. Multiple WHO-GMP pip-tazo lines on the M Care roster, including WHO PQ-listed manufacturers for Global Fund and Africa CDC tender qualification. Registered-market preference goes to facilities already holding the relevant destination registration.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier status per destination, AWaRe Watch antibiotic stewardship documentation, MHRA shortage-cover Special-form annex (if applicable), and the documentation pack. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Ambient-temperature dispatch lane (lyophilised vial is room-temperature stable; cold-chain kicks in at the hospital post-reconstitution), in-transit logging, on-arrival inspection. Photo evidence of seal integrity on request.
- After delivery. Batch records, CoA and thermal logs archived for the full shelf life. Pharmacovigilance contact opened on registration; vancomycin-co-admin AKI, severe hypersensitivity, hypokalaemia, thrombocytopenia, hepatotoxicity and Aspergillus galactomannan false-positive episodes remain the PSUR priority signals. AMR Stewardship surveillance reporting included for AWaRe Watch compliance.
Piperacillin-tazobactam supply — the specific questions.
What strengths of piperacillin-tazobactam do you supply?
Lyophilised vials in 2.25g (2g pip + 0.25g tazo) and 4.5g (4g pip + 0.5g tazo). Reconstitute with 10ml or 20ml sterile water for injection respectively (giving a 200 mg/ml solution); further dilute in 0.9% NaCl, 5% glucose, or compatible IV fluid to 50-150 mg/ml for slow IV infusion (≥30 min standard, or 4-hour extended infusion for severe Pseudomonas-targeted regimens). The 4.5g strength is the high-volume ICU tender line; 2.25g covers paediatric dosing and renal-impaired adult titration. Lactated Ringer's diluent is incompatible — calcium precipitates the formulation.
Can you supply pip-tazo against MHRA shortage cover for the UK?
Yes. Pip-tazo has been on the MHRA shortage register multiple times — most notably the 2017-2018 global supply disruption (Hangzhou China factory explosion) and intermittent post-2020 events. The MHRA Specials / named-patient import route is well-trodden for this molecule, and M Care prepares the manufacturer-side Special-form documentation pack (WHO-GMP certificate, batch CoA + MoA, CoPP, pack insert, AMR Stewardship Programme compliance set) so the importing UK pharmacy's Responsible Person can complete the import notification without paperwork delay. Air-freight from Mumbai to a UK bonded warehouse runs 3-5 days once the Special form is signed.
Is your pip-tazo compliant with WHO AWaRe Watch antibiotic classification?
Yes. Piperacillin-tazobactam is on the WHO AWaRe (Access, Watch, Reserve) classification as a Watch antibiotic — recommended for narrow indications, surveillance-critical, dispensed against antimicrobial stewardship oversight. Our documentation pack includes Antimicrobial Stewardship Programme (ASP) alignment material for the receiving hospital pharmacy committee, including: dosing protocol with renal adjustment table, extended-infusion pharmacokinetic dosing guidance, vancomycin-co-admin AKI risk warning (recommend cefepime as preferred Gram-negative partner with concurrent vancomycin), Aspergillus galactomannan false-positive flag for haematology / oncology patients, and AMR resistance-monitoring (ESBL, KPC, NDM) reporting templates. WHO PQ certificate available for Global Fund and Africa CDC tender qualification where AWaRe Watch documentation is a stewardship requirement.
Which markets can you ship piperacillin-tazobactam into?
The UK (NHS hospital pharmacy supply or named-patient / MHRA Specials route during shortage — well-trodden route for this molecule), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — ICU formulary is the main channel — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital supply with WHO PQ pathway support — Global Fund sepsis-commodity grants are a high-volume channel — Egypt, Jordan, Iraq on the Levant side, Germany under §72 AMG, France under ANSM-equivalent route, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). We do not supply into India. Full market coverage is at markets.
What documentation is included with a piperacillin-tazobactam consignment?
Every consignment ships with a batch-specific Certificate of Analysis (HPLC piperacillin assay, HPLC tazobactam assay, related substances per Ph.Eur./USP, water content by Karl Fischer, pH on reconstitution, sterility, bacterial endotoxin, particulate matter), Method of Analysis, Certificate of Pharmaceutical Product (CoPP) where required, WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where applicable, Certificate of Origin (chamber-attested), destination-language pack insert with AWaRe Watch antibiotic stewardship label, renal dose adjustment table, extended-infusion PK guidance, vancomycin-AKI co-administration warning, Lactated Ringer's incompatibility flag and Aspergillus galactomannan false-positive alert, Antimicrobial Stewardship Programme documentation for hospital pharmacy committee approval, plus temperature logs from pre-dispatch through on-arrival. PV contact nominated in the destination market on registration.
Do you provide CTD dossiers for piperacillin-tazobactam registration?
Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, TMDA, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. Combination-product dossier covers identity + potency of each component (piperacillin and tazobactam separately) and the fixed 8:1 ratio. Pip-tazo has a well-established CMC template — lead time on a dossier against a new registration is typically 4-6 weeks from NDA signature. WHO PQ dossier prepared separately for Global Fund and Africa CDC qualification. AWaRe Watch antimicrobial stewardship documentation prepared as a CTD addendum. See dossier preparation.
What are typical lead times for piperacillin-tazobactam orders, and does it need cold-chain transit?
For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (Global Fund, Africa CDC, NUPCO, KEMSA, CMS Ghana), the lead time is set in the tender award document. For UK NHS hospital pharmacy ad-hoc supply with MHRA shortage-cover urgency flagged, air-freight out of Mumbai can be on a flight within 72 hours. Made-to-order batches run 6-10 weeks inclusive of QC release and destination artwork. Pip-tazo lyophilised vial does not require cold-chain in transit — it ships at 15-25°C ambient. Cold-chain only kicks in at the hospital end after reconstitution: reconstituted pip-tazo is stable for 24 hours at 2-8°C. Transit temperature is logged on every consignment for QA traceability.
Send the specifics. You'll have a price inside one working day.
Strength (2.25g or 4.5g), vial volume, destination, NHS hospital pharmacy / MHRA shortage cover / GCC ICU tender / African public-sector / Global Fund sepsis-commodity grant / NGO, target delivery, AMR stewardship documentation if required. That's the enquiry. Everything else is on us.