Zometa (zoledronic acid) is licensed for skeletal-related events in bone metastases and hypercalcaemia of malignancy, while the same molecule at a lower annual dose, sold as Aclasta or Reclast, treats osteoporosis and Paget's disease of bone, and licensed generic zoledronic acid now covers both dosing bands.
M Care Exports is a merchant exporter of zoledronic acid, a nitrogen-containing bisphosphonate originated by Novartis that reaches hospital formularies under two separate brand identities for the same molecule: Zometa for oncology bone disease and Aclasta (marketed in the US as Reclast) for osteoporosis and Paget's disease. We source the originator brands and licensed generic zoledronic acid concentrate through Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Zoledronic acid exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and MoH tender orders, M Care quotes zoledronic acid against buyer specification: the 4 mg/5 mL oncology concentrate dosed every 3-4 weeks, or the 5 mg/100 mL ready-to-infuse osteoporosis and Paget's presentation dosed once yearly, brand or licensed generic, and destination-market import documentation. Because the two dosing bands are not interchangeable and a mismatched strength on an oncology ward is a genuine safety error, we confirm indication and infusion protocol at enquiry stage before building a quote, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Nitrogen-containing bisphosphonate; osteoclast-mediated bone resorption inhibitor, sourced and documented for export.
Zoledronic acid is a third-generation, nitrogen-containing bisphosphonate. It binds hydroxyapatite in bone and inhibits farnesyl pyrophosphate synthase in osteoclasts, which suppresses osteoclast-mediated bone resorption far more potently than earlier bisphosphonates such as pamidronate. The same active ingredient is sold under two brand identities at two different strengths for two different clinical settings. As Zometa, the FDA label covers treatment of patients with multiple myeloma and documented bone metastases from solid tumours, in conjunction with standard antineoplastic therapy, and treatment of hypercalcaemia of malignancy, dosed as a 4 mg concentrate. As Aclasta (Reclast in the US), the licensed indications are treatment and prevention of postmenopausal osteoporosis, increasing bone mass in men with osteoporosis, treatment and prevention of glucocorticoid-induced osteoporosis, and Paget's disease of bone, dosed as a 5 mg ready-to-infuse solution once yearly or once every two years for prevention. Both presentations are given by intravenous infusion of no less than 15 minutes; neither is oral or self-administered.
Active ingredient
zoledronic acid (as zoledronic acid monohydrate). Nitrogen-containing bisphosphonate; osteoclast-mediated bone resorption inhibitor.
Forms and strengths
4 mg/5 mL concentrate for solution for infusion; 5 mg/100 mL ready-to-infuse solution for infusion.
Indications
Third-generation nitrogen-containing bisphosphonate given by intravenous infusion. Marketed as Zometa (4 mg) for skeletal-related events in bone metastases and hypercalcaemia of malignancy, and as Aclasta/Reclast (5 mg) for osteoporosis and Paget's disease of bone. Supplied from Indian WHO-GMP facilities as originator brand or licensed generic to regulated and semi-regulated markets outside India.
Administration
intravenous. Concentrate for solution for infusion and ready-to-infuse solution for infusion.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for zoledronic acid split across two clinical populations on the same tender list: hospital oncology and haematology pharmacists managing bone metastases and hypercalcaemia of malignancy on the Zometa-strength protocol, and rheumatology, endocrinology and care-of-the-elderly services running annual-infusion osteoporosis and Paget's clinics on the Aclasta-strength protocol. National and regional MoH tender desks across our GCC and African markets typically list both strengths under a single bisphosphonate line, alongside licensed pharmaceutical wholesalers and importers stocking a bone-metabolism range and NGO or foundation programmes supporting cancer-supportive-care access where local registration is in place.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on zoledronic acid.
Renal function drives every zoledronic acid decision. Both strengths require a documented estimated creatinine clearance before each infusion: Aclasta and Reclast are contraindicated below 35 mL/min, while the Zometa oncology regimen uses tiered dose reductions between 50 and 60 mL/min and is not recommended below 30 mL/min. Adequate hydration before infusion is a standing pre-medication check, since dehydration is the single biggest modifiable risk factor for the acute renal deterioration bisphosphonates can cause. Infusion time is a fixed safety parameter, not a convenience setting: no less than 15 minutes, because faster administration measurably raises renal-injury risk in the label's own trial data. Osteonecrosis of the jaw is a recognised risk with long-term bisphosphonate exposure, so a dental check before the first infusion, particularly ahead of invasive dental work, is standard practice rather than a defensive add-on. A transient acute-phase reaction, flu-like myalgia and pyrexia in the days after a first infusion, is common and usually managed with paracetamol rather than treated as a hypersensitivity event. Oral calcium and vitamin D supplementation should accompany the osteoporosis and Paget's regimen unless the patient is already hypercalcaemic.
The documentation pack a regulator actually asks for.
Zoledronic acid ships as a room-temperature concentrate for infusion; neither the Zometa nor the Aclasta/Reclast presentation needs special storage conditions, and once opened or diluted the solution holds for 24 hours refrigerated at 2-8C, which keeps freight simpler than the cold-chain lanes M Care validates for biologics. It is not a controlled substance in any market we review, so the import documentation sits with standard batch-level certificate of analysis, WHO-GMP manufacturing site paperwork and CDSCO export documentation from the Mumbai desk, with CTD/eCTD dossier support for destination regulators such as MHRA, SFDA, MOHAP, NAFDAC, PPB or SAHPRA that require local registration before import. WHO added zoledronic acid to the Model List of Essential Medicines in 2017 under the malignancy-related bone disease indication, covering prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia; the osteoporosis and Paget's indication sits outside that EML listing and is a formulary-specific addition most tender desks carry alongside it. On brand versus generic: Novartis originated both Zometa and Aclasta, and Sandoz now holds UK marketing authorisation for Aclasta, while licensed generic zoledronic acid concentrate is separately registered and marketed in the US and EU from multiple manufacturers, including Dr. Reddy's Laboratories and Fresenius Kabi, and, most recently, Avenacy's 2025 US launch. Buyers genuinely have a brand-or-generic choice on either strength; M Care quotes against the tender specification and destination-market registration status, since the two dose strengths are never interchangeable regardless of brand.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
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The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for zoledronic acid.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Zoledronic acid supply, the specific questions.
Does a generic version of Zometa or Aclasta exist?
Yes. Licensed generic zoledronic acid concentrate is registered and marketed in the US and EU from multiple manufacturers, including Dr. Reddy's Laboratories and Fresenius Kabi, with newer entrants such as Avenacy launching a US product in 2025 alongside the Novartis-originated brands. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
What is the difference between the 4 mg and 5 mg zoledronic acid strengths?
They are the same molecule at two different doses for two different uses. The 4 mg concentrate, sold as Zometa, treats bone metastases and hypercalcaemia of malignancy on a repeated three-to-four-weekly schedule. The 5 mg ready-to-infuse solution, sold as Aclasta or Reclast, treats osteoporosis and Paget's disease as a single yearly infusion. The two are not interchangeable, and a tender should always specify which one it needs.
Does zoledronic acid need cold-chain shipping?
No. Neither the Zometa nor the Aclasta/Reclast presentation requires special storage conditions before use; both are stable at room temperature. Once opened or diluted, the solution should be used or refrigerated within 24 hours, but the unopened product moves on standard ambient logistics rather than a validated cold-chain lane.
Is zoledronic acid on the WHO Essential Medicines List?
Yes, for one of its two indications. WHO added zoledronic acid to the Model List of Essential Medicines in 2017 for prevention of skeletal-related events and treatment of hypercalcaemia in patients with malignant bone disease. The separate osteoporosis and Paget's disease use is not the EML-listed indication.
What renal checks are needed before a zoledronic acid infusion?
Estimated creatinine clearance must be documented before every dose. Aclasta and Reclast are contraindicated below 35 mL/min; the Zometa oncology regimen uses tiered dose reductions from 50 to 60 mL/min and is not recommended below 30 mL/min. Patients should also be adequately hydrated beforehand, since dehydration is the main modifiable risk factor for acute renal deterioration with this class.
Can M Care supply zoledronic acid to our market?
Yes, on an import basis. We source Zometa, Aclasta/Reclast and licensed generic zoledronic acid through Indian distribution and manufacturing channels and dispatch against your import authorisation and destination-market registration requirements for the specific strength your tender needs, with CTD/eCTD-aligned dossier documentation and batch-specific certificates of analysis included.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-13.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.