Zoledronic Acid Pre-Filled Syringe / Lyophilized, 4 MG
Categories:, , SKU: 00002-100
Zoledronic Acid Pre-Filled Syringe / Lyophilized, 4 MG

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Description

PRODUCT DESCRIPTION:

 

Zoledronic Acid is a potent third-generation bisphosphonate used in oncology and metabolic bone disease settings.

It effectively reduces skeletal-related events in patients with cancers that have metastasized to bone and is also widely used in the management of osteoporosis and hypercalcemia of malignancy.

Its once-yearly or quarterly dosing and strong binding affinity to bone matrix make it a preferred treatment for long-term bone protection.

Formulation & Presentation:

  • Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
  • Presentation: Pre-Filled Syringe (customizable as per market demand)
  • Available Strengths:
    • 4 MG (Pre-Filled Syringe/ Lyophilized Inj
  • Route of Administration: Slow Intravenous (IV) over 30 Minutes Minimum, as per clinical indication and severity. Reconstituted as per protocol Intravenous Injection. To be administered under supervision of a qualified oncologist or day-care oncology units. (As per physician’s discretion or decision) Administered as part of chemotherapy regimens.

Therapeutic Indications:

  • Treatment of Hypercalcemia of Malignancy
  • Prevention of Skeletal-Related Events (SREs) in patients with bone metastases from solid tumors
  • Management of Osteoporosis (including postmenopausal osteoporosis and glucocorticoid-induced osteoporosis)
  • Paget’s Disease of Bone

Side Effects:

  • COMMON:
    • Flu-Like Symptoms,
    • Bone Or Joint Pain,
    • Fatigue,
    • Anemia,
    • Nausea
  • SERIOUS (RARE):
    • Osteonecrosis Of The Jaw (ONJ),
    • Renal Impairment
    • Severe Hypocalcemia
    • Anaphylactic Reactions
  • PRECAUTIONS:
    • Ensure adequate hydration prior to administration
    • Monitor renal function before each dose
    • Supplement with calcium and vitamin D during therapy
    • Dental examination advised before initiation to reduce risk of ONJ

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TECHNICAL INFORMATION

Product Specifications

  • HSN Code: To be assigned per international classification standards & import jurisdiction
  • Weight: Approx. 40g per carton (with packaging)
  • Dimensions: 15 x 1 x 8 CMS
  • Shelf Life: 24–36 months under recommended storage conditions from date of manufacture (subject to country-specific guidelines)
  • Storage:
    • Pre-Filled Syringes: Store between 2°C–8°C (Do not freeze)
    • Lyophilized Form: Store below 25°C
    • PFS requires cold-chain logistics
    • Protect from moisture and direct sunlight
    • Use strictly as per label guidelines

Regulatory Status & Supply Information

  • Regulatory Status: WHO-GMP Compliant Manufacturing
  • Documentation: COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support (on request)
  • Export Dossiers: COA, COPP, Dossier Available (CTD/eCTD formats)
  • Standards: Complies with USP/EP/BP
  • Stability: Compliant
  • MOQ: Negotiable based on market & registration status
  • Export Options: Available for private label, institutional supply, or branded export

Who Should Source This Product?

  • Oncology centers and cancer care hospitals managing metastatic bone disease
  • National procurement agencies and public health programs for osteoporosis care
  • Pharmaceutical importers and tender participants requiring WHO-GMP injectable oncology support
  • Humanitarian aid organizations and NGOs focused on women’s health and cancer management
  • Orthopedic and endocrinology departments managing bone disorders

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation for smooth registration in target markets
  • Trusted consortium network simplifying India's complex pharma supply chain
  • Multiple approved manufacturers for best fit in import country
  • Audited, compliant manufacturers across India
  • Customizable branding, packaging & formulation flexibility
  • End-to-end logistics & cold-chain support
  • Extensive experience exporting specialty injectables worldwide

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