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Description
PRODUCT DESCRIPTION:
Bupivacaine Hydrochloride Injection is a long-acting amide-type local anesthetic widely used for regional anesthesia, including epidural, spinal, and peripheral nerve blocks.
It offers profound and prolonged sensory blockade with limited motor blockade when used in appropriate concentrations, making it a preferred agent in obstetrics, orthopedic surgeries, and postoperative pain control.
Our Bupivacaine Injection is manufactured under stringent GMP conditions to ensure precision in formulation, consistent potency, and low risk of systemic toxicity.
Available in multiple concentrations and vial formats, it provides optimal flexibility for anesthetic needs across different surgical and clinical scenarios.
Formulation & Presentation:
- Dosage Form: Sterile Injectable
- Presentation: Clear Sterile Solution in Clear/Amber Glass Vial/ Ampoule (customizable as per market demand)
- Available Strengths:
- 10 MG/ ML
- 25% w/v
- 5% w/v
- 75% w/v
- 5 MG/ML
- Route of Administration: Epidural (lumbar and caudal) / Spinal (intrathecal) / Peripheral nerve block / Infiltration anesthesia. (To be used under strict medical supervision) To be used after appropriate reconstitution or as per clinical indication and recommendation. Reconstituted as per protocol for injection in country of use.
Therapeutic Indications:
- Surgical anesthesia (epidural, spinal, caudal, or nerve block)
- Obstetric analgesia (including labor epidurals)
- Postoperative pain control
- Local infiltration anesthesia
Side Effects:
- COMMON:
- Hypotension
- Nausea
- Dizziness
- Tingling or numbness
- Mild bradycardia
- SERIOUS (RARE):
- Central nervous system toxicity (seizures, loss of consciousness)
- Cardiac arrhythmias
- Respiratory depression
- Anaphylaxis
- Prolonged or permanent nerve block
- PRECAUTIONS:
- Should be used with resuscitative equipment readily available
- Avoid intravascular injection; always aspirate before administration
- Adjust dosage in elderly, debilitated, or hepatic-impaired patients
- Not recommended for intravenous regional anesthesia (Bier’s block)
- Caution in patients with cardiovascular diseases
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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: (15x1x8 CMS)
- Shelf Life (Subject To Country Specific Guidelines): 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications
- Storage: Store below 25°C (Do not freeze). Does not require cold-chain logistics. Vial/ Ampoule to be stored strictly at recommended temperature range only. Protect from moisture, direct sunlight & children.
Regulatory Status & Supply Information:
- Regulatory Status: WHO-GMP Complaint Manufacturing. COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support (on request). Further certifications available on request
- Exports Ready Dossiers: COA, COPP, Dossier Available (CTD/eCTD formats). Complies with USP/EP/BP Standards
- 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?
- Hospital Anesthesia Departments & Surgery Centers
- Obstetric and Orthopedic Surgical Units
- Importers and Tender Agencies for Critical Care Anesthetics
- Medical Colleges and Teaching Institutions
- Distributors of OR/ER Essential Medications Across Africa, LATAM, CIS & Southeast Asia
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation support for effective registration support
- Trusted consortium network, simplifying India’s complex pharma supply chain
- Multiple approved manufacturers for best fit in import country
- Network of audited, compliant manufacturers across India
- Customizable & Flexible branding, packaging & formulation flexibility
- End to End Logistics support flexibility & support
- Deep expertise in exporting specialty injectables & all products
CONTACT DETAILS:
- E-MAIL: hello@pharmet.io
- Phone/WhatsApp Number: +91 9999091881
- Website: www.pharmet.io
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