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Description
PRODUCT DESCRIPTION:
Diclofenac Sodium Injection is a potent, fast-acting NSAID widely used for the management of moderate to severe pain and inflammation associated with musculoskeletal conditions, post-operative pain, and acute injury.
Its parenteral route ensures rapid relief, making it an essential analgesic in emergency and hospital settings.
The product is presented in Pre-Filled Syringe (PFS) format to enhance clinical convenience, accurate dosing, and reduced contamination risk, offering healthcare professionals an ideal solution for swift and sterile pain relief delivery.
Formulation & Presentation:
- Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
- Presentation: Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 75 MG/ ML (Pre-Filled Syringe)
- Route of Administration: Intramuscular (IM) or Deep Gluteal to minimize local irritation. To be used in advanced clinical settings, as per clinical indication and severity. To be administered under supervision of a qualified specialist only. (As per physician’s discretion or decision)
Therapeutic Indications:
- Acute musculoskeletal pain
- Post-operative pain and inflammation
- Renal colic and biliary colic
- Dysmenorrhea (severe menstrual cramps)
- Pain and swelling due to sprains, strains, and fractures
- As adjunct in fever and inflammatory states
Side Effects:
- COMMON:
- Pain or redness at injection site
- Nausea or abdominal discomfort
- Dizziness or headache
- Gastric irritation or bloating
- SERIOUS (RARE):
- Gastrointestinal bleeding or ulceration
- Renal dysfunction
- Allergic reactions including skin rashes or bronchospasm
- Elevated liver enzymes or hepatitis
- Cardiovascular risk with prolonged use
- PRECAUTIONS:
- Use cautiously in patients with a history of gastric ulcers, renal or hepatic impairment
- Avoid use in pregnancy (especially 3rd trimester)
- Not recommended in children under 18 years
- Concurrent use with other NSAIDs should be avoided
- Monitor kidney function and blood pressure in long-term users
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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 for Pre-Filled Syringes/Lyophilized (Do not freeze). Does not require cold-chain logistics. Protect from moisture and direct sunlight. The solution should be used strictly as per label guidelines.
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?
- Hospitals, emergency care units, and surgical departments
- Government procurement agencies and relief missions
- NGOs and humanitarian organizations managing field hospitals
- Importers and distributors focusing on pain management injectables
- Pharmaceutical buyers catering to public health, trauma, and orthopedic care
- Healthcare providers in Africa, LATAM, and South Asia requiring reliable injectable NSAIDs
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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