Composition: Paracetamol 500 mg + Diclofenac Sodium 50 mg
Additional proposed strength: 325 mg + 50 mg (verification required)
Manufacturer: Healthy Life Pharma Pvt. Ltd. (certification to verify)
Exporter: Healthy Inc (credentials to verify)
SKU: paracetamol-diclofenac-sodium-tablets
Categories: Contract Manufacturer · Formulations Exporter India · Manufacturing Pharmaceutical Company India · Pharmaceutical Exporter India · Pharmaceutical Formulations India · Tablets Manufacturer · WHO GMP Certified Formulations
Paracetamol & Diclofenac Sodium Tablets is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.
Paracetamol and Diclofenac Sodium Tablets combine an analgesic-antipyretic (paracetamol) with a nonsteroidal anti-inflammatory drug (diclofenac sodium). This combination may be considered for pain accompanied by inflammation where approved by the relevant regulator and prescribed by a clinician.
The described main strength is Paracetamol 500 mg + Diclofenac Sodium 50 mg. A 325 mg paracetamol option is mentioned in the supplied marketing description but its complete approved formulation must be verified. Healthy Life Pharma Pvt. Ltd. is named as manufacturer and Healthy Inc as exporter; manufacturing and export credentials should be confirmed.
| Product name | Paracetamol & Diclofenac Sodium Tablets |
|---|---|
| Primary described composition | Paracetamol 500 mg + Diclofenac Sodium 50 mg |
| Additional proposed strength | Paracetamol 325 mg + Diclofenac Sodium 50 mg (verify approved composition) |
| Dosage form | Oral tablet; coating and release type to be confirmed |
| Therapeutic class | Analgesic / Antipyretic + NSAID |
| CAS | Paracetamol 103-90-2; Diclofenac Sodium 15307-79-6 |
| Standards, packaging, shelf life | As established in approved specifications, stability data and product labeling |
Formulation development should establish compatibility of both APIs, uniform blending, tablet hardness, disintegration, dissolution, and stability under proposed storage conditions. Immediate-release, film-coated, and enteric-coated presentations have different release characteristics and must not be represented as interchangeable without product-specific evidence.
Proposed packaging and moisture-protection systems require validation for the finished product. Details of equipment, coating process and manufacturing site should be confirmed from batch records and quality documentation.
Quality control should include identity, assay, content uniformity where applicable, dissolution appropriate to the approved release type, related substances, and finished-product stability. Limits and test methods must follow the registered product specification; a universal 85% in 30 minutes or 100% assay requirement should not be assumed.
Paracetamol provides analgesic and antipyretic activity. Diclofenac Sodium is an NSAID that inhibits cyclooxygenase pathways and reduces prostaglandin synthesis, contributing anti-inflammatory and analgesic effects.
Potential clinical uses may include selected musculoskeletal, dental or postoperative pain conditions, subject to local approval. The combination is not automatically safer than diclofenac alone and should not be promoted as a general fever treatment without an approved indication.
B2B buyers can enquire about contract manufacturing, registration documentation, certificates of analysis, product specifications, packaging and export arrangements. WHO-GMP status, COPP, free-sale certificates, CTD/ACTD dossiers, and shipping terms must be verified for the specific manufacturer, product and destination market.
What is the difference between diclofenac sodium and potassium?
They are different salt forms of diclofenac. Release rate depends on both the salt and the finished dosage-form design.
Does this combination prevent stomach ulcers?
No. Diclofenac can cause ulcers and gastrointestinal bleeding even when combined with paracetamol or taken with food.
Who should confirm the formulation?
The manufacturer and regulatory team should verify the 500/50 mg product and any proposed 325/50 mg variant against approved labels.
Use only according to the approved local prescribing information and the advice of a qualified healthcare professional. Dosing depends on the formulation, patient factors, other medicines, and duration of treatment. Do not assume that taking a tablet after meals eliminates gastrointestinal risk. Avoid taking other products containing paracetamol or additional NSAIDs unless instructed by a clinician.
Important risks: Diclofenac may cause gastrointestinal ulceration or bleeding, cardiovascular thrombotic events, kidney injury, fluid retention and hypersensitivity reactions. Paracetamol overdose may cause serious liver injury. Seek urgent care for vomiting blood, black stools, chest pain, breathing difficulty, severe rash or suspected overdose.
People with previous GI bleeding, significant heart, kidney or liver disease, NSAID-sensitive asthma, or pregnancy require specific medical assessment. Systemic NSAIDs should generally be avoided from about 20 weeks of pregnancy unless specifically directed by a clinician and are contraindicated in late pregnancy under many labels.
Store according to the approved pack label and validated stability conditions, protected from excessive moisture and light where specified. Keep out of reach of children. Shelf life and temperature limits must be supported by product-specific stability studies.