How to Source Paracetamol + Codeine tablets for Pharmaceutical Formulation
Paracetamol + Codeine tablets (Tablets, 300 mg paracetamol + 30 mg codeine; 300 mg + 60 mg) is classified under Analgesic. It is therapeutically aligned with reference brands such as Tylenol with Codeine(US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Paracetamol + Codeine tablets for formulation, R&D, or bulk manufacturing.
Product Overview:
Paracetamol + Codeine combine analgesic effects, with codeine activating mu-opioid receptors to block pain signals and paracetamol reducing prostaglandin synthesis for pain and fever relief. Benefits include effective moderate pain control, rapid onset, and improved comfort. Caution is needed due to dependence risk and strict regulations.
1. Regulatory Compliance & Documentation
Ensure suppliers provide:
- ✔ Valid DMF (Drug Master File)
- ✔ COA (Certificate of Analysis) for each batch
- ✔ GMP, ISO, or ICH Q7 compliance certificates
2. Purity, Grade & Specification Matching
Paracetamol + Codeine tablets must meet exact grade and purity for your dosage form:
- ✔ USP / EP / JP grade verification
- ✔ Particle size distribution check
- ✔ Residual solvent and heavy metal limits
3. Supplier Reliability & Audit History
- ✔ Positive past audit reports
- ✔ Pharma client references
- ✔ Years of proven API manufacturing experience
4. Commercial Terms: Pricing, MOQ & Flexibility
- ✔ Transparent pricing
- ✔ Pilot batch MOQ flexibility
- ✔ Volume-based discounts
5. Lead Time, Inventory & Logistics
Typical lead time for Paracetamol + Codeine tablets is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Conclusion
Sourcing Paracetamol + Codeine tablets is more than procurement—it’s a strategic partnership. With its tablets form and 300 mg paracetamol + 30 mg codeine; 300 mg + 60 mg specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.
Next Step: Get expert assistance in sourcing Paracetamol + Codeine tablets.
Frequently Asked Questions For Sourcing of Paracetamol + Codeine tablets
What is the typical lead time for Paracetamol + Codeine tablets?
Lead times range from 4–6 weeks depending on supplier and region.
Is Paracetamol + Codeine tablets available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Paracetamol + Codeine tablets require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Paracetamol + Codeine tablets?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Paracetamol + Codeine tablets?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Paracetamol + Codeine tablets?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Paracetamol + Codeine tablets suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Paracetamol + Codeine tablets be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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