How to Source Ketoprofen tablets for Pharmaceutical Formulation
Ketoprofen tablets (Tablets, 50 mg, 100 mg) is classified under Analgesic. It is therapeutically aligned with reference brands such as Oruvail(US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Ketoprofen tablets for formulation, R&D, or bulk manufacturing.
Product Overview:
Ketoprofen inhibits cyclooxygenase enzymes (COX-1 and COX-2), reducing prostaglandin synthesis responsible for pain and inflammation. It provides effective relief from acute and chronic pain, arthritis, and inflammatory conditions. Benefits include rapid pain relief, anti-inflammatory effects, and suitability for short-term use, improving mobility and quality of life.
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
Ketoprofen 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 Ketoprofen 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 Ketoprofen tablets is more than procurement—it’s a strategic partnership. With its tablets form and 50 mg, 100 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 Ketoprofen tablets.
Frequently Asked Questions For Sourcing of Ketoprofen tablets
What is the typical lead time for Ketoprofen tablets?
Lead times range from 4–6 weeks depending on supplier and region.
Is Ketoprofen tablets available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Ketoprofen 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 Ketoprofen 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 Ketoprofen 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 Ketoprofen tablets?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Ketoprofen 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 Ketoprofen 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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