Ibuprofen USP EP BP API Supplier (USFDA Approved) – Complete Buyer’s Guide (2026)
Ibuprofen is one of the most widely used Active Pharmaceutical Ingredients (APIs) in the global pharmaceutical industry. For bulk buyers, procurement managers, and formulation manufacturers, choosing a supplier with USP, EP, BP compliance and USFDA-approved manufacturing is critical.
This guide explains quality standards, regulatory requirements, and key factors to help you select a reliable Ibuprofen API supplier for regulated and global markets.
1) What is Ibuprofen API?
Ibuprofen API is the active ingredient used in pain-relief, anti-inflammatory, and fever-reducing medicines. It belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) category.
- Tablets and capsules
- Syrups and suspensions
- Topical gels and creams
- Pediatric and OTC formulations
The API is supplied as a pharma-grade white crystalline powder and must meet strict pharmacopeial and regulatory standards before use in finished dosage forms.
2) Understanding USP, EP, and BP standards
- USP (United States Pharmacopeia): Recognised quality and purity standards for the US and global markets
- EP (European Pharmacopoeia): Accepted quality benchmarks across the European Union
- BP (British Pharmacopoeia): UK pharmacopeial standards aligned with global expectations
When an API complies with USP, EP, and BP, it meets rigorous international benchmarks for safety, stability, and consistency.
3) What does USFDA-approved manufacturing mean?
USFDA approval indicates that the manufacturing facility follows USFDA cGMP regulations and has been inspected or approved for compliance.
- Manufacturing facility follows strict cGMP guidelines
- Strong quality systems and data integrity controls
- API suitable for formulations intended for the US market
- Higher confidence for global regulatory acceptance
4) Why Ibuprofen API quality matters for pharma manufacturers
- Avoid batch rejections and regulatory observations
- Reduce risk of recalls and approval delays
- Ensure consistent therapeutic performance
- Maintain stable, scalable production
5) Key specifications of high-quality Ibuprofen API
- CAS Number: 15687-27-1
- Purity (Assay): 98.5% – ≥99%
- Physical form: White crystalline powder
- Melting point: ~75–78°C
- Shelf life: 36–60 months
6) How to choose the right Ibuprofen USP EP BP API supplier
- USP / EP / BP compliant product
- USFDA-approved or USFDA-inspected facility
- Certificate of Analysis (COA)
- DMF / CEP / regulatory documentation support
- Strong quality testing and impurity profiling
- Reliable bulk production capacity and logistics
7) Handling, storage & safety guidelines
- Store in a cool, dry place
- Protect from moisture and direct light
- Use tightly sealed containers
- Follow GMP handling and storage protocols
8) Conclusion
Choosing a trusted Ibuprofen USP EP BP API supplier with USFDA-approved manufacturing ensures long-term reliability, regulatory confidence, and consistent product quality. For pharmaceutical companies, this translates into smoother approvals and competitive advantage in regulated markets.
9) Contact us for Ibuprofen USP EP BP API supply
Looking to source Ibuprofen USP EP BP API manufactured in a USFDA-approved facility? Contact us for pricing, documentation, and bulk supply support.
Phone: +91 99044 98877 | +91 95580 12935 | +91 93131 88670
Email: mail@globaux.net