Ultimate guide to Glimepiride USP EP CEP API exporter
If you are an API buyer, procurement manager, or pharmaceutical manufacturer, this guide explains everything you need to know about sourcing Glimepiride API that meets USP, EP, and CEP standards for global markets.
1) What is Glimepiride API?
- Glimepiride is an active pharmaceutical ingredient used in antidiabetic medicines.
- It belongs to the sulfonylurea class and helps control blood glucose levels.
- CAS Number: 93479-97-1
- Chemical Formula: C24H34N4O5S
2) Why is Glimepiride API in high global demand?
- Clinically proven effectiveness in Type 2 diabetes treatment
- Once-daily dosing improves patient compliance
- Flexible formulation options for tablets and combinations
3) Understanding USP, EP and CEP standards
- USP: Required for North American markets, defines purity and impurity limits
- EP: Mandatory for Europe, ensures compliance with EU quality benchmarks
- CEP: Issued by EDQM, confirms API compliance with EP requirements
4) Why buyers prefer APIs with USP, EP & CEP
- Easier and faster product registration
- Reduced regulatory queries
- Higher acceptance in regulated markets
5) What makes a reliable Glimepiride API exporter?
- ≥99% purity with controlled impurity profile
- WHO-GMP / GMP certified manufacturing facilities
- Complete documentation: CoA, GMP, stability data, MSDS
- Regulatory filings such as USDMF and CEP
6) Global export capability checklist
- Experience supplying EU and US markets
- Strong logistics and freight coordination
- Consistent bulk supply capability
7) Benefits of sourcing Glimepiride API from Globaux
- USP, EP & CEP compliant Glimepiride API
- Bulk quantities with full regulatory documentation
- Competitive pricing and global shipping support
- Reliable supply and responsive support
8) Frequently asked questions
- What is Glimepiride API used for? Manufacturing antidiabetic medicines.
- Can it be exported to Europe? Yes, CEP supports EU compliance.
- What standards should I verify? USP, EP, CEP and GMP.
9) Conclusion
Choosing a trusted Glimepiride USP EP CEP API exporter ensures product quality, smooth regulatory approvals, and long-term supply security for your business.
10) Ready to buy Glimepiride API?
Contact us for bulk orders, documentation support, and export-ready supply.
Phone: +91 99044 98877 | +91 95580 12935 | +91 93131 88670
Email: mail@globaux.net