Ibuprofen API DMF Available Supplier – A Complete Guide for API Buyers (2026)
If you are looking for a trusted Ibuprofen API supplier with DMF available, this guide will help you understand why DMF status matters, how to verify supplier credentials, and how to select the right partner for bulk procurement.
1) What is Ibuprofen API?
Ibuprofen API is the active pharmaceutical ingredient used to manufacture ibuprofen medicines. These medicines are widely used as pain relievers, fever reducers, and anti-inflammatory drugs across global markets.
- CAS Number: 15687-27-1
- Physical form: White crystalline powder
- Applications: Tablets, gels, suspensions, and other formulations
- Pharmacopeia grades: USP, BP, IP, and EP
2) Why API with DMF is crucial for buyers
DMF (Drug Master File) is a confidential technical document submitted by API manufacturers to regulatory authorities such as the USFDA. It provides detailed information on manufacturing processes, quality controls, and safety data.
- Ensures compliance with global regulatory expectations
- Supports use of API in regulated markets
- Facilitates ANDA or NDA submissions
- Protects manufacturer intellectual property
3) How to check DMF status before buying
- Request the DMF number from the supplier
- Verify the DMF on official regulatory databases
- Confirm that the DMF is active and accepted
- Check for CEP availability for European markets
Suppliers with multiple DMF filings generally demonstrate strong regulatory expertise and global compliance capability.
4) Grades and specifications to consider
- USP – United States Pharmacopeia
- EP / CEP – European Pharmacopoeia
- BP – British Pharmacopoeia
- IP – Indian Pharmacopoeia
Most high-quality Ibuprofen APIs offer purity levels of ≥ 98.5% along with detailed impurity profiles to ensure formulation stability.
5) How to choose the right Ibuprofen API DMF supplier
- Availability of active DMF and regulatory documents
- cGMP-compliant manufacturing facility
- Quality certificates such as COA and MSDS
- Consistent production capacity and supply reliability
- Audit access and traceability
- Competitive pricing and export logistics
- Pre-shipment sample testing
6) Benefits of buying from a DMF-approved supplier
- Easier regulatory approval in target markets
- Lower compliance and rejection risk
- Access to regulated global markets
- Consistent quality and batch reliability
- Long-term supply confidence
7) Conclusion
Selecting an Ibuprofen API supplier with an active DMF is essential for success in regulated markets. Always verify DMF status, quality certifications, and regulatory compliance before finalizing your supplier to ensure smooth approvals and long-term business growth.
8) Contact us for Ibuprofen API DMF supply
Ready to buy Ibuprofen API from a DMF-available supplier? Contact us for pricing, documentation, and bulk supply support.
Phone: +91 99044 98877 | +91 95580 12935 | +91 91067 95854
Email: mail@globaux.net