Ibuprofen DMF: Global Regulatory Insights & Top Suppliers

When it comes to global demand, few active pharmaceutical ingredients rival Ibuprofen, a widely trusted, fast-acting NSAID used across hospitals, retail shelves, and emergency protocols.

But behind every approved formulation is something invisible yet critical: a Drug Master File (DMF). For procurement heads, regulatory professionals, and sourcing strategists, understanding the Ibuprofen DMF landscape is essential to de-risk decisions and ensure compliance.

In this blog, we break down what makes Ibuprofen a regulatory staple, explore Ibuprofen DMF trends, and highlight top manufacturers.

Let’s dive in.

What is Ibuprofen?

Ibuprofen doesn’t just sit on pharmacy shelves—it powers through inflammation, pain, and fever in over 100 countries.

Discovered in the early 1960s by Dr. Stewart Adams and his team at Boots UK, the drug was initially developed as a safer alternative to aspirin. By 1969, it gained approval in the UK. Five years later, it entered the U.S. market.

Classification and How It Works

Ibuprofen is classified as a, nonsteroidal anti-inflammatory drug (NSAID)—specifically, a derivative of propionic acid. Its chemical name: isobutylphenylpropionic acid. What makes it effective is its ability to block COX-1 and COX-2 enzymes. When those are suppressed, the body produces fewer prostaglandins—the chemical messengers behind pain, fever, and inflammation.

The drug is formulated for multiple delivery systems: oral tablets and suspensions, topical creams, and even intravenous infusions. Most patients feel relief within 30 to 60 minutes.

How It's Used Around the World?

Doctors reach for Ibuprofen because it works—and fast. It’s routinely used to treat:

• Pain from headaches, surgeries, muscle strains, or arthritis
• Inflammation in joints and soft tissues
• Fever, whether due to infection or vaccination

Because of its wide utility, Ibuprofen has become a staple in medicine cabinets, hospitals, and emergency kits. It’s also included in the World Health Organization’s Model List of Essential Medicines, a list reserved for drugs considered critical for global health.

Understanding DMF in Pharmaceuticals

In pharmaceuticals, trust is essential, but so is confidentiality. That’s where the Drug Master File (DMF) comes in.

A DMF is a confidential regulatory document submitted to authorities like the US FDA, EDQM, or WHO. It contains detailed information about the manufacturing, processing, and control of an active pharmaceutical ingredient (API), excipient, or packaging component.

Instead of disclosing sensitive data to every client, manufacturers file a DMF once—and authorize access as needed.

What Is the Purpose of a DMF?

The core goal of a DMF is to:

• Protect the manufacturer’s intellectual property
• Support a formulation company's drug application (e.g., ANDA, NDA, EU MA)
• Enable regulatory bodies to review the safety and quality of the substance

Once filed, the DMF acts as a secure reference for multiple applications—without repeated submissions.

Types of DMFs

While several types exist, the most relevant for APIs is the Type II DMF.

Note: Type I DMFs (Facility/Site) are now obsolete under US FDA guidelines.

Ibuprofen DMF A Global Regulatory Snapshot

If you're sourcing Ibuprofen, your first question should be: Is there a valid DMF on file? If not, walk away.

How Many Ibuprofen DMFs Are Active?

As of 2024, over 77 US-DMFs for Ibuprofen have been submitted to the U.S. Food and Drug Administration (USFDA). These filings come from leading API manufacturers like IOL Chemicals, BASF, Granules India, and Shandong Xinhua.

Multiple companies hold more than one DMF, often reflecting process improvements or updated compliance data.

These DMFs are typically Type II, specific to the drug substance—and are key indicators of a manufacturer’s regulatory strength.

Regional Breakdown of Ibuprofen DMFs

While the U.S. hosts the largest volume of filings, Ibuprofen is regulated globally under multiple frameworks:

Note: Not all manufacturers file globally, but top-tier suppliers submit across multiple agencies—maximizing market access.

Year-Wise Trend of Filings

Filings for Ibuprofen DMFs began in the late 20th century and accelerated after the patent expired in 1985. Over the last decade, updates have increased due to:

• Evolving GMP standards
• Process upgrades
• Regulatory pressure for transparency

Here’s a rough timeline to illustrate the trend:

Top leading pharma database provider in India such that Chemxpert Database—let you filter API suppliers by DMF type, geography, and regulatory approvals in seconds. It’s speed with compliance built-in.

Top Ibuprofen Manufacturers with Active DMFs

If you're evaluating Ibuprofen suppliers, don’t just ask for samples, ask for their DMF history. It’s your shortcut to trust.

Who Are the Key Players?

More than 70 companies globally have filed USDMFs for Ibuprofen, but only a handful stand out in both regulatory strength and market reliability.

Here are some of the top names:

Several of these firms have filed multiple DMFs over time—often signaling process innovation or compliance upgrades.

How to choose the right API manufacturer?

When shortlisting Ibuprofen API suppliers, regulatory filing is just the beginning. You should also evaluate:

• Number of active DMFs and update history
• Global reach (USDMF, CEP, WHO PQ, JDMF, etc.)
• GMP certifications and audit track record
• Supply reliability and production scalability

With our powerful and most updated pharma database, all these information is just a single click away, so you don’t have to toggle between PDFs or spreadsheets. Chemxpert Database provides you all the latest information at a single platform.

Conclusion

In pharma, the real leverage isn’t in the product—it’s in the data behind it. And Ibuprofen? It’s not just another over-the-counter painkiller. It’s a global commodity driven by compliance, credibility, and control.

With 77+ USDMFs, a legacy of safety, and wide therapeutic demand, Ibuprofen is one of the most actively regulated APIs on the planet. But the smartest companies aren’t just sourcing it. They’re vetting every DMF. Every audit. Every update.

That’s how leaders operate.

They don’t guess. They move fast, with clarity. And that’s what Chemxpert Database delivers: real-time regulatory intel, global DMF coverage, and supplier insights, all in one platform. No fluff. No friction. Just facts that close the gap between decision and execution.

So here’s the play: if you’re not using a platform like Chemxpert Database, you’re not sourcing—you’re gambling.

Make your next move a calculated one.

Frequently Asked Questions (FAQs)

1. What is the USDMF number for Ibuprofen?

The USDMF number for Ibuprofen varies by manufacturer. Each approved supplier has a unique Drug Master File number registered with the USFDA. You can view and verify these numbers through trusted platforms like Chemxpert Database or the FDA DMF database.

2. How many Ibuprofen suppliers are DMF-approved in India?

As of 2024, more than 15 Indian manufacturers hold active US DMFs for Ibuprofen. Leading names include IOL Chemicals, Granules India, Solara Active Pharma Sciences, and SMS Pharmaceuticals. Platforms like Chemxpert Database offer filtered lists of India-based, DMF-approved Ibuprofen API suppliers with up-to-date compliance data.

3. What’s the difference between USDMF and CEP?

• USDMF (U.S. Drug Master File): Submitted to the USFDA, it details the manufacturing and quality control of APIs for the U.S. market.
• CEP (Certificate of Suitability): Issued by the European Directorate for the Quality of Medicines (EDQM), it certifies that the API complies with European Pharmacopeia standards.

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