Propacetamol is a fast-acting injectable painkiller that hospitals rely on when patients can't take oral medication. It's growing into a $2.5 billion market by 2033. But here's the catch: you can't manufacture, import, or sell it without the right Drug Master File (DMF).
No verified DMF means no regulatory approval. No approval means you're stuck watching competitors capture market share while you're drowning in paperwork rejections.
This guide breaks down everything about Propacetamol DMF, what it contains, why regulators care, and how to find verified DMF holders without wasting months on dead ends.
A Drug Master File is basically a confidential dossier containing all the technical details about how an API (Active Pharmaceutical Ingredient) is manufactured, tested, and quality-controlled.
Think of it as the API's resume for regulators. It proves the substance meets safety and quality standards without revealing proprietary manufacturing secrets to your competitors.
DMF is submitted to the following authorities:
For APIs like Propacetamol that go into injectable drugs, having a valid DMF is non-negotiable. Regulators use it to verify GMP compliance, product safety, and manufacturing consistency. FOR
The DMF supports your regulatory dossiers by supplying validated information for Modules 2 and 3 of the CTD (Common Technical Document)—the technical sections that make or break approval timelines.
Propacetamol (CAS No. 66532-86-3) is a water-soluble prodrug that converts rapidly into paracetamol once it enters the bloodstream. It's designed specifically for intravenous use when patients can't swallow pills.
The conversion happens via plasma esterases, delivering full pain relief within 30 minutes. This speed makes it perfect for acute pain scenarios.
Common hospital uses include:
It's especially valuable when you need rapid onset and predictable plasma levels. Most usage happens in hospital environments where IV access is standard.
The dosage math is straightforward: 2 grams of Propacetamol delivers the same effect as 1 gram of paracetamol. This allows precise titration in IV formulations.
Propacetamol has active DMF filings across multiple regulated markets—US, EU, India, and Korea. These filings support injectable formulations and hospital-grade products.
Key regulatory markets:
Known DMF holders for Propacetamol include companies like Curia Global and other injectable-grade API manufacturers. However, not all DMF filings are publicly listed—this is where a pharma database provider in India like Chemxpert Database becomes crucial for sourcing intelligence.
Each regulatory body requires the Common Technical Document (CTD) format, especially Modules 2 and 3 covering drug substance and quality data. These filings enable faster product registrations and market entry, provided the Propacetamol DMF is complete and compliant with ICH guidelines.
Propacetamol DMFs must include detailed Chemistry, Manufacturing, and Controls (CMC) data to meet global regulatory standards—especially for injectable use where purity matters most.
Understanding these types of data in pharmaceutical industry documentation helps you evaluate whether a DMF holder meets injectable standards or just generic API quality.
Filtration integrity, sterility testing, and container-closure validation are mandatory inclusions. Regulators expect robust data packages demonstrating consistency across batches. Incomplete or vague documentation delays product approvals or triggers site audits that cost time and money.
Manufacturers must align their Propacetamol DMF with the latest GMP and ICH Q6A–Q8 quality standards to ensure faster acceptance and fewer regulatory queries.
Most pharmaceutical intelligence platforms give you either basic supplier lists or incomplete regulatory data. Chemxpert, as a leading pharma database service provider company, delivers both—plus real-time updates that keep you ahead of compliance changes.
Companies using Chemxpert report cutting supplier qualification time by 70% while identifying more qualified manufacturers than traditional search methods.
The Propacetamol market is growing to $2.5 billion by 2033, but without proper DMF documentation, you can't participate. Your DMF needs to be complete, clean, and compliant—regulators won't wait, and neither will your competitors.
Manual searching through databases wastes weeks and often misses critical regulatory details. Modern pharmaceutical companies use verified intelligence platforms to make sourcing and regulatory decisions faster.
Chemxpert helps streamline that journey with verified DMF data, supplier intelligence, and regulatory tracking—all in one place. Explore Propacetamol DMFs, identify global manufacturers, and stay ahead in this growing market with confidence.
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