Propacetamol is an injectable prodrug of paracetamol, fast-acting, hospital-grade, and ideal when oral delivery isn’t an option. But getting it approved or sourced isn’t just about price or formulation. It’s about paperwork. Specifically, DMF.
If you're in regulatory affairs, procurement, or formulation, here’s the bottom line:
No verified DMF = no smooth approval.
A Propacetamol DMF contains everything regulators care about—how it’s made, how pure it is, and whether it meets injectable standards.
That’s where Chemxpert Database comes in. Our platform connects you to verified Propacetamol DMF holders, their regulatory status, and audit trail—all in one place.
A drug master file is a set of confidential data, the information contained by a DMF is on manufacturing, testing, and API quality submitted to regulators.
Regulatory agencies where DMFs are submitted are USFDA, FDA, EMA and CDSCO, they accept DMFs to verify if the API is compliant without disclosing any proprietary details to the finished dosage manufacturers.
Here are the different types of DMFs:
APIs like Propacetamol require a DMF when they are part of injectable or regulated formulations. This helps ensure product safety, consistency, and GMP compliance.
The DMF supports regulatory dossiers by supplying validated information for Modules 2 and 3 of the CTD (Common Technical Document).
Propacetamol (CAS No. 66532-86-3) is a water-soluble prodrug of paracetamol designed for intravenous use. It converts rapidly into active paracetamol in the body.
The conversion occurs via plasma esterases, with full effect seen within 30 minutes. This makes it ideal for acute pain scenarios where oral dosing isn't possible.
Common use cases include:
It’s especially useful when rapid onset and predictable plasma levels are required. The drug is typically used in hospitals.
Dosage equivalence is simple: 2?g of Propacetamol delivers the effect of 1?g of paracetamol. This allows precise titration in IV formulations.
Propacetamol has active DMF filings across multiple regulated markets, including the US, EU, India, and Korea. These filings support injectable formulations and hospital-grade products.
The USDMF for Propacetamol is submitted to the FDA for use in IV pain management drugs. In the EU, it follows the Active Substance Master File (ASMF) format, reviewed by national authorities or the EMA.
In India, DMFs are evaluated by CDSCO as part of fixed-dose combination approvals or injectable formulations. Korea accepts KDMFs for similar use cases.
Known DMF holders for Propacetamol include companies like Curia Global and others that offer injectable-grade APIs. However, not all DMF filings are public.
Each regulatory body requires the Common Technical Document (CTD) format, especially Modules 2 and 3, which cover 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.
Global Propacetamol filings are essential for manufacturers targeting multiple markets.
Propacetamol DMFs must include detailed Chemistry, Manufacturing, and Controls (CMC) data to meet global regulatory standards—especially for injectable use.
Key CMC elements include:
One of the major compliance challenges is controlling 4-aminophenol, a toxic impurity associated with paracetamol degradation. Acceptable limits are set below 50 ppm for parenteral use.
Particulate matter is another red flag. Injectable Propacetamol must meet USP <788> standards for visible and sub-visible particles.
Endotoxin and pyrogen testing is non-negotiable. Only batches with low endotoxin levels (<0.5 EU/mL) are considered injectable-grade.
Filtration integrity, sterility testing, and container-closure validation are mandatory inclusions in the DMF.
Regulators expect robust data packages that demonstrate consistency across batches. Incomplete or vague documentation may delay product approvals or trigger site audits.
Manufacturers must align their Propacetamol DMF with the latest GMP and ICH Q6A–Q8 quality standards to ensure faster acceptance and fewer regulatory queries.
As of 2024, the global market value of propacetamol is around $ 1.2 billion, that is growing at a CAGR of 9.2% and is expected to reach a market size of $ 2.5 billion by 2033.
Here is a list of key factors that are reason for such exponential growth:
The Propacetamol market is expanding fast, but consistent quality, compliance, and innovation will determine who leads by 2033.
Propacetamol is growing fast, thanks to its delivery of fast relief, and being a good replacement for the oral medications. Propacetamol fits as the perfect post operation protocols.
However, without DMF you can’t access the market. If you're planning to enter this space, your DMF needs to be complete, clean, and compliant. Regulators won’t wait. Neither will the competition.
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