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Drug Master Files (DMF) of Paracetamol

Admin
27 February 2024

Paracetamol, also known as acetaminophen, is a popular over the counter medicinal product to reduce pain and fever. Its efficacy and low side effects justify its popularity, if taken correctly. However, behind the scenes of this widely available medicine lies an intricate regulatory process known as the Drug Master File (DMF). In this blog, get an overview for the Drug Master Files (DMF) of Paracetamol and its significance, as well as what it means.

What Are DMFs?

A Drug Master File (DMF) is a confidential document submitted to regulatory authorities containing detailed information about the processes, ingredients, and facilities used in the manufacturing, processing, packaging, and storing of a drug substance. In order to support the approval process for new medicinal products or variations of existing medicinal products, manufacturers, suppliers or holders of proprietary information shall submit such files.

Paracetamol Overview

Paracetamol, commonly known as Acetaminophen, is a widely used analgesic and antipyretic.
It is a non-opioid medication, making it a safer choice for pain management.
There are different formulations of paracetamol, including tablets, capsules and liquids.

Why Is the DMF Important for Paracetamol?

Critical information on the chemical properties, manufacturing processes and quality control of Paracetamol is contained in its Data Management Facility.
During the drug approval process, DMFs are relied upon by regulatory authorities, such as the U.S. Food and Drug Administration (FDA).

The Significance of DMF for Paracetamol:

Confidentiality: The DMF for Paracetamol is exclusively available to the Regulatory Authorities in order to allow them to assess the quality, safety and efficacy of the product with no disclosure of privileged information.
Regulatory Compliance: For completely aligning with the regulatory guidelines, the DMF helps pharma companies in many aspects. It facilitates the Drug Approval Application by providing holistic data on the quality and safety of the drug.
Complex Manufacturing Processes: Manufacturing of paracetamol involves a series of complex steps, including synthesis and purification of the medicinal product, formulation and QC. These processes shall be laid down by the DMF to maintain transparency and simplification of regulatory assessment.

Key Components of Paracetamol DMF:

1. General information: The manufacturer's name, contact details and the common and chemical names of the medicinal product are included in this section.

2. Facilities and Equipment: It provides an overview of the manufacturing facilities, including their location, design, equipment used, and compliance with Good Manufacturing Practices (GMP).

3. Active Pharmaceutical Ingredient (API): The process of Paracetamol synthesis, including the precursors, intermediates and purification methods used are described in the DMF. The API specifications, analytical methods, and stability data are also covered.

4. Formulation and Finished Product: The formulation of Paracetamol tablets or capsules, which include excipients used, specifications and manufacturing processes shall be described in this section. Stability data and packaging details are also included in this report.

5. Quality Control: A comprehensive quality control section, including raw material testing, in process controls and final product tests is part of the DMF. Analytical methods, specifications, impurity profiles and validation reports are included.

6. Packaging and Storage: Details of packaging materials, labelling and storage conditions are presented. Stabilization studies to evaluate shelf life are also part of the package.

Specifics of Paracetamol DMF:

• DMF Number: Every DMF has a unique identification number.

• Submission Date: It shows on which date the DMF was submitted.

• Type II DMF: Paracetamol comes under this class, which covers drug substance info.

• Status: Active or inactive status.

• GDUFA Review Date: It is a Relevant for Generic Drug User Fee Amendments (GDUFA) reviews.

• Supplier Information: It gives name of pharma companies which are manufacturing Paracetamol.

Role of Chemical Databases

Chemxpert database, a pharmaceutical database provider company, provides information on paracetamol production, including details of large producers in countries such as India and China. Chemxpert's extensive database is offering realtime updates, facilitating buyer and supplier interaction, ensuring compliance with legislation, identifying the top sellers on the market. Stakeholders in the paracetamol industry are provided with a valuable resource by this platform, which links them to each other.

Conclusion

In conclusion, to ensure the quality, safety and regulatory compliance of products, it is essential that Paracetamol DMFs are understood. The DMFs are playing an important role in the future of healthcare as we move forward with pharmaceutical science.