Information profile @ a Glance
- Pharmaceutical grade Paracetamol is white. However, on prolonged
exposure to air, a grey or pink colour develops.
- Paracetamol is a well established and proven analgesic and
antipyretic drug
- Acetaminophen, p-Hydroxy acetanilide, p-acetyl aminophenol,
Acamol, Abensanil are alternate names
- Paracetamol are commercially produced namely powder and granules
- Paracetamol is also an important intermediate in the manufacture of
other pharmaceuticals like the
antimalarial amodiaquine
- he analgesic action of Paracetamol involves peripheral and central
influences. Paracetamol is a valuable central analgesic but weak
peripheral anti inflammatory agent and
exhibits good and prompt antipyretic action. It does not stimulate
respiration and causes less gastric irritation and have no effect on
cellular metabolism or clotting factors
- There are number of manufacturers of Paracetamol in the country.
Earlier, most of the units were setup in small scale level with low
capacities. In view of the uneconomic capacity, several units where
closed in the past.
- Paracetamol is extensively used in India. There are many brand names
for Paracetamol in India, which are sold in the market in the formulated
form.
- Paracetamol is currently the safest and most widely used agent in
the treatment of fever, muscle and body aches, flu and cold symptoms.
Its side effect are few. It is economical and effective
- Paracetamol is made by reacting 4-aminophenol with ethanoic
anhydride (more commonly
called acetic anhydride). This reaction forms an amide bond and ethanoic
acid as a byproduct.
When the reaction is complete the paracetamol is then isolated and
purified
- Paracetamol manufacturing process consists of Acetylation,
purification, drying & pulverizing, blending, Tablet punching packing
etc
- The critical process parameters were identified with the help of
process capability and evaluated by challenging its lower & upper
release specification. Three initial process validation batches (I, II &
III) of same size, method, equipment & validation criteria was taken.
The critical parameter involved in sifting, dry mixing, preparation of
granulating agent, wet mixing, wet milling, drying, sizing, lubrication,
compression stages & coating were identified and evaluated as per
validation master plan. The outcome indicated that this process
validation data provides high degree of assurance that manufacturing
process produces product meeting its predetermined specifications and
quality attributes.
- Companies such as Granules India, Mallinckrodt, Anqi Lu’an
Pharmaceutical Co. Ltd., and Taixing Yangzi Pharm Chemical Co. Ltd. are
focusing to surge the market in developing nations to optimize the cheap
labour and newly built infrastructure.
- The global paracetamol market is expected to reach US$1,049.7 mn by
2022 as compared to its valuation of US$900.2 mn in 2014
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Basics
- About Paracetamol
- Paracetamol Chemistry
- Pharmaceutical
Manufacturing
Product
Information
- Background Information
- Monograph
- Quality Evaluation
- Analysis of Paracetamol in Different
Drug Samples
- Information to Patients
Technology Information
- Manufacturing Process & Flow chart
- Process Validation for
paracetamol 500mg tablets dosage formulation
- Process & Product development
- Development & Validation
- Formulation Development
- Starch on Paracetamol properties
- Determination of methyldopa and
paracetamol in pharmaceutical samples.
- Design of Controlled
Release System
- Paracetamol Based on Modified Lignin
- Formation of a solvate of
paracetamol.
- Paracetamol Honey Suspension
- Manufacturing Technology
Patents Information
- Paracetamol based pharmaceutical
compositions
- Oral Pharmaceutical Formulations
- Paracetamol for parental
administration
- Method & composition for
preparing stable liquid formulations of Paracetamol
Regulatory Authorization
- DMF Basics
- DMF Preparation
- ASEAN Guideline on Submission of
Manufacturing Process Validation Data for Drug Registration
- Request for
authorization - application
- Marketing authorisation for
Paracetamol tablets
- Public Assessment Report
- Public Assessment -Report
- Assessment - paracetamol
500mg tablets
- Scientific data for the
approval of Paracetamol Disphar 1000 mg, granules
- Modified Release: Paracetamol
Poison Standard
- Paracetamol (modified
release)
- Food and Drug Administration's
Process Analytical Technology
Project Information
- Contract Manufacturing
- Project Data
Companies
- Pharmaceutical Development Company
- Indian Company presentation
- Company annual report -
2018-2019
- State of the art Pharmaceutical company
- Biotechnology Company -
India
- WHO GMP Certified Facility
- In House developed green
technology
Applications
- The Properties and Uses of Paracetamol
- Properties & Uses
- Centrally acting analgesics
- Pain relief for Children
- COX2 Inhibitor
- Cardiovascular Risk
- Use of Paracetamol
Syrup
Market Scenario
- Paracetamol & its combinations in
India
- Company Investments & Performance analysis
- Marketed Brands of Paracetamol Tablets in
India
- Chinese Industry
- Consultant - Market Reports
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