Manufacturing Process of Paracetamol + Ibuprofen Suspension (125mg + 100mg/5ml) by Den Mark Pharmaceuticals Pvt. Ltd.
In order to guarantee the creation of quality pharmaceutical products, Den Mark Pharmaceuticals Pvt. Ltd., an Indian bulk drugs manufacturing company, follows the strict requirements established by the World Health Organization (WHO) Good Manufacturing Practices (GMP).
Ibuprofen and paracetamol is used to treat fever and discomfort. Pains associated with headaches, moderate migraines, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, painful menstruation, and muscle and tooth aches are all relieved by it.
A number of exact processes are involved in the production of Paracetamol + Ibuprofen Suspension (125 mg + 100 mg/5 ml) in order to ensure each batch's efficacy, safety, and uniformity.
1. Raw Material Procurement and Quality Control:
Den Mark Pharmaceuticals sources pharmaceutical-grade raw materials for Paracetamol and Ibuprofen from approved suppliers. Before being used in production, each batch undergoes rigorous quality control checks to ensure compliance with WHO GMP standards.
2. Dispensing:
The predetermined quantities of Paracetamol and Ibuprofen are accurately weighed and dispensed using calibrated equipment in a designated area to prevent cross-contamination.
3. Mixing:
The dispensed Paracetamol and Ibuprofen powders are transferred to a stainless steel mixing vessel. Purified water, sorbitol solution, preservatives, and flavouring agents are added under controlled conditions. The mixture is homogenized using a high-speed mixer until a uniform suspension is obtained.
4. Filtration:
The homogenized suspension undergoes filtration through a sterile filter to remove particulate matter and ensure clarity.
5. Sterilization:
The filtered suspension is sterilized using a validated method, such as autoclaving or sterile filtration, to eliminate microbial contamination.
6. Filling and Packaging:
The sterilized suspension is transferred to sterile filling equipment in a designated cleanroom environment. The syrup is filled into amber-coloured glass or plastic bottles to protect it from light and moisture. Each bottle is capped and sealed under controlled conditions to maintain product integrity.
7. Labelling and Inspection:
Bottles are labelled with all necessary information, including product name, strength, dosage instructions, batch number, and expiry date. Visual inspection ensures that each bottle meets quality standards and is defects-free.
8. Batch Release and Quality Assurance:
Samples of Paracetamol + Ibuprofen Suspension from each batch undergo rigorous quality control testing in Den Mark Pharmaceuticals' in-house laboratory to verify potency, purity, and microbial limits. Only batches that meet all specifications are released for distribution.
9. Storage and Distribution:
To maintain stability, the finished Paracetamol + Ibuprofen Suspension is stored in a controlled environment with temperature and humidity monitoring. Proper documentation and traceability systems are in place to track the distribution of each batch.
10. Continuous Monitoring and Improvement:
Den Mark Pharmaceuticals (Third Party Pharmaceutical Manufacturing Company) continuously monitors and evaluates all aspects of the manufacturing process to identify opportunities for improvement. Regular audits and inspections ensure ongoing compliance with WHO GMP guidelines and regulatory requirements.
Conclusion:
Den Mark Pharmaceuticals Pvt. Ltd. employs a rigorous manufacturing process guided by WHO GMP principles to produce the highest-quality Paracetamol and ibuprofen Suspension syrup. Through meticulous raw material selection, precise formulation, stringent quality control measures, and adherence to regulatory standards, we ensure the safety and effectiveness of our pharmaceutical products for consumers worldwide.