Chlorpheniramine Maleate + Dextromethorphan Hydrobromide Syrup

1. Raw Material Selection and Testing:

• The manufacturing process begins with procuring pharmaceutical-grade raw materials, including Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, excipients, and purified water. All incoming raw materials undergo rigorous testing for identity, purity, and potency according to WHO GMP standards before approval for use in production.

2. Dispensing:

• To ensure accuracy, precise quantities of the tested raw materials are dispensed using automated systems. The dispensing area is maintained under controlled environmental conditions to prevent contamination.

3. Mixing and Dissolution:

• The dispensed active pharmaceutical ingredients (APIs) and excipients are transferred to a stainless steel mixing vessel with agitation mechanisms. They are blended thoroughly until uniformity is achieved. Purified water is added gradually to facilitate the dissolution of the ingredients.

4. Heating and Homogenization:

• The mixture undergoes controlled heating to promote dissolution and homogenization of the components. Temperature and agitation parameters are closely monitored and adjusted to maintain uniformity throughout the process.

5. Filtration:

• The homogenized syrup solution is passed through sterile filters to remove particulate matter or microbial contaminants. This step is critical for ensuring the clarity and purity of the final product.

6. Sterilization:

• The filtered syrup is sterilized using validated methods, such as heat or filtration through a sterile membrane. This step eliminates any remaining microorganisms to ensure the product's microbial safety.

7. Addition of Flavoring Agents and Preservatives

• Once sterilized, flavoring agents such as cherry or menthol are added to enhance palatability, followed by incorporating preservatives to extend the product's shelf life. The quantities of these additives are carefully controlled to meet regulatory requirements and consumer preferences.

8. Filling and Packaging:

• Using automated filling equipment, the sterile syrup is transferred to sanitized containers, such as amber glass bottles or plastic containers. The containers are sealed under controlled conditions to prevent contamination and ensure product integrity. Labels containing essential product information, including dosage, expiration date, and storage instructions, are affixed to the packaging.

9. Quality Control:

• Throughout the manufacturing process, samples are collected at various stages for analysis in the quality control laboratory. To confirm compliance with WHO GMP standards, these samples undergo rigorous testing for parameters such as potency, purity, uniformity, and microbial contamination.

10. Final Release and Distribution

• Upon successful completion of quality control testing, the Chlorpheniramine Maleate + Dextromethorphan Hydrobromide Syrup (2mg+10mg /5ml) is released for distribution to pharmacies, hospitals, and other healthcare providers. The distribution process is closely monitored to maintain proper storage and handling conditions to preserve the product's quality until it reaches the end-user.

Conclusion:

• A complete manufacturing procedure governed by WHO GMP guidelines is used by Den Mark Pharmaceuticals Pvt. Ltd., a WHO-GMP Certified pharmaceutical manufacturing company, to create Chlorpheniramine Maleate + Dextromethorphan Hydrobromide Syrup (2mg+10mg /5ml) of the finest quality. We are dedicated to providing safe and efficient pharmaceutical goods that satisfy the needs of patients and healthcare professionals around the globe by upholding stringent quality control procedures at every turn.