Manufacturing Process of Amoxicillin + Clavulanate Potassium Dry Syrup by Den Mark Pharmaceuticals Pvt. Ltd.
Top-quality Amoxicillin + Clavulanate Potassium Dry Syrup is a pharmaceutical product designed to effectively treat a variety of bacterial infections. This dry syrup combines two active ingredients: Amoxicillin, a penicillin-type antibiotic, and clavulanate potassium, which enhances the effectiveness of Amoxicillin by inhibiting certain bacterial enzymes that can render the antibiotic ineffective.
Den Mark Pharmaceuticals Pvt. Ltd. is a pharmaceutical contract manufacturing company that follows the stringent guidelines of the World Health Organization's Good Manufacturing Practices (WHO GMP) to produce top-quality Amoxicillin + Clavulanate Potassium Dry Syrup. This process ensures the medication's safety, efficacy, and consistency.
Procurement of Raw Materials
- The manufacturing process begins with the procurement of high-quality raw materials from approved suppliers. Den Mark Pharmaceuticals ensures that all raw materials meet the specified pharmacopeial standards and undergo rigorous testing for purity, potency, and quality.
Formulation:
- The formulation stage involves the precise combination of Amoxicillin and Clavulanate Potassium in predetermined ratios. This step is crucial to ensure the efficacy and stability of the final product. Den Mark Pharmaceuticals employs state-of-the-art equipment and follows standardized procedures to achieve accurate formulation.
Mixing:
- Once the formulation is prepared, it undergoes mixing in a controlled environment to achieve uniform distribution of the active ingredients. The mixing process is carefully monitored to prevent any variations in particle size or composition, ensuring consistent quality throughout.
Granulation:
- The mixed formulation is then subjected to granulation, where it is converted into granules of uniform size. This step improves flow properties, facilitates drying, and enhances the compressibility of the powder, ultimately leading to uniform tablet weight and dosage.
Drying:
- The granules are dried using advanced drying technology to remove excess moisture and achieve the desired moisture content. Drying is a critical step in the manufacturing process as it ensures the stability and shelf-life of the final product while preventing microbial growth and degradation.
Blending:
- After drying, the granules are blended with excipients and lubricants to improve flowability and prevent caking. This blending process is conducted under controlled conditions to ensure homogeneity and uniformity of the blend, thereby guaranteeing consistent dosage in each unit of the dry syrup.
Packaging:
- The blended mixture is then transferred to the packaging area, where it is filled into appropriate containers, such as bottles or sachets. Den Mark Pharmaceuticals employs automated packaging equipment to minimize contamination and ensure accurate filling of the containers.
Quality Control:
- Throughout the manufacturing process, rigorous quality control checks are conducted at various stages to ensure compliance with WHO GMP guidelines and adherence to pharmacopeial standards. These checks include in-process testing, stability testing, and microbial testing to verify the purity, potency, and safety of the final product.
Conclusion
Den Mark Pharmaceuticals Pvt. Ltd. follows a meticulous manufacturing process for Amoxicillin + Clavulanate Potassium Dry Syrup in accordance with WHO GMP guidelines. By adhering to strict quality control measures and utilizing state-of-the-art technology, Den Mark Pharmaceuticals ensures the production of top-quality dry syrup that meets the highest standards of efficacy, safety, and reliability.