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Manufacturing Process of Top-Quality Dapagliflozin Tablets by Den Mark Pharmaceuticals Pvt. Ltd.

Den Mark Pharmaceuticals Pvt. Ltd. is Pharmaceutical Bulk Manufacturing Company producing high-quality Dapagliflozin tablets following the World Health Organization (WHO) Good Manufacturing Practices (GMP) guidelines.

1. Raw Material Sourcing and Testing:

  • We source Dapagliflozin Active Pharmaceutical Ingredient (API) and excipients (inactive ingredients) from qualified suppliers with documented quality histories.
  • Each batch of raw material undergoes rigorous testing in our on-site laboratory to ensure they meet predefined specifications for identity, purity, potency, and other critical parameters per pharmacopeial standards.
  • Materials are quarantined until test results are approved.

2. Pre-Production Activities:

  • A well-defined production plan is created considering batch size, equipment availability, and workforce.
  • A detailed Batch Production Record (BPR) outlines every step of the manufacturing process for this specific batch.
  • Qualified personnel ensure all equipment is calibrated correctly, cleaned, and sanitized following established procedures.

3. Manufacturing Process:

  • Weighing and Dispensing: Precisely weighed amounts of Dapagliflozin API and excipients are dispensed according to the approved BPR.
  • Mixing and Granulation: The API and excipients are uniformly blended using appropriate mixing equipment. Granulation techniques might be employed to create granules with optimal flow properties for tableting.
  • Compression: The granules are compressed into tablets using calibrated tableting machines. Critical parameters like tablet weight, uniformity of weight, hardness, and friability are monitored and documented throughout the process.
  • Coating (Optional): Depending on product specifications, a thin film coating may be applied for taste masking, moisture protection, or controlled release.

4. In-Process Quality Control:

  • Predefined checkpoints with specific quality control tests are implemented throughout the manufacturing process. These tests ensure the tablets meet the required weight, uniformity, hardness, disintegration, and dissolution profile specifications.
  • Data from these tests are documented in the BPR, ensuring complete traceability of the batch.

5. Packaging and Labelling:

  • Approved, pre-printed packaging materials are used for the tablets.
  • Accurate product information, including brand name, generic name, dosage strength, batch number, expiry date, and storage instructions, is affixed to labels.
  • Samples are retained for future reference.

6. Finished Product Testing:

  • Representative samples from the final packaged batch undergo comprehensive testing per pharmacopeial standards. This includes tests for identity, purity, potency, dissolution profile, and microbial limits.
  • The BPR is reviewed and approved by qualified personnel before product release.

7. Warehousing and Distribution:

  • Finished Dapagliflozin tablets are stored under appropriate conditions (temperature, humidity, light) per specifications.
  • A documented system ensures proper stock control and distribution practices.

8. Quality Management System:

  • Den Mark Pharmaceuticals Pvt. Ltd. maintains a robust Quality Management System (QMS) encompassing all aspects of production.
  • This includes procedures for deviation handling, corrective and preventive actions (CAPA), and continuous improvement.
  • Regular audits by qualified personnel ensure ongoing compliance with WHO GMP guidelines.

By following these stringent manufacturing procedures, Den Mark Pharmaceuticals Pvt. Ltd. ensures consistent production of top-quality Dapagliflozin tablets that meet the highest safety and efficacy standards as per Third party marketing companies requirements across the globe.