Den Mark Pharmaceuticals Pvt. Ltd. is a Safe Pharmaceutical Company committed to manufacturing high-quality Pantoprazole tablets following strict WHO Good Manufacturing Practices (GMP) guidelines.
Here's a breakdown of the process:
1. Raw Material Management:
- All starting materials, including pantoprazole sodium sesquihydrate and excipients, undergo rigorous quality control testing per pre-defined specifications for manufacturing process.
- Material is quarantined until approved for production/manufacturing process.
- Documented procedures ensure proper labelling, storage, and traceability throughout the manufacturing process.
2. Weighing and Blending:
- Precisely weighed quantities of pantoprazole and excipients, following approved formulations, are used for manufacturing process.
- Excipients may include fillers (microcrystalline cellulose), disintegrants (croscarmellose sodium), lubricants (magnesium stearate), and glidants (silicon dioxide).
- Blending is done in a closed blending vessel for a predetermined time to achieve uniform distribution of all components.
3. Granulation (Optional):
- A wet or dry granulation process might improve flowability and tableting properties depending on the formulation.
- In wet granulation, a binder solution is used to create granules, which are dried and sized.
4. Compression
- The blended or granulated material is transferred to a high-speed tablet press.
- The material is compressed into tablets of consistent weight, dimension, and hardness using tools of the appropriate size and shape.
5. Quality Control:
- In-process quality checks are performed throughout the manufacturing process to ensure adherence to specifications.
- Samples are drawn for weight uniformity, friability, disintegration time, and dissolution testing.
6. Coating (Optional):
- For enteric-coated pantoprazole tablets, a film coating is applied to protect the drug from degradation in the stomach and allow release in the intestine.
- The coating material is sprayed onto the tablets in a coating pan.
7. Post-Production Activities:
- Finished tablets are inspected visually for defects like cracks or chips.
- Packaging complies with GMP guidelines, including proper labelling with product information, expiry date, and batch number.
8. Documentation and Batch Release:
- All production activities, including raw material usage, process parameters, and quality control results, are meticulously documented.
- Batches are only released for sale after final approval by the Quality Assurance department.
9. Continuous Improvement:
- Den Mark Pharmaceuticals is committed to continuous improvement.
- Regularly reviewing processes, conducting audits, and implementing corrective actions ensure consistent production of high-quality Pantoprazole tablets.
Den Mark Pharmaceuticals being a pharmaceutical supply chain prioritizes patient safety and product quality following WHO GMP guidelines at every step of the Pantoprazole tablet manufacturing process. We offer contract manufacturing and third party manufacturing of Pantoprazole with timely delivery.