Den Mark Pharmaceuticals Pvt. Ltd. is a WHO-GMP Pharmaceutical Manufacturing company committed to adhering to the highest quality standards, following the guidelines set by the World Health Organization's Good Manufacturing Practices (WHO GMP). Here's a comprehensive overview of our process for manufacturing top-quality Aceclofenac + Paracetamol Tablets:
1. Raw Material Procurement and Quality Control:
- The pharma outsourcing of pharmaceutical-grade Aceclofenac and Paracetamol from approved suppliers who meet stringent quality criteria.
- Upon arrival, each batch of raw materials undergoes rigorous quality testing in our state-of-the-art laboratory to ensure compliance with pharmacopeial standards.
2. Granulation:
- The first step of manufacturing process involves blending Aceclofenac, Paracetamol, and other excipients, such as fillers and binders, in a granulator.
- The mixture is then granulated using a suitable solvent or binder solution to form uniform size and consistency granules of Aceclofenac + Paracetamol Tablets.
3. Drying:
- The wet granules are dried to remove moisture using a fluidized bed or tray dryer under controlled temperature and humidity conditions.
- Proper drying ensures stability and enhances the flow properties of the granules.
4. Milling and Sieving:
- The dried granules are milled to achieve the desired particle size distribution.
- Sieving is performed to remove any oversized or undersized particles , ensuring uniformity in the final blend.
5. Lubrication:
- Lubricants such as magnesium or sodium stearyl fumarate are added to the milled granules to prevent adhesion and facilitate tablet compression of Aceclofenac + Paracetamol Tablets.
6. Compression:
- The lubricated granules are compressed into tablets of the specified size and shape using high-precision tablet compression machines.
- Compression force and dwell time are carefully controlled to ensure uniformity of weight and hardness among Aceclofenac + Paracetamol Tablets.
7. Coating (Optional):
- In some Pharmaceutical formulations, a protective coating may be applied to the Aceclofenac + Paracetamol Tablets to improve appearance, taste masking, or to provide enteric protection.
- Coating is performed using a coating pan or a fluidized bed coater, followed by drying to obtain a smooth and glossy finish for the Aceclofenac + Paracetamol Tablets.
8. Quality Assurance:
- Quality control checks are conducted throughout the manufacturing process to monitor critical parameters such as blend uniformity, content uniformity, hardness, and disintegration time.
- Samples from each batch are subjected to thorough analysis in our quality control laboratory to ensure compliance with regulatory standards.
9. Packaging:
- The finished Aceclofenac + Paracetamol Tablets are packed into blister packs or bottles using automated packaging equipment in a controlled environment to prevent contamination.
- Proper labelling with batch details, expiry date, dosage instructions, and safety information is ensured according to regulatory requirements.
10. Storage and Distribution:
- The packaged Aceclofenac + Paracetamol Tablets are stored in designated warehouses under appropriate temperature and humidity conditions to maintain stability.
- Before distribution, final quality checks are performed to verify integrity and compliance with specifications.
Being a Pharmaceutical Contract Manufacturing Company Den Mark Pharmaceuticals Pvt. Ltd. is dedicated to manufacture Aceclofenac + Paracetamol Tablets of the highest quality, meeting the healthcare needs of patients worldwide while upholding the principles of safety, efficacy, and regulatory compliance outlined by WHO GMP guidelines.