Paracetamol + Phenylephrine+Chlorpheniramine Powder Sachet

1. Raw Material Procurement:

• Den Mark Pharmaceuticals sources high-quality raw materials from approved suppliers who comply with WHO GMP standards.
• Raw materials include Paracetamol, Phenylephrine, Chlorpheniramine, excipients, and packaging materials.

2. Weighing and Mixing:

• The required quantities of Paracetamol, Phenylephrine, and Chlorpheniramine are accurately weighed according to the formulation.
• These active pharmaceutical ingredients (APIs) are blended uniformly in a high-capacity mixer.
• Excipients like fillers, binders, and disintegrants are added to the blend to enhance stability and facilitate tablet formation.

3. Granulation:

• The homogeneous mixture is granulated using a wet or dry granulation process.
• In wet granulation, a binder solution is added to the powder blend, followed by mixing and subsequent drying.
• Dry granulation involves compaction of the powder blend and milling to obtain granules.

4. Compression:

• The granules are compressed into tablets using high-speed rotary tablet presses.
• The compression process ensures consistent tablet weight and hardness.

5. Coating (Optional):

• If required, tablets may undergo a coating process to improve appearance, taste masking, or to provide enteric properties.
• Coating solutions are prepared according to specified formulations and applied using coating pans or fluidized bed equipment.

6. Sachet Filling:

• Once manufactured, the tablets are counted and filled into individual sachets.
• Per the product specifications, each sachet contains the prescribed dose of Paracetamol, Phenylephrine, and Chlorpheniramine.

7. Quality Control:

• Stringent quality control measures are implemented at every stage throughout the manufacturing process.
• In-process checks ensure that the product meets the required specifications for uniformity, content, dissolution, and other critical parameters.
• Sampling and testing of raw materials, intermediates, and finished products are conducted in well-equipped quality control laboratories.

8. Packaging:

• The filled sachets are sealed and packed into secondary packaging materials.
• Packaging materials are selected to maintain product integrity and comply with regulatory requirements.
• Labeling is done accurately, including batch numbers, expiry dates, and dosage information.

9. Storage and Distribution:

• Finished products are stored in designated warehouses under controlled conditions to maintain their stability and efficacy.
• Following Good Distribution Practices (GDP) is carried out to ensure product quality and safety during transportation.

10. Compliance and Regulatory Affairs:

• Den Mark Pharmaceuticals maintains meticulous documentation of the manufacturing process and quality assurance activities.
• Regulatory submissions and compliance with local and international regulations are ensured to meet the highest pharmaceutical manufacturing standards.