Paracetamol, Pheniramine Maleate , Phenylephrine HCl & Ascorbic acid Sachets

Manufacturing Process of Paracetamol, Pheniramine Maleate, Phenylephrine HCl, & Ascorbic Acid (325mg + 20mg + 10mg + 50mg) Sachets for Oral Suspension

Den Mark Pharmaceuticals Pvt. Ltd. manufactures over-the-counter medicines like high-quality sachets containing Paracetamol (325mg), Pheniramine Maleate (20mg), Phenylephrine HCl (10mg), and Ascorbic Acid (50mg) following strict WHO GMP (Good Manufacturing Practice) guidelines. Here's a comprehensive overview of the process:

1. Raw Material Procurement and Testing:

  • Den Mark Pharmaceuticals sources raw materials from approved suppliers, ensuring their compliance with quality standards.
  • Each raw material undergoes rigorous testing for identity, purity, potency, and microbial contamination before acceptance for manufacturing.

2. Weighing and Mixing:

  • The required quantities of Paracetamol, Pheniramine Maleate, Phenylephrine HCl, and Ascorbic Acid are accurately weighed according to the formulation.
  • These ingredients are then thoroughly mixed in a high-capacity blender under controlled conditions to achieve homogeneity.

3. Granulation:

  • The homogeneous mixture is granulated using a wet process to improve flow properties and compressibility.
  • Granules are formed by adding a suitable binder solution and passing the damp mass through a granulator.
  • The granules are dried to reduce moisture content and enhance stability.

4. Compression:

  • The dried granules are compressed into individual sachets using high-speed rotary tablet presses equipped with punches of the appropriate size.
  • Compression parameters such as compression force, tablet thickness, and hardness are closely monitored to ensure uniformity.

5. Quality Control Checks:

  • Throughout the manufacturing process, in-process quality control checks are conducted at critical stages to verify compliance with specifications.
  • Samples are collected and analyzed for content uniformity, dissolution rate, and physical characteristics.

6. Sachet Filling:

  • The compressed sachets are transferred to a dedicated filling line equipped with automatic sachet filling machines.
  • Each sachet is accurately filled with the appropriate dose of the oral suspension formulation.

7. Sealing and Packaging:

  • Filled sachets are hermetically sealed using heat sealing technology to prevent contamination and preserve product integrity.
  • Sealed sachets are then packed into primary packaging materials such as aluminum foil or laminate films, ensuring protection from moisture and light.
  • Finally, the packaged sachets are labeled with product information, including dosage instructions, batch number, and expiry date.

8. Finished Product Testing:

  • Random samples from each batch undergo comprehensive testing in the quality control laboratory to verify compliance with specifications.
  • Final testing includes assays for active ingredients, microbiological analysis, dissolution testing, and stability studies.

9. Storage and Distribution:

  • Finished products are stored in a controlled environment with appropriate temperature and humidity conditions to maintain stability.
  • Before distribution, products are inspected to confirm packaging integrity and compliance with labeling requirements.
  • Products are then dispatched to wholesalers, distributors, and, ultimately, pharmacies for distribution to end consumers.

Den Mark Pharmaceuticals Pvt. Ltd. is committed to upholding the highest standards of quality and safety throughout the manufacturing process, ensuring that each sachet of Paracetamol, Pheniramine Maleate, Phenylephrine HCl, & Ascorbic Acid Oral Suspension meets the stringent requirements of WHO GMP guidelines and delivers optimal therapeutic efficacy to patients.