Introduction: Den Mark Pharmaceuticals Pvt. Ltd. is dedicated to drug development services, producing high-quality pharmaceutical products adhering to the guidelines set forth by the World Health Organization's Good Manufacturing Practices (WHO GMP). Artesunate Injection 60 mg is a critical medication in treating severe malaria, and our manufacturing process ensures its efficacy, safety, and compliance with regulatory standards.
Raw Material Procurement: Den Mark Pharmaceuticals procures raw materials from reputable suppliers who comply with WHO GMP standards. Critical raw materials include:
- Artesunate API
- Excipients (e.g., solvents, stabilizers)
- Packaging materials (ampoules, vials, closures)
1. Dispensing: The dispensing process involves accurately weighing and measuring the raw materials according to the formulation requirements. Strict controls are in place to prevent contamination and mix-ups during this stage.
2. Mixing and Dissolution: The accurately measured raw materials are mixed using appropriate equipment to ensure uniform distribution. The artesunate API is dissolved in a solvent under controlled conditions to achieve the desired concentration.
3. Filtration: The solution undergoes filtration to remove any particulate matter or impurities, ensuring clarity and sterility of the final product. Filters meeting WHO GMP standards are used, and filtration is carried out under aseptic conditions.
4. Sterilization: Sterilization is a critical step to ensure the safety of the injection. The filtered solution is sterilized using validated methods such as autoclaving or sterile filtration. Parameters such as time, temperature, and pressure are closely monitored to achieve sterility without compromising the quality of the product.
5. Filling and Sealing: The sterilized solution is filled into pre-sterilized glass ampoules using automated filling equipment. Accurate filling volumes are maintained to ensure each ampoule contains the specified dosage of 60 mg of artesunate. The filled ampoules are then sealed under controlled conditions to prevent contamination.
6. Inspection and Quality Control: Each filled and sealed Artesunate Injection 60 mg ampoule undergoes rigorous visual inspection and quality control tests to ensure compliance with specifications. Parameters such as appearance, particulate matter, and seal integrity are evaluated. Samples are also subjected to analytical testing to verify the potency and purity of the product.
7. Packaging and Labeling: The inspected Artesunate Injection 60 mg ampoules are then packed into secondary packaging materials, such as cartons, with appropriate labeling indicating product information, dosage, expiry date, and storage conditions. Packaging is designed to provide adequate protection during storage and transportation.
8. Storage and Distribution: Finished Artesunate Injections 60 mg are stored in controlled conditions to maintain stability and integrity until distribution. Temperature and humidity are monitored to prevent degradation. Products are distributed following proper channels to ensure timely availability to healthcare providers and patients
Conclusion: Den Mark Pharmaceuticals Pvt. Ltd. employs a comprehensive manufacturing process for Artesunate Injection 60 mg that adheres to WHO GMP guidelines. Every step, from raw material procurement to distribution, is meticulously executed to produce a top-quality medication for treating severe malaria. Our commitment to quality and compliance ensures the safety and efficacy of our products, contributing to global efforts in combating malaria and improving public health.