Manufacturing Process of Bromhexine HCl + Guaiphenesin + Terbutaline Sulphate Syrup by Den Mark Pharmaceuticals Pvt. Ltd.
For patients with asthma and COPD (chronic obstructive pulmonary disease), BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+TERBUTALINE SULPHATE is administered to treat coughs that are accompanied by violent and abundant mucus. The body uses coughing, whether dry or productive, to keep pollutants out of the airways and to keep infections at away.
Among the best Pharmaceutical Companies in India, Den Mark Pharmaceuticals Pvt. Ltd. offers Third-Party Contract Manufacturing Services and adheres to the WHO-GMP guidelines to ensure the production of high-quality pharmaceutical products. The manufacturing process of Bromhexine HCl + Guaiphenesin + Terbutaline Sulphate Syrup involves several critical steps to guarantee efficacy, safety, and consistency in every batch produced.
Raw Material Procurement and Testing:
- The first step in manufacturing process is procuring raw materials from approved suppliers. These include Bromhexine HCl, Guaiphenesin, Terbutaline Sulphate, excipients, and packaging materials. Each raw material undergoes stringent quality testing according to established specifications before being accepted for use in production.
Dispensing:
- Once the raw materials pass quality control, they are dispensed in the required quantities according to the formulation recipe. This process is conducted in a controlled environment to prevent contamination and ensure accuracy.
Preparation of Solution:
- The dispensed raw materials are then transferred to a suitable vessel mixed with purified water to form a homogeneous solution. The solution is continuously agitated to facilitate uniform distribution of the active ingredients and excipients.
Filtration and Homogenization:
- The solution undergoes filtration to remove particulate matter or impurities. Subsequently, homogenization is carried out to ensure particle size and distribution uniformity throughout the syrup.
Sterilization:
- Sterilization of the syrup is crucial to eliminate any microbial contamination. This is typically achieved through heat sterilization or filtration using sterilizing-grade filters under controlled conditions.
Filling and Packaging:
- The sterilized syrup is then filled into clean, sterile containers under aseptic conditions to maintain its integrity. Accurate filling is ensured using automated filling equipment calibrated to deliver precise volumes. The filled containers are sealed with tamper-evident closures and labeled according to regulatory requirements.
Quality Control Testing:
- Samples from each batch of syrup undergo comprehensive quality control testing to verify compliance with specifications for potency, purity, stability, and microbiological safety. This includes analysis of active ingredient content, dissolution rate, pH, viscosity, microbial limits, and stability under various storage conditions.
Stability Studies:
- Stability studies assess the shelf-life of the syrup under different environmental conditions. Samples are stored at specified temperatures and humidity levels for predetermined periods, and periodic testing monitors any changes in quality attributes over time.
Documentation and Record Keeping:
- Throughout the manufacturing process, detailed documentation records all critical steps, deviations, and quality control activities. This documentation ensures traceability and provides a comprehensive record of the manufacturing history of each batch.
Conclusion:
- Den Mark Pharmaceuticals Pvt. Ltd. ensures the production of top-quality Bromhexine HCl + Guaiphenesin + Terbutaline Sulphate Syrup through adherence to WHO GMP guidelines and rigorous quality control measures at every stage of the manufacturing process. By prioritizing safety, efficacy, and consistency, Den Mark Pharmaceuticals Pvt. Ltd. continues to deliver pharmaceutical products of the highest standard through its Pharmaceutical Export Facility to meet the healthcare needs of patients worldwide.