Manufacturing Process of Clobetasol + Neomycin + Miconazole Cream (0.05% + 0.5% + 2% w/w) by Den Mark Pharmaceuticals Pvt. Ltd.

Introduction:

Combining Clobetasol, miconazole, and Neomycin promotes healthy-looking skin and helps address various skin care issues. In addition to eliminating dead skin cells and softening the skin, its antibacterial qualities help treat fungal infections.

It is advised to be used on skin affected by fungal infections and other stated skincare concerns. Apply a thin patch to the affected region using clean, dry hands. Please do not use it when exposed to the sun.

Den Mark Pharmaceuticals Pvt. Ltd., a Pharmaceutical Formulation Company in India, adheres strictly to the WHO GMP guidelines to ensure the highest quality standards in the manufacturing process of Clobetasol + Neomycin + Miconazole Cream. This cream is a potent combination used in dermatological applications to treat various skin conditions, including eczema, dermatitis, and fungal infections.

Raw Material Procurement: The manufacturing process begins with procuring high-quality raw materials from approved suppliers. These include Clobetasol propionate, Neomycin sulfate, Miconazole nitrate, emulsifying agents, preservatives, and other excipients. Each raw material undergoes rigorous quality testing to ensure compliance with pharmacopeial standards.

Weighing and Mixing: Once the raw materials pass quality control checks, they are accurately weighed according to the formulation specifications. The measured quantities of Clobetasol propionate, Neomycin sulfate, and Miconazole nitrate are transferred to a clean mixing vessel. Emulsifying agents and other excipients are added as per the formulation requirements. The mixture is then homogenized under controlled conditions to ensure uniform dispersion of all components.

Emulsification and Heating: A high-shear mixer transfers The homogenized mixture to an emulsification vessel. Emulsification is carried out at a controlled temperature to achieve a stable emulsion. Heating may be required to facilitate the emulsification process and ensure proper solubilization of the active pharmaceutical ingredients. The emulsification process is closely monitored to prevent overheating and degradation of sensitive components.

Cooling and Addition of Preservatives: Once the emulsification is complete, the emulsion can cool to room temperature while maintaining agitation to prevent phase separation. Preservatives are added to the cooled emulsion to prevent microbial contamination during storage and under aseptic conditions to ensure product safety and stability.

Quality Control Testing: Samples from each batch are subjected to comprehensive quality control testing to assess parameters such as pH, viscosity, content uniformity, microbial contamination, and stability. Den Mark Pharmaceuticals Pvt. Ltd. utilizes state-of-the-art analytical instrumentation and validated testing methods to ensure product quality and compliance with regulatory standards.

Packaging and Labeling: Once the cream passes all quality control tests, it is transferred to the packaging area, where automated filling equipment fills it into sterile tubes or jars. The filled containers are then sealed and labeled with all necessary information, including product name, strength, batch number, manufacturing date, and expiry date. Packaging materials are chosen carefully to maintain product integrity and protect against environmental factors.

Final Inspection and Release: Before release for distribution, each batch undergoes a final inspection to verify packaging integrity and labeling accuracy. Only batches that meet all quality criteria are released for distribution to ensure customer satisfaction and compliance with regulatory requirements.

Conclusion: Den Mark Pharmaceuticals Pvt. Ltd. follows a careful and stringent quality controlled manufacturing process guided by WHO-GMP principles to produce top-quality Clobetasol + Neomycin + Miconazole Cream. We ensure that our customers receive safe, effective, and reliable dermatological products by adhering to strict quality control measures at every production stage.