Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) Manufacturing Process by Den Mark Pharmaceuticals Pvt. Ltd.
The antibiotic Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) is a lincomycin antibiotic class member, which inhibits or halts bacterial growth. It is not recommended to use Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) orally, ophthalmically, or intravaginally. It is only intended for topical application. If you are allergic to the lincomycin class of antibiotics or have susceptible skin, you should avoid using a Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w). Applying Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) to areas of skin that are wounded, scraped, sunburned, or eczema-affected is not advised.
Den Mark Pharmaceuticals Pvt. Ltd. manufactures Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) following the World Health Organization (WHO) Good Manufacturing Practices (GMP) guidelines with all the drug development services. This ensures a high-quality, consistent, and safe product.
Process Flow
1. Raw Material Handling and Testing:
All incoming raw materials (Clindamycin Phosphate, Nicotinamide, gel base components, purified water) are quarantined upon arrival.
Accompanied by certificates of analysis, ensuring they meet Den Mark's specifications.
Samples are tested internally to verify their identity, purity, and potency.
Only released materials are used for production.
2. Weighing and Mixing:
A designated weighing area, following GMP guidelines, is used.
Accurately weighed amounts of Clindamycin Phosphate and Nicotinamide are dispensed according to a pre-determined master formula.
The gel base components are measured and added to a mixing vessel.
3. Dissolution and Homogenization:
Clindamycin Phosphate and Nicotinamide are dissolved in a suitable solvent within the mixing vessel.
The mixture is homogenized using a high-shear mixer to ensure uniform distribution of the active ingredients throughout the gel base.
4. Filling and Packaging:
Using appropriate filling equipment, the gel is filled into pre-sterilized and validated containers under aseptic conditions.
Containers are sealed with tamper-evident closures.
Labels are applied according to product specifications.
5. Quality Control:
Samples of Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) from each batch are retained for further testing.
These tests evaluate physical characteristics (pH, viscosity), uniformity of dosage units, and sterility.
The final Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) is released for packaging only after all quality control tests are met.
6. Packaging and Labeling:
Packaged Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) are labeled according to regulatory requirements.
Labels include product names, ingredients, concentrations, manufacturing and expiry dates, batch numbers, storage instructions, and manufacturer information.
7. Quarantine and Release:
Finished Clindamycin Phosphate + Nicotinamide Gel (1.0%w/w+4%w/w) is quarantined until the Quality Control department gives its final approval.
Products are released for distribution only after meeting all specifications.
8. Documentation and Records:
For traceability purposes, detailed records of all manufacturing steps, including raw material usage, production logs, and quality control results, are maintained.
Batch production records are archived as per regulatory requirements.
Additional Considerations
Den Mark Pharmaceuticals Pvt. Ltd. employs a well-trained staff who understand and adhere to GMP principles.
The manufacturing environment is maintained clean and free from contamination.
Regular equipment calibration and maintenance are performed to ensure consistent product quality.
Stability testing is conducted to determine the shelf life of the product.
By following these strict procedures, Den Mark Pharmaceuticals Pvt. Ltd. a Bulk Drug Manufacturing Company, ensures the production of high-quality Clindamycin Phosphate + Nicotinamide Gel that meets all regulatory requirements and delivers therapeutic benefits to patients.