Den Mark Pharmaceuticals Pvt. Ltd. (Drug Manufacturing Company) follows stringent guidelines outlined by the World Health Organization's Good Manufacturing Practices (WHO GMP) to ensure the production of top-quality Atorvastatin tablets. Atorvastatin is a widely used medication for lowering cholesterol levels in the bloodstream, thus reducing the risk of heart disease and stroke.
Here is a comprehensive overview of the manufacturing process:
- Raw Material Procurement: Den Mark Pharmaceuticals sources high-quality raw materials from approved suppliers. Key ingredients include Atorvastatin calcium and excipients such as microcrystalline cellulose, lactose, and magnesium stearate.
- Dispensing: Raw materials undergo precise weighing and measurement according to the formulation recipe. Automated systems ensure accuracy and consistency in dispensing, minimizing human error.
- Granulation: The powdered blend of active pharmaceutical ingredients (API) and excipients undergoes granulation to form uniform granules. This step enhances flow properties and facilitates compression during tablet formation.
- Blending: Granules are thoroughly mixed to achieve uniform distribution of API and excipients, ensuring homogeneity of the final product. Blending is conducted in controlled environments to prevent contamination.
- Compression: The blended mixture is compressed into tablets using high-quality tablet compression machines. Parameters such as compression force, tablet hardness, and thickness are closely monitored to ensure the consistency and uniformity of each tablet.
- Coating (Optional): In some cases, enteric coating may be applied to Atorvastatin tablets to protect the API from gastric degradation and improve patient compliance. Coating formulations are prepared and applied using specialized coating equipment under controlled conditions.
- Pharmaceutical Quality Control: Stringent quality control measures are implemented at various stages throughout the manufacturing process. Samples are collected and analyzed for attributes such as assay, dissolution, uniformity of dosage units, and physical characteristics to ensure compliance with quality standards.
- Packaging: Finished Atorvastatin tablets are packaged in blister packs or bottles under controlled conditions to maintain product integrity and stability. Packaging materials are selected based on their compatibility with the product and regulatory requirements.
- Labeling and Serialization: Each packaged unit is labeled with product information, dosage instructions, batch number, expiry date, and other regulatory requirements. Serialization codes are applied to enable traceability and counterfeit prevention.
- Storage and Distribution: Finished Atorvastatin tablets are stored in temperature-controlled facilities to maintain stability and potency. Proper inventory management and distribution practices ensure timely delivery to wholesalers, pharmacies, and, ultimately, patients.
- Continuous Improvement: Den Mark Pharmaceuticals continuously evaluates and improves its manufacturing processes through regular audits, training programs, and feedback mechanisms of bulk Drug Manufacturing. Continuous product quality monitoring and compliance with WHO GMP guidelines ensure the production of top-quality Atorvastatin tablets by Den Mark Pharmaceuticals Pvt. Ltd .
In conclusion, Den Mark Pharmaceuticals Pvt. Ltd. obeys the WHO-GMP guidelines to manufacture top-quality Atorvastatin tablets. From raw material procurement to Pharmaceutical packaging solutions and pharmaceutical distribution, each step is carefully controlled to ensure product safety, efficacy, and compliance with regulatory standards. Continuous improvement efforts further enhance the company's manufacturing capabilities and uphold its commitment to delivering high-quality pharmaceutical products.
We are also known as one of the leading Pharmaceutical contract manufacturing companies for Atorvastatin Tablets in India.