Manufacturing Process of Cefixime + Potassium Clavulanate Tablet – Den Mark Pharmaceuticals Pvt. Ltd.
Cefixime and Potassium Clavulanate enhance each other's effectiveness, making the medication more potent against a broader spectrum of bacteria. It's important to note that this medication should only be used under the supervision of a healthcare professional, as indiscriminate use of antibiotics can lead to antibiotic resistance and other complications. Always follow the prescribed dosage and duration of treatment.
Den Mark Pharmaceuticals Pvt. Ltd. adheres to safe pharmaceuticals strictly to the World Health Organization's Good Manufacturing Practice (GMP) guidelines to ensure the production of top-quality Cefixime + Potassium Clavulanate Tablets. This process involves several stages, each meticulously designed and executed to guarantee the final product's efficacy, safety, and consistency.
Stage 1: Raw Material Procurement and Testing
- The manufacturing process commences with procuring high-quality raw materials from approved suppliers. Each raw material undergoes rigorous testing in our state-of-the-art quality control laboratory upon arrival. This testing includes assessment for identity, purity, potency, and absence of contaminants, ensuring compliance with stringent quality standards.
Stage 2: Granulation
The active pharmaceutical ingredients (APIs), Cefixime, Potassium Clavulanate, and excipients are precisely weighed and blended according to the formulation specifications. The mixture is then granulated using a suitable binder solution to form uniform-sized and consistent granules. This step is critical for achieving the final tablet's proper drug distribution and release characteristics.
Stage 3: Compression
The granules are compressed into tablets using high-precision tablet compression machines under controlled conditions. Compression ensures uniformity of tablet weight, thickness, and hardness, which is crucial for accurate dosing and ease of handling during packaging and administration.
Stage 4: Coating (Optional)
In some formulations, a coating may be applied to the tablets to enhance stability, mask taste, or provide additional protection against environmental factors. The coating solution prepared using appropriate excipients, is sprayed onto the tablets in a coating pan and dried to form a smooth, uniform coating layer.
Stage 5: Quality Control
Throughout the manufacturing process, quality control checkpoints are implemented to monitor and verify the tablets' quality attributes at various stages. This includes in-process testing of physical parameters, such as tablet hardness, thickness, and friability, as well as chemical analysis to confirm the potency and purity of the active ingredients.
Stage 6: Packaging
Once the tablets have passed all quality control tests, they proceed to the packaging stage. The tablets are carefully counted, sorted, and packed into blister packs or bottles, depending on the specified packaging format. Each pack is labeled with essential product information, including dosage instructions, expiry date, and batch number, to ensure safe and accurate use by the end consumer.
Stage 7: Final Inspection and Release
Before release for distribution, the packaged tablets undergo a final inspection to verify compliance with all regulatory requirements and internal quality standards. Samples from each batch are retained for future reference and quality assurance purposes.
Conclusion:
Den Mark Pharmaceuticals Pvt. Ltd. employs a comprehensive manufacturing process for Cefixime + Potassium Clavulanate Tablets, guided by WHO GMP principles. From raw material procurement to final inspection, every step is meticulously executed to produce a pharmaceutical product of the highest quality, efficacy, and safety, meeting healthcare professionals' and patients' needs and expectations worldwide.