Unlock Competitive Insights with Our Rosuvastatin Production Cost Reports

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Rosuvastatin is a widely prescribed drug belonging to the class of statins, which are used primarily to manage cholesterol levels in patients, helping to prevent heart disease and stroke. It is known for its effectiveness in lowering low-density lipoprotein (LDL) cholesterol levels while raising high-density lipoprotein (HDL) cholesterol. As a generic drug, the rosuvastatin production cost reports is influenced by various factors, including raw materials, manufacturing processes, research and development, regulatory compliance, and market competition. This report will provide an in-depth analysis of the cost structure involved in the production of rosuvastatin.

1. Overview of Rosuvastatin​

Rosuvastatin, commonly known by its brand name Crestor , is part of the HMG-CoA reductase inhibitors (statins) family. It works by inhibiting the enzyme HMG-CoA reductase, which is involved in the production of cholesterol in the liver. This action helps lower LDL cholesterol and triglycerides in the blood, while also raising HDL cholesterol. Rosuvastatin is prescribed for individuals with high cholesterol, high triglycerides, and those at risk of cardiovascular diseases.

Key Markets :

• Pharmaceutical Market : Rosuvastatin is used globally, with its demand coming from various health systems, including the US, Europe, and emerging markets.
• Generic Production : Following the expiration of the original patent in 2016, generic versions of rosuvastatin have entered the market, resulting in cost reductions for manufacturers and consumers.

2. Raw Materials and Active Pharmaceutical Ingredient (API) Costs​

The production cost of rosuvastatin is heavily influenced by the cost of the active pharmaceutical ingredient (API) , which is rosuvastatin calcium. This compound is the active ingredient responsible for its therapeutic effects.

Key Raw Materials:​

1. Rosuvastatin Calcium : The primary raw material used in the production of rosuvastatin tablets. The process involves the synthesis of the statin molecule, which requires the combination of various reagents and solvents. The cost of raw materials such as solvents, acids, and reagents used in the production of rosuvastatin calcium can fluctuate based on market conditions.
2. Solvents and Reagents : Organic solvents, acids, and other chemicals are used throughout the synthesis and purification process. These are typically sourced from chemical suppliers, and their cost will vary based on raw material prices and environmental regulations governing their use.
3. Excipients : These are the inactive ingredients used in tablet formulations to ensure the correct dosage, stability, and ease of administration. Common excipients in rosuvastatin production include binders, fillers, disintegrants, and coating agents. The costs of these materials are relatively low compared to the API, but still play a role in determining the final production cost.
4. Packaging Materials : Packaging for rosuvastatin tablets, including blister packs, bottles, and labels, is essential to ensure product stability and compliance with regulatory requirements. The cost of packaging materials depends on factors such as the material type, design, and regulatory standards.

3. Synthesis Process​

The production of rosuvastatin follows a multi-step process that includes synthesis, formulation, and final packaging . The overall production cost is influenced by the efficiency of each stage, as well as the complexity of the chemical synthesis and formulation.

A. Chemical Synthesis of Rosuvastatin Calcium​

The chemical synthesis of rosuvastatin involves several complex reactions, including the coupling of specific chemical groups to form the statin backbone. The typical steps in this synthesis include:

1. Synthesis of the Hydroxy-3-methylglutaryl-CoA (HMG-CoA) Reductase Inhibitor : The key chemical structure of rosuvastatin is built using various intermediates, starting with simpler organic compounds like cyclic amines, acids, and alcohols.
2. Purification : After the synthesis of the basic statin molecule, extensive purification is carried out to remove by-products and impurities. This can be done using techniques like crystallization or chromatography.
3. Formation of Rosuvastatin Calcium : Rosuvastatin calcium is synthesized by reacting the purified intermediate with calcium salts. This step is crucial for producing the stable, bioavailable form of rosuvastatin required for pharmaceutical use.

The cost of raw materials, reagents, and energy required for chemical synthesis contributes significantly to the overall API cost. Advanced technologies like continuous-flow synthesis and catalysis can help reduce raw material waste, improving cost-efficiency.

B. Formulation Process​

Once the active pharmaceutical ingredient (API) is synthesized, it must be formulated into a suitable dosage form, typically in tablet or capsule form.

1. Granulation : The API is mixed with excipients in a process called granulation, where small particles are bound together to form granules that ensure uniformity in the final product.
2. Compression : The granules are then compressed into tablets. The compression process is highly automated, and the quality control (QC) measures ensure the tablets meet dosage specifications and consistency.
3. Coating : To improve tablet stability, ease of swallowing, and to control the release of the drug, some rosuvastatin tablets are coated with a thin layer of a protective material. This can increase the cost, especially if the coating involves advanced release mechanisms (eg, extended-release formulations).
4. Packaging : After formulation, the tablets are packaged in blister packs or bottles and labeled according to regulatory requirements. Packaging costs can vary depending on the materials used (eg, plastic, glass) and any special features, such as tamper-proof seals or child-resistant packaging.

Contact Us:​

Company Name: Procurement Resource

Contact Person: Leo Frank

Email: sales@procurementresource.com

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