Atorvastatin

Atorvastatin, a statin-class medication, is one of the most prescribed drugs globally for the effective management of hypercholesterolemia and prevention of cardiovascular diseases. As a leading third-party manufacturer, we specialize in the contract manufacturing of Atorvastatin tablets, capsules, and other dosage forms, meeting the highest standards of quality, safety, and efficacy. Our facility is equipped with advanced technology and staffed by experienced pharmaceutical professionals dedicated to delivering world-class products for national and international markets.

Why Choose Our Third-Party Manufacturing for Atorvastatin?

1. State-of-the-Art Infrastructure:
Our GMP- and WHO-certified manufacturing units are equipped with cutting-edge machinery for the large-scale production of Atorvastatin formulations. This infrastructure enables us to produce tablets with consistent potency, uniformity, and stability, ensuring batch-to-batch reproducibility.

2. Regulatory Compliance:
We strictly adhere to regulatory guidelines laid down by authorities such as the US FDA, EMA, MHRA, TGA, and CDSCO. Our production processes include rigorous in-process checks and final product testing, ensuring our Atorvastatin medicines comply with pharmacopeial standards (USP, BP, EP, IP) and customer-specific requirements.

3. Customizable Strengths and Dosage Forms:
We offer Atorvastatin in various strengths—such as 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg—available in tablets, film-coated tablets, or as per client specifications. Our flexible manufacturing allows customers to market Atorvastatin formulations that suit their regional market demands.

4. Dedicated R&D Support:
Our experienced research and development team works closely with clients to customize formulations, develop improved bioavailability profiles, or create fixed-dose combinations with other cardiovascular agents, such as Amlodipine. This gives our clients a competitive edge in crowded markets.

5. Cost-Effective Manufacturing:
Our efficient processes, economies of scale, and lean supply chain help minimize production costs without compromising on quality. We pass these savings on to our partners, enabling them to offer Atorvastatin at competitive prices in their markets.

Manufacturing Process Overview

Our manufacturing process for Atorvastatin tablets involves precise steps to ensure consistent quality:

• API Procurement: We source Atorvastatin Calcium, the active pharmaceutical ingredient (API), from certified and audited suppliers. The API undergoes identity, purity, and potency verification in our in-house labs.
• Granulation: Using high-shear mixers, the API is blended with excipients such as microcrystalline cellulose, lactose, and binders. Wet or dry granulation is chosen based on the formulation design to achieve the desired tablet properties.
• Compression: The granulated mixture is compressed using rotary tablet presses, maintaining uniform weight, hardness, and friability across all tablets.
• Coating: Tablets can be film-coated with protective layers that enhance stability, mask taste, and improve patient compliance. Coatings are customizable (e.g., immediate-release, delayed-release, or taste-masked).
• Packaging: Blister packs, bottles, or customized bulk packing options are available. Our packaging solutions ensure protection against moisture, light, and contamination.
• Quality Control: Every batch undergoes stringent testing for assay, dissolution, uniformity, stability, microbial limits, and other critical parameters.

Quality Assurance: A Commitment to Excellence

Our robust quality assurance protocols are designed to ensure that every batch of Atorvastatin meets predefined quality specifications:

• Analytical Testing: Our in-house laboratories are equipped with HPLC, UV-Vis spectrophotometers, and other advanced equipment to test the API and finished dosage forms.
• Stability Studies: We conduct accelerated and long-term stability studies in line with ICH guidelines to guarantee shelf life under various climatic zones.
• Documentation: Comprehensive batch manufacturing records, certificates of analysis, and stability data are provided to our partners, facilitating smooth product registration and marketing authorization in their target countries.

Value-Added Services

Our role as your third-party manufacturing partner goes beyond production:

• Private Labeling: We offer complete private labeling solutions, allowing you to market Atorvastatin under your brand name with customized packaging.
• Regulatory Support: Our experienced team assists with dossier preparation, CTD/eCTD submissions, and country-specific documentation to accelerate market approvals.
• Supply Chain Management: We provide seamless logistics support, from raw material procurement to last-mile delivery, ensuring timely and reliable supply.
• Technical Transfer: For clients with proprietary formulations or specialized requirements, we provide full technical transfer services, including technology adaptation and process optimization.

Advantages of Third-Party Manufacturing for Atorvastatin

• Faster Time to Market: Leveraging our existing infrastructure allows clients to launch Atorvastatin quickly without investing in their own production facilities.
• Reduced Operational Burden: Outsourcing production enables partners to focus on marketing, distribution, and business development.
• Scalability: Our flexible capacity supports production of small pilot batches for clinical trials as well as large commercial batches.
• Consistency and Reliability: Our proven track record ensures a consistent supply of high-quality Atorvastatin formulations, reducing the risk of stockouts or recalls.

Therapeutic Applications of Atorvastatin

Atorvastatin belongs to the HMG-CoA reductase inhibitor class and is indicated for:

• Reducing elevated total cholesterol, LDL cholesterol, ApoB, and triglycerides.
• Increasing HDL cholesterol levels in patients with primary hyperlipidemia and mixed dyslipidemia.
• Prevention of cardiovascular events in patients at risk of coronary heart disease, stroke, or other vascular complications.

As a widely used statin, it has a favorable safety and efficacy profile, making it a mainstay in cardiovascular risk management.

Our Commitment to Sustainability

We believe in responsible manufacturing practices. Our facilities are equipped with effluent treatment plants, and we adhere to environmental standards to minimize our carbon footprint. We also ensure the ethical sourcing of raw materials and implement practices that promote sustainability in our supply chain.

Partner with Us for Atorvastatin Third-Party Manufacturing
Choosing our manufacturing services for Atorvastatin means choosing reliability, superior quality, and a team committed to your success. Contact us today to discuss your specific needs, request a quote, or schedule a facility visit. Together, we can deliver high-quality Atorvastatin formulations to improve the lives of millions worldwide.