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Atorvastatin Calcium (Form-P)

Atorvastatin Calcium (Form-P)-API

Atorvastatin Calcium (Form-P) API

CAS Number: 134523-03-8

Atorvastatin Calcium (Form-P) API

Therapeutic Category
Lipid modifying agents
Cardiovascular

API Technology
Synthetic

Dose Form
Oral Solids

Dr Reddy's Development Status
Available

Available Regulatory Filing
USA, Europe, Australia, New Zealand, Taiwan, Brazil

Mechanism of Action

As with other statins, atorvastatin is a competitive inhibitor of HMG-CoA reductase. Unlike most others, however, it is a completely synthetic compound. HMG-CoA reductase catalyzes the reduction of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, which is the rate-limiting step in hepatic cholesterol biosynthesis. Inhibition of the enzyme decreases de novo cholesterol synthesis, increasing expression of low-density lipoprotein receptors (LDL receptors) on hepatocytes. This increases LDL uptake by the hepatocytes, decreasing the amount of LDL-cholesterol in the blood. Like other statins, atorvastatin also reduces blood levels of triglycerides and slightly increases levels of HDL-cholesterol.

Indication

LIPITOR is anHMG-CoA reductase inhibitorindicatedas an adjunct therapy to diet to:

  • Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors.
  • Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors .
  • Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adult patients with CHD .
  • Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDLC in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia .
  • Reduce elevated TG inadultpatientswith hypertriglyceridemiaand primary dysbetalipoproteinemia.
  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH)
  • Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Atorvastatin Calcium (Form-P) API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Atorvastatin Calcium (Form-P) API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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Related Resources

The synthesis of active pharmaceutical ingredients (APIs) using continuous flow chemistry

The synthesis of active pharmaceutical ingredients (APIs) using continuous flow chemistry

The continuous flow method is a concrete indispensable process and an effective tool where the reaction is carried out by mixing the reagents to generate a chemical reaction. Then, this liquid or solution is allowed to go through an observation tube for further completion of the reaction process. Thus continuous-flow method also helps to monitor the kinetics of chemical reactions in solution.

The continuous flow synthesis allows combinatorial synthesis and space integration of reactions, making it the most innovative synthetic and pharmaceutical research tool. Various compounds can be synthesized sequentially using a single flow reactor and flow switch. The routes are designed for commercially synthetic processes and preparative standards than the normal batches to expand the synthetic proficiencies.

The active pharmaceutical ingredient manufacturing or synthesis in a lab is sometimes difficult for the scale-up process using the reaction equipment owing to their size and performance criteria. Hence the process optimization of the scale-up reaction is always a challenge in such cases considering the monitoring of the reaction parameters, which emphasizes that using continuous flow reactors helps understand and maintain the process requirements for the optimization techniques. Continuous flow reactors are devices that carry out synthetic transformations in a continuous flowing stream. They can be designed and customized according to the need and characteristics of the reaction. Hence customized flow reactors are available for the respective flow synthetic reaction to be carried out.

The continuous flow method gives comprehensive and additional insights into managing the flow chemistry pattern and the transformational process that makes the method a potentially competent and technically powerful tool.

It is undoubtedly one of the most widely used and enabling techniques where the specified volumes of the substrates and reagents are added into the small reactor units. This process is maintained in a controlled and reproducible manner. The regulation parameters such as heat and mass transfer are controlled. The flow reaction configuration is upgraded and customized to comply with the reaction parameters and processing requirements. The reactor is made by assembling the integrated component systems involving heating and cooling units, tubing coils, and separators. The arrangement is made so that it facilitates smooth and continuous operation. It also ensures hazardous and critical processes run smoothly without any interference and helps investigate and identify any operational difficulties that can be monitored and improved for safety concerns.

Active pharmaceutical ingredient manufacturing has been developed in a modified and innovative way to optimize and standardize the process involved. Flow synthesis of high- volume pharmaceuticals is conducted for many APIs using a microreactor. A continuous flow synthesis process is carried out where each step is optimized and standardized by taking the quality reagents for the reaction to avoid any downstream difficulties and troubles. Final purification is carried out at the end of the process of sequence.

Similarly, one of the examples of another pharmaceutical flow synthesis has been developed for the API of tyrosine kinase inhibitor Gleevec. This flow process synthesis has the key steps involving an amide formation reaction followed by a nucleophilic substitution reaction and ends with Buchwald–Hartwig coupling reaction in the flow process.

The reactors are available made with PTFE or PFA, stainless steel, microchips, or can be fixed bed or agitating microsphere reactors depending upon the length and type of the reactor required. The reactor temperature is controlled and monitored where the reagents are added through a micromixer.

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Dr. Reddys at 5th CII LIFE SCIENCES SUMMIT 2023 - Making India a Global Pharma and Lifesciences Innovation Hub

Dr. Reddys at 5th CII LIFE SCIENCES SUMMIT 2023 - Making India a Global Pharma and Lifesciences Innovation Hub

Dr. Reddys at 5th CII LIFE SCIENCES SUMMIT 2023

Mr. Gunjan Singh, VP & Head (Europe & U.S.), API Sales and Marketing at Dr. Reddys API, shared profound insights at the recent summit themed "Making India a Global Pharma and Lifesciences Innovation Hub." His comprehensive coverage included pivotal topics such as evolving business models, bridging academia-industry gaps, fermenting technology for robust API manufacturing, enforcing the new Schedule M, and fostering a new Indian vaccine ecosystem.

Mr. Gunjan Singh, VP & Head (Europe & U.S.)

Gunjan Singh emphasized India's potential for self-sufficiency in API and outlined strategies for achieving cost competitiveness. Intellectual property rights were underscored as a key focus area for long-term results. His invaluable recommendations have garnered widespread appreciation from participants and stakeholders within the Pharma and Biotech industry.

The summit witnessed the convergence of senior Government officials, policymakers, key industry experts, innovators, and academicians. Together, they deliberated to propel India into an Innovation Hub in the Lifesciences Sector.

Making India a Global Pharma and Lifesciences Innovation Hub

  • Business Evolution: Exploring new business models for Lifesciences innovation.
  • Academia-Industry Synergy: Strengthening collaboration between academic research and industry.
  • Technological Advancements: Development of fermentation technology for enhanced API manufacturing.
  • Regulatory Framework: Insights on the impact of the new Schedule M.

Mr. Gunjan Singh's contribution at the summit marks a significant step forward in shaping the future of India's Pharma and Biotech landscape. The collaborative efforts showcased the nation's commitment to becoming a global leader in Lifesciences innovation.

Media Coverage Click here.

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Disclaimer

No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.

FAQs

It is available in tablet dosage form with 10, 20, 40 and 80mg strengths.

A drug used to lower the amount of cholesterol in the blood and to prevent stroke, heart attack, and angina (chest pain). It is also being studied in the prevention and treatment of some types of cancer and other conditions.

It belongs to class 2 of BCS classification

We offer Crystalline Form-1

Store atorvastatin at room temperature between 68°F (20°C) and 77°F (25°C). Keep it away from high temperatures.

Avoid eating foods high in fat or cholesterol, or atorvastatin will not be as effective. Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage. Grapefruit may interact with atorvastatin and lead to unwanted side effects.

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