Quetiapine Hemifumarate (111974-72-2) API Manufacturers & Suppliers in India

Quetiapine Hemifumarate (CAS number 111974-72-2) is a widely used atypical antipsychotic medication primarily prescribed for the treatment of various mental health disorders. It is marketed under various brand names, including Seroquel, and is used to manage conditions such as schizophrenia, bipolar disorder, and major depressive disorder. The active pharmaceutical ingredient (API), Quetiapine Hemifumarate, is produced by a number of pharmaceutical manufacturers, with India being one of the leading suppliers globally.

As India has become a hub for API production, many international pharmaceutical companies source Quetiapine Hemifumarate from Indian manufacturers due to the country’s robust infrastructure, cost-effective manufacturing, and stringent adherence to international quality standards. In this article, we will explore the importance of Quetiapine Hemifumarate, its manufacturing process, and why India is the preferred destination for sourcing this highly complex and potent API.

What is Quetiapine Hemifumarate?

Chemical Structure and Properties

Quetiapine Hemifumarate is the hemifumarate salt form of Quetiapine, which itself is a dibenzothiazepine derivative. Its chemical structure is designed to optimize its pharmacological properties, particularly in relation to its activity on the serotonin and dopamine receptors in the brain. Quetiapine Hemifumarate has a chemical formula of C21H25N3O2S·C4H4O4, and the CAS number associated with it is 111974-72-2.

Quetiapine Hemifumarate is known for its broad therapeutic uses in psychiatric medicine. It is typically available in tablet or extended-release tablet forms and is taken orally. The hemifumarate salt form of Quetiapine enhances the solubility of the compound, improving its bioavailability, which is essential for effective treatment.

Pharmacological Actions and Uses

Quetiapine Hemifumarate acts as a dopamine receptor antagonist (D2) and a serotonin receptor antagonist (5HT2A). It is considered an atypical antipsychotic because it has a different side effect profile compared to older, typical antipsychotic drugs. The drug helps regulate neurotransmitter activity in the brain, which is often imbalanced in patients suffering from psychiatric disorders.

Common uses of Quetiapine Hemifumarate include:

• Schizophrenia: Quetiapine Hemifumarate is commonly prescribed for the treatment of schizophrenia, a disorder characterized by delusions, hallucinations, and disorganized thinking.


• Bipolar Disorder: It is effective in both the manic and depressive phases of bipolar disorder. Quetiapine is often used in combination with other mood stabilizers or antidepressants to provide comprehensive treatment.


• Major Depressive Disorder: Quetiapine is sometimes used as an adjunctive treatment for major depressive disorder when other antidepressants are not sufficient.


• Anxiety Disorders and Insomnia: While not officially indicated for anxiety or sleep disorders, Quetiapine is sometimes prescribed off-label for its sedative effects.

Because of these uses, Quetiapine Hemifumarate plays a significant role in the management of mental health conditions, helping patients manage symptoms and improve their quality of life.

Dosage Forms

Quetiapine Hemifumarate is commonly available in tablet and extended-release tablet forms. The typical dosages are:

• Schizophrenia: 150-750 mg per day, depending on the severity of the condition and patient response.


• Bipolar Disorder: 200-400 mg per day for acute manic episodes or as maintenance therapy.


• Major Depressive Disorder: 50-300 mg per day, typically as an adjunct to an antidepressant.

For each patient, dosing is personalized based on their condition, age, and health status. The extended-release formulations allow for better patient compliance due to the reduced frequency of dosing and minimized side effects.

Manufacturing of Quetiapine Hemifumarate API in India

India has emerged as a key player in the global pharmaceutical manufacturing industry, particularly in the production of complex and potent APIs like Quetiapine Hemifumarate. The manufacturing process of Quetiapine Hemifumarate requires high expertise, strict quality controls, and sophisticated technologies, ensuring that the API meets global safety and regulatory standards.

Synthesis of Quetiapine Hemifumarate

The process of manufacturing Quetiapine Hemifumarate API involves multiple stages, starting with the synthesis of the base compound Quetiapine and then forming the hemifumarate salt. Here’s a simplified overview of the synthesis process:

1. Synthesis of Quetiapine: The production of Quetiapine begins with complex organic synthesis, where various intermediates are combined to form the core structure of Quetiapine. This involves the use of specialized chemicals, solvents, and catalysts to ensure the desired molecular structure is obtained.


2. Fumarate Salt Formation: Once Quetiapine is synthesized, it is reacted with fumaric acid to form Quetiapine Hemifumarate. This is a key step, as the hemifumarate form enhances the solubility of the drug, thereby improving its absorption and bioavailability.


3. Purification: The resulting Quetiapine Hemifumarate is purified through several steps to remove impurities or by-products. Techniques such as crystallization, filtration, and solvent extraction are used to ensure that the API meets the desired purity specifications.


4. Drying and Blending: After purification, the API is dried to remove any residual solvents. It is then blended to ensure uniformity before being packaged for further processing into tablet forms. This step is crucial for ensuring that the API is of consistent quality and ready for incorporation into pharmaceutical formulations.


5. Final Quality Control: Before the API is released for distribution, it undergoes rigorous testing to confirm that it meets the specifications for identity, purity, potency, and microbiological safety. These tests include techniques such as High-Performance Liquid Chromatography (HPLC), Infrared Spectroscopy (IR), and Gas Chromatography (GC).

Quality Control and Compliance

Quality control is a critical part of the manufacturing process for Quetiapine Hemifumarate. Leading Indian manufacturers ensure that they meet the rigorous standards set by global regulatory agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO). Some of the key aspects of quality control include:

• Purity and Impurity Testing: Ensuring that the API does not contain harmful impurities or residual solvents.


• Potency Assay: Verifying that the API contains the correct amount of active ingredient.


• Stability Testing: Ensuring that the API remains effective and safe over time, under various environmental conditions.


• Microbial Testing: Ensuring the API is free from harmful microorganisms.

Manufacturers use advanced laboratory equipment and highly skilled chemists to conduct these tests, ensuring compliance with the strictest regulatory standards.

Packaging and Distribution

After passing all quality control tests, Quetiapine Hemifumarate API is packaged in moisture-proof containers, which ensure that the product remains stable and uncontaminated during transport and storage. The packaging also provides important information about the product, such as batch numbers, expiration dates, and storage conditions.

The final API is distributed to pharmaceutical companies worldwide for use in the production of oral tablets or extended-release formulations.

Why India is the Leading Destination for Quetiapine Hemifumarate API Production?

India’s pharmaceutical manufacturing sector is globally recognized for its capabilities in producing high-quality APIs, including Quetiapine Hemifumarate. Several factors contribute to India’s success as a hub for manufacturing and supplying complex APIs like Quetiapine Hemifumarate.

1. Cost-Effective Manufacturing

India is known for its cost-effective manufacturing practices, allowing pharmaceutical companies to produce APIs at a lower cost compared to other regions. The low labor costs, availability of raw materials, and favorable business environment enable Indian manufacturers to offer competitive prices to international clients.

2. Expertise in API Synthesis

Indian pharmaceutical companies possess a deep knowledge of advanced synthetic chemistry. The country has a pool of skilled chemists and engineers who specialize in the production of complex and high-potency APIs like Quetiapine Hemifumarate. This expertise ensures that Indian manufacturers can produce APIs with high precision and consistency.

3. Adherence to International Standards

Indian API manufacturers follow international regulatory guidelines such as Good Manufacturing Practices (GMP), ISO certifications, and pharmacopoeial standards set by global regulatory bodies. This ensures that the APIs produced meet stringent quality, safety, and efficacy standards required for use in pharmaceutical products.

4. Strong Export Network

India is one of the largest exporters of pharmaceutical products, including APIs, to countries across the globe. Indian manufacturers have a well-established supply chain and export infrastructure, which ensures that Quetiapine Hemifumarate reaches global markets in a timely and efficient manner.

5. R&D and Innovation

Indian pharmaceutical companies invest heavily in research and development (R&D) to improve existing API production methods and develop new compounds. The focus on innovation ensures that India remains at the forefront of API production, meeting the evolving needs of the global pharmaceutical market.

Leading Manufacturers of Quetiapine Hemifumarate in India

Several pharmaceutical companies in India are recognized for their expertise in manufacturing high-quality Quetiapine Hemifumarate API. Some of the leading manufacturers include:

KekulePharma

KekulePharma is a top-tier manufacturer of Quetiapine Hemifumarate API, known for its commitment to quality, reliability, and innovation. The company adheres to GMP standards and provides APIs that meet international regulatory requirements.

Aurobindo Pharma

Aurobindo Pharma is one of India’s largest and most well-established pharmaceutical companies. The company produces a wide range of APIs, including Quetiapine Hemifumarate, and is known for its consistent product quality and cost-effective manufacturing processes.

Sun Pharmaceutical Industries

Sun Pharmaceutical Industries is another prominent manufacturer of Quetiapine Hemifumarate API. With a strong global presence, Sun Pharma ensures that its products meet the highest standards of quality and safety.

Quetiapine Hemifumarate (111974-72-2) is a critical API used in the treatment of various mental health disorders, including schizophrenia, bipolar disorder, and major depressive disorder. India has emerged as a global leader in the manufacturing and supply of Quetiapine Hemifumarate due to its cost-effective production methods, skilled workforce, adherence to international quality standards, and strong export capabilities.

Leading pharmaceutical companies in India, such as KekulePharma, Aurobindo Pharma, and Sun Pharmaceutical Industries, ensure that Quetiapine Hemifumarate is produced with the highest levels of quality and precision, meeting global regulatory standards. As the global demand for mental health medications continues to rise, India will remain a key supplier of high-quality Quetiapine Hemifumarate API, contributing to the improvement of mental health outcomes worldwide.