Flupentixol Decanoate

Flupentixol Decanoate API: Premium Quality Bulk Supply by Ayurvite Wellness Pvt. Ltd.

In the highly specialized field of pharmaceuticals, the quality and consistency of Active Pharmaceutical Ingredients (APIs) are critical to the efficacy and safety of medicinal products. Ayurvite Wellness Pvt. Ltd. is a leading exporter of Flupentixol Decanoate API, committed to delivering superior quality ingredients that meet global regulatory standards. Our state-of-the-art manufacturing facilities, dedicated research and development team, and stringent quality assurance protocols make us the preferred partner for pharmaceutical companies worldwide. This detailed product page explores the various facets of Flupentixol Decanoate API, including its chemical properties, mechanism of action, therapeutic uses, manufacturing excellence, and the unique benefits of partnering with Ayurvite Wellness.

What is Flupentixol Decanoate API?

Flupentixol Decanoate is a long-acting antipsychotic medication belonging to the thioxanthene class of drugs. It is primarily used in the management of schizophrenia and other psychotic disorders. As an API, Flupentixol Decanoate serves as the active ingredient in various pharmaceutical formulations, ensuring the therapeutic efficacy of antipsychotic medications. Its decanoate ester form provides a prolonged duration of action, allowing for less frequent dosing and improved patient compliance.

Chemical Composition

Flupentixol Decanoate is a well-defined chemical compound with specific properties that contribute to its pharmacological effects.

IUPAC Name: 1-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)-N,N-dimethylpropan-2-amine decanoate
Molecular Formula: C₃₃H₄₄Cl₂N₂O₂S₂
Molecular Weight: 656.29 g/mol
CAS Number: 614-16-7

Chemical Specifications

Appearance: White to off-white crystalline powder
Purity: ≥ 99.0%
Solubility: Soluble in chloroform, ethanol, and methanol; sparingly soluble in water
Melting Point: 240-245°C
pH: 7.0-7.5 (1% solution)

Mechanism of Action

Flupentixol Decanoate functions primarily as an antagonist of dopamine D₂ receptors in the brain. By blocking these receptors, it effectively inhibits the action of dopamine, a neurotransmitter involved in the regulation of mood, behavior, and cognition. This action helps in reducing the positive symptoms of schizophrenia, such as hallucinations and delusions, and also has a moderating effect on negative symptoms like social withdrawal and apathy.

Dopamine Antagonism: Flupentixol Decanoate binds to D₂ receptors, preventing dopamine from activating these receptors, thereby stabilizing mood and reducing psychotic symptoms.
Serotonin Receptor Interaction: It also exhibits affinity for certain serotonin receptors, contributing to its overall antipsychotic profile and improving mood regulation.
Prolonged Action: The decanoate ester provides a sustained release of the active drug, ensuring prolonged therapeutic effects and reducing the frequency of dosing.

Indications and Therapeutic Uses

Flupentixol Decanoate API is utilized in the formulation of medications aimed at treating various psychiatric conditions. Its primary therapeutic applications include:

Schizophrenia: Effective in managing both acute and chronic phases of schizophrenia by alleviating psychotic symptoms.
Psychotic Disorders: Used in the treatment of other psychotic conditions, including schizoaffective disorder and acute psychosis.
Depression: At lower doses, Flupentixol Decanoate has antidepressant properties, making it useful in managing depressive symptoms associated with schizophrenia.
Anxiety Disorders: Helps in reducing anxiety symptoms in patients with underlying psychotic disorders.
Behavioral Disorders: Utilized in managing aggressive and disruptive behaviors in psychiatric patients.

Pharmacokinetics

Understanding the pharmacokinetic profile of Flupentixol Decanoate is essential for optimizing its therapeutic use and ensuring patient safety.

Absorption: Flupentixol Decanoate is administered intramuscularly, where it is slowly absorbed into the bloodstream, providing a prolonged duration of action.
Distribution: Widely distributed throughout the body, including the central nervous system, due to its ability to cross the blood-brain barrier.
Metabolism: Metabolized in the liver via cytochrome P450 enzymes, primarily CYP3A4 and CYP2D6, leading to the formation of active and inactive metabolites.
Excretion: Excreted mainly through renal pathways, with metabolites being eliminated in the urine.
Half-Life: Approximately 7-14 days, allowing for once-weekly dosing regimens, which enhances patient compliance.

Quality Assurance and Manufacturing Excellence

At Ayurvite Wellness Pvt. Ltd., quality is the cornerstone of our manufacturing philosophy. Our Flupentixol Decanoate API is synthesized and processed in compliance with the highest international standards, ensuring purity, potency, and safety.

Manufacturing Facilities

Our state-of-the-art manufacturing units are equipped with advanced technologies and operated by a team of experienced chemists and quality control experts. Located in key pharmaceutical hubs, our facilities adhere to stringent Good Manufacturing Practices (GMP) guidelines, ensuring consistent and reliable API production.

Quality Control Measures

Raw Material Verification: All raw materials undergo rigorous testing to confirm their identity, purity, and compliance with specifications before use.
In-Process Testing: Continuous monitoring during the synthesis and processing stages ensures adherence to quality parameters and early detection of deviations.
Final Product Testing: Comprehensive analytical testing, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Infrared (IR) spectroscopy, and dissolution studies, guarantees the API meets all required specifications.
Stability Testing: Our APIs undergo stability assessments to determine shelf-life and ensure efficacy over time under various storage conditions.

Certifications and Compliance

Ayurvite Wellness Pvt. Ltd. holds multiple certifications attesting to our commitment to quality and regulatory compliance:

ISO 9001:2015: Demonstrates our dedication to quality management systems.
cGMP Certification: Confirms our adherence to current Good Manufacturing Practices.
FDA Approval: Our manufacturing facilities are approved by the U.S. Food and Drug Administration, facilitating seamless export to global markets.
EU GMP Compliance: Ensures our APIs meet the stringent quality standards required by the European Union.

Regulatory Approvals

Navigating the complex landscape of global pharmaceutical regulations is a testament to our expertise and reliability. Ayurvite Wellness Pvt. Ltd. ensures that our Flupentixol Decanoate API complies with the regulatory requirements of major markets, including:

United States (FDA)
European Union (EMA)
Japan (PMDA)
India (DCGI)
Middle East (SFDA, MFDS)
South East Asia (BPOM, TGA)

Our comprehensive documentation and quality assurance processes facilitate smooth regulatory approvals, enabling our clients to bring their products to market swiftly and efficiently.

Applications of Flupentixol Decanoate API

Flupentixol Decanoate API’s versatile pharmacological profile makes it a valuable ingredient in various pharmaceutical formulations. Key applications include:

Injectable Formulations: Primarily used in long-acting injectable antipsychotic formulations for the management of schizophrenia and other psychotic disorders.
Oral Tablets and Capsules: Incorporated into oral dosage forms for maintenance therapy in psychiatric patients, ensuring steady drug levels and improved compliance.
Combination Therapies: Employed in multi-API formulations to target multiple psychiatric symptoms simultaneously, enhancing therapeutic outcomes.
Extended-Release Formulations: Developed for sustained therapeutic effects, reducing the frequency of dosing and improving patient adherence.
Depot Injections: Utilized in depot formulations to provide continuous drug release over an extended period, minimizing the need for frequent administrations.

Benefits of Choosing Ayurvite Wellness Pvt. Ltd. for Flupentixol Decanoate API

Partnering with Ayurvite Wellness Pvt. Ltd. for your Flupentixol Decanoate API needs offers numerous advantages that set us apart in the pharmaceutical API export sector.

Uncompromising Quality

Our Flupentixol Decanoate API is manufactured under stringent quality controls, ensuring each batch meets the highest standards of purity and efficacy. We employ advanced analytical techniques and adhere to global quality benchmarks, providing our clients with reliable and consistent API supply.

Competitive Pricing

Understanding the financial dynamics of the pharmaceutical industry, we offer our Flupentixol Decanoate API at competitive prices without compromising on quality. Our efficient manufacturing processes and economies of scale enable us to deliver cost-effective solutions to our clients.

Global Supply Chain Expertise

With an extensive global distribution network, Ayurvite Wellness Pvt. Ltd. ensures timely and secure delivery of Flupentixol Decanoate API to any corner of the world. Our logistics team is adept at navigating international shipping regulations, ensuring smooth and hassle-free procurement for our clients.

Customization and Flexibility

We recognize that different clients have unique requirements. Whether it’s specific mesh sizes or customized packaging, we offer flexible solutions to meet your precise needs. Our dedicated R&D team works closely with clients to develop bespoke formulations that align with their product specifications.

Regulatory Support

Navigating regulatory landscapes can be challenging. Our team of regulatory experts provides comprehensive support, assisting clients in obtaining necessary certifications and ensuring compliance with regional and international regulations. This support accelerates the time-to-market for your pharmaceutical products.

Sustainability and Ethical Practices

At Ayurvite Wellness Pvt. Ltd., we prioritize sustainable and ethical manufacturing practices. Our processes are designed to minimize environmental impact, and we adhere to ethical labor standards, ensuring that our operations contribute positively to society and the environment.

Manufacturing Process of Flupentixol Decanoate API

The synthesis of Flupentixol Decanoate API involves meticulous processes to ensure the highest quality and efficacy. Below is an overview of our manufacturing process:

Synthesis of Flupentixol Base

Raw Material Preparation: High-purity starting materials are selected and subjected to preliminary purification to eliminate impurities.
Chemical Synthesis: Flupentixol is synthesized through a multi-step chemical reaction involving the condensation of appropriate precursors under controlled conditions.
Purification: The crude Flupentixol base undergoes recrystallization and other purification techniques to achieve the desired purity level.
Characterization: The purified base is characterized using analytical techniques such as Nuclear Magnetic Resonance (NMR), Infrared (IR) spectroscopy, and mass spectrometry to confirm its structure and purity.

Formation of Flupentixol Decanoate

Decanoate Ester Formation: The purified Flupentixol base is reacted with decanoic acid in the presence of a suitable catalyst to form Flupentixol Decanoate.
Crystallization: The reaction mixture is crystallized to obtain pure Flupentixol Decanoate crystals.
Drying and Milling: The crystals are dried under controlled conditions and milled to achieve the desired particle size and consistency.

Quality Control and Assurance

Blending: Flupentixol Decanoate is blended to ensure uniform distribution of the API.
Final Quality Testing: Comprehensive testing, including assay, purity, and dissolution studies, is conducted to verify that the API meets all specified criteria.
Packaging: The finished API is packaged in moisture-proof and contamination-resistant containers, ensuring stability and longevity.

Stability and Shelf Life

Flupentixol Decanoate API manufactured by Ayurvite Wellness Pvt. Ltd. exhibits excellent stability under recommended storage conditions. Our stability testing ensures that the API maintains its efficacy, potency, and safety over its intended shelf life.

Storage Conditions: Store in a cool, dry place away from direct sunlight and moisture.
Shelf Life: Typically, the Flupentixol Decanoate API has a shelf life of 24 months from the date of manufacture when stored under optimal conditions.

Safety and Handling

Handling Flupentixol Decanoate API requires adherence to safety protocols to ensure the well-being of personnel and maintain product integrity.

Safety Precautions

Personal Protective Equipment (PPE): Wear appropriate PPE, including gloves, safety goggles, and lab coats, to prevent direct contact.
Ventilation: Ensure adequate ventilation in the workspace to avoid inhalation of dust or vapors.
Storage: Store the API in labeled, secure containers away from incompatible substances.

First Aid Measures

Inhalation: Move to fresh air immediately. Seek medical attention if symptoms persist.
Skin Contact: Rinse affected area with plenty of water. Remove contaminated clothing and seek medical advice if irritation occurs.
Eye Contact: Rinse thoroughly with water for at least 15 minutes and seek medical assistance.
Ingestion: Rinse mouth and seek medical attention immediately.

Disposal Considerations

Dispose of Flupentixol Decanoate API and its containers in accordance with local, regional, and national regulations. Avoid releasing the substance into the environment to prevent contamination.

Packaging and Delivery

Ayurvite Wellness Pvt. Ltd. offers flexible packaging solutions tailored to the specific needs of our clients. Our Flupentixol Decanoate API is available in bulk quantities to facilitate ease of handling and storage.

Packaging Options

Bulk Packaging: Available in 10 kg, 25 kg, 50 kg, and 100 kg drums for large-scale manufacturing needs.

Delivery Logistics

Our robust logistics network ensures timely and secure delivery of Flupentixol Decanoate API to any destination worldwide. We collaborate with trusted shipping partners to facilitate efficient transportation, whether by air, sea, or land.

Documentation: Comprehensive documentation, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and regulatory compliance certificates, accompany each shipment.
Tracking: Real-time tracking options are available to monitor the status of your order from dispatch to delivery.
Customs Clearance: Our experienced team assists with customs clearance processes to minimize delays and ensure smooth entry into the destination country.

Benefits of Choosing Ayurvite Wellness Pvt. Ltd. for Flupentixol Decanoate API

Partnering with Ayurvite Wellness Pvt. Ltd. for your Flupentixol Decanoate API needs offers numerous advantages that set us apart in the pharmaceutical API export sector.

Uncompromising Quality

Competitive Pricing

Global Supply Chain Expertise

Customization and Flexibility

Regulatory Support

Sustainability and Ethical Practices

Manufacturing Process of Flupentixol Decanoate API

The synthesis of Flupentixol Decanoate API involves meticulous processes to ensure the highest quality and efficacy. Below is an overview of our manufacturing process:

Synthesis of Flupentixol Base

Raw Material Preparation: High-purity starting materials are selected and subjected to preliminary purification to eliminate impurities.
Chemical Synthesis: Flupentixol is synthesized through a multi-step chemical reaction involving the condensation of appropriate precursors under controlled conditions.
Purification: The crude Flupentixol base undergoes recrystallization and other purification techniques to achieve the desired purity level.
Characterization: The purified base is characterized using analytical techniques such as Nuclear Magnetic Resonance (NMR), Infrared (IR) spectroscopy, and mass spectrometry to confirm its structure and purity.

Formation of Flupentixol Decanoate

Decanoate Ester Formation: The purified Flupentixol base is reacted with decanoic acid in the presence of a suitable catalyst to form Flupentixol Decanoate.
Crystallization: The reaction mixture is crystallized to obtain pure Flupentixol Decanoate crystals.
Drying and Milling: The crystals are dried under controlled conditions and milled to achieve the desired particle size and consistency.

Quality Control and Assurance

Blending: Flupentixol Decanoate is blended to ensure uniform distribution of the API.
Final Quality Testing: Comprehensive testing, including assay, purity, and dissolution studies, is conducted to verify that the API meets all specified criteria.
Packaging: The finished API is packaged in moisture-proof and contamination-resistant containers, ensuring stability and longevity.

Stability and Shelf Life

Storage Conditions: Store in a cool, dry place away from direct sunlight and moisture.
Shelf Life: Typically, the Flupentixol Decanoate API has a shelf life of 24 months from the date of manufacture when stored under optimal conditions.

Safety and Handling

Handling Flupentixol Decanoate API requires adherence to safety protocols to ensure the well-being of personnel and maintain product integrity.

Safety Precautions

Personal Protective Equipment (PPE): Wear appropriate PPE, including gloves, safety goggles, and lab coats, to prevent direct contact.
Ventilation: Ensure adequate ventilation in the workspace to avoid inhalation of dust or vapors.
Storage: Store the API in labeled, secure containers away from incompatible substances.

First Aid Measures

Inhalation: Move to fresh air immediately. Seek medical attention if symptoms persist.
Skin Contact: Rinse affected area with plenty of water. Remove contaminated clothing and seek medical advice if irritation occurs.
Eye Contact: Rinse thoroughly with water for at least 15 minutes and seek medical assistance.
Ingestion: Rinse mouth and seek medical attention immediately.

Disposal Considerations

Dispose of Flupentixol Decanoate API and its containers in accordance with local, regional, and national regulations. Avoid releasing the substance into the environment to prevent contamination.

Packaging and Delivery

Packaging Options

Bulk Packaging: Available in 10 kg, 25 kg, 50 kg, and 100 kg drums for large-scale manufacturing needs.

Delivery Logistics

Documentation: Comprehensive documentation, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and regulatory compliance certificates, accompany each shipment.
Tracking: Real-time tracking options are available to monitor the status of your order from dispatch to delivery.
Customs Clearance: Our experienced team assists with customs clearance processes to minimize delays and ensure smooth entry into the destination country.

Benefits of Choosing Ayurvite Wellness Pvt. Ltd. for Flupentixol Decanoate API

Partnering with Ayurvite Wellness Pvt. Ltd. for your Flupentixol Decanoate API needs offers numerous advantages that set us apart in the pharmaceutical API export sector.

Uncompromising Quality

Competitive Pricing

Global Supply Chain Expertise

Customization and Flexibility

Regulatory Support

Sustainability and Ethical Practices

Frequently Asked Questions (FAQs)

1. What is Flupentixol Decanoate API used for?

Flupentixol Decanoate API is primarily used in the formulation of long-acting antipsychotic medications aimed at treating schizophrenia and other psychotic disorders. It helps in managing symptoms such as hallucinations, delusions, mood disturbances, and behavioral issues.

2. Does Ayurvite Wellness Pvt. Ltd. offer custom formulations of Flupentixol Decanoate API?

Yes, we offer customized formulations to meet specific client requirements, including adjustments in mesh size and customized packaging formats.

3. What certifications does Ayurvite Wellness hold for Flupentixol Decanoate API?

Our Flupentixol Decanoate API is manufactured in facilities certified with ISO 9001:2015, cGMP, and holds approvals from regulatory bodies such as the US FDA, EU EMA, Japan PMDA, and more.

4. How does Ayurvite ensure the quality of Flupentixol Decanoate API?

We implement rigorous quality control measures at every stage of the manufacturing process, including raw material verification, in-process testing, final product analysis, and stability testing to ensure the highest quality standards.

5. What is the typical shelf life of Flupentixol Decanoate API?

Our Flupentixol Decanoate API typically has a shelf life of 24 months when stored under recommended conditions—cool, dry places away from direct sunlight and moisture.

6. Can Ayurvite Wellness Pvt. Ltd. handle large-scale bulk orders of Flupentixol Decanoate API?

Absolutely. Our manufacturing facilities have a total reactor volume exceeding 1200 KL, enabling us to accommodate extensive API requirements for large-scale pharmaceutical productions.

7. What packaging options are available for Flupentixol Decanoate API?

We offer bulk packaging options in 10 kg, 25 kg, 50 kg, and 100 kg drums, tailored to meet large-scale manufacturing needs.

8. How does Ayurvite manage international shipments of Flupentixol Decanoate API?

Our experienced logistics team ensures that all international shipments comply with local and international regulations. We provide comprehensive documentation, real-time tracking, and assist with customs clearance to ensure seamless delivery.

9. What safety measures are in place during the manufacturing of Flupentixol Decanoate API?

Our manufacturing facilities adhere to stringent safety protocols, including the use of Personal Protective Equipment (PPE), proper ventilation systems, and secure storage practices to ensure the safety of our personnel and the integrity of the product.

10. How can I place an order for Flupentixol Decanoate API with Ayurvite Wellness Pvt. Ltd.?

You can place an order or make an inquiry by visiting our contact page at https://apiexporter.com/contact/. Our customer service representatives will guide you through the ordering process and assist with any specific requirements you may have.

Conclusion

In the realm of pharmaceutical APIs, Ayurvite Wellness Pvt. Ltd. distinguishes itself through an unwavering commitment to quality, regulatory excellence, and customer satisfaction. Our Flupentixol Decanoate API embodies these values, offering pharmaceutical manufacturers a reliable, high-quality ingredient essential for developing effective and safe antipsychotic medications. Partner with us to leverage our expertise, state-of-the-art facilities, and global reach, ensuring your products meet the highest standards and achieve market success.

For inquiries, quotations, or further information about our Flupentixol Decanoate API, please visit our contact page at https://apiexporter.com/contact/.

Quantity	10 kg, 25 kg, 50 kg, 100 kg

Flupentixol Decanoate