Amisulpride API Manufacturers in India

Amisulpride API is a well-regarded antipsychotic agent primarily used for the treatment of schizophrenia and mood disorders. Bio-Synth, as a reliable Amisulpride API manufacturer in India, ensures superior quality and compliance with international standards, providing consistent and effective solutions to pharmaceutical companies.

Description

Name of the product: Amisulpride

Chemical Name : 4-Amino-N-[(2RS)-(1-ethyl-2-pyrrolidinyl) methyl] -5-ethylsulfonyl-2-methoxybenzamide

CAS Number71675-85-9

Molecular weight: 369.48 g/mol

Molecular formula: C17H27N3O4S

Category: BCS Class II

Therapeutic use:  Antipsychotic

Usage: Used to treat schizophrenia and mood disorders

Form: Crystalline powder

Color: White

Size of package: As per requirement

StorageStore in airtight container protected from light

SynonymsAminosultopride, Solian, Deniban, Barhemsys, DAN 2163, Sulamid, Sulpitac, and APD421

SolubilityPractically insoluble in water, freely soluble in methylene chloride, sparingly soluble in anhydrous ethan

Amisulpride API Specification

Bio-Synth adheres to stringent quality protocols to ensure that each batch of Amisulpride API meets comprehensive global quality standards. Our robust quality control practices confirm the purity, potency, and safety of our products, ensuring reliable therapeutic results.

 

Quality Standards and Manufacturing Excellence at Bio-Synth

Bio-Synth operates with an unwavering commitment to quality. Our manufacturing processes integrate

  • WHO-GMP (Good Manufacturing Practices) compliance
  • ISO 9000:2015 certification
  • Adherence to ICH guidelines and pharmacopeia standards
 Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.

Applications of Amisulpride API

Schizophrenia Treatment: Effective in managing both acute and    chronic symptoms, providing patients with improved stability and symptom relief.

Mood Disorders: Utilized in treatment plans for depressive episodes, aiding in emotional regulation and symptom management.

Therapeutic Uses and Indications

Amisulpride is specifically formulated to offer therapeutic benefits in the treatment of:

Schizophrenia: Helps alleviate both positive and negative symptoms, promoting better overall functionality.

Mood Disorders: Supports treatment regimens for mood stabilization and reduced depressive symptoms.

Mechanism of Action

Amisulpride is a dopamine receptor antagonist that selectively works on dopamine D2 and D3 receptors. As an antipsychotic agent, amisulpride alleviates both positive and negative symptoms of schizophrenia, and it exhibits antidepressant properties in patients with psychiatric disorders, dysthymia, and major depression. Amisulpride predominantly works in the limbic system, which explains its relatively lower risk of extrapyramidal adverse effects compared to other atypical antipsychotic agents. Oral tablets of amisulpride are used as treatment for acute and chronic schizophrenic disorders, as well as secondary negative symptoms in mental health disorders such as affective disorders, depressive mood, and mental retardation.

Advantages and Key Features

High Purity and Quality Assurance: Every batch undergoes rigorous testing to maintain high purity levels and ensure reliable therapeutic outcomes.

Non-Sedative Profile: Minimal central nervous system penetration, reducing sedative effects compared to first-generation antipsychotics.

Timely Delivery: Bio-Synth’s commitment to timely and reliable delivery meets the demanding schedules of pharmaceutical partners.

Competitive Pricing: Affordable pricing without compromising on quality, ensuring accessible solutions for clients.

Customizable Solutions: Tailored production to meet specific client needs.

Amisulpride Intermediates in India

As a comprehensive supplier, Bio-Synth also provides Amisulpride intermediates, essential components in the synthesis of Amisulpride API. Our high-purity intermediates are produced under stringent quality controls to support the development of effective and reliable antipsychotic medications. By ensuring the purity and consistency of these intermediates, Bio-Synth facilitates the seamless manufacturing of Amisulpride API for pharmaceutical companies worldwide.

Key Features of Amisulpride Intermediates


High Purity Levels: Maintained through rigorous quality testing and advanced manufacturing practices.

Compliance with Global Standards: Adheres to WHO-GMP and ISO 9000:2015 certifications.

Supply Chain: Ensures timely delivery and reliable sourcing for manufacturers.

Customization Capabilities: Tailored production to meet specific client specifications and project needs.

                With our expertise as Amisulpride API manufacturers in India, Bio-Synth’s provision of Amisulpride intermediates positions us as a one-stop solution for pharmaceutical manufacturers seeking high-quality inputs for antipsychotic medication production.

Frequently asked questions

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    Amisulpride is primarily prescribed for the treatment of schizophrenia and mood disorders. It helps manage both acute and chronic symptoms, providing effective relief from psychotic episodes and mood disturbances. This antipsychotic agent promotes symptom stabilization, enabling patients to maintain better mental health and daily functionality.

    Amisulpride functions by selectively blocking dopamine D2 and D3 receptors in the brain, regulating dopamine transmission to manage and reduce psychotic symptoms. Its targeted mechanism ensures effective treatment without excessive sedation, making it suitable for long-term use and helping prevent the recurrence of psychotic episodes.

    Bio-Synth stands out as a trusted Amisulpride API manufacturer in India due to its strict adherence to global standards, such as WHO-GMP and ISO 9000:2015 certifications. We focus on high-quality, reliable production, offering competitive pricing and customizable solutions. Our robust quality control and consistent supply make Bio-Synth a dependable partner for pharmaceutical companies needing top-quality Amisulpride API.

    To place an order for Amisulpride API, contact Bio-Synth through our customer service team or by filling out the contact form on our website. We provide comprehensive support to guide you through the order process and ensure timely delivery to meet your specific project needs.