Aripiprazole API & Manufacturer
Vubrix Pharma | GMP-Certified · India
Leading Aripiprazole manufacturer and supplier from India. GMP-certified API for regulated markets.
About Aripiprazole
Looking for Aripiprazole API & Manufacturer? Vubrix Pharma is a certified Aripiprazole API manufacturer in India, supplying GMP-grade material to formulation partners and distributors worldwide.
Aripiprazole is a second-generation atypical antipsychotic medication that acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and as an antagonist at serotonin 5-HT2A receptors. This unique mechanism of action makes it effective in treating schizophrenia, bipolar disorder, and as an adjunctive treatment for major depressive disorder. Vubrix Pharma manufactures Aripiprazole API in compliance with GMP standards, ensuring high purity (>99.5%) and consistent quality for pharmaceutical formulations worldwide.
As a trusted Aripiprazole manufacturer, we supply Aripiprazole API from our facility in Surat, Gujarat, with scale-up capability and full regulatory documentation (DMF/CTD) support for US, EU, and regulated markets.
Applications
- Treatment of schizophrenia in adults and adolescents
- Acute and maintenance treatment of bipolar I disorder
- Adjunctive therapy for major depressive disorder
- Treatment of irritability associated with autistic disorder in pediatric patients
Technical Specifications
- Molecular Formula: C23H27Cl2N3O2
- Molecular Weight: 448.38 g/mol
- Appearance: White to off-white crystalline powder
- Purity: ≥99.5% (by HPLC)
- Water Content: ≤0.5% (KF)
- Residual Solvents: Meets ICH Q3C requirements
- Heavy Metals: ≤20 ppm
- Assay: 98.0% - 102.0%
Storage & Handling
Storage Conditions
Store in a cool, dry place at controlled room temperature (15-30°C). Keep container tightly closed and protected from light. Store in original container.
Handling Instructions
Handle in accordance with good industrial hygiene and safety practices. Avoid contact with skin and eyes. Use appropriate personal protective equipment.
- CAS No.: 126722-12-6
- End Application: Antipsychotic
- GMP Certified
- DMF Available
- USP/EP Grade
Frequently Asked Questions
1.What is Aripiprazole used for?
Aripiprazole is primarily used in treatment of schizophrenia in adults and adolescents. It also finds applications in acute and maintenance treatment of bipolar i disorder, adjunctive therapy for major depressive disorder, treatment of irritability associated with autistic disorder in pediatric patients.
2.Is Aripiprazole GMP certified?
Yes, Vubrix Pharma manufactures Aripiprazole in compliance with Good Manufacturing Practices (GMP) standards. Our facility is GMP-certified and we supply pharmaceutical-grade material suitable for use in regulated markets including US, EU, and other international markets.
3.What documentation do you provide with Aripiprazole?
We provide comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), DMF/CTD support documents, and regulatory documentation as required. For APIs, we can provide Drug Master Files (DMF) for US FDA and European regulatory submissions.
4.What is the minimum order quantity for Aripiprazole?
Minimum order quantities vary based on the product and your specific requirements. We offer flexible ordering options from laboratory-scale quantities for R&D purposes to commercial-scale multi-ton supplies. Please contact our sales team for detailed pricing and MOQ information.
5.How do you ensure quality of Aripiprazole?
Quality assurance is integral to our manufacturing process. We employ rigorous quality control measures including HPLC analysis, GC-MS, NMR spectroscopy, and other advanced analytical techniques. All batches undergo comprehensive testing against pharmacopoeial standards (USP/EP/BP) before release. Our quality management system is ISO certified and follows ICH guidelines.
6.Can you provide custom synthesis of Aripiprazole?
Yes, Vubrix Pharma offers custom synthesis services for Aripiprazole and related compounds. Our R&D team can develop optimized synthetic routes, scale up processes, and provide custom modifications to meet your specific requirements. We work closely with clients from development through commercial production.
Why choose Vubrix Pharma as your Aripiprazole API & Manufacturer?
As your Aripiprazole API & Manufacturer, we offer GMP-certified manufacturing, DMF/CTD support, multi-ton capacity, and validated supply chain for US, EU, and regulated markets.