Montelukast Sodium API & Manufacturer
Vubrix Pharma | GMP-Certified · India
Leading Montelukast Sodium manufacturer and supplier from India. GMP-certified API for regulated markets.
About Montelukast Sodium
Looking for Montelukast Sodium API & Manufacturer? Vubrix Pharma is a certified Montelukast Sodium API manufacturer in India, supplying GMP-grade material to formulation partners and distributors worldwide.
Leukotriene receptor antagonist API used in the prophylaxis and chronic treatment of asthma and allergic rhinitis. Vubrix Pharma manufactures Montelukast Sodium Active Pharmaceutical Ingredient in compliance with Good Manufacturing Practices (GMP) standards. Our state-of-the-art facility in Surat, Gujarat, India, produces high-quality pharmaceutical-grade material suitable for use in regulated markets worldwide. We maintain strict quality control throughout the manufacturing process, ensuring consistent purity, low impurity profiles, and compliance with pharmacopoeial standards (USP/EP/BP). Our Montelukast Sodium is manufactured with scale-up capability and full regulatory documentation support, including DMF/CTD preparation for US, EU, and other international regulatory submissions.
As a trusted Montelukast Sodium manufacturer, we supply Montelukast Sodium 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
- Montelukast Sodium is used as a pharmaceutical active ingredient in the production of leukotriene receptor antagonist api used in the prophylaxis and chronic treatment of asthma and allergic rhinitis.
- Manufacturing of pharmaceutical formulations requiring Montelukast Sodium
- Research and development applications in pharmaceutical synthesis
- Custom synthesis projects and contract manufacturing
Technical Specifications
- CAS Number: Available on request
- Type: API
- Category: apis
- Purity: Meets pharmacopoeial standards
- Quality: GMP certified
- Packaging: Available in various sizes
Storage & Handling
Storage Conditions
Store in a cool, dry place in a tightly closed container, protected from light and moisture, at controlled room temperature (15-30°C).
Handling Instructions
Handle with appropriate safety measures. Avoid contact with skin and eyes. Use in a well-ventilated area with proper personal protective equipment. Refer to Material Safety Data Sheet (MSDS) for detailed handling instructions.
- Therapeutic class: Antiasthmatic
- End application: Asthma and allergy formulations
Frequently Asked Questions
1.What is Montelukast Sodium used for?
Montelukast Sodium is primarily used in montelukast sodium is used as a pharmaceutical active ingredient in the production of leukotriene receptor antagonist api used in the prophylaxis and chronic treatment of asthma and allergic rhinitis.. It also finds applications in manufacturing of pharmaceutical formulations requiring montelukast sodium, research and development applications in pharmaceutical synthesis, custom synthesis projects and contract manufacturing.
2.Is Montelukast Sodium GMP certified?
Yes, Vubrix Pharma manufactures Montelukast Sodium 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 Montelukast Sodium?
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 Montelukast Sodium?
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 Montelukast Sodium?
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 Montelukast Sodium?
Yes, Vubrix Pharma offers custom synthesis services for Montelukast Sodium 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 Montelukast Sodium API & Manufacturer?
As your Montelukast Sodium API & Manufacturer, we offer GMP-certified manufacturing, DMF/CTD support, multi-ton capacity, and validated supply chain for US, EU, and regulated markets.