Levot Syrup is a multi-ingredient formulation designed to address respiratory conditions through synergistic action of its active components. The combination of Levosalbutamol (1mg), Ambroxol Hydrochloride (30mg), and Guaiphenisin (50mg) is carefully balanced to ensure stability, solubility, and uniform dispersion in the 100ml syrup base. Levosalbutamol, a selective β2-agonist, is formulated to enhance bronchodilation, while Ambroxol Hydrochloride acts as a mucolytic agent to reduce mucus viscosity. Guaiphenisin, a cough suppressant, complements the formulation by modulating bronchial secretions. The excipients, including purified water, citric acid, and preservatives, are selected for their compatibility with active ingredients and to maintain pH stability. The syrup’s viscous consistency ensures prolonged contact with mucosal surfaces, enhancing therapeutic efficacy. Formulation development involved rigorous compatibility testing, dissolution profiling, and stability studies to ensure uniform drug release and shelf-life compliance.
Manufacturing Capability
Our manufacturing infrastructure is engineered to meet the complexities of multi-ingredient syrup formulations. The facility is equipped with state-of-the-art pharmaceutical-grade equipment, including high-speed mixers, homogenizers, and sterile filling lines, ensuring precise blending and consistent product quality. Sterile processing is achieved through validated aseptic techniques, with dedicated cleanrooms maintaining Class 10,000 to Class 100 air quality standards. Good Manufacturing Practice (GMP) compliance is enforced through ISO 9001-certified quality management systems, ensuring adherence to international standards for pharmaceutical production. Production scalability is supported by modular manufacturing units capable of handling bulk orders while maintaining batch uniformity. Automated quality control checkpoints, including in-process testing and real-time monitoring, ensure deviations are detected and corrected promptly. The facility’s robust quality systems include validated analytical methods for potency, impurity profiling, and microbial testing, ensuring compliance with regulatory requirements.
Available Strengths and Packaging
Composition: Levosalbutamol 1mg + Ambroxol Hydrochloride 30mg + Guaiphenisin 50mg Syp.
Packaging: 100ml
The product is available in a single strength formulation, with each 100ml bottle containing 1mg of Levosalbutamol, 30mg of Ambroxol Hydrochloride, and 50mg of Guaiphenisin. The packaging is designed for stability during transportation and storage, with tamper-evident closures and child-resistant features to ensure product integrity.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where clients can brand the product under their own trademarks, and contract manufacturing for OEM/ODM requirements. We support customization of packaging, labeling, and dosage forms while maintaining compliance with global regulatory standards. Our team collaborates closely with clients to align formulations with specific market requirements, ensuring adherence to pharmacopeial standards and quality specifications. Whether producing for domestic or international markets, we provide scalable solutions that meet the demands of bulk supply, export, and specialty pharmaceuticals.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with pharmaceutical quality standards. Each production batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for potency, dissolution testing for bioavailability, and microbial limit testing for sterility. Raw materials are sourced from certified suppliers and subjected to in-process testing to ensure purity and consistency. Finished products are validated against USP, EP, and BP monographs, with documentation traceable to raw material origins. Automated data systems ensure real-time monitoring of critical parameters, while batch records are maintained for audit trails. Our commitment to quality is reinforced by continuous improvement programs, ensuring adherence to Good Manufacturing Practice (GMP) and regulatory expectations.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practice (GMP), World Health Organization (WHO) guidelines, and international standards such as ISO 9001 and ISO 14001. Our manufacturing processes adhere to FDA, EMA, and PIC/S regulations, enabling seamless export to global markets. Certifications include ISO 17025 for laboratory testing and ISO 22000 for food safety management, reflecting our dedication to quality and safety. Regulatory documentation, including batch certificates of analysis (CoA), stability data, and regulatory filings, is prepared to meet the requirements of regulatory authorities worldwide. Our compliance framework ensures that products meet pharmacopeial standards and are eligible for registration in target markets, reducing time-to-market for pharmaceutical buyers.
Global Supply Capability
Our global supply capability is supported by an extensive international distribution network, enabling efficient export to over 150 countries. We offer bulk supply options tailored to meet the demands of large-scale distributors, exporters, and contract manufacturers. Our logistics partners provide end-to-end solutions, including customs clearance, temperature-controlled shipping, and real-time tracking systems to ensure timely delivery. The facility’s capacity to produce in bulk ensures consistent supply chains, with inventory management systems to mitigate disruptions. We prioritize supply chain reliability through redundant production lines, strategic regional warehouses, and long-term partnerships with logistics providers. This infrastructure supports pharmaceutical buyers seeking dependable, scalable solutions for global market expansion.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in multi-ingredient syrup formulation, regulatory compliance, and bulk supply capabilities. Our commitment to quality, combined with scalable manufacturing and global distribution networks, positions us as a reliable partner for diverse market needs. We offer competitive pricing, customized solutions, and transparent communication to build long-term partnerships. With a proven track record of meeting stringent regulatory standards and delivering on-time deliveries, we provide the assurance required for pharmaceutical buyers to succeed in competitive markets.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com. Our dedicated team is ready to assist with order placements, customization requests, and regulatory documentation to support your pharmaceutical supply chain.
FAQs
What manufacturing standards does Levot Syrup comply with?
Levot Syrup is manufactured in compliance with Good Manufacturing Practice (GMP), ISO 9001, and WHO guidelines, ensuring adherence to international quality standards.
Can Levot Syrup be produced in bulk for export?
Yes, our facility is equipped for bulk production, supporting scalable supply for global markets with reliable export capabilities.
What excipients are used in the formulation?
The syrup contains purified water, citric acid, and preservatives selected for compatibility with active ingredients and pH stability.
Does the product meet pharmacopeial standards?
Yes, Levot Syrup is validated against USP, EP, and BP monographs, ensuring compliance with regulatory requirements.
Can third-party manufacturers produce this formulation?
We offer contract manufacturing services, enabling third-party buyers to produce Levot Syrup under their brand while maintaining quality standards.
What is the shelf life of Levot Syrup?
The product has a shelf life of 24 months when stored under recommended conditions, as confirmed by stability testing.
Is the packaging child-resistant?
Yes, the 100ml packaging includes child-resistant closures to ensure product safety.
How is quality assured during production?
Quality is ensured through in-process testing, batch validation, and continuous monitoring against GMP and ISO standards.
Can the formulation be customized for specific markets?
Yes, we support customization of packaging, labeling, and dosage forms to meet regional regulatory and market requirements.
What documentation is provided for regulatory submissions?
Comprehensive documentation, including batch certificates of analysis (CoA), stability data, and regulatory filings, is provided to support global market registration.
