Ambrodel Syrup is a meticulously formulated combination syrup designed to address respiratory tract secretion management and bronchodilation. The formulation integrates four active ingredients: Ambroxol (15mg), Terbutaline (1.25mg), Guaiphenesin (50mg), and Menthol (1mg). Ambroxol, a mucolytic agent, works by increasing the solubility of respiratory secretions, facilitating their removal. Terbutaline, a β2-agonist, provides bronchodilation by relaxing bronchial smooth muscle. Guaiphenesin acts as an expectorant, enhancing mucus clearance, while Menthol contributes to a soothing effect and improves the sensory properties of the syrup.
From a formulation perspective, the syrup is prepared using a pH-adjusted aqueous base to ensure stability and palatability. The active ingredients are dissolved in a compatible solvent system, with excipients such as preservatives, stabilizers, and flavoring agents added to maintain product integrity and enhance patient compliance. The formulation is designed to ensure uniform dispersion of active components, preventing precipitation and ensuring consistent therapeutic delivery. The final product is clear, isotonic, and free from particulate matter, meeting stringent pharmaceutical quality standards.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce Ambrodel Syrup with precision and scalability. The facility adheres to current Good Manufacturing Practices (cGMP) and is certified under ISO 9001 and ISO 14001 standards. The production process includes advanced sterile processing capabilities, ensuring contamination-free manufacturing for sensitive formulations.
The syrup is prepared in a dedicated formulation unit with state-of-the-art equipment, including high-speed dissolvers, homogenizers, and filtration systems. The process involves precise blending of active pharmaceutical ingredients (APIs) with excipients, followed by sterilization and packaging. The facility supports large-scale production, with a daily capacity of 10,000 liters, ensuring bulk supply for global markets.
Quality systems are integrated throughout the manufacturing lifecycle, with real-time monitoring of critical parameters such as pH, viscosity, and microbial load. The facility is equipped with a validated cleanroom environment (Class 10,000) to maintain sterility and prevent cross-contamination. Additionally, the infrastructure supports customization for private-label manufacturing and contract production, accommodating diverse regulatory and market requirements.
Available Strengths and Packaging
Composition: Ambroxol 15mg + Terbutaline 1.25mg + Guaiphenesin 50mg + Menthol 1mg Syp
Packaging: 100ml
Ambrodel Syrup is available in a single strength formulation, with each 100ml bottle containing the specified active ingredients. The packaging is designed for stability during storage and transportation, ensuring product integrity under varied environmental conditions.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our capabilities include private-label manufacturing, where we produce under a client’s brand name, and contract manufacturing for OEM/ODM requirements.
The facility is equipped to handle complex multi-ingredient formulations, ensuring precise dosing and consistent quality. We support customization of packaging, labeling, and dosage forms to meet specific market demands. Our team collaborates closely with clients to align production with regulatory requirements, including FDA, EMA, and WHO guidelines.
For bulk supply, we provide scalable solutions, with the ability to adjust production volumes based on market needs. Our contract manufacturing services are ideal for pharmaceutical distributors, exporters, and manufacturers seeking to expand their product portfolio without in-house production constraints.
Quality Assurance
Our quality assurance framework ensures rigorous control over every stage of Ambrodel Syrup production. Raw materials undergo stringent supplier qualification, with analytical testing for purity, potency, and heavy metal content. During manufacturing, in-process controls monitor parameters such as pH, viscosity, and homogeneity.
Batch testing includes dissolution testing, microbial limit testing, and stability studies to confirm shelf-life and efficacy. Analytical validation methods, including HPLC and UV spectroscopy, are employed to quantify active ingredients and ensure compliance with pharmacopoeial standards.
All products are tested against ICH guidelines and pharmacopoeial monographs (USP, EP, BP) to guarantee consistency and safety. The quality control team conducts regular audits and maintains detailed batch records, ensuring full traceability and compliance with international quality standards.
Regulatory Compliance
Ambrodel Syrup is manufactured in full compliance with global regulatory frameworks, including GMP, WHO guidelines, and ISO standards. The facility is certified under ISO 9001 for quality management and ISO 14001 for environmental management, reflecting our commitment to sustainable and compliant manufacturing.
Production adheres to cGMP regulations, with documented procedures for each step of the manufacturing process. The product is registered with regulatory authorities in key markets, including the FDA, EMA, and WHO, ensuring seamless export and market access. Our compliance with these standards ensures that Ambrodel Syrup meets the highest quality and safety benchmarks for international distribution.
Global Supply Capability
We provide robust global supply capabilities, including export-ready manufacturing, international distribution networks, and bulk supply solutions. Our logistics partners ensure timely delivery to over 50 countries, with a focus on reliability and compliance.
The facility is equipped for bulk production, with the capacity to supply large volumes to meet regional and global demand. Our supply chain is designed for resilience, with redundant systems to ensure uninterrupted delivery even during disruptions. We support both short-term and long-term contracts, offering flexible pricing and volume-based discounts for bulk orders.
Export compliance is managed through rigorous documentation, including Certificates of Analysis (CoA), batch-specific regulatory filings, and customs-ready packaging. This ensures seamless clearance and adherence to import regulations across target markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, multi-therapeutic formulations like Ambrodel Syrup. Our strengths include compliance with global regulatory standards, scalable manufacturing, and a proven track record in bulk supply.
We offer competitive pricing, with volume discounts for large orders, and prioritize customer collaboration to align production with market-specific requirements. Our commitment to quality, combined with a reliable supply chain and flexible manufacturing capabilities, positions us as a preferred partner for B2B buyers seeking trusted pharmaceutical solutions.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical manufacturers and distributors worldwide.
FAQs
What is the composition of Ambrodel Syrup?
Ambrodel Syrup contains Ambroxol 15mg, Terbutaline 1.25mg, Guaiphenesin 50mg, and Menthol 1mg per 100ml.
Can Ambrodel Syrup be manufactured in bulk?
Yes, our facility supports large-scale production, with a daily capacity of 10,000 liters for bulk supply.
What certifications does your manufacturing facility hold?
Our facility is certified under ISO 9001, ISO 14001, and adheres to cGMP and WHO guidelines.
Do you offer private-label manufacturing services?
Yes, we provide private-label manufacturing, allowing clients to brand the product under their own name.
What regulatory standards does Ambrodel Syrup comply with?
The product complies with FDA, EMA, WHO, and pharmacopoeial standards (USP, EP, BP).
Can you accommodate customized packaging and labeling?
Yes, we offer customization for packaging, labeling, and dosage forms to meet specific market needs.
What is the shelf life of Ambrodel Syrup?
The product has a shelf life of 24 months when stored under recommended conditions.
How do you ensure quality control during production?
We implement rigorous in-process controls, batch testing, and analytical validation to ensure consistency and safety.
What export compliance documentation do you provide?
We supply Certificates of Analysis (CoA), regulatory filings, and customs-ready documentation for seamless international trade.
How can I inquire about bulk supply?
Contact us at **info@delwishealthcare.com** for detailed information on bulk supply and pricing.
