Dextrom Syrup is a multi-ingredient formulation designed for the symptomatic relief of respiratory conditions. The active ingredients—Dextromethorphan, a centrally acting cough suppressant; Phenylephrine, a nasal decongestant; and Chlorpheniramine Maleate, an antihistamine—work synergistically to address cough, nasal congestion, and allergic rhinitis. The syrup’s formulation ensures optimal solubility, stability, and palatability, with a balanced pH and viscosity to enhance patient compliance. From a manufacturing perspective, the product is developed using advanced excipient compatibility testing to ensure stability of active pharmaceutical ingredients (APIs) under varying storage conditions. The formulation process involves precise blending of APIs with excipients such as purified water, preservatives, and flavoring agents, followed by homogenization to achieve a uniform suspension. The final product is packaged in a 100ml container, ensuring ease of administration and shelf stability.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce Dextrom Syrup at scale, adhering to current Good Manufacturing Practices (cGMP) and international quality standards. The facility includes state-of-the-art equipment for API synthesis, formulation development, and bulk packaging, including high-speed mixers, homogenizers, and aseptic filling lines for non-sterile products. The production process is validated for consistency, with rigorous controls over temperature, humidity, and particle size to ensure product homogeneity. Our quality systems integrate Hazard Analysis and Critical Control Points (HACCP) principles to mitigate contamination risks. The facility is certified under ISO 9001 and ISO 14001, ensuring compliance with environmental and operational excellence standards. Scalability is achieved through modular production lines, allowing seamless transitions from small batches to large-scale manufacturing without compromising quality.
Available Strengths and Packaging
Composition: Dextromethorphan 10mg + Phenylephrine 5mg + Chlorpheniramine Maleate 2mg Syp.
Packaging: 100 ml
The product is available in a standardized 100ml syrup formulation, ensuring consistent dosing and ease of use. The combination of active ingredients is calibrated to meet therapeutic requirements while maintaining stability in the aqueous medium. The packaging is designed for bulk distribution, with a focus on durability and compliance with pharmaceutical storage guidelines.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and private label services tailored to pharmaceutical buyers. Our capabilities include formulation development, API sourcing, and full-scale production of finished dosage forms, with flexibility to accommodate custom specifications. We support third-party manufacturers by providing turnkey solutions, from raw material procurement to regulatory documentation, ensuring compliance with global standards. Our expertise extends to private label manufacturing, enabling clients to brand products under their own trademarks while leveraging our production efficiency and quality assurance systems.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation and batch-specific testing protocols. Each production batch undergoes comprehensive testing for potency, dissolution, impurities, and microbial limits using high-performance liquid chromatography (HPLC) and UV spectrophotometry. Process validation ensures consistency in formulation, while stability studies confirm shelf-life compliance under accelerated and real-time conditions. Quality control systems are integrated with real-time monitoring tools, enabling traceability and corrective action protocols. Compliance with International Council for Harmonisation (ICH) guidelines and United States Pharmacopeia (USP) standards ensures product reliability for global markets.
Regulatory Compliance
We adhere to stringent regulatory frameworks, including cGMP, WHO guidelines, and ISO 17025 accreditation for laboratory testing. Our manufacturing processes comply with regional and international regulations, such as the U.S. FDA’s current good manufacturing practice (CGMP) and the European Medicines Agency (EMA) guidelines. Documentation for audits, including batch records, stability data, and validation reports, is maintained to meet regulatory inspections. Additionally, our facility is registered with key regulatory bodies, ensuring seamless compliance for exports to markets in the EU, Asia, and the Americas.
Global Supply Capability
Our global supply chain is designed to meet the demands of international pharmaceutical markets. With a network of logistics partners, we ensure timely delivery of bulk supplies to over 50 countries. The 100ml packaging is optimized for bulk storage and transportation, with temperature-controlled shipping options to maintain product integrity. Our supply chain reliability is supported by redundant inventory systems, real-time tracking, and compliance with international shipping regulations. We prioritize sustainable practices, including eco-friendly packaging and carbon-neutral shipping options, to align with global environmental standards.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant formulations. Our competitive advantages include ISO-certified manufacturing, flexible production scales, and a dedicated team of pharmacists and engineers. We offer end-to-end solutions, from formulation development to global distribution, ensuring seamless integration into clients’ supply chains. Our commitment to innovation, combined with rigorous quality control, positions us as a reliable partner for bulk supply and regulatory compliance.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Dextrom Syrup adhere to?
Dextrom Syrup is produced under cGMP, ISO 9001, and ISO 14001 certifications, ensuring compliance with global pharmaceutical standards.
Can the product be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own trademarks.
What is the shelf life of Dextrom Syrup?
The product has a shelf life of 24 months when stored at controlled room temperature (15–30°C).
Does the packaging support bulk export requirements?
The 100ml packaging is designed for bulk distribution, with compliance to international shipping and storage regulations.
What quality control measures are in place for batch testing?
Each batch undergoes potency, dissolution, impurity, and microbial testing using HPLC and UV spectrophotometry.
Can the formulation be adjusted for different markets?
Yes, we offer formulation customization to meet regional regulatory requirements and therapeutic preferences.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be discussed based on production capacity and client needs.
How does your supply chain ensure reliability for international exports?
Our logistics network includes temperature-controlled shipping, real-time tracking, and compliance with global shipping regulations.
Are there options for eco-friendly packaging?
Yes, we provide sustainable packaging solutions, including recyclable materials and carbon-neutral shipping options.
What regulatory documentation is provided for exports?
We supply complete regulatory documentation, including batch certificates, stability data, and compliance reports for global markets.
