Dropet CPM is a dual-action syrup formulated with Levodropropizine (30mg/5ml) and Chlorpheniramine Maleate (2mg/5ml), designed to provide synergistic therapeutic effects for respiratory and allergic conditions. The formulation employs a stable aqueous base with excipients such as purified water, citric acid, and sodium bicarbonate to ensure compatibility, homogeneity, and pH stability. Levodropropizine, a centrally acting antitussive, is formulated to enhance expectoration and reduce cough reflex, while Chlorpheniramine Maleate, a first-generation antihistamine, targets allergic symptoms such as rhinorrhea and sneezing. The combination is optimized for uniform dispersion, ensuring consistent dosing and bioavailability. The syrup’s viscous consistency and preservative-free formulation support long-term storage and ease of administration. From a manufacturing perspective, the product is developed using advanced blending and homogenization techniques to achieve a stable, isotonic solution with minimal particulate matter, ensuring compliance with pharmaceutical formulation standards.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production, with state-of-the-art facilities compliant with cGMP, ISO 9001, and WHO guidelines. The facility includes a dedicated syrup formulation line equipped with high-speed blending, homogenization, and filtration systems to ensure precision in active pharmaceutical ingredient (API) dispersion. Sterile processing capabilities are available for critical components, supported by validated cleanroom environments and aseptic filling systems. Production scalability is achieved through modular manufacturing units capable of handling bulk orders for 100ml packaging, with capacity to scale up to meet global demand. Quality systems include real-time monitoring, automated process controls, and rigorous validation protocols to ensure reproducibility and consistency. The facility is regularly audited by third-party agencies and regulatory bodies to maintain compliance and operational excellence.
Available Strengths and Packaging
Composition: Levodropropizine 30mg + Chlorpheniramine Maleate 2mg /5ml Syp.
Packaging: 100ml
The product is available in a standardized 100ml packaging, with each 5ml dose containing 30mg Levodropropizine and 2mg Chlorpheniramine Maleate. This formulation ensures precise dosing and ease of administration, supporting both institutional and retail distribution.
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 we produce under a client’s brand name, and contract manufacturing for OEM/ODM requirements. We support customization of packaging, labeling, and formulation parameters to align with regional regulatory standards and market-specific demands. Our team collaborates closely with clients to ensure adherence to specifications, including API sourcing, formulation development, and regulatory documentation. Whether you require bulk supply or specialized packaging solutions, our flexible manufacturing infrastructure ensures timely delivery and compliance with global quality benchmarks.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Every production batch undergoes comprehensive testing, including HPLC for API quantification, microbial limit testing, and pH/viscosity analysis to ensure product integrity. Quality control systems are integrated with automated data collection and traceability tools to maintain transparency throughout the supply chain. We validate raw materials, in-process samples, and finished products against USP, EP, and ICH guidelines, ensuring consistency and safety. Additionally, our facility maintains a robust corrective and preventive action (CAPA) program to address deviations and continuously improve manufacturing processes.
Regulatory Compliance
We ensure full compliance with GMP, WHO guidelines, ISO 9001, and regional regulatory frameworks such as FDA, EMA, and PIC/S. Our manufacturing processes are validated to meet the requirements of ICH Q7 for API manufacturing and ICH Q8 for quality by design (QbD) principles. All documentation, including batch records, stability data, and regulatory filings, is maintained in accordance with Good Documentation Practices (GDP). Our facility is registered with key regulatory authorities and holds certifications for export to markets across Europe, Asia, and the Americas. This ensures seamless compliance with global standards and facilitates smooth market entry for pharmaceutical buyers.
Global Supply Capability
With a robust international distribution network, we provide reliable bulk supply to over 50 countries, supported by strategic partnerships with logistics providers and customs brokers. Our export capabilities include compliance with phytosanitary, sanitary, and regulatory requirements for destination markets. The 100ml packaging is optimized for bulk transportation, with secure storage and shipping solutions to maintain product integrity during transit. Our supply chain is designed for scalability, with inventory management systems to ensure timely delivery and minimize lead times. We prioritize supply chain reliability through redundant manufacturing capabilities, real-time tracking, and contingency planning to meet urgent demand without compromising quality.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in high-quality formulation, compliance-driven manufacturing, and global supply capabilities. Our commitment to cGMP, ISO, and WHO standards ensures that every product meets the highest quality benchmarks. With a proven track record in bulk supply and private label manufacturing, we deliver cost-effective solutions tailored to your business needs. Our responsive customer support, transparent documentation, and scalable production infrastructure position us as a reliable partner for expanding your market reach.
Bulk Supply Inquiry
We offer seamless bulk supply solutions for Dropet CPM. For inquiries regarding large-scale procurement, packaging customization, or export requirements, contact our team at info@delwishealthcare.com.
FAQs
Is Dropet CPM manufactured under cGMP standards?
Yes, our manufacturing processes adhere to current Good Manufacturing Practices (cGMP) and ISO 9001 standards to ensure quality and consistency.
Can Dropet CPM be customized for different packaging sizes?
While the standard packaging is 100ml, we offer customization options for bulk supply and specialized packaging formats upon request.
What regulatory certifications does Dropet CPM hold?
The product complies with GMP, WHO guidelines, and ISO standards, with certifications for export to major global markets including the EU, US, and Asia.
How does your facility ensure product stability?
We employ advanced formulation techniques, including pH adjustment and preservative-free excipients, to ensure stability during storage and transportation.
Can you provide private label manufacturing for Dropet CPM?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own name while maintaining quality and compliance.
What is the minimum order quantity for bulk supply?
Bulk supply is available in flexible quantities, with minimum order requirements tailored to client needs and production capacity.
How do you ensure compliance with international regulatory frameworks?
Our facility is registered with global regulatory authorities, and all documentation is prepared to meet FDA, EMA, and PIC/S requirements.
What is your lead time for bulk orders?
Lead times vary based on order size and customization requirements, but we prioritize efficient production and delivery to meet urgent demand.
Can you assist with export documentation and customs clearance?
Yes, our team provides support for export documentation, including phytosanitary certificates and compliance with destination country regulations.
How do you handle quality deviations during production?
We maintain a robust CAPA program to investigate deviations, implement corrective actions, and prevent recurrence through continuous improvement.
