DG Cap is a synergistically formulated combination medication designed for pharmaceutical manufacturers requiring a high-quality, ready-to-market product for respiratory and allergic symptoms. The formulation integrates five active pharmaceutical ingredients (APIs) in precise therapeutic dosages: Dextromethorphan 15mg (a centrally acting cough suppressant), Cetrizine 5mg (an antihistamine for allergic rhinitis), Phenylephrine 10mg (a decongestant for nasal congestion), Ambroxol 30mg (an expectorant for mucus clearance), and Guaiphenesin 100mg (a mucolytic agent to enhance bronchial secretion). The combination is designed to address multiple symptoms associated with upper respiratory tract infections, allergic reactions, and bronchial secretions.
From a formulation perspective, DG Cap employs a stable, solid dosage form optimized for uniformity, disintegration, and dissolution. The APIs are combined with excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure compatibility, flowability, and compression integrity. The formulation is designed to maintain chemical stability under standard storage conditions (15–30°C, RH 35–65%) and to resist degradation from environmental factors. The manufacturing process ensures precise blending, compression, and coating (if applicable) to meet pharmaceutical quality standards.
Manufacturing Capability
Delwis Healthcare’s pharmaceutical manufacturing infrastructure is equipped to produce DG Cap at scale, adhering to stringent Good Manufacturing Practice (GMP) standards. The facility includes state-of-the-art tablet compression machines, high-speed mixers, and advanced granulation systems to ensure consistent API distribution and tablet hardness. Sterile processing capabilities are available for critical components, with dedicated cleanrooms classified at ISO 7 and ISO 8 standards to prevent cross-contamination.
The manufacturing process is fully compliant with GMP guidelines, ensuring traceability, documentation, and batch-specific quality control. Production scalability is achieved through modular manufacturing lines capable of handling bulk orders while maintaining consistency in dosage form characteristics. Quality systems include real-time monitoring of critical parameters such as tablet weight, disintegration time, and dissolution efficiency. The facility also supports private label manufacturing and contract manufacturing services, enabling pharmaceutical buyers to customize packaging, labeling, and regulatory documentation.
Available Strengths and Packaging
DG Cap is formulated with fixed dosages of Dextromethorphan 15mg, Cetrizine 5mg, Phenylephrine 10mg, Ambroxol 30mg, and Guaiphenesin 100mg, ensuring therapeutic consistency across batches. The product is available in the packaging format of 10x10 Alu Alu, which provides a tamper-evident, moisture-resistant, and light-protected environment for pharmaceutical distribution. This packaging ensures product stability during transportation and storage while meeting global regulatory requirements for over-the-counter (OTC) medications.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive third-party manufacturing services, including private label and contract manufacturing, to meet the needs of pharmaceutical buyers seeking to source high-quality OTC products. Our facility is equipped to produce DG Cap under private label agreements, allowing clients to brand the product under their own trademarks while maintaining compliance with regulatory standards. Contract manufacturing capabilities include full-process support from API sourcing to final packaging, with flexibility to adapt to regional regulatory requirements.
For pharmaceutical manufacturers, DG Cap can be produced under a contract manufacturing agreement (CMA) with customized specifications, including dosage form modifications, packaging preferences, and labeling requirements. The facility’s compliance with GMP, ISO 9001, and WHO guidelines ensures that all products meet international quality benchmarks. This service is ideal for buyers seeking to expand their product portfolio without investing in in-house manufacturing infrastructure.
Quality Assurance
Delwis Healthcare’s quality assurance systems are designed to ensure the consistency, purity, and efficacy of DG Cap. Each batch undergoes rigorous analytical testing, including High-Performance Liquid Chromatography (HPLC) for API quantification, dissolution testing to assess drug release profiles, and microbial limit testing to ensure sterility. The quality control process also includes physical testing for tablet hardness, disintegration time, and weight variation to meet pharmacopeial standards.
Analytical validation is performed to confirm the accuracy of testing methods, ensuring reproducibility and reliability. All quality control data is documented and traceable, with batch-specific reports available for regulatory submissions. Compliance with pharmacopeial standards (USP, EP, BP) and international quality guidelines ensures that DG Cap meets the requirements of global markets.
Regulatory Compliance
DG Cap is manufactured in full compliance with Good Manufacturing Practice (GMP) standards, as mandated by the FDA, EMA, and WHO. The facility is certified under ISO 9001 for quality management systems and adheres to WHO guidelines for pharmaceutical production, including documentation, traceability, and environmental monitoring.
Regulatory compliance extends to packaging and labeling, which are designed to meet the requirements of the U.S. FDA, EU MDR, and other international regulatory frameworks. The product is also compliant with the ICH Q7 guidelines for API manufacturing and the ICH Q8 for quality by design (QbD) principles. These measures ensure that DG Cap is suitable for export to markets with stringent regulatory environments.
Global Supply Capability
Delwis Healthcare has a robust global supply chain infrastructure, enabling seamless export and distribution of DG Cap to over 50 countries. The company maintains a network of international logistics partners, ensuring reliable transportation of bulk orders through air, sea, and land routes. Bulk supply capacity is supported by a dedicated warehouse and inventory management system, with the ability to fulfill large-scale orders without compromising quality or delivery timelines.
Supply chain reliability is ensured through real-time tracking systems, compliance with international shipping regulations, and adherence to customs documentation requirements. The facility is equipped to handle both small and large-volume orders, with flexibility to adjust production schedules to meet market demand. This capability positions DG Cap as a dependable choice for pharmaceutical distributors and exporters seeking consistent supply chain performance.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from Delwis Healthcare’s expertise in producing high-quality, compliant OTC products like DG Cap. Our facility’s adherence to GMP, ISO, and WHO standards ensures that every batch meets the highest quality benchmarks. The ability to offer private label and contract manufacturing services provides flexibility for buyers to customize products for specific markets.
Additionally, our global supply chain infrastructure and bulk supply capabilities ensure timely delivery and cost-effective solutions for international clients. Delwis Healthcare’s commitment to innovation, compliance, and customer support makes us a trusted partner for pharmaceutical manufacturers seeking to expand their product offerings.
Bulk Supply Inquiry
Delwis Healthcare offers bulk supply capabilities for DG Cap, tailored to meet the needs of pharmaceutical buyers. For inquiries regarding bulk orders, packaging customization, or regulatory documentation, please contact us at info@delwishealthcare.com.
FAQs
What is the manufacturing process for DG Cap?
DG Cap is manufactured using a combination of direct compression and granulation techniques, ensuring uniform API distribution and tablet integrity. The process adheres to GMP standards and includes rigorous quality control checkpoints.
What excipients are used in DG Cap formulation?
The formulation includes microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide as excipients to ensure stability, flowability, and compression characteristics.
Is DG Cap compliant with international regulatory standards?
Yes, DG Cap is manufactured in compliance with FDA, EMA, WHO, and ISO standards, ensuring suitability for global markets.
Can DG Cap be produced under private label agreements?
Yes, Delwis Healthcare offers private label manufacturing services, allowing clients to brand DG Cap under their own trademarks.
What is the shelf life of DG Cap?
DG Cap has a shelf life of 24 months when stored under recommended conditions (15–30°C, RH 35–65%).
What packaging options are available for DG Cap?
DG Cap is available in 10x10 Alu Alu packaging, providing moisture resistance and tamper-evident protection.
Can DG Cap be customized for specific regional markets?
Yes, Delwis Healthcare offers customization options for packaging, labeling, and regulatory documentation to meet regional requirements.
What is the minimum order quantity for bulk supply?
Bulk supply options are flexible, with minimum order quantities tailored to the client’s requirements.
How does Delwis Healthcare ensure quality consistency?
Quality consistency is ensured through HPLC, dissolution testing, and microbial limit testing, with batch-specific documentation available for audit.
What export certifications does DG Cap have?
DG Cap is certified under GMP, ISO 9001, and WHO guidelines, ensuring compliance with international export regulations.
