Delom-20 is formulated with Omeprazole 20mg as the active pharmaceutical ingredient (API), encapsulated in a robust, moisture-resistant hard gelatin capsule. The formulation is designed to ensure stability, uniformity, and bioavailability, meeting stringent pharmaceutical standards. The excipients include microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide, which enhance flow properties, disintegration, and tablet integrity. The capsule shell is manufactured to withstand environmental stressors while maintaining the API’s potency. The formulation process involves precise blending, compression, and encapsulation techniques to ensure consistent dosing and compliance with pharmacopeial requirements. The product’s pH-neutral formulation and controlled-release mechanism are optimized for stability during storage and transportation, ensuring product integrity across diverse climatic conditions.
Manufacturing Capability
Delwis Healthcare operates a state-of-the-art pharmaceutical manufacturing facility compliant with current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards. The facility is equipped with advanced infrastructure, including high-speed encapsulation machines, automated blending systems, and aseptic processing units for sterile drug production. Our manufacturing process adheres to strict quality control protocols, ensuring consistent product quality and regulatory compliance. The facility supports scalable production, enabling seamless transition from small batch trials to large-scale bulk supply. Sterile processing capabilities are maintained through ISO Class 7 and Class 8 cleanrooms, with real-time monitoring of critical parameters such as temperature, humidity, and particulate control. Quality systems are integrated throughout the production lifecycle, from raw material sourcing to final packaging, ensuring traceability and compliance with global pharmaceutical standards.
Available Strengths and Packaging
Composition: Omeprazole 20mg Cap.
Packaging: 10x10 Strip
Delom-20 is available exclusively in 20mg strength, packaged in a 10x10 strip format. The 10x10 strip ensures efficient storage, transportation, and retail display while maintaining product integrity. The packaging is designed to protect the API from light, moisture, and contamination, ensuring shelf stability up to the specified expiration date.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing, private label, and third-party manufacturing services tailored to pharmaceutical buyers. Our capabilities include API sourcing, formulation development, and full-scale production of finished dosage forms, enabling clients to leverage our expertise without upfront capital investment. We support private label manufacturing, allowing brands to produce high-quality products under their own trademarks while benefiting from our compliance-driven processes. Our contract manufacturing services are designed to meet the specific requirements of global markets, including adherence to local regulatory frameworks and labeling standards. By partnering with Delwis Healthcare, pharmaceutical buyers gain access to scalable production, cost-effective solutions, and end-to-end supply chain support.
Quality Assurance
Delwis Healthcare’s quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with international pharmacopeial standards. Each production batch undergoes comprehensive testing, including High-Performance Liquid Chromatography (HPLC) for API purity, dissolution testing for bioavailability, and microbial limit checks for sterility. Quality control systems are integrated at every stage, from raw material inspection to finished product release, ensuring adherence to ICH, USP, and EP guidelines. Our analytical laboratory is equipped with advanced instrumentation, including UV-Vis spectrophotometers, pH meters, and moisture analyzers, to validate product consistency. All quality records are maintained in accordance with cGMP requirements, providing transparency and traceability for pharmaceutical buyers.
Regulatory Compliance
Delwis Healthcare ensures full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 standards. Our manufacturing processes align with global regulatory frameworks, including the FDA’s Current Good Manufacturing Practice (CGMP) regulations and the European Medicines Agency (EMA) guidelines. The facility is certified under ISO 9001:2015, demonstrating a commitment to quality management systems. Additionally, we maintain compliance with WHO Prequalification criteria, enabling seamless export to low- and middle-income countries. All documentation, including batch records, stability data, and regulatory filings, is prepared to meet the requirements of international markets. This ensures that Delom-20 meets the highest standards of safety, efficacy, and quality for global distribution.
Global Supply Capability
Delwis Healthcare is a trusted exporter with a robust international distribution network spanning over 50 countries. Our bulk supply capacity is supported by a strategically located logistics infrastructure, enabling efficient and timely delivery to global markets. We offer flexible supply chain solutions, including long-term contracts, just-in-time delivery, and regional warehouse partnerships to ensure supply chain reliability. The company’s export capabilities are bolstered by compliance with international trade regulations, including the FDA’s Import Alert and the EU’s GMP guidelines. Bulk supply is managed through automated inventory systems, ensuring accurate order fulfillment and reduced lead times. Our commitment to supply chain transparency and reliability makes Delom-20 a preferred choice for pharmaceutical distributors and exporters seeking consistent, high-quality supply.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose Delwis Healthcare for its unwavering commitment to quality, regulatory compliance, and scalable production. Our expertise in bulk supply, combined with a proven track record of meeting global standards, ensures reliable access to high-purity Omeprazole 20mg capsules. The company’s investment in advanced manufacturing infrastructure and quality systems provides clients with competitive advantages, including cost-effective production, reduced time-to-market, and compliance-ready products. Delwis Healthcare’s dedication to innovation, sustainability, and customer-centric solutions further strengthens its position as a preferred partner in the pharmaceutical industry.
Bulk Supply Inquiry
Delwis Healthcare offers bulk supply of Delom-20 to meet the demands of pharmaceutical buyers worldwide. For inquiries regarding bulk orders, pricing, or customized packaging solutions, please contact us at info@delwishealthcare.com.
FAQs
What are the available strengths of Delom-20?
Delom-20 is exclusively available in 20mg strength, tailored for pharmaceutical buyers requiring standardized dosing.
What packaging options are available for Delom-20?
Delom-20 is packaged in a 10x10 strip format, designed for efficient storage, transportation, and retail display.
Does Delwis Healthcare offer contract manufacturing services?
Yes, Delwis Healthcare provides end-to-end contract manufacturing, private label, and third-party manufacturing solutions for pharmaceutical buyers.
What quality standards does Delom-20 comply with?
Delom-20 meets cGMP, WHO, ISO 9001:2015, and pharmacopeial standards (USP, EP, and BP), ensuring global regulatory compliance.
Can Delom-20 be supplied in bulk?
Yes, Delwis Healthcare offers bulk supply of Delom-20, with production capabilities to meet large-scale demand.
What certifications does Delwis Healthcare hold?
The company is certified under ISO 9001:2015, GMP, and WHO Prequalification, ensuring adherence to international quality standards.
How does Delwis Healthcare ensure supply chain reliability?
Our logistics infrastructure, regional warehouse partnerships, and automated inventory systems ensure timely and reliable bulk supply.
What is the shelf life of Delom-20?
Delom-20 has a shelf life of up to 24 months when stored under recommended conditions, as validated by stability testing.
Can Delwis Healthcare support customized packaging?
Yes, we offer customized packaging solutions to meet specific client requirements, including regional labeling and branding.
How can I inquire about bulk supply of Delom-20?
For bulk supply inquiries, please contact **info@delwishealthcare.com** to discuss pricing, order requirements, and logistics.
