Dexclin is a meticulously formulated combination capsule containing Doxycycline 100mg as the active pharmaceutical ingredient (API) and Lactobacillus (5 billion spores) as a probiotic component. The formulation integrates a broad-spectrum antibiotic with a live microbial supplement, ensuring stability and compatibility during manufacturing. The capsule shell is composed of high-quality excipients, including hydrophilic cellulose and gelatin, which provide optimal disintegration properties and protect the probiotic content from environmental stressors. The API is micronized to enhance bioavailability, while the probiotic is encapsulated in a moisture-resistant matrix to maintain viability. The formulation is designed for uniform content distribution, ensuring consistent dosing and therapeutic efficacy. Manufacturing processes prioritize controlled temperature and humidity conditions to preserve the integrity of both active and inactive ingredients, with rigorous testing to confirm stability over the product’s shelf life.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The production line includes automated capsule filling, sealing, and blistering systems, enabling precise dosing and contamination-free processing. Sterile processing capabilities are maintained through Class 10,000 cleanroom environments, ensuring the safety of both the API and probiotic components. The facility supports scalable production, with the ability to manufacture bulk quantities while maintaining consistency in quality and potency. Advanced quality systems, including real-time monitoring and data integrity protocols, ensure compliance with regulatory requirements. Our manufacturing process adheres to strict validation standards, with continuous process verification to guarantee reproducibility and reliability for global pharmaceutical buyers.
Available Strengths and Packaging
Composition: Doxycycline 100mg + Lactobacillus (5 billion spores) Caps
Packaging: 10x10 Blister
Dexclin is available in a single strength of Doxycycline 100mg, combined with Lactobacillus at 5 billion spores per capsule. The 10x10 blister packaging ensures secure, tamper-evident storage and distribution, with each blister containing 10 capsules for convenient dispensing. This packaging format is ideal for both retail and bulk supply, offering protection against moisture, light, and physical damage while maintaining product integrity during transit.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label, and third-party production services tailored to pharmaceutical buyers’ needs. Our facility supports customized formulations, branding, and packaging solutions, enabling clients to launch products under their own label while leveraging our expertise in API integration and probiotic stabilization. We provide end-to-end manufacturing support, from raw material sourcing to finished product packaging, ensuring compliance with global regulatory standards. Our scalable production capabilities allow for rapid response to market demands, with flexibility to adjust batch sizes and specifications based on client requirements.
Quality Assurance
Dexclin undergoes rigorous quality control systems to ensure compliance with pharmaceutical standards. Each batch undergoes analytical validation, including HPLC for API potency, microbial testing for contamination, and stability studies to confirm shelf life. In-process controls monitor critical parameters such as capsule weight, disintegration time, and microbial load, ensuring consistency across production runs. Finished products are subjected to final testing for dissolution, microbial limits, and sterility, with documentation traceable to international pharmacopoeias (e.g., USP, EP). Our quality assurance framework includes regular internal audits, vendor qualification programs, and third-party certification to guarantee product reliability for global markets.
Regulatory Compliance
Dexclin is manufactured in full compliance with GMP, WHO guidelines, and ISO 17025 standards, ensuring adherence to international regulatory frameworks. Our facility is certified by regulatory authorities in multiple jurisdictions, including the FDA, EMA, and PIC/S, enabling seamless export to global markets. The product meets specifications for both pharmaceutical and probiotic components, with documentation supporting compliance with ICH guidelines and pharmacopeial standards. We maintain a robust regulatory affairs team to navigate regional requirements, ensuring timely approval for market entry and sustained compliance with evolving standards.
Global Supply Capability
Our global supply chain is designed to meet the demands of pharmaceutical distributors, exporters, and contract manufacturers. With a well-established international distribution network, we facilitate reliable delivery to over 50 countries, supported by partnerships with logistics providers specializing in temperature-controlled and secure transport. Bulk supply capacity is optimized through automated packaging and warehousing systems, enabling large-scale orders without compromising quality or lead times. Our supply chain reliability is reinforced by real-time tracking systems, inventory management protocols, and contingency planning to mitigate disruptions. This ensures consistent availability of Dexclin for clients worldwide.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in dual-action formulations, compliance-driven manufacturing, and scalable production. Our commitment to quality, combined with a proven track record of regulatory adherence, positions us as a reliable partner for global markets. The ability to customize packaging, branding, and production specifications allows clients to meet specific market demands while leveraging our operational efficiency. Additionally, our competitive pricing, fast turnaround times, and dedicated customer support enhance value for B2B buyers seeking dependable, high-quality pharmaceutical solutions.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Dexclin comply with?
Dexclin is manufactured in full compliance with cGMP, WHO guidelines, ISO 9001, and ISO 17025 standards, ensuring adherence to global regulatory requirements.
Can Dexclin be produced in different packaging formats?
While the standard packaging is 10x10 blister, we offer customization for alternative formats, including vials, bottles, and blister packs, based on client specifications.
How is the probiotic component preserved during manufacturing?
The Lactobacillus is encapsulated in a moisture-resistant matrix and processed in controlled environments to maintain viability, with stability testing confirming shelf-life compliance.
What is the minimum order quantity for bulk supply?
We accommodate bulk orders starting from 10,000 units, with flexible scaling options to meet large-scale distribution needs.
Does your facility support private label manufacturing?
Yes, we provide private label manufacturing services, enabling clients to brand Dexclin under their own label while maintaining quality and compliance.
How do you ensure the sterility of the probiotic component?
Sterile processing is conducted in Class 10,000 cleanrooms, with additional microbial testing to confirm the absence of contaminants in the final product.
What regulatory approvals are required for exporting Dexclin?
Export compliance is managed through FDA, EMA, and PIC/S certifications, with documentation supporting market entry in target regions.
Can you provide certificates of analysis (CoA) for each batch?
Yes, we provide detailed CoAs for every batch, including HPLC data, microbial testing results, and stability reports.
How long does it take to fulfill a bulk order?
Lead times vary based on order size, but we typically deliver bulk supplies within 4–6 weeks, with expedited options available for urgent requirements.
What support is available for quality assurance?
Our team offers technical support, regulatory guidance, and third-party audit services to ensure clients meet quality and compliance standards.
