Cefadel -200 LB is a meticulously formulated combination tablet integrating Cefixime 200mg, a third-generation cephalosporin antibiotic, with Lactic Acid Bacillus, a probiotic strain. The formulation leverages advanced excipient compatibility testing to ensure stable co-existence of the active pharmaceutical ingredient (API) and probiotic component. Cefixime, known for its broad-spectrum antibacterial activity against Gram-positive and Gram-negative organisms, is combined with Lactic Acid Bacillus to enhance gastrointestinal tolerability and support microbiome balance. The tablet’s disintegration profile is optimized for rapid dissolution, ensuring consistent bioavailability of Cefixime while maintaining the viability of the probiotic strain. The formulation employs a controlled-release matrix to prolong therapeutic effect, with excipients selected for their chemical stability and compatibility with both the API and probiotic. This dual-ingredient approach addresses the growing demand for combination therapies that balance antimicrobial efficacy with gut health considerations, making it a versatile option for pharmaceutical manufacturers.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production, with state-of-the-art facilities equipped for sterile processing, high-volume tablet compression, and rigorous quality control. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains ISO 9001 certification, ensuring compliance with international standards. Advanced tabletting equipment, including high-speed rotary compressors and precision-coating systems, enables scalable production of Cefadel -200 LB while maintaining consistent tablet weight, hardness, and disintegration properties. The sterile processing capability includes isolator systems for probiotic integration, ensuring contamination-free handling of sensitive biological components. Our production lines are capable of scaling from small batch trials to large-scale commercial runs, with automated quality assurance systems monitoring critical process parameters in real time. The facility’s quality systems include validated analytical methods for API content uniformity, microbial limit testing, and stability studies, ensuring product consistency across all manufacturing batches.
Available Strengths and Packaging
Cefadel -200 LB is available in a single strength of 200mg Cefixime combined with Lactic Acid Bacillus. The product is packaged in 10x10 Alu Alu blister packs, offering a secure, moisture-resistant, and light-protected format ideal for pharmaceutical distribution. The blister packaging ensures tamper-evident sealing and facilitates efficient storage and transportation, meeting the needs of global supply chains.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to the needs of pharmaceutical buyers. Our private label manufacturing capabilities allow clients to brand and distribute products under their own trademarks, with full flexibility in packaging, labeling, and regulatory documentation. We specialize in producing high-quality combination therapies, including Cefadel -200 LB, for global markets, ensuring compliance with regional and international regulations. Our team of experts supports end-to-end production, from raw material sourcing to finished product release, enabling clients to streamline their supply chain while maintaining control over product specifications. Whether you require small-scale trials or large-volume commercial production, our scalable manufacturing infrastructure ensures timely delivery without compromising quality.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch-specific testing, and adherence to pharmacopoeial standards. Every production batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for API content verification, microbial limit testing, and dissolution profiling to ensure therapeutic efficacy. The probiotic component is validated for viability, potency, and stability under accelerated storage conditions, ensuring shelf-life consistency. Our quality control systems are ISO 17025 accredited, with dedicated laboratories equipped for advanced analytical techniques such as mass spectrometry and spectroscopy. All raw materials and finished products are subjected to stringent documentation and traceability protocols, ensuring compliance with USP, EP, and BP standards. This robust quality assurance approach guarantees that Cefadel -200 LB meets the highest benchmarks for pharmaceutical safety and performance.
Regulatory Compliance
We ensure full compliance with global regulatory frameworks, including Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001 and ISO 14001 standards. Our manufacturing processes are aligned with the requirements of the U.S. FDA, EU GMP, and ICH guidelines, enabling seamless export to international markets. Each batch of Cefadel -200 LB is documented with batch-specific certificates of analysis (CoA) and regulatory filings, supporting compliance with local and international pharmacopeial standards. Our facility maintains regular audits by regulatory authorities and third-party certification bodies, ensuring continuous adherence to evolving pharmaceutical regulations. This commitment to regulatory excellence positions us as a reliable supplier for pharmaceutical manufacturers seeking to meet global quality and safety benchmarks.
Global Supply Capability
With a proven track record in international pharmaceutical distribution, we provide reliable bulk supply capabilities to meet the demands of global markets. Our export infrastructure includes a well-established international distribution network, enabling efficient delivery to over 150 countries. We offer flexible bulk supply options, including containerized shipments and temperature-controlled logistics, to ensure product integrity during transit. Our supply chain reliability is supported by real-time tracking systems, inventory management tools, and partnerships with logistics providers specializing in pharmaceutical freight. Whether you require short-term trials or long-term bulk procurement, our team ensures timely delivery without compromising product quality. This global supply capability makes us a strategic partner for pharmaceutical distributors and exporters seeking consistent, high-quality supply chains.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our unmatched combination of quality, scalability, and regulatory expertise. Our cGMP-compliant manufacturing facilities ensure consistent product quality, while our global supply chain capabilities enable seamless international distribution. As a trusted supplier, we offer end-to-end solutions, from raw material sourcing to finished product delivery, reducing logistical complexities for buyers. Our commitment to innovation and compliance, coupled with competitive pricing and flexible production options, positions us as a preferred partner for manufacturers seeking reliable, high-quality pharmaceutical solutions.
Bulk Supply Inquiry
We offer robust bulk supply capabilities for Cefadel -200 LB. For inquiries regarding large-scale procurement, please contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Cefadel -200 LB comply with?
Cefadel -200 LB is manufactured in accordance with cGMP, ISO 9001, and WHO guidelines, 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 and distribute Cefadel -200 LB under their own trademarks.
What is the shelf life of Cefadel -200 LB?
The product has a shelf life of 24 months when stored under recommended conditions, with stability data validated through accelerated testing.
Is the packaging suitable for export?
The 10x10 Alu Alu blister packaging is designed for international distribution, offering moisture resistance, light protection, and tamper-evident sealing.
Can you produce small batches for trial purposes?
Yes, our scalable manufacturing infrastructure supports small-scale production for trial runs, with full documentation for regulatory compliance.
What quality control tests are performed on the product?
Each batch undergoes HPLC analysis, microbial limit testing, dissolution profiling, and probiotic viability testing to ensure product integrity.
What are the export capabilities for bulk supply?
We provide bulk supply options for global markets, with temperature-controlled logistics and real-time tracking to ensure product safety during transit.
How do you ensure regulatory compliance for international markets?
Our facility maintains regular audits by regulatory bodies and provides documentation aligned with FDA, EU GMP, and ICH guidelines for seamless global compliance.
Can the formulation be adapted for different dosage strengths?
Yes, our formulation expertise allows for customization of dosage strengths, subject to regulatory and pharmacological validation.
What is the minimum order quantity for bulk procurement?
Minimum order quantities are flexible and can be tailored to meet the specific needs of pharmaceutical buyers, with no rigid limits.
