Vildet 100 is a solid dosage form containing Vildagliptin as the active pharmaceutical ingredient (API), formulated into 100mg tablets. The tablet composition includes excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide, ensuring optimal disintegration, dissolution, and stability. The formulation is designed to maintain chemical and physical integrity under varied storage conditions, with a focus on bioavailability and shelf life. The manufacturing process employs high-speed tablet compression technology to achieve uniform content, hardness, and weight variation, while excipients are selected for compatibility with the API and to ensure stability against environmental factors such as humidity and light. The final product meets pharmacopoeial standards for purity, potency, and dissolution profile, ensuring consistency for pharmaceutical manufacturers seeking reliable raw materials or finished dosage forms.
Manufacturing Capability
Our 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 advanced tablet compression machines, coating systems, and automated packaging equipment to ensure precision and scalability. Sterile processing capabilities are available for critical components, with controlled environments to prevent contamination. The facility adheres to rigorous quality systems, including real-time monitoring, in-process testing, and batch-specific documentation to guarantee product consistency. Production scalability is supported by modular design, enabling seamless transitions from small-scale trials to bulk manufacturing. Quality systems are integrated with traceability protocols, ensuring full compliance with regulatory requirements for pharmaceutical suppliers and manufacturers.
Available Strengths and Packaging
Composition: Vildagliptin 100mg Tablets
Packaging: 10x10 Alu/Alu
The product is available in a 100mg strength, packaged in 10x10 blister packs with aluminum/aluminum (Alu/Alu) layers. This packaging provides robust protection against moisture, light, and physical damage, ensuring product stability during storage and transportation. The blister format is ideal for pharmaceutical manufacturers requiring secure, tamper-evident packaging for bulk supply or 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. Our capabilities include private label manufacturing, where we produce finished dosage forms under a client’s brand name, as well as contract manufacturing for API-based formulations. We support customization of packaging, dosage strengths, and formulation parameters to meet specific regulatory and market requirements. Our team collaborates closely with clients to ensure adherence to global standards, including GMP, WHO, and FDA guidelines, while maintaining cost-efficiency and scalability for bulk supply.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with international pharmacopoeial standards. Each production batch undergoes in-process testing for critical parameters such as content uniformity, disintegration time, and dissolution efficiency. Final product testing includes potency assays, impurity analysis, and microbial limits to ensure safety and efficacy. Advanced analytical techniques, including HPLC and mass spectrometry, are employed for method validation and stability testing. All quality control measures are documented to meet the requirements of pharmaceutical suppliers, exporters, and regulatory authorities, ensuring consistent quality for bulk supply and global distribution.
Regulatory Compliance
We adhere to stringent regulatory frameworks, including GMP, WHO guidelines, and ISO 9001 standards, to ensure compliance with global pharmaceutical requirements. Our manufacturing processes align with ICH guidelines for quality risk management and pharmacopeial standards for API and dosage form specifications. We maintain certifications for WHO prequalification and FDA registration, enabling seamless export to markets in the EU, US, and Asia. Regulatory compliance is integrated into every stage of production, from raw material sourcing to final packaging, ensuring that our products meet the demands of pharmaceutical manufacturers, distributors, and regulatory bodies worldwide.
Global Supply Capability
Our global supply chain is designed to support bulk supply, international distribution, and reliable export logistics. We maintain strategic partnerships with logistics providers to ensure timely delivery to over 50 countries, with compliance to international shipping regulations and customs protocols. Bulk supply capacity is supported by scalable production lines and inventory management systems, enabling rapid response to market demands. Our export capabilities include compliance with pharma-specific documentation, such as COA, MSDS, and regulatory approvals, ensuring smooth clearance through customs. Supply chain reliability is reinforced by redundant systems, real-time tracking, and a proven track record of meeting contractual obligations for pharmaceutical exporters and distributors.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in bulk supply, regulatory compliance, and end-to-end manufacturing solutions. Our commitment to quality, combined with scalable production and global distribution networks, ensures competitive advantage in the pharmaceutical market. We offer tailored services to meet the unique needs of clients, from API sourcing to finished product manufacturing, while maintaining strict adherence to GMP and ISO standards. Our transparent communication, responsive customer support, and cost-effective solutions position us as a reliable partner for pharmaceutical manufacturers seeking high-quality, compliant products for global markets.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customization, pricing, and logistics for pharmaceutical manufacturers and exporters.
FAQs
What manufacturing capabilities do you offer for Vildet 100?
We provide contract manufacturing, private label production, and bulk supply services for Vildet 100, adhering to GMP and ISO standards.
Can you customize packaging for Vildet 100?
Yes, we offer flexible packaging options, including 10x10 Alu/Alu blister packs, tailored to meet specific regulatory and market requirements.
What regulatory standards does your production process follow?
Our manufacturing process complies with GMP, WHO guidelines, ISO 9001, and ICH standards, ensuring global regulatory compliance.
How do you ensure quality control for Vildet 100?
Each batch undergoes rigorous testing for potency, dissolution, impurities, and microbial limits, with full documentation for pharmaceutical suppliers.
Can you support export to international markets?
Yes, we have a global distribution network and compliance with pharma-specific documentation for seamless export to over 50 countries.
What is the minimum order quantity for bulk supply?
We offer flexible bulk supply options, with quantities tailored to meet the needs of pharmaceutical manufacturers and exporters.
Do you provide analytical validation for Vildet 100?
Yes, our quality assurance includes HPLC and mass spectrometry validation for method accuracy and stability testing.
How do you ensure supply chain reliability?
Our supply chain is supported by real-time tracking, redundant systems, and partnerships with logistics providers for timely delivery.
Can you produce Vildet 100 under a private label?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own name.
What is your lead time for bulk orders?
Lead times vary based on order size and customization requirements, with priority given to pharmaceutical exporters and distributors.
