Fluvip 10 is a solid dosage form containing Flunarizine as the active pharmaceutical ingredient (API), formulated into a 10mg tablet for consistent therapeutic delivery. The tablet is designed with a stable excipient matrix to ensure uniformity in weight, hardness, and disintegration time. The formulation incorporates disintegrants, binders, and lubricants to optimize tablet integrity and flow properties during manufacturing. The excipient selection ensures compatibility with Flunarizine’s chemical stability, minimizing degradation risks during storage and transportation. The tablet’s physicochemical properties, including solubility and bioavailability, are tailored to meet pharmaceutical specifications for efficacy and consistency. The formulation process adheres to strict quality parameters to ensure reproducibility and compliance with regulatory standards for dosage form development.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities for tablet compression, coating, and blister packaging, supporting scalable production of Fluvip 10. The facility complies with current Good Manufacturing Practices (cGMP) and maintains a controlled environment to ensure product purity and consistency. Sterile processing capabilities are available for critical components, with dedicated cleanrooms certified to ISO 7 and ISO 8 standards. The production line is designed for flexibility, enabling seamless transitions between batch sizes and formulations. Quality systems include real-time monitoring of critical parameters such as tablet weight, thickness, and dissolution rates. Our facility supports large-scale manufacturing, with a production capacity of up to 50 million tablets per month, ensuring timely delivery for global demand.
Available Strengths and Packaging
Composition: Flunarizine 10mg Tab
Packaging: 4x5x10 Blister
Fluvip 10 is available in a single strength of 10mg, optimized for therapeutic efficacy. The blister packaging (4x5x10) ensures secure, tamper-evident storage and distribution, with individual tablet compartments to prevent contamination and degradation. This format is ideal for retail and institutional markets, offering convenience for both patients and healthcare providers. The blister design supports extended shelf life, with airtight seals and UV protection to maintain API stability. The packaging dimensions and material specifications are tailored to meet international regulatory requirements for pharmaceutical products.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing services for pharmaceutical buyers, including private label production and third-party manufacturing solutions. Our facility is equipped to handle API sourcing, formulation development, and packaging for a wide range of dosage forms, including tablets, capsules, and injectables. We support customization of packaging formats, labeling, and dosage strengths to meet specific client requirements. Our team of pharmacists and engineers ensures compliance with regulatory guidelines while maintaining cost-efficiency and scalability. For pharmaceutical exporters and distributors, we provide end-to-end solutions, from raw material procurement to finished product delivery, ensuring seamless integration into global supply chains.
Quality Assurance
Our quality assurance systems are designed to meet the highest standards of pharmaceutical excellence. Every batch of Fluvip 10 undergoes rigorous testing, including in-process controls for tablet hardness, disintegration time, and content uniformity. Final product testing includes high-performance liquid chromatography (HPLC) analysis to confirm API purity and dissolution testing to ensure bioavailability. Analytical validation protocols are aligned with ICH and USP guidelines, ensuring data integrity and reproducibility. We maintain detailed batch records and stability studies to support shelf-life claims and regulatory submissions. Our quality control team employs advanced instrumentation and statistical process control (SPC) to monitor deviations and ensure consistent product quality.
Regulatory Compliance
Fluvip 10 is manufactured in full compliance with cGMP, WHO guidelines, and ISO 9001:2015 quality management standards. Our facility is certified by regulatory authorities in multiple jurisdictions, including the FDA, EMA, and PIC/S, ensuring adherence to global pharmaceutical regulations. Documentation processes are streamlined to meet requirements for regulatory submissions, including batch records, stability data, and deviation reports. We maintain compliance with Good Distribution Practices (GDP) to ensure safe and secure product handling throughout the supply chain. Our commitment to regulatory excellence extends to environmental sustainability, with waste management systems aligned with ISO 14001 standards.
Global Supply Capability
We specialize in exporting high-quality pharmaceutical products to over 50 countries, with a robust international distribution network covering key markets in Asia, Europe, and the Americas. Our bulk supply capacity ensures timely delivery of Fluvip 10 to meet large-scale demand, supported by a logistics infrastructure that includes temperature-controlled shipping and customs clearance expertise. Supply chain reliability is guaranteed through strategic partnerships with freight forwarders and local distributors, ensuring minimal lead times and consistent availability. We prioritize compliance with international trade regulations, including HS code classification and import documentation, to facilitate smooth cross-border transactions. Our ability to scale production and distribution makes us a preferred partner for pharmaceutical exporters and contract manufacturers.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our combination of technical expertise, regulatory compliance, and operational efficiency. Our cGMP-certified facility ensures product quality and consistency, while our flexible manufacturing capabilities allow customization to meet diverse market needs. We offer competitive pricing without compromising on quality, supported by a dedicated account management team to address client requirements promptly. Our global supply chain expertise and commitment to sustainability further enhance our value proposition, making us a reliable partner for long-term collaboration.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customized solutions, pricing, and delivery timelines.
FAQs
What certifications does your facility hold?
Our facility is certified under cGMP, ISO 9001:2015, and PIC/S, ensuring compliance with global pharmaceutical standards.
Can you customize packaging formats for Fluvip 10?
Yes, we offer customization of packaging formats, including blister packs, to meet specific client requirements.
What is the shelf life of Fluvip 10?
Fluvip 10 has a shelf life of 24 months when stored under recommended conditions, as confirmed by stability studies.
Do you support third-party manufacturing for Fluvip 10?
Yes, we provide third-party manufacturing services, including private label production and API sourcing.
What regulatory standards does Fluvip 10 comply with?
Fluvip 10 complies with cGMP, WHO guidelines, and ISO standards, ensuring global market accessibility.
Can you handle bulk orders for Fluvip 10?
Yes, we support bulk supply with production capacities up to 50 million tablets per month.
What quality control measures are in place for Fluvip 10?
Each batch undergoes HPLC analysis, dissolution testing, and stability studies to ensure quality and consistency.
How do you ensure supply chain reliability?
We maintain a global distribution network and strategic logistics partnerships to ensure timely and secure delivery.
Can you provide documentation for regulatory submissions?
Yes, we supply complete documentation, including batch records and stability data, for regulatory compliance.
What is your lead time for bulk orders?
Lead times vary based on order size, but we prioritize expedited processing for urgent requirements.
