Olavip-10 MD is a robustly formulated 10mg olanzapine tablet designed for consistent therapeutic performance and stability. The tablet’s core composition includes olanzapine as the active pharmaceutical ingredient (API), combined with excipients such as microcrystalline cellulose, croscarmellose sodium, and magnesium stearate to ensure uniformity in dosage and disintegration. The formulation is engineered to meet stringent pharmaceutical requirements, including controlled disintegration time, optimal dissolution rates, and chemical stability under varied storage conditions. The tablet’s coating ensures protection against moisture and light, preserving the API’s integrity during transit and shelf life. From a manufacturing standpoint, the formulation balances compressibility, flowability, and tablet hardness to facilitate efficient production while maintaining compliance with pharmacopeial standards. The excipient selection also supports compatibility with automated packaging systems, enhancing scalability and reducing production downtime.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the demands of high-volume pharmaceutical production while adhering to Good Manufacturing Practice (GMP) standards. The facility features state-of-the-art equipment, including high-speed tablet presses, fully automated packaging lines, and advanced quality control systems. Sterile processing capabilities are available for critical dosage forms, ensuring contamination-free production. The manufacturing process for Olavip-10 MD is optimized for scalability, with modular production lines capable of handling bulk orders without compromising quality. Our quality systems include real-time monitoring, data integrity protocols, and validation of critical process parameters to ensure consistency. The facility is certified under ISO 9001 and maintains rigorous documentation for traceability and audit readiness.
Available Strengths and Packaging
Composition: Olanzapine 10mg Tablets
Packaging: 10x15 Blister
Olavip-10 MD is available in a single strength of 10mg, tailored for standardized dosing. The 10x15 blister packaging ensures secure, tamper-evident storage and distribution, with each blister containing 10 tablets arranged in 15 rows. This packaging format is ideal for retail and hospital settings, offering ease of use and compliance with regulatory packaging requirements.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label production and contract manufacturing for pharmaceutical buyers. Our capabilities extend to custom formulation development, API integration, and full-scale production of dosage forms such as tablets, capsules, and oral suspensions. We support clients in meeting specific regulatory and quality requirements, with flexible production schedules and adherence to global Good Manufacturing Practice (GMP) standards. Our private label manufacturing solutions enable brands to launch products without upfront capital investment, while our contract manufacturing services ensure cost-effective scalability for global markets.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with international pharmaceutical standards. Each production batch undergoes extensive testing, including High-Performance Liquid Chromatography (HPLC) for API purity, dissolution testing to ensure consistent bioavailability, and microbial limit testing for contamination control. We employ validated analytical methods for potency, disintegration time, and physical appearance checks, ensuring product consistency. All quality control procedures are documented and traceable, with continuous monitoring of critical quality attributes. Our systems also align with pharmacopeial standards, such as USP and EP, to guarantee regulatory compliance and market readiness.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practice (GMP) guidelines, World Health Organization (WHO) standards, and ISO 9001 quality management systems. Our manufacturing processes adhere to global regulatory frameworks, including FDA, EMA, and PIC/S requirements, enabling seamless export to international markets. All documentation, including batch records, stability data, and certificates of analysis (CoA), is prepared in accordance with regulatory expectations. Our facility is regularly audited by third-party agencies and regulatory bodies, ensuring continuous alignment with evolving pharmaceutical regulations.
Global Supply Capability
Our global supply chain is designed to deliver reliable, timely, and scalable solutions to pharmaceutical buyers worldwide. With a network spanning Asia, Europe, North America, and the Middle East, we support bulk supply to meet the demands of large-scale distributors and exporters. Our logistics partners ensure secure, temperature-controlled transportation, minimizing risks during transit. We maintain strategic inventory management systems to guarantee supply chain reliability, even during peak demand periods. Our bulk supply capacity is supported by automated warehousing and inventory tracking, enabling efficient order fulfillment and reduced lead times.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our combination of expertise, compliance, and scalability. Our GMP-certified facility ensures consistent product quality, while our flexible manufacturing solutions accommodate diverse client needs. As a trusted supplier, we provide end-to-end support, from formulation development to global distribution, reducing time-to-market for new products. Our commitment to regulatory compliance and sustainability further strengthens our value proposition, enabling partners to meet stringent market requirements with confidence.
Bulk Supply Inquiry
We offer robust bulk supply capabilities for pharmaceutical manufacturers and exporters. For inquiries regarding large-scale orders, please contact us at info@delwishealthcare.com.
FAQs
What certifications does your facility hold?
Our facility is certified under GMP, ISO 9001, and WHO guidelines, ensuring compliance with global pharmaceutical standards.
Can you customize packaging formats for Olavip-10 MD?
While Olavip-10 MD is currently available in 10x15 blister packaging, we can accommodate custom packaging requests upon consultation.
What regulatory standards does your manufacturing process follow?
We adhere to FDA, EMA, PIC/S, and WHO guidelines, with full compliance for international market entry.
How do you ensure the stability of Olavip-10 MD during storage?
The tablet’s formulation includes moisture-resistant coatings and excipients that maintain stability under standard storage conditions.
What is the minimum order quantity for bulk supply?
We offer flexible bulk supply options, with minimum order quantities tailored to client requirements.
Can you provide certificates of analysis (CoA) for each batch?
Yes, we provide detailed CoA for every production batch, including HPLC, dissolution, and microbial testing results.
What is your export capability for Olavip-10 MD?
We have a global distribution network and can export to over 50 countries, with compliance for international regulatory frameworks.
How do you handle quality control during production?
We implement real-time monitoring, batch testing, and validated analytical methods to ensure consistent quality throughout the manufacturing process.
Can you support private label manufacturing for Olavip-10 MD?
Yes, we offer private label solutions, allowing brands to launch products without upfront capital investment.
What is your lead time for bulk orders?
Lead times vary based on order size and production schedules, but we prioritize timely delivery to meet client deadlines.
