The PCOS formulation is a meticulously designed multivitamin blend engineered for pharmaceutical precision. Each tablet contains Myo Inositol (1000 mg), a key insulin-sensitizing agent, and D-Chiro Inositol (25 mg), which synergizes with Myo Inositol to modulate insulin resistance. L-Methyl Folate (500 mcg) ensures optimal folate metabolism, while Vitamin D3 (1000 IU) supports calcium homeostasis and immune function. Chromium Picolinate (100 mcg) enhances glucose metabolism and insulin sensitivity. The formulation is developed using advanced excipient compatibility testing to ensure stability, uniformity, and bioavailability. The tablet matrix is optimized for disintegration, dissolution, and shelf-life preservation, adhering to pharmaceutical-grade standards for active pharmaceutical ingredient (API) integration and excipient compatibility.
Manufacturing Capability
Delwis Healthcare operates a state-of-the-art pharmaceutical manufacturing facility equipped with ISO 9001:2015-certified systems, fully compliant with current Good Manufacturing Practices (cGMP). The facility features aseptic processing capabilities for sterile tablet production, including high-efficiency particulate air (HEPA) filtration systems and laminar flow chambers. Automated tablet compression lines ensure precise dosing and consistent tablet weight, while advanced coating systems maintain product integrity. The manufacturing process adheres to strict quality control protocols, including in-process testing for particle size, dissolution profiling, and microbial limits. Scalability is achieved through modular production lines capable of handling bulk orders while maintaining compliance with regulatory standards.
Available Strengths and Packaging
The PCOS formulation is available in a single strength: Myo Inositol 1000 mg + D-Chiro Inositol 25 mg + L-Methyl Folate 500 mcg + Vitamin D3 1000 IU + Chromium Picolinate 100 mcg. The packaging is 10x1x10 Alu Alu, a high-barrier aluminum blister pack designed for moisture, light, and oxygen protection. This packaging format ensures product stability during storage and transportation while facilitating efficient inventory management for pharmaceutical buyers.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our private label manufacturing capabilities allow clients to brand and distribute products under their own trademarks, with full transparency in formulation, sourcing, and production. We provide flexible contract manufacturing options for small to large-scale orders, ensuring compliance with regulatory requirements and quality standards. Our team supports global clients by adapting formulations to meet regional specifications and local market demands.
Quality Assurance
Quality assurance at Delwis Healthcare is anchored in rigorous analytical validation and batch testing protocols. Each production batch undergoes comprehensive testing for potency, dissolution, disintegration, and impurity analysis using high-performance liquid chromatography (HPLC) and ultraviolet (UV) spectrophotometry. Raw materials are sourced from certified suppliers and subjected to incoming quality control (IQC) checks. Finished products are tested for microbial limits, heavy metals, and residual solvents to ensure compliance with pharmacopeial standards. Our quality control systems are integrated with real-time monitoring tools to maintain consistency and traceability throughout the supply chain.
Regulatory Compliance
Delwis Healthcare ensures full compliance with global regulatory frameworks, including cGMP, WHO guidelines, and ISO 17025 accreditation. Our manufacturing processes adhere to the International Council for Harmonisation (ICH) guidelines, ensuring product safety, efficacy, and quality for international markets. The facility is registered with regulatory authorities in key regions, including the FDA, EMA, and PMDA, enabling seamless export and compliance with local import requirements. All documentation, including batch records, stability data, and certificates of analysis (CoA), is maintained in accordance with pharmacopeial and regulatory standards.
Global Supply Capability
Delwis Healthcare is a trusted exporter with a robust international distribution network spanning North America, Europe, Asia, and the Middle East. Our bulk supply capacity is supported by a logistics infrastructure designed for reliability, with partnerships ensuring timely delivery to global markets. The 10x1x10 Alu Alu packaging format is optimized for efficient storage and transportation, reducing spoilage risks and enhancing supply chain resilience. We maintain inventory reserves to meet urgent demand and offer customized packaging solutions for regional regulatory requirements.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select Delwis Healthcare for our unwavering commitment to quality, regulatory compliance, and scalable production. Our expertise in multivitamin formulation, combined with advanced manufacturing capabilities, ensures consistent product performance and market readiness. As a reliable supplier, we offer end-to-end support, from raw material sourcing to global distribution, enabling clients to meet market demands with confidence.
Bulk Supply Inquiry
Delwis Healthcare provides bulk supply solutions for pharmaceutical buyers. For inquiries regarding large-scale orders, please contact us at info@delwishealthcare.com.
FAQs
What manufacturing standards does Delwis Healthcare follow?
Delwis Healthcare adheres to cGMP, ISO 9001:2015, and WHO guidelines to ensure product quality and compliance.
Can the PCOS formulation be customized for regional regulatory requirements?
Yes, our team adapts formulations to meet regional specifications and local market demands.
What is the shelf life of the 10x1x10 Alu Alu packaging?
The packaging ensures a shelf life of 24 months under recommended storage conditions.
Does Delwis Healthcare offer private label manufacturing?
Yes, we provide private label manufacturing services for branded pharmaceutical products.
What quality control measures are in place for batch testing?
Each batch undergoes potency, dissolution, microbial limit, and impurity testing using HPLC and UV methods.
Can Delwis Healthcare support export to international markets?
Yes, our facility is registered with global regulatory authorities, enabling seamless export compliance.
What is the minimum order quantity for bulk supply?
We accommodate small to large-scale orders, with minimum quantities tailored to client requirements.
How does Delwis Healthcare ensure supply chain reliability?
Our logistics network and inventory reserves ensure timely delivery, with customized solutions for regional demands.
Are raw materials sourced from certified suppliers?
Yes, all raw materials are sourced from ISO-certified suppliers and subjected to incoming quality checks.
Can Delwis Healthcare provide documentation for regulatory submissions?
We supply complete documentation, including CoA, batch records, and stability data, to support regulatory submissions.
