Entra L is formulated as a combination oral contraceptive with Levonorgestrel (0.15mg) and Ethinyl estradiol (0.03mg) in tablet form. The active ingredients are blended with excipients to ensure stability, uniformity, and optimal dissolution during manufacturing. The formulation employs advanced pharmaceutical techniques to achieve consistent drug release, ensuring precise dosing and bioavailability. The tablet matrix is designed for rapid disintegration and absorption, while maintaining chemical stability under varied storage conditions. The excipients include fillers, binders, and coatings that enhance tablet integrity, ease of swallowing, and resistance to environmental factors. The formulation adheres to strict pharmaceutical guidelines, ensuring compatibility between the two hormones and minimizing potential interactions. The final product is engineered for shelf-life consistency and compliance with international quality standards.
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 process includes sterile processing capabilities for high-purity active pharmaceutical ingredients (APIs), ensuring contamination-free manufacturing. The facility is designed for scalability, allowing seamless transition from small-scale trials to large-volume production while maintaining product consistency. Advanced automation and quality control systems ensure precise dosing, uniform tablet weight, and accurate coating application. The manufacturing line incorporates real-time monitoring for critical parameters such as temperature, humidity, and particle size, ensuring adherence to regulatory requirements. Comprehensive quality systems, including traceability and documentation protocols, guarantee full compliance with pharmaceutical quality standards.
Available Strengths and Packaging
Composition: Levonorgestrel 0.15mg + Ethinyl estradiol 0.03mg Tab
Packaging: 10x1x21 Blister
Entra L is available in a single strength formulation, with each blister pack containing 21 tablets. The 10x1x21 blister format ensures tamper-evident packaging, protecting the product from moisture, light, and physical damage. The design facilitates easy dispensing and patient compliance, while the blister’s structural integrity ensures long-term stability. This packaging format is ideal for bulk supply and distribution, supporting efficient storage and transportation.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and private label services tailored to pharmaceutical buyers. Our capabilities include full-scale production of customized formulations, packaging solutions, and labeling services, enabling clients to meet specific market demands. We support third-party manufacturing for global clients, ensuring adherence to regulatory standards and quality specifications. Our flexible production model accommodates both small and large orders, with dedicated teams to manage project timelines, documentation, and compliance. Whether you require a private label product or a contract manufacturing partnership, we provide end-to-end solutions to streamline your supply chain and ensure market readiness.
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 active ingredient quantification, dissolution testing for bioavailability assessment, and microbial limit checks for sterility. Raw materials and finished products are subject to stringent quality control measures, ensuring consistency in potency, purity, and stability. We maintain detailed documentation for traceability, supporting audits and regulatory inspections. Our quality systems are aligned with ICH guidelines and WHO recommendations, ensuring that every product meets the highest standards of safety and efficacy.
Regulatory Compliance
We adhere to global regulatory frameworks, including cGMP, WHO guidelines, and ISO 9001 standards, ensuring compliance with international pharmaceutical regulations. Our manufacturing processes are validated to meet the requirements of the FDA, EMA, and other regulatory bodies, enabling seamless approval for global markets. We maintain certifications for Good Distribution Practices (GDP) and implement quality management systems that align with ISO 13485 for medical devices and ISO 27001 for information security. Our commitment to regulatory compliance extends to environmental sustainability, with adherence to REACH and CLP regulations for chemical safety. This ensures that Entra L meets the legal and safety requirements of all target markets.
Global Supply Capability
Our export capabilities are supported by a robust international distribution network, enabling efficient delivery to over 50 countries. We offer bulk supply options to meet the demands of large-scale distributors and pharmaceutical exporters, with a minimum order quantity adaptable to client needs. Our supply chain is designed for reliability, featuring real-time tracking, inventory management, and contingency planning to mitigate disruptions. We maintain strategic partnerships with logistics providers to ensure timely and cost-effective transportation, while maintaining product integrity during transit. Our facility is equipped for large-volume production, supporting consistent supply without compromising quality. This ensures that clients receive uninterrupted access to Entra L, regardless of market demand fluctuations.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality production, regulatory compliance, and scalable supply solutions. Our commitment to cGMP standards, advanced manufacturing technology, and global regulatory alignment ensures that Entra L meets the demands of diverse markets. We provide end-to-end services, from formulation to packaging, enabling clients to reduce time-to-market and operational costs. Our dedicated team offers personalized support, ensuring seamless collaboration and tailored solutions. By choosing us, you gain access to a reliable partner with a proven track record in pharmaceutical manufacturing and global supply chain management.
Bulk Supply Inquiry
We offer bulk supply capabilities for Entra L, tailored to meet the needs of pharmaceutical buyers. For inquiries regarding large-scale orders, packaging customization, or export logistics, please contact us at info@delwishealthcare.com.
FAQs
What are the regulatory standards your facility complies with?
Our manufacturing facility adheres to cGMP, WHO guidelines, ISO 9001, and ISO 13485 standards, ensuring compliance with global pharmaceutical regulations.
Can you provide private label manufacturing for Entra L?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own label while maintaining quality and compliance.
What is the minimum order quantity for bulk supply?
We accommodate flexible order quantities, with bulk supply options tailored to meet the needs of distributors and exporters.
How do you ensure product stability during storage and transport?
Our packaging, including the 10x1x21 blister format, is designed to protect the product from moisture, light, and physical damage, ensuring long-term stability.
What quality control measures are in place for Entra L?
Each batch undergoes rigorous testing, including HPLC, dissolution testing, and microbial limit checks, ensuring compliance with international quality standards.
Can you support export to specific regions?
Yes, we have a global distribution network and can support exports to over 50 countries, adhering to local regulatory requirements.
What is your production scalability for Entra L?
Our facility is designed for scalable production, enabling seamless transitions from small-scale trials to large-volume manufacturing.
How do you ensure supply chain reliability?
We maintain strategic partnerships with logistics providers and implement real-time tracking systems to ensure timely and reliable delivery.
Do you offer contract manufacturing for other formulations?
Yes, we provide contract manufacturing services for a wide range of pharmaceutical products, with expertise in combination hormonal contraceptives.
How can I contact your team for bulk supply inquiries?
For bulk supply inquiries or partnership opportunities, please contact us at **info@delwishealthcare.com**.
