Festeron 200 SR is a sustained-release formulation of progesterone, engineered to deliver a controlled and prolonged release of the active ingredient. The tablet’s composition includes a proprietary matrix system that ensures uniform drug release over an extended period, minimizing peak fluctuations and enhancing therapeutic efficacy. The formulation is based on advanced excipient compatibility studies, ensuring stability under varying pH and temperature conditions. The manufacturing process involves precision compression techniques to achieve optimal tablet hardness, disintegration time, and dissolution profile, meeting stringent pharmaceutical standards. The sustained-release mechanism is validated through in vitro dissolution testing, ensuring compliance with pharmacopeial requirements. The product’s design supports long-term therapeutic adherence, making it suitable for applications requiring continuous hormonal activity.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities designed to produce high-quality pharmaceutical products like Festeron 200 SR. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains a sterile processing environment to ensure product integrity. Advanced tablet compression machines, coating systems, and packaging lines enable precise control over critical quality attributes, including dosage uniformity, disintegration time, and dissolution rate. The production process is scalable to meet bulk supply demands while maintaining consistency in formulation and quality. Our quality systems include rigorous validation protocols for equipment, processes, and materials, ensuring compliance with international regulatory standards. The facility is also capable of producing small to large batches, accommodating diverse market requirements without compromising on product specifications.
Available Strengths and Packaging
Composition: Progesterone Sustained Release Tablets 200 mg
Packaging: 10x1x10 Blister
Festeron 200 SR is available in a single strength of 200 mg, formulated to meet the specific therapeutic needs of hormonal applications. The blister packaging (10x1x10) ensures product protection against moisture, light, and contamination, while facilitating easy storage and distribution. This packaging format is ideal for pharmaceutical manufacturers requiring secure, tamper-evident packaging for bulk supply and retail distribution.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to the needs of pharmaceutical buyers. Our capabilities include private label manufacturing, where we produce finished dosage forms under a client’s brand, ensuring full compliance with regulatory and quality standards. We also provide contract manufacturing solutions for sustained-release formulations, leveraging our expertise in controlled-release technology and formulation development. Our flexible production model allows for customization of dosage forms, packaging, and labeling, enabling clients to meet specific market demands. Whether you are a brand owner or a distributor, our team works closely with you to ensure seamless production, compliance, and supply chain integration.
Quality Assurance
Our quality assurance systems are designed to ensure the highest standards of product safety, efficacy, and consistency. Every batch of Festeron 200 SR undergoes rigorous testing, including in-process controls, finished product analysis, and stability testing. Key analytical methods such as High-Performance Liquid Chromatography (HPLC) and dissolution testing are employed to validate the drug release profile and active ingredient content. We maintain detailed batch records and documentation to support traceability and regulatory compliance. Our quality control team adheres to International Council for Harmonisation (ICH) guidelines and pharmacopeial standards, ensuring alignment with global quality expectations. Additionally, we conduct periodic internal audits and third-party validations to maintain operational excellence and continuous improvement.
Regulatory Compliance
Festeron 200 SR is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international quality standards such as ISO 9001 and ISO 14001. Our facility is certified by regulatory authorities in multiple jurisdictions, ensuring adherence to global pharmaceutical regulations. We maintain compliance with the ICH Q7 guidelines for active pharmaceutical ingredients (APIs) and the ICH Q8 framework for quality by design (QbD) approaches. Our documentation and quality systems are aligned with the requirements of the U.S. FDA, EMA, and other regulatory bodies, enabling seamless approval processes for global markets. We also support regulatory submissions and provide technical documentation to facilitate product registration and market access.
Global Supply Capability
As a leading exporter and bulk supplier, we have a robust international distribution network and the capacity to supply Festeron 200 SR in large volumes to meet global demand. Our logistics partners ensure timely delivery to key markets, including North America, Europe, Asia, and the Middle East. We offer flexible bulk supply options, including FOB and CIF terms, to accommodate diverse buyer requirements. Our supply chain is designed for reliability, with redundant systems in place to mitigate disruptions and ensure consistent delivery. We also provide customized packaging solutions and logistics support to meet specific export and distribution needs. With a focus on sustainability and compliance, we ensure that all shipments meet environmental and regulatory standards for international trade.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our expertise in sustained-release formulations, compliance-driven manufacturing, and global supply capabilities. Our commitment to quality, innovation, and regulatory excellence ensures that products like Festeron 200 SR meet the highest standards of safety and efficacy. We offer competitive pricing, scalable production, and end-to-end support to help you succeed in the global pharmaceutical market. Our team of specialists provides tailored solutions, from formulation development to regulatory submissions, ensuring seamless integration into your supply chain. With a proven track record of reliability and customer satisfaction, we are your trusted partner in delivering high-quality pharmaceutical products worldwide.
Bulk Supply Inquiry
We offer bulk supply capabilities for Festeron 200 SR, tailored to meet the needs of pharmaceutical manufacturers and distributors. For inquiries regarding bulk orders, packaging customization, or export requirements, please contact us at info@delwishealthcare.com.
FAQs
What manufacturing standards does Festeron 200 SR comply with?
Festeron 200 SR is manufactured in full compliance with cGMP, WHO guidelines, and ISO 9001 standards, ensuring adherence to global pharmaceutical quality requirements.
Can Festeron 200 SR be produced in different packaging formats?
While the standard packaging is 10x1x10 blister, we offer customization options for bulk supply and alternative packaging formats upon request.
What is the shelf life of Festeron 200 SR?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability testing.
Does your facility support contract manufacturing for sustained-release products?
Yes, we specialize in contract manufacturing for sustained-release formulations, including Festeron 200 SR, with full compliance to regulatory standards.
Can you provide documentation for regulatory submissions?
We provide comprehensive technical documentation, including batch records, stability data, and analytical reports, to support regulatory submissions.
What is your capacity for bulk supply?
We offer scalable bulk supply capabilities, with production volumes tailored to meet the requirements of large-scale distributors and exporters.
How do you ensure quality control during manufacturing?
Our quality control system includes in-process testing, finished product analysis, and third-party validations to ensure consistency and compliance.
Are you certified for international export?
Yes, our facility is certified for international exports, with compliance to FDA, EMA, and WHO regulations to facilitate global market access.
Can you customize labeling and packaging for private label manufacturing?
Absolutely. We support private label manufacturing with customized labeling, packaging, and branding to meet client-specific requirements.
How do you handle supply chain disruptions?
Our supply chain is designed with redundancy and flexibility, ensuring uninterrupted delivery even in the face of logistical challenges.
