Chymodel Forte is a high-purity enzymatic tablet formulation featuring Trypsin-chymotrypsin at 100,000 A.U. per tablet, engineered for consistent proteolytic activity and shelf stability. The formulation integrates advanced excipient systems to ensure optimal dissolution, moisture resistance, and compatibility with pharmaceutical processing. The active ingredients, Trypsin and chymotrypsin, are derived from porcine pancreas and undergo rigorous purification to meet pharmaceutical-grade specifications. The tablet matrix is designed for uniformity in weight, disintegration, and content uniformity, ensuring reliable performance during storage and handling. Manufacturing processes prioritize thermal stability, enzymatic potency retention, and adherence to excipient compatibility standards. The product’s formulation is optimized for scalability, with no compromise on quality or efficacy during large-scale production.
Manufacturing Capability
Our manufacturing infrastructure is built to meet the stringent demands of pharmaceutical production, with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP). The facility includes ISO Class 7 and Class 8 cleanrooms for sterile processing, ensuring contamination-free environments for sensitive enzymatic formulations. Advanced tablet compression lines, including high-speed rotary presses, enable precise dosing and consistent tablet morphology. The production process incorporates automated quality control checkpoints, such as in-process testing for moisture content, hardness, and disintegration time. Our scalable manufacturing capabilities support batch sizes ranging from pilot runs to large-scale commercial production, with flexible configurations to accommodate varying client requirements. Quality systems are integrated throughout the production lifecycle, including HACCP-based risk management and traceability protocols to ensure product integrity.
Available Strengths and Packaging
Chymodel Forte is available in a single strength of 100,000 A.U. per tablet, formulated to deliver consistent enzymatic activity. The product is packaged in 10x10 Alu Alu blister packs, offering robust protection against moisture, light, and physical damage. This packaging format ensures tamper-evidence and secure storage, making it ideal for both domestic and international distribution. The aluminum blister design also facilitates efficient inventory management and compliance with regulatory packaging standards.
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 API sourcing, formulation development, and full-scale production of customized enzymatic products. Clients can leverage our expertise to bring their formulations to market without owning production infrastructure. We support private label manufacturing by ensuring compliance with client-specific branding and packaging requirements, while maintaining adherence to global regulatory standards. Our contract manufacturing division is equipped to handle complex pharmaceutical requirements, from small-scale trials to large-volume commercial production, with a focus on cost-effectiveness and quality assurance.
Quality Assurance
Our quality assurance framework is designed to ensure compliance with pharmaceutical standards and deliver consistent product performance. Every batch undergoes rigorous testing, including potency analysis using HPLC and spectrophotometric methods, to verify enzymatic activity. Microbial contamination testing, dissolution profiling, and physical property assessments are conducted in accordance with ICH and USP guidelines. Analytical validation protocols are implemented to ensure method accuracy, precision, and reproducibility. Quality control systems are integrated with real-time monitoring tools, enabling proactive issue detection and resolution. All processes are validated to meet cGMP requirements, with documented records maintained for traceability and audit readiness.
Regulatory Compliance
Chymodel Forte is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001:2015 and ISO 14001:2015 standards. Our facility is registered with regulatory authorities in multiple jurisdictions, including the FDA, EMA, and WHO, ensuring adherence to global quality frameworks. The product meets specifications outlined in pharmacopeias such as USP and EP, with documentation supporting compliance for international markets. We maintain regulatory filings for all active pharmaceutical ingredients (APIs) and excipients, ensuring transparency and traceability. Our quality management systems are regularly audited by third-party agencies to confirm ongoing compliance with evolving regulatory requirements.
Global Supply Capability
With a robust international distribution network, we provide reliable bulk supply capabilities to pharmaceutical buyers worldwide. Our export logistics infrastructure includes partnerships with global freight forwarders and customs compliance experts, ensuring seamless cross-border shipments. The 10x10 Alu Alu packaging format is optimized for bulk supply, with efficient storage and transportation solutions to minimize degradation risks. We maintain strategic inventory levels and production capacity to meet urgent demand, supported by a resilient supply chain with contingency planning for disruptions. Our commitment to timely delivery is reinforced by real-time tracking systems and dedicated customer support teams.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in enzyme-based formulations and scalable production. Our reputation for compliance, quality, and reliability positions us as a preferred supplier in the global pharmaceutical market. We offer competitive pricing without compromising on regulatory adherence, ensuring cost-effective solutions for buyers. Our dedicated team provides end-to-end support, from formulation development to post-market compliance, reducing operational complexities for clients. With a focus on innovation and sustainability, we deliver value-driven solutions tailored to meet the evolving needs of the pharmaceutical industry.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customized solutions, pricing, and logistics.
FAQs
What manufacturing standards does Chymodel Forte comply with?
Chymodel Forte is manufactured in compliance with cGMP, WHO guidelines, and ISO 9001:2015 standards, ensuring adherence to global pharmaceutical regulations.
Can the product be customized for different packaging formats?
Yes, we offer flexible packaging solutions, including the standard 10x10 Alu Alu format, to meet client-specific requirements.
What is the shelf life of Chymodel Forte?
The product has a shelf life of 24 months when stored under recommended conditions, with stability data validated through accelerated testing.
Is third-party manufacturing available for Chymodel Forte?
Yes, we provide contract manufacturing services, enabling clients to produce the product under their brand name while maintaining quality control.
What regulatory approvals are required for exporting Chymodel Forte?
Export compliance is managed through WHO and FDA registrations, with documentation tailored to destination-specific regulatory frameworks.
Can bulk supply be arranged for urgent orders?
Our scalable production capacity and inventory management systems support urgent bulk supply requests, with expedited shipping options available.
What quality control measures are in place for batch testing?
Each batch undergoes potency, microbial, and dissolution testing, with results documented to ensure compliance with pharmacopeia standards.
How does your supply chain ensure reliability?
Our supply chain is supported by real-time tracking, strategic partnerships, and contingency planning to guarantee consistent delivery and product integrity.
Are there options for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product while maintaining compliance and quality standards.
What certifications does your facility hold?
Our facility is certified under ISO 9001:2015, ISO 14001:2015, and cGMP, with regular audits to ensure ongoing compliance.
