Clopram Plus is a dual-action pharmaceutical formulation combining Clonazepam (a benzodiazepine) and Escitalopram (a selective serotonin reuptake inhibitor). The tablet is formulated using advanced excipient blends to ensure optimal dissolution, stability, and uniformity. The manufacturing process involves precise blending of active pharmaceutical ingredients (APIs) with excipients such as microcrystalline cellulose, magnesium stearate, and hydroxypropyl methylcellulose. The formulation is designed to maintain chemical stability under varying storage conditions, with a pH-neutral matrix to prevent degradation of either API. The tabletting process employs high-speed compression technology to achieve consistent hardness, disintegration time, and weight variation. Coating is applied to enhance patient compliance and reduce gastric irritation. The product’s formulation adheres to strict pharmaceutical standards, ensuring compatibility with global regulatory requirements.
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 facility includes ISO Class 7 cleanrooms for sterile processing, advanced tabletting machinery, and automated packaging lines. We specialize in large-scale production of combination tablets, with the capacity to scale up or down based on demand. The manufacturing process incorporates real-time quality monitoring systems, including in-line particle size analysis and moisture content checks. Our quality systems ensure traceability, batch-specific documentation, and adherence to pharmacopeial standards. The facility is also certified for hazardous substance handling and waste management, ensuring environmental compliance.
Available Strengths and Packaging
Clopram Plus is available in a single strength: Clonazepam 0.5mg + Escitalopram 5mg. The product is packaged in 10x10 Alu Alu blister packs, which provide robust protection against moisture, light, and physical damage. The aluminum blister format ensures tamper-evident sealing and extended shelf life, making it ideal for both domestic and international distribution.
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 formulation development, API blending, tablet compression, and packaging for third-party brands. We support customization of dosage forms, excipient selection, and packaging specifications to meet specific market requirements. Our team collaborates closely with clients to ensure compliance with regulatory standards and to deliver cost-effective solutions. Whether you require small-batch trials or large-scale production, our flexible manufacturing framework ensures timely delivery without compromising quality.
Quality Assurance
Our quality assurance system is built on rigorous analytical validation and continuous process monitoring. Every batch undergoes extensive testing, including high-performance liquid chromatography (HPLC) for API content, dissolution testing, and microbial limit checks. We employ advanced analytical instruments to validate potency, purity, and stability, ensuring compliance with ICH and USP guidelines. Batch-specific documentation, including stability data and process validation reports, is maintained for traceability. Our quality control team conducts routine audits and participates in external proficiency testing programs to maintain industry benchmarks.
Regulatory Compliance
Clopram Plus is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001 standards. Our facility is registered with regulatory authorities in key markets, including the FDA, EMA, and PMDA, ensuring seamless global distribution. We adhere to strict documentation protocols, including batch records, deviation investigations, and change control processes. Our quality management system is aligned with international pharmacopeial standards, ensuring consistency in product quality and regulatory approval readiness.
Global Supply Capability
We provide end-to-end export solutions, including bulk supply capacity and a robust international distribution network. Our logistics partners enable reliable delivery to over 50 countries, with options for air, sea, and land transport. The facility’s scalable production capacity ensures timely fulfillment of large orders without compromising quality. We maintain strategic inventory management systems to guarantee supply chain reliability, even during peak demand periods. Our export compliance team ensures adherence to customs regulations, import documentation, and duty requirements, streamlining the global supply process.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturers select us for our expertise in combination drug development, regulatory compliance, and scalable production. Our commitment to quality, coupled with a proven track record of meeting global standards, positions us as a reliable partner for bulk supply needs. We offer competitive pricing, rapid turnaround times, and dedicated customer support to ensure long-term collaboration. Our ability to navigate complex regulatory landscapes and deliver consistent product quality makes us an ideal choice for businesses seeking a trusted manufacturer and supplier.
Bulk Supply Inquiry
For bulk supply inquiries, contact our sales team at info@delwishealthcare.com to discuss customization options, pricing, and delivery schedules.
FAQs
What manufacturing standards does Clopram Plus adhere to?
Clopram Plus is manufactured in compliance with cGMP, ISO 9001, and WHO guidelines, ensuring adherence to global pharmaceutical standards.
Can Clopram Plus be customized for private label manufacturing?
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 shelf life of Clopram Plus in 10x10 Alu Alu packaging?
The product has a shelf life of 24 months when stored under recommended conditions (25°C, 60% RH).
Does the manufacturing process ensure sterility?
While the product is not sterile, the manufacturing process employs ISO Class 7 cleanrooms to minimize contamination risks.
What regulatory approvals are required for exporting Clopram Plus?
Export compliance includes FDA, EMA, and PMDA registrations, along with documentation for customs clearance and import regulations.
Can you handle small-batch production for contract manufacturing?
Yes, our facility supports small-batch trials and pilot production to meet specific client requirements.
How do you ensure the stability of the combination formulation?
Stability is ensured through rigorous testing, including accelerated degradation studies and pharmacopeial monograph validation.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be tailored to meet the buyer’s specific needs, with options for small or large-scale orders.
Do you provide quality control reports for each batch?
Yes, comprehensive quality control reports, including HPLC data and stability profiles, are provided for every batch.
How do you support supply chain reliability for international distribution?
Our logistics network and inventory management systems ensure timely delivery, with dedicated teams to monitor and resolve supply chain challenges.
