Dentolac Tab is a dispersible tablet formulation containing 10mg of Ketorolac Tromethamine, designed for pharmaceutical manufacturing with a focus on stability, uniformity, and scalability. The formulation employs a combination of excipients, including disintegrants, binders, and lubricants, to ensure consistent tablet integrity and rapid disintegration in aqueous environments. The dispersible form enhances solubility and dissolution rates, critical for pharmaceutical applications requiring controlled release or rapid bioavailability. The tablet’s physical properties, such as hardness, disintegration time, and dissolution profile, are optimized to meet industry standards for tablet performance. The formulation is engineered to maintain potency and purity throughout the manufacturing process, ensuring compliance with regulatory requirements for active pharmaceutical ingredients (APIs) and finished dosage forms.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities to produce Dentolac Tab with precision and efficiency. The facility includes high-speed tablet compression lines, advanced coating systems, and automated packaging units, enabling scalable production to meet bulk supply demands. Sterile processing capabilities are integrated to ensure contamination-free manufacturing, with dedicated cleanrooms maintaining Class 10,000 to Class 100 air quality standards. All production processes adhere to Good Manufacturing Practice (GMP) guidelines, with continuous monitoring of critical parameters such as temperature, humidity, and particle count. The facility is certified under ISO 9001 and ISO 14001, ensuring quality management and environmental sustainability. Production scalability is supported by modular design, allowing adjustments to meet varying order sizes without compromising product consistency.
Available Strengths and Packaging
Composition: Ketorolac Tromethamine 10mg Dispersible Tablets
Packaging: 10x15 Alu Alu
Dentolac Tab is available in a 10mg strength, packaged in 10x15 aluminum blister packs. Each blister contains 10 tablets, with 15 blisters per pack, ensuring secure, moisture-resistant, and light-protected storage. The aluminum packaging provides tamper-evidence and extended shelf life, making it ideal for distribution and retail environments. The design supports efficient logistics handling, with minimal risk of contamination or degradation during transportation.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer contract manufacturing, private label production, and third-party manufacturing services tailored to pharmaceutical buyers’ needs. Our capabilities include producing Dentolac Tab under a client’s brand name, with full flexibility in formulation adjustments, packaging specifications, and regulatory compliance. We support both small-scale trials and large-volume production, ensuring adherence to GMP and regional regulatory standards. Our team collaborates closely with clients to align with their quality control protocols, offering end-to-end solutions from raw material sourcing to finished product delivery. This partnership model enables pharmaceutical companies to leverage our expertise while maintaining brand autonomy and market competitiveness.
Quality Assurance
Our quality assurance systems are designed to ensure compliance with global pharmaceutical standards. Every batch of Dentolac Tab undergoes rigorous testing, including in-process checks for particle size, moisture content, and dissolution rates. Final product validation includes potency testing, impurity analysis, and stability studies using high-performance liquid chromatography (HPLC) and ultraviolet (UV) spectrophotometry. Analytical validation ensures accuracy, precision, and reproducibility, meeting pharmacopoeial requirements such as USP, EP, and BP. Regular internal audits and third-party inspections reinforce our commitment to quality, with documentation traceable to international regulatory frameworks.
Regulatory Compliance
We comply with stringent regulatory standards, including Good Manufacturing Practice (GMP), World Health Organization (WHO) guidelines, and ISO 9001/14001 certifications. Our manufacturing processes align with International Council for Harmonisation (ICH) guidelines, ensuring consistency with global regulatory expectations. Dentolac Tab meets the requirements of the U.S. FDA, European Medicines Agency (EMA), and other regional authorities, facilitating seamless export and market access. Compliance with WHO prequalification criteria further enhances our credibility as a reliable supplier in international pharmaceutical markets.
Global Supply Capability
With a robust international distribution network, we provide reliable bulk supply to clients worldwide. Our logistics partnerships ensure timely delivery to over 50 countries, supported by temperature-controlled shipping and real-time tracking systems. Bulk supply capacity is scalable, accommodating orders ranging from small trials to large-scale commercialization. Our supply chain reliability is reinforced by redundant inventory management, localized warehouses, and contingency planning to mitigate disruptions. This infrastructure ensures uninterrupted supply, critical for pharmaceutical buyers relying on consistent product availability.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in quality, compliance, and scalability. Our reputation as a trusted manufacturer is built on adherence to GMP, ISO certifications, and regulatory excellence. We offer competitive pricing without compromising on quality, supported by a dedicated customer service team for tailored solutions. Our global supply capability and flexible manufacturing options make us an ideal partner for companies seeking reliable, high-quality products for international markets.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss your requirements and receive a customized quotation.
FAQs
What manufacturing standards does Dentolac Tab comply with?
Dentolac Tab is manufactured under GMP guidelines, ISO 9001, and ISO 14001, ensuring compliance with global pharmaceutical standards.
Can Dentolac Tab be produced in different packaging formats?
While the standard packaging is 10x15 Alu Alu, we offer customization options for alternative packaging to meet specific client requirements.
What is the shelf life of Dentolac Tab?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability studies.
Is Dentolac Tab suitable for export to international markets?
Yes, Dentolac Tab complies with WHO prequalification criteria and regulatory requirements for export to over 50 countries.
Can you accommodate private label manufacturing for Dentolac Tab?
Absolutely. We provide private label manufacturing services, allowing clients to brand the product under their own name.
What quality control measures are in place for Dentolac Tab?
Each batch undergoes rigorous testing, including HPLC analysis, dissolution testing, and impurity profiling, ensuring compliance with pharmacopoeial standards.
How does your supply chain ensure reliability for bulk orders?
Our logistics network includes temperature-controlled shipping, real-time tracking, and localized warehouses to guarantee timely and consistent delivery.
What certifications do you hold for pharmaceutical manufacturing?
We are certified under GMP, ISO 9001, ISO 14001, and WHO prequalification, ensuring adherence to international quality standards.
Can you scale production to meet large-volume demands?
Yes, our modular manufacturing infrastructure supports scalable production, from small trials to mass commercialization.
How do you handle regulatory compliance for different regions?
Our team ensures Dentolac Tab meets the regulatory requirements of the FDA, EMA, and other regional authorities, facilitating seamless global distribution.
