Acloverin is a fixed-dose combination tablet designed for pharmaceutical manufacturers requiring a dual-action therapeutic profile. The formulation combines Aceclofenac, a nonsteroidal anti-inflammatory drug (NSAID) with potent analgesic and anti-inflammatory properties, and Drotaverine, a spasmolytic agent that alleviates smooth muscle spasms. The tablet is manufactured using advanced excipient blends, including microcrystalline cellulose, lactose monohydrate, and magnesium stearate, to ensure optimal disintegration, dissolution, and stability. The formulation is designed to maintain chemical compatibility between the active ingredients, ensuring consistent pharmacokinetic profiles during storage and shelf life. The tablet’s physical properties, such as hardness, thickness, and weight variation, are strictly controlled to meet international pharmaceutical standards. The combination of Aceclofenac and Drotaverine provides a synergistic effect, making Acloverin suitable for applications requiring rapid pain relief and antispasmodic action.
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 for Acloverin includes automated tablet compression, ensuring precise dosing and uniformity. The facility is designed for non-sterile solid dosage form manufacturing, with dedicated lines for blending, granulation, and tableting. Advanced quality control systems monitor critical parameters such as particle size distribution, moisture content, and tablet hardness to ensure consistency. The production line supports scalability, enabling seamless transitions from small-scale trials to large-volume manufacturing. Our quality systems include validated cleaning protocols, environmental monitoring, and continuous process validation to maintain product integrity. The facility is also equipped for batch record tracking, traceability, and real-time data capture to meet regulatory requirements.
Available Strengths and Packaging
Composition: Aceclofenac 100mg + Drotaverine 80mg Tab
Packaging: 10x10 Alu Alu
Acloverin is available in a single strength of 100mg Aceclofenac and 80mg Drotaverine, formulated as a film-coated tablet. The 10x10 Alu Alu packaging ensures tamper-evidence, moisture resistance, and light protection, making it ideal for both domestic and international distribution. The blister pack design facilitates easy handling, storage, and transportation while maintaining product stability.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our private label manufacturing capabilities allow clients to produce branded products under their own trademarks, with full flexibility in formulation, packaging, and labeling. We support custom development for new drug combinations, including stability testing, formulation optimization, and regulatory documentation. Our team collaborates closely with clients to align production processes with their quality control systems and market requirements. Whether you are a generic drug manufacturer, a brand owner, or a distributor, we provide end-to-end solutions to meet your supply chain needs.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to global pharmaceutical standards. Each batch of Acloverin undergoes in-process testing for active pharmaceutical ingredient (API) content, disintegration time, and dissolution rate to ensure compliance with USP, EP, and BP monographs. Advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry are employed for potency and impurity analysis. Finished products are subjected to microbial limit testing, heavy metal analysis, and particulate matter inspection to guarantee safety and purity. Our quality control systems are integrated with real-time monitoring tools to detect deviations during production, ensuring consistent product quality.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international regulatory frameworks such as the FDA’s 21 CFR Part 211 and the European Medicines Agency (EMA) standards. Our facilities are certified under ISO 9001:2015 and ISO 14001:2015 for quality management and environmental responsibility. We maintain detailed documentation for regulatory submissions, including master production records, stability data, and analytical reports. Our compliance programs are regularly audited by third-party agencies to ensure adherence to global standards, enabling seamless market entry in regions such as the EU, US, and Asia-Pacific.
Global Supply Capability
Our export capabilities are supported by a robust international distribution network and bulk supply infrastructure. We specialize in large-volume manufacturing, with the ability to fulfill orders ranging from small trials to mass production. Our logistics partners ensure timely delivery to over 50 countries, with customized solutions for temperature-sensitive and shelf-stable products. We maintain a reliable supply chain through strategic inventory management, supplier diversification, and contingency planning. Our bulk supply capacity is scalable to meet the demands of pharmaceutical distributors, exporters, and contract manufacturers, ensuring uninterrupted supply chain operations.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in scalable production, regulatory compliance, and global supply chain reliability. Our commitment to quality, combined with flexible manufacturing solutions, positions us as a preferred partner for clients seeking cost-effective, high-quality pharmaceutical products. We offer competitive pricing, rapid turnaround times, and dedicated customer support to meet your business objectives. With a proven track record in the industry, we deliver consistent results, ensuring your products meet the highest standards of safety, efficacy, and compliance.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is ready to assist with customized manufacturing solutions, export documentation, and supply chain logistics.
FAQs
What is the composition of Acloverin?
Acloverin contains Aceclofenac 100mg and Drotaverine 80mg in a film-coated tablet formulation.
What packaging options are available for Acloverin?
Acloverin is available in 10x10 Alu Alu blister packs, ensuring protection against moisture and light.
Can Acloverin be manufactured in different strengths?
Currently, Acloverin is produced in a single strength of 100mg Aceclofenac + 80mg Drotaverine. Custom formulations can be developed upon request.
What regulatory standards does Acloverin comply with?
Acloverin adheres to GMP, WHO guidelines, and international standards such as USP, EP, and BP.
Is Acloverin suitable for export to international markets?
Yes, Acloverin is manufactured to meet global regulatory requirements, enabling seamless export to regions such as the EU, US, and Asia-Pacific.
What quality control measures are in place for Acloverin?
Each batch undergoes rigorous testing for potency, dissolution, microbial limits, and physical properties to ensure compliance with pharmaceutical standards.
Can Acloverin be produced under private label or contract manufacturing?
Yes, we offer private label and contract manufacturing services, allowing clients to produce branded products under their own trademarks.
What is the minimum order quantity for bulk supply?
Bulk supply options are flexible and tailored to client requirements. Contact us for customized pricing and order details.
How does your company ensure supply chain reliability?
We maintain a robust logistics network and inventory management system to ensure timely delivery and uninterrupted supply chain operations.
What certifications does your manufacturing facility hold?
Our facility is certified under ISO 9001:2015, ISO 14001:2015, and complies with cGMP and WHO standards.
