Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
Global Compliant Excipient Silicon Dioxide for Pharmaceuticals (CEP & US DMF Registered)
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Global Compliant Excipient Silicon Dioxide for Pharmaceuticals (CEP & US DMF Registered)
PRODUCT DETAILS
Product Description
This globally compliant excipient silicon dioxide is a premium pharmaceutical excipient exclusively designed for export-oriented pharmaceutical manufacturers and international drug product production. Produced via a refined production process, it delivers a minimum SiO₂ assay of 99.6%, with completed EU CEP (Certificate of Suitability) and US DMF (Drug Master File) Type II registration. It fully complies with USP, EP, and Ph.Eur pharmaceutical excipient standards, delivering consistent glidant and disintegrant performance for global pharmaceutical formulation needs.
Key Specifications
Parameter | Specification |
Product Name | Global Compliant Excipient Silicon Dioxide for Pharmaceuticals |
Appearance | White, ultra-fine, odorless, tasteless, fluffy powder |
Particle Size Range | 1–30 μm (customizable for international formulation requirements) |
SiO₂ Assay | ≥99.6% |
pH (5% Aqueous Suspension) | 3.5–7.5 (international pharmaceutical excipient standards) |
Typical Dosage | 0.1%–4% (subject to national pharmaceutical excipient limit requirements) |
Shelf Life | 24 months |
Packaging | 20/25 kg international pharmaceutical excipient standard moisture-proof drums |
Sample Availability | Complimentary samples available on request |
Core Applications
This globally registered grade is optimized for export-oriented oral solid dosage forms, including tablets, capsules, and granules sold in the EU, North America, and other regulated markets. It effectively addresses flowability and caking challenges in international pharmaceutical manufacturing, with completed CEP and US DMF registration to support seamless drug product registration and commercialization in over 80 countries worldwide, with no impact on export regulatory testing or compliance.
Manufacturing Advantages
We operate a dedicated international-grade pharmaceutical excipient production line, certified to both Chinese pharmaceutical GMP and international current Good Manufacturing Practices (cGMP), with additional FSSC 22000 certification. Our complete CEP and US DMF registration dossiers are fully available for customer regulatory use. With a proven track record of exporting to over 80 countries and regions worldwide, we have extensive experience in global pharmaceutical excipient supply chain management, and provide dedicated regulatory support for your international drug product registration needs.
Packaging, Storage & Logistics
- Standard Packaging: 20/25 kg international pharmaceutical excipient standard moisture-proof drums with moisture-proof composite film inner liners, fully meeting global long-distance transportation requirements.
- Storage & Handling: Store in a cool, dry, well-ventilated area in tightly sealed original packaging. This product is classified as non-hazardous for global transportation, with full support for international pharmaceutical supply chain logistics.
- Labeling: All packaging features full bilingual (English/Chinese) regulatory labeling, including product name, pharmaceutical excipient designation, CEP/DMF registration numbers, and full English product specifications, with customizable shipping marks per international customer requirements.
Frequently Asked Questions
Q: What international pharmaceutical excipient registrations have been completed for this product?
A: This product has completed EU CEP (Certificate of Suitability to the European Pharmacopoeia) registration and US DMF (Drug Master File) Type II filing, with full, up-to-date dossiers available to support your international regulatory filing needs.
Q: Which countries and regions can this product be exported to?
A: This globally compliant grade can be exported to over 80 countries and regions, including the European Union, North America, Southeast Asia, and Australia, fully meeting the local pharmaceutical excipient regulatory requirements of each market.
Why Choose Our Silicon Dioxide Products?
With decades of specialized experience in pharmaceutical and medical grade silica manufacturing, we are a trusted supplier for pharmaceutical and medical device manufacturers worldwide. All our products are manufactured under strict GMP/cGMP standards, with full regulatory compliance and consistent batch-to-batch quality. We offer customizable particle sizes, complimentary samples, full regulatory documentation support, and reliable global supply chain solutions. Contact us today to discuss your specific pharmaceutical silica requirements and get a customized quote.
Packaging and Shipping
Zhongqi (Guangdong) Silicon Materials Co., Ltd., with over 20 years of experience in the food-grade silica field, is a national high-tech enterprise and a Guangdong Province specialized and innovative enterprise. Trusted by numerous international food giants, it is a leader in high-end food-grade silica. Shandong Zhonglian Chemical Co., Ltd. is Zhongqi's sole officially authorized overseas sales subsidiary.
laboratory
The company has established a world-leading R&D and intelligent manufacturing system, built GMP-standardized workshops, constructed 10,000-ton intelligent production lines, established a national-level testing center equipped with cutting-edge international equipment, and built its own high-standard microbiological testing laboratory. From raw material screening to finished product delivery, the entire process strictly adheres to domestic and international food safety management certifications, achieving simultaneous leadership in both "quality" and "quantity."
Customer Visit
We are committed to silicon dioxide for 20 years, our product is well know in the world and cooperate with some Fortune 500 companies, such as the Nestlé，Yihai Kerry，COFCO，China Resources，Budweiser，Symrise, and so on.
HONOR
In 2021, the company was listed on the Guangdong Stock Exchange, marking the beginning of its international expansion. Today, Zhongqi Silicon Industry, with an open vision, empowers the global food industry's safety system with the power of "Made in China." Going forward, the company will continue to focus on molecular-level safety to ensure peace of mind and, with a global perspective, to create a purer quality of life. Because true strength lies in making invisible protections visible to the world.
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Jinan City, Shandong Province,China
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Guangzhou City, Guangdong Province
