Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
FDA Approved Pharmaceutical Silicon Dioxide Excipient
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
FDA Approved Pharmaceutical Silicon Dioxide Excipient
PRODUCT DETAILS
1. Product Description
The FDA Approved Pharmaceutical Silicon Dioxide Excipients is registered and filed with the FDA, custom-developed for pharmaceutical excipient use with a purity of ≥ 99.7%. It conforms to FDA 21 CFR relevant standards, as well as USP, EP and Chinese Pharmacopoeia (ChP) 2025 Edition pharmaceutical excipients standards. Featuring outstanding glidant and dispersing performance and excellent compatibility with various pharmaceutical raw and auxiliary materials, it is suitable for North American and global FDA-compliant pharmaceutical formulations, keeping pace with the global FDA certification trend for pharmaceutical excipients.
2. Key Specifications
Parameter | Details |
Product Name | FDA Approved Pharmaceutical Silicon Dioxide Excipients |
Appearance | White, odorless, tasteless, ultra-fine fluffy powder with excellent dispersibility |
Particle Size Range | 1-25μm (FDA approved excipient-specific, customizable) |
Silicon Dioxide Content | ≥99.7% |
pH Value | 3.5-7.2 (5% suspension, FDA pharmaceutical excipient standard) |
Typical Addition Level | 0.1%-3.5% (in accordance with FDA excipient usage norms) |
Shelf Life | 24 months |
Packaging | 20/25kg FDA grade pharmaceutical excipient sealed moisture-proof drums |
Sample | Free sample available (with FDA certification and filing related instructions) |
3. Applications
With the core advantage of FDA certification and filing, it is suitable for North American and global FDA-compliant pharmaceutical formulations including oral tablets, capsules, and sustained-release formulations. As a pharmaceutical excipient, it features core glidant and dispersing functions, solving the pain points of poor flowability and uneven mixing of excipients. Fully compliant with FDA 21 CFR standards, it can be directly used in the production of FDA-compliant formulations, meeting the needs of overseas FDA-certified pharmaceutical enterprises.
4. Factory Advantages
We have a dedicated production line for FDA approved pharmaceutical silicon dioxide excipients, holding triple FDA, GMP and cGMP certifications. Equipped with an FDA special testing laboratory, we strictly control production in accordance with FDA 21 CFR standards and conduct 38 full-process tests. We can provide FDA certification and filing documents as well as exclusive test reports, with sufficient production capacity and a lead time of 7-10 days, meeting the bulk procurement needs of overseas FDA customers.
5. Shipping & Packaging
- Standard Packaging: 20/25kg FDA grade pharmaceutical excipient sealed moisture-proof drums with double-layer pharmaceutical-grade PE inner liners for moisture and contamination prevention, marked with FDA certification logo.
- Storage & Transportation: Store in a cool, dry, sealed and light-protected place. Non-hazardous chemical, supporting global regular/cold chain transportation for FDA grade pharmaceutical excipients.
- Labeling Norms: Marked with FDA approved, pharmaceutical excipient, applicable standards, and Chinese-English instructions, complying with overseas FDA acceptance criteria.
6. FAQs
Q: Can FDA certification and filing documents be provided for this product?
A: Yes. We can issue FDA certification and filing related documents as well as conformity statements, and simultaneously provide special test reports conducted in accordance with FDA standards to meet overseas formulation filing requirements.
Q: Which regions' FDA-compliant formulation production is it suitable for?
A: It is suitable for FDA-compliant pharmaceutical formulation production in North America (the United States, Canada) and all regions worldwide that require FDA certification, fully complying with relevant FDA 21 CFR standards.
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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