Anhui Poly Pharmaceutical's Magnesium Hydroxide API Approved for Market, with a Yearly Production Capacity of Up to 200 Tons!

Anhui Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui Poly") recently received a notice of approval for the market application of chemical API from the National Medical Products Administration. The approved product is the Magnesium Hydroxide API.

The approval of market application signifies that Anhui Poly's Magnesium Hydroxide API can be utilized in various downstream dosage forms. Anhui Poly will continue to maintain stable product quality and production capacity to meet market demands and ensure the smooth production and operation of the company.

Notable Advantages of Anhui Poly's Magnesium Hydroxide

Magnesium Hydroxide is classified as an antacid medication known for neutralizing stomach acid and alleviating diarrhea. Additionally, as a food additive, it has a magnesium-supplementing effect and, to some extent, an anxiety-reducing function.

The downstream applications of this API include its use in various pharmaceutical formulations, such as Famotidine Calcium Magnesium Chewable Tablets, Alum-Mag Aspirin Tablets, Alum-Mag Chewable Tablets, Alum-Mag Suspension, Alum-Mag Dimethicone Chewable Tablets, Lansoprazole Enteric-coated Tablets, etc. It is also utilized in specialized medical foods (intestinal nutrient solutions) and contributes magnesium ions in enteral suspension products. Furthermore, in the food sector, Magnesium Hydroxide is widely employed as a dietary supplement, food additive, neutralizing agent, and inhibitor.

According to the IMS database, global sales of Magnesium Hydroxide pharmaceutical products reached $100 million in 2022, with global API consumption totaling 1,276 tons.

Quality Advantages:

Anhui Poly's Magnesium Hydroxide is prepared using an ammonia synthesis method, and it effectively eliminates impurities through precision filtration. In contrast, Magnesium Hydroxide from mineral sources is produced using high-temperature hydrolysis of mineral magnesium oxide, making it difficult to remove impurities, resulting in a higher presence of foreign materials.

During the production process, Anhui Poly's Magnesium Hydroxide forms complexes with ammonia and metal ions, effectively removing metal elements and significantly reducing the residual metal ions in the product, especially elements of Class I and Class 2A, well below the required limits.

In contrast, Magnesium Hydroxide from mineral sources does not have an effective methods to remove impurities, and the residual risk of elemental impurities is high, which has potential safety risks.

Anhui Poly's Magnesium Hydroxide controls the rate of crystallization effectively, producing larger particle sizes, typically around 100 microns. All particle size requirements of D (90) 2-100 microns can be met by grinding;

The quality of Anhui Poly's Magnesium Hydroxide complies with ChP, JP, EP, USP, and KP standards.

Scale Advantages:

1.Dedicated production lines ensure a stable supply.

2.The annual production capacity can reach up to 200 tons.

Regulatory Advantages:

In the US: The US DMF number is 036567 (Status: A). 

In China: The CN registration number is Y20220000127 (Status: A). 

In the EU: Has obtained the CEP certificate issued by EDQM, certificate number: R0-CEP 2022-010-Rev 00; Has passed the GMP compliance inspection and obtained the WC certificate

Additionally, registration work in other markets such as South Korea and Japan is ongoing. 

About Anhui Poly: 

Anhui Poly Pharmaceutical Co., Ltd. is a professional supplier of APIs committed to providing high-quality specialty APIs and services to the global pharmaceutical, healthcare, and skincare industries. 

Leveraging its strong research and development capabilities and technology transfer capabilities, Anhui Poly Pharmaceutical has successfully completed Magnesium Hydroxide API process development and quality research, and has smoothly achieved commercial production in Anqing, the international high-end API production base. The product is currently in Status A, enabling associations with downstream formulations, ensuring stable and continuous service to global customers. 

Inorganic APIs have a simple structure and clear mechanisms of action, offering vast market prospects. The approval of Magnesium Hydroxide marks a solid step forward for Poly Pharmaceutical in the inorganic API market. 

Feel free to contact us

Look forward to future cooperation!

Contact: Dr. Nie 18857693467

Contact: Director Xue 13616530509

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