Introduction to Medicinal Raw and Excipient Products

Ⅰ.Product Catalog

Contact persons：Mr.Guan(+86 13570741390),Mr.Feng(13926930559).

II. Product Introduction 

【I】. Biopharmaceutical: (1) AGX Powder Cell Culture Media:

1. A joint venture between Ajinomoto, a multinational company with in-depth research in amino acids, and Genexine, a professional biotechnology company in South Korea.

2. The annual production capacity of powdered media exceeds 100 tons, and its sales scale ranks around No. 4-5 globally.

3. Key customers include Roche Group, Samsung Biologics, and Celltrion (first monoclonal antibody company in Korea). In January 2021, Celltrion announced the establishment of a 120,000-liter CDMO factory in Wuhan.

4. Ensured raw material safety and batch-to-batch stability of the products. Sales and cooperation models include commercial media sales, CMO manufacturing, optimization of media formulations, and commissioned research/development.

5. In the second half of 2021, AGX will establish a customer service center for media in Shanghai, benefiting from geographical security and convenience.

6. AGX has experience in deep collaboration with customers, cost advantages, and a strong sense of service and responsiveness. It is supported by comprehensive technical/quality systems.

7. Packaging specifications: 1.0 kg/composite aluminum bag, 4.75L/plastic drum.

(2) Pharmaceutical Amino Acid Series:

1. Varieties include histidine, histidine hydrochloride, arginine, arginine hydrochloride, methionine, aspartic acid, glycine, etc. These amino acids are used as lyoprotectants, excipients, or buffer solutions in biopharmaceuticals.

2. All products have API registration numbers and are in the activated A status. They comply with the Chinese Pharmacopoeia 2020 edition, USP, EP, and JP. They support dual filings in China and the US or China and Europe, and some have DMF numbers.

3. Produced in foreign-owned domestic factories with a secure supply chain. Purchasing customers can arrange on-site quality audits.

4. Packaging specifications: 25 kg/drum.

(3) Mannitol Series:

1. Product models include Mannitol PEARLITOL BIOPHARMA (low endotoxin, biopharmaceutical grade) and Mannitol (injectable grade). They are used as protectants for developing and manufacturing freeze-dried injections and biologics with lower endotoxin requirements.

2. Registration numbers are F20190000635 and Y20170001658. The products comply with the Chinese Pharmacopoeia 2020 edition, USP, EP, and JP. They support dual filings in China and the US or China and Europe, and have DMF numbers.

3. They are manufactured by an international brand professional producer and adopted by multiple well-known biopharmaceutical companies, providing seamless technical support and solutions.

4. The products have stable quality and a shelf life of 3 years.

5. Packaging specifications: 12 kg/25 kg/50 kg/drum.

(4) Trehalose:

1. Originated from Japan, the product undergoes fermentation and is refined to injection-grade with a complete industry chain production. It is legally imported and traceable.

2. The product is registered with the registration number F20170000105.

3. The product quality complies with the Chinese Pharmacopoeia 2020 edition, USP, EP, and JP. It supports dual filings in China and the US or China and Europe. Purchasing customers can schedule on-site quality audits.

4. The product has stable quality and a shelf life of 3 years.

5. Packaging specifications: 1 kg/20 kg/carton.

【II】. Chemical Pharmaceuticals: (1) Aspartame (Acesulfame Potassium):

1. Originated from Japan, the product is produced by the original manufacturer, legally imported, and traceable.

2. According to the regulations (Pharmaceutical Related Evaluation and Approval No. 56 of 2019), the product does not require registration and can be directly verified for increased supplier usage.

3. The product quality complies with the Chinese Pharmacopoeia 2020 edition, USP, EP, and JP. It supports dual filings in China and the US or China and Europe. It also serves as an industry standard, particularly in terms of substance impurities and conductivity, becoming a technical reference standard for the new edition of the Pharmacopoeia.

4. The product has stable quality and a shelf life of up to 5 years.

5. Packaging specifications: 25 kg/box.