According to the GMP standard,the company has built 10000 m2 plant equipped the advanced equipment. The factory has a complete Q.A. & Q.C.system.We own several sets of analyzing instruments with high efficiency and high sensitivity, such as HPLC, GC and UV spectrophotometer to analyze and control the products. The company has gotten the approval of ISO9001.We have the authority of export and import, the fine chemical, biochemical, pharmaceutical & its intermediates distributed by the company are sold both in the domestic and international market and highly recommended by our clients.In order to develop the market further, we are eager to cooperate with the manufactory and trading company around the globe to make a prosperous future.
From production to the factory test to the laboratory test, we will To make sure the products are at great quality,will test each batch products for 3 testing.All products purity are pure.
| The factory production, QC, warehousing facilities and power equipment are fully&well equipped. 3M has 30,000 square meters clean production workshop meet the GMP certification standards including a genetic engineering production line, a biochemistry production line, a sterile peptides powder production line, a small capacity injection production line. Factory environment is elegant and transportation is convenient. |
Ultrapure water equipment
Freeze dryer
The fermentation equipment
The production workshop:
High Performance Liquid Chromatography HPLC
HGH samples should be tested according to following items
| Items of Test | Standard | |
| Characters | White lyophilized powder | |
| Identification | ||
| A. | IEF | CORRESPONDS TO THE REFERENCE |
| B. | HPLC/RP | CORRESPONDS TO THE REFERENCE |
| C. | PEPTIDE MAPPING | CORRESPONDS TO THE REFERENCE |
| D. | HPLC/SEC | CORRESPONDS TO THE REFERENCE |
| RELATED PROTEINS (HPLC/RP) | ≤ 13.0% | |
| DIMER&RELATED SUBSTANCES OF HIGHER MOLECULAR MASS (HPLC/SEC) |
≤ 6.0% | |
| ISOFORM DISTRIBUTION | CORRESPONDS TO THE REFERENCE | |
| WATER | ≤ 3.0% | |
| BACTERIAL ENDOTOXINS | ＜ 5.0 IU/mg hGH | |
| HOST-CELL-DRIVED PROTEINS | ≤ 30 ng/mg hGH | |
| HOST-CELL & VECTOR-DERIVED DNA | ≤ 10 ng/dose hGH | |
| TEST FOR STERILITY | conformed | |
| ASSAY (HPLC/SEC) | 89.0% - 105.0 % the amount of Somatropin stated on the label | |
| Purity (HPLC) | ≥ 95% | |
We have the area for Q.C of about 800sqm, equipped with the newest instruments:
4 sets of HPLC
2 sets of GC with head space
2 sets of Chambers for Stability test·
Medicine dissolution test meter
UV spectrophotometer
Polarimeter
Particle size analyzer
The main functions of our Q.C. department are:
Testing and approval of raw material
Testing and approval of all the intermediates and final API for export
Monitoring of manufacturing process
Implementation of GMP
Documentation of technical
The Testing Procedures:
The Factory have hundreds of tests that are used to determine purity, potence and quality of the materials and end products all of which utilize state of the art equipment which ensures complete accuracy.
Product Testing:
At any point during production a product may be tested. If it doesn't meet regulation standard the batch is immediately withdrawn and in the final stages of production the product must undergo the final quality control procedures before it may receive the 'pass' grading which releases it for sale.
Repeated Checks:
As well as the standard checks the raw materials and finished products are tested for heavy metal content. In recent years there has been a significant problem with the underground Factory's producing poor quality products that are filled with toxic heavy metals. This is because they are no licensed and therefore under no obligation to test for these; when you buy cheap products - you pay the price with your health.
While the level of heavy metals found in the raw materials may be acceptable, once it has been mixed with other compounds and reactions taken place these levels can change. Testing throughout the production process therefore ensures our Factory only ever release the safest and most effective compounds.
R&D Strategy:
To put technical innovation at the core of the corporate development strategy
To set up a management mechanism to keep pace with the development of high technology
To keep a fair investment in R&D
To undertake world advanced, sustainable projects to fill in the blanks in China
To take in foreign technology and make use of the technology market
To put the emphasis on industralization and marketization in the field of technology innovations
To make a set of rewarding guidelines regarding talent retaining and competition in techology innovation. Custom Synthesis and Custom manufacturing
R&D focusing:
Hormones API and its intermediates
Steroid API and its intermediates
