原料药生产中使用的水应当证明适合于其预定的用途。
Water used in the manufacture of APIs should be demonstrated to be suitable for its intended use.
目前我国已经是制药原料药生产的大国，但不是强国。
Now China has been a big country which produce bulk medicine, but not strong.
比如，意大利目前是第二大原料药生产国，所占份额为10%。
Italy, for example, at 10%, is the second-biggest producer of raw pharmaceutical materials.
近年来我国化学原料药的生产和出口迅猛发展，我国已经成为原料药生产和出口大国。
With the rapid development of production and export of chemical crude drugs in recent years, China has become a great country in this field.
在原料药生产工业，尤其是非肠道用药的原料，在水系统中通常用到超滤和反渗透系统。
In the bulk drug substance industry, particularly for parenteral grade substances, it is common to see Ultrafiltration and Reverse Osmosis systems in use in water systems.
FDA在1992年对使用普通设备生产的活性激素产品和非激素产品的国外原料药生产商提出了进口警告。
FDA a instituted an import alert in 1992 on a foreign bulk pharmaceutical manufacturer which manufactured potent steroid products as well as non-steroidal products using common equipment.
FDA在1992年对使用普通设备生产的活性激素产品和非激素产品的国外原料药生产商提出了进口警告。
FDA instituted an import alert in 1992 on a foreign bulk pharmaceutical manufacturer which manufactured potent steroid products as well as non-steroidal products using common equipment.
在原料药生产工艺中，特别是某些如类固醇的高效化学制品生产中，如果设备不是专用的，必须考虑副产品的问题。
In a bulk process, particularly for very potent chemicals such as some steroids, the issue of by-products needs to be considered if equipment is not dedicated.
中间体或原料药生产过程中使用的主要设备(如反应釜、贮存容器)和永久性安装的工艺管道，应当作适当的识别标志。
Major equipment (e. g. reactors storage containers) and permanently installed processing lines used during the production of an intermediate or API should be appropriately identified.
尤其对那些原料药生产商来说，反应物，反应堆或设备间的管道系统可以只是用冲洗溶液样品取样，这样做就很正确了。
This would be particularly true for the bulk drug substance manufacturer where reactors and centrifuges and piping between such large equipment can be sampled only using rinse solution samples.
天象生物主要生产的兽用原料药有延胡索酸泰妙菌素、磷酸替米考星、盐酸头孢噻呋、氧阿笨达唑等。
The mainly products of Raw materials of Tianxiang Bio-pharmacy are Tiamulin Fumarate, Tilmicosin Phosphate, Ceftiofur Hydrochloride, Albendazole Oxide, etc.
因此，剂型生产商评估每个供应商原料药的杂质情况是相当重要的。
Therefore, it is essential that the dosage-form manufacturer evaluate each supplier's drug substance impurity profiles.
因此，剂型生产商评估每个供应商原料药的杂质情况是相当重要的。
Therefore, it is essential that the dosage-form manufacturer evaluate each supplier's drug substance impurity profiles.
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