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.
生物负载可能存在于原料、原料药的起始物料、中间体或原料药中的微生物的水平和种类(例如，致病的或不致病的)。
Bioburden The level and type (e. g. objectionable or not) of micro-organisms that can be present in raw materials, API starting materials, intermediates or APIs.
分析了申报原料药的管理和质量控制中存在的问题，简述了药品注册中原料药管理和质量控制的几点建议。
This article analyses the common problems in the registration application and quality control of drug substance, and gives some suggestions for the issues concerned.
总体来说，不鼓励加入过量原料药以补偿生产过程或产品存贮期中原料药的降解，或用以延长保存期。
In general, use of an overage of a drug substance to compensate for degradation during manufacture or a product's shelf life, or to extend shelf life, is discouraged.
对于含有多个原料药的制剂，还应讨论各原料药间的兼容性。
For products that contain more than one drug substance, the compatibility of the drug substances with each other should also be evaluated.
主要生产生物化工产品、皮质激素原料药、原料药、医药中间体、药用及饲料用氨基酸产品等。
It mainly manufactures Bio-chemical products, corticosteroid raw materials, raw materials for drugs, pharmaceutical intermediates, amino acid products for medicine and animal feeds and etc.
其中皮质激素类原料药生产能力居世界第一，氨基酸原料药目前国内品种最多，生产能力最大。
The capacity for manufacturing corticosteroid raw materials rank first all over the world. Amino acid raw materials get the most varieties in the whole nation with the largest manufacturing capacity.
星湖生物化学制药厂建成投产，主要生产肌苷、脯氨酸等原料药，现在已经成为全球最具规模的肌苷原料药生产基地。
Star Lake Bio-Chemical Pharmaceutical Factory was founded and went into operation, with main products inosine, L-Proline, Now it becomes the largest inosine manufacture on globe.
星湖生物化学制药厂建成投产，主要生产肌苷、脯氨酸等原料药，现在已经成为全球最具规模的肌苷原料药生产基地。
Star Lake Bio-Chemical Pharmaceutical Factory was founded and went into operation, with main products inosine, L-Proline, Now it becomes the largest inosine manufacture on globe.
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