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The source of safety and effectiveness of drugs lies in the quality assurance of raw materials. When selecting suppliers that meet the criteria of supplier selection and evaluation, different selection methods are selected according to the actual procurement situation. In order to obtain the lowest procurement cost and risk, it is necessary to establish long-term cooperation with suppliers with the highest product quality.First of all, raw material supply enterprises must pass the national GMP certification, without data integrity problems, and long-term stable supply. If you change the API ve...
Date: 2019 / 10 / 23
浏览次数:103
On September 16, CDE released the publication of the catalogue of chemical generic reference preparations (the 24th batch), which is now published for comments.Publicity period: September 16, 2019 to September 27, 2019 (10 working days)。Contact mail: cdecbzj@cde.org.cnThe drug evaluation center of the State Drug Administration has newly published the catalog of the 24th batch of reference preparations, which includes 211 catalogs involving 118 varieties.Among them, there are 55 injections (34 varieties) and 10 eye drops (6 varieties). Since the eye drops were listed in the 21st batch of r...
Date: 2019 / 10 / 08
浏览次数:219
In recent years, the price of raw materials has risen rapidly. Some people think that the important reason is industry monopoly, but why does monopoly suddenly increase? Let's take a look at the relevant policies in the past few years, such as the two vote system, business to value-added system, generic drug consistency evaluation, etc. The purpose of these policies is very good, and can be said to be the right medicine, but the so-called 'three poisons of medicine'. The side effects of these policies are gradually emerging, which leads to the increase of industry concentration and...
Date: 2019 / 09 / 24
浏览次数:269
On August 28, the drug evaluation center of the State Food and Drug Administration issued the publication of the catalogue of the 23rd batch of chemical generic reference formulations, with the publication date from August 28 to September 10. This time, there are 318 product specifications, involving 169 drugs (see the attached table at the end of the article for details). Among them, 170 injection specifications accounted for 53.5%.2224 reference formulations have been published, with 630 injection varietiesAccording to statistics, up to now, FDA has released a total of 2224 reference fo...
Date: 2019 / 08 / 30
浏览次数:295
When it comes to pharmaceutical API wastewater, many people frown. In fact, the recycling of pharmaceutical API wastewater is also beneficial. Let's take a look at the following small weaving of pharmaceutical raw materials.① From an economic point of view, the recycling of API wastewater not only saves water resources, but also reduces the cost of sewage discharge and other costs, which has significant economic benefits.② From the perspective of water volume, the wastewater volume of API in biological industry, industry, medicine, etc. is almost the same as that of water, while rainwater ...
Date: 2019 / 08 / 29
浏览次数:96
In accordance with the Announcement on the Issuance of Procedures For the Selection and Determination of Chemical Generic Reference Formulations  (No. 25, 2019) issued by the State Drug Administration on March 28, 2019, in order to standardize the review and consistency evaluation of generic drugs, optimize the working procedures, strengthen service guidance, and ensure fairness, fairness and openness, the drug review center organized the selection of the 22nd batch of reference formulations Publicity will be held from June 3 to 17, 2019.In our study, the number of published referenc...
Date: 2019 / 07 / 04
浏览次数:299
APIs are intended to be used in the manufacture of any substance or mixture of substances.  When used in a drug, it  will become the active ingredient of the drug. Decolorization of APIs has always been a concern. we will introduce the decolorization technology of API to you.http://www.shop-tosun.comGenerally, APIs is white. For some colored impurities in APIs, we need to decolorize them. API impurities are generally macromolecular organic compounds containing groups. In most cases, API or isomers of similar substances close to API, but the content is low. If they are removed, a...
Date: 2019 / 06 / 24
浏览次数:50
On December 22, 2017, CDE organized the drafting of 'technical requirements for conformity assessment of  chemical generic drugs(injection)', and solicited public opinions.The selection of reference formulation described in the 'draft' is as follows:As a reference formula, the original research product should have complete and sufficient safety and effectiveness data as the basis for listing. If the above requirements are met, the enterprise is recommended to select the reference formula in the following order:The original research drugs listed in the domestic ma...
Date: 2019 / 06 / 18
浏览次数:46
Xinhua news agency, Beijing, May 19 (Xinhua) -- it was learned from the State Drug Administration that the 'measures for the administration of imported drugs' had recently been promulgated and would come into force on January 1 next year. 'The method will further strictly implement the implementation standards of imported medicinal materials and strengthen the traceability management.' The head of the drug registration administration of the State Drug Administration said.One of the highlights of the 'measures' is to implement the reform requirements of 'release and ...
Date: 2019 / 05 / 30
浏览次数:142
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