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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
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
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
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
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
If the original auxiliary packaging obtains the approval certificate before the implementation of the relevant approval policies and continues to be used for formulation, it shall be transferred to the registration platform by the SDA, and the registration number shall be indicated.The generic APIs that have been listed on the market in China may not be associated with pharmaceutical formulations when they are registered, that is, they are registered separately and reviewed independently. After review, the registration status is marked with 'A' and the registration status is ...
Date: 2019 / 04 / 13
1. List of reference formulationThe first step is to look at the list of reference formulations. So far, more than 1000 regulations have been promulgated in 18 batches.2. Principles of selection and determination and what to record?In short: those that are not published should be put on record, and only after the record is passed can they be used.3. What is the filing of reference formulation?Reference is made to the 'registration and recommendation procedures for reference formulations used to assess the consistency of the quality and efficacy of generic drugsThe manufacturer shall f...
Date: 2019 / 03 / 26
In the face of such strict requirements, many API enterprises are afraid, and some small enterprises have gradually withdrawn from the market due to various pressures. However, there may be some real powerful brand enterprises taking the high-end line in the world. Although some traditional enterprises have increased environmental inspection and infrastructure investment, transformation and upgrading are not inevitable. The so-called cold lip, in the face of the new storm of API, API equipment industry is also facing tremendous pressure and challenges, and relevant enterprises have to consider...
Date: 2019 / 03 / 19
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