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[GMP相关] 通过WHO认证31家中国药企

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药士
发表于 2018-3-1 22:23:04 | 显示全部楼层 |阅读模式

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恭喜31家中国药企通过WHO认证

原创 2018-03-01 翻译组 GMP办公室

WHO PQ认证()是独立于国家食品药品监督管理总局(CFDA)的认证。WHO PQ认证在全球许多国家是公开认可的,一旦通过了WHO PQ认证,有利于在许多进口国的注册,还可以获得符合国际GMP要求的确认,减少其他进口国的检查。

只有产品通过了WHO PQ认证,才能成为联合国采购供应商,不仅会受到联合国采购的关注,世界银行、亚洲开发银行等国际组织和机构在进行全球采购时,也都会在联合国采购的注册采购供应商中进行选择。但中国企业真正参与并且分享这个市场的屈指可数。

以下是GMP办公室整理的通过WHO PQ认证的中国药企名单,他们在中国制药国际化道路上的辛勤努力,也恭喜他们的药品质量体系得到世界卫生组织的认可,恭喜他们在国际化道路上走出的坚实一步!
[td]
No
序号
Company
企业
Medicines/Finished Pharmaceutical Products
制剂成品
01
Zhejiang Huahai Pharmaceutical Co Ltd
浙江华海制药有限总公司
02
Hainan Poly Pharma Co Ltd
海南普利制药有限公司
03
Shenzhen Zhijun Pharmaceutical Co Ltd
深圳致君制药有限公司
04
Shanghai Desano Bio-Pharmaceutical Co Ltd
上海迪赛诺生物制药有限公司
05
Shanghai Desano Bio-pharmaceutical Co.,  Ltd.
上海迪赛诺生物制药有限公司
06
Guilin  Pharmaceutical Co Ltd
桂林药业股份有限公司
07
Shanghai Dahua Pharmaceutical Co Ltd
上海达华药业有限公司
08
China Resources Zizhu Pharmaceutical Co  Ltd
华润紫竹制药有限公司
09
Hisun Pharmaceutical (Hangzhou) Co Ltd
海正药业(杭州)有限公司
10
NCPC International Corp
华北制药集团国际医药有限公司
Active Pharmaceutical Ingredients
原料药
11
Zhejiang Langhua Pharmaceutical Co Ltd
浙江朗华制药有限公司
12
Shanghai Desano Chemical Pharmaceutical  Co Ltd
上海迪赛诺化学制药有限公司
13
Pen Tsao  Chemical Industry Ltd
秉信化工有限公司
14
KPC Pharmaceuticals Inc
昆药集团股份有限公司
15
Qinhuangdao Zizhu Pharmaceutical Co Ltd
秦皇岛紫竹制药有限公司
16
Shijiazhuang Lonzeal Pharmaceuticals Co  Ltd
石家庄龙泽制药有限公司
17
Second Pharma Co Ltd
浙江新赛科药业有限公司
18
Zhejiang Hisun Pharmaceutical Co Ltd
浙江海正药业有限公司
19
Guilin Pharmaceutical Co Ltd
桂林药业股份有限公司
20
Zhuhai Rundu Pharmaceutical Co Ltd
珠海润都制药有限公司
21
North China Pharmaceutical Huasheng Co  Ltd
华北制药华胜有限公司
22
Chongqing  Holley Wuling Mountain Pharmaceutical Co Ltd
重庆华立武陵山制药有限公司
23
Livzon Group Fuzhou Fuxing Pharmaceutical  Co Ltd
丽珠集团福州福兴医药有限公司
24
Changzhou Yabang-QH Pharmachem Co Ltd
常州亚邦齐晖制药有限公司
25
Shenyang Antibiotic Manufacturer
沈阳抗生素厂
26
Shangyu Jingxin Pharmaceutical Co Ltd
上虞京新药业有限公司
27
Taizhou Taifa Pharmaceutical Co Ltd
台州太法药业有限公司
28
Zhejiang Jiangbei Pharmaceutical Co Ltd
浙江江北药业有限公司
29
Jiangsu Grand Xianle Pharmaceutical Co  Ltd
江苏远大仙乐药业有限公司
30
Anhui Biochem United Pharmaceutical Co.,  Ltd
安徽贝克联合制药有限公司
31
Chongqing Kangle Pharmaceutical Co Ltd
重庆康乐制药有限公司



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药士
 楼主| 发表于 2018-3-1 22:35:11 | 显示全部楼层
1、WHO pre-qualification相关的制剂查询网站
Medicines/Finished Pharmaceutical Products

其中在制剂层面,在中国的生产场地(包括代工)共通过了25个制剂产品,那么我们来看一下在印度的生产场地(包括代工)共通过多少产品??(335个,对,你没有看错);
那么2017年(自然年),中国共通过多少产品呢,共5个,而其中印度是39个。


2、WHO pre-qualification相关的API查询网站
https://extranet.who.int/prequal/content/active-pharmaceutical-ingredients-0


其中在API层面,在中国的生产场地(包括代工)共通过了43个API产品,而印度通过了68个API产品








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药士
 楼主| 发表于 2018-3-1 23:45:01 | 显示全部楼层
本帖最后由 beiwei5du 于 2018-3-1 23:47 编辑

那么盘点2017年FDA中中国ANDA的情况,可以参考对比一下!
其中中国在2017年共获得38个ANDA,参见下面文章:【年终盘点】2017年中国药企获FDA批准的38个ANDA

那么印度在2017年共获得多少个ANDA呢??(共计300多个),参见下面文章:
Indian pharma cos get record 300 USFDA generic drug nods,其中 Zydus一家企业在2017年就批准了66个ANDA
而其中最有价值的首仿药(FDA2017自然年共批准了80个),各自分别是多少呢??,那么可以参见下面网址2017 First Generic Drug Approvals
其中印度有17个,,其中Aurobindo Pharma Limited,有七个;而中国有2个(恒瑞有1个+台湾Pharmadax Inc)



序号
公司
1
Sun  Pharmaceutical Industries Inc.
2
Rubicon Research Private Limited
3
Natco Pharma Limited
4
Lupin Inc.
5
Luitpold Pharmaceuticals, Inc.
6
Inventia Healthcare Private Limited
7
Glenmark Pharmaceuticals Limited
8
Gland Pharma Limited
9
Dr. Reddys Laboratories International SA
10
Aurobindo Pharma Limited
11
Aurobindo Pharma Limited
12
Aurobindo Pharma Limited
13
Aurobindo Pharma Limited
14
Aurobindo Pharma Limited
15
Aurobindo Pharma Limited
16
Aurobindo Pharma Limited
17
Accord Healthcare Inc.
18
Pharmadax Inc.
19
Jiangsu Hengrui Medicine Co., Ltd.
20
Zydus Pharmaceuticals (USA), Inc
21
Zydus Pharmaceuticals (USA) Inc.
22
Zydus Pharmaceuticals (USA) Inc.
23
Zydus Pharmaceuticals (USA) Inc.
24
Watson Laboratories, Inc.
25
Watson Laboratories, Inc.
26
Watson Laboratories, Inc.
27
Upsher-Smith Laboratories, Inc.
28
Teva Pharmaceuticals USA, Inc.
29
Teva Pharmaceuticals USA, Inc.
30
Teva Pharmaceuticals USA
31
Teva Pharmaceuticals USA
32
Teva Pharmaceuticals
33
Teligent  Pharma, Inc.
34
Taro Pharmaceuticals USA, Inc.
35
Taro Pharmaceuticals USA Inc.
36
Taro Pharmaceuticals USA Inc.
37
Sandoz Inc.
38
Sandoz Inc.
39
Roxane Laboratories, Inc.
40
Perrigo UK Finco Limited Partnership
41
Perrigo R&D Company
42
Par Pharmaceuticals, Inc.
43
Par Pharmaceutical, Inc.
44
Par Pharmaceutical, Inc.
45
Par Pharmaceutical, Inc.
46
Par Pharmaceutical Inc.
47
Par Pharmaceutical Inc.
48
Pack Pharmaceuticals, LLC
49
Nostrum Laboratories, Inc.
50
Nexus Pharmaceuticals, Inc.
51
Nesher Pharmaceuticals (USA) LLC
52
Mylan Pharmaceuticals Inc.
53
Mylan Pharmaceuticals Inc.
54
Mylan Pharmaceuticals
55
Mylan Laboratories Limited
56
Mylan Laboratories Limited
57
Mylan Laboratories Limited
58
Mikart, Inc.
59
Mayne Pharma, Inc.
60
IntelliPharmaCeutics Corp.
61
Ingenus Pharmaceuticals, LLC
62
Impax   Laboratories Inc.
63
Hospira, Inc.
64
Hansamed, Inc.
65
Fresenius Kabi USA, LLC
66
Belcher Pharmaceuticals, LLC
67
Apotex, Inc.
68
Amneal Pharmaceuticals LLC
69
Amneal Pharmaceuticals Company GmbH
70
Alvogen Malta Operations Ltd.
71
Akorn, Inc.
72
Akorn Inc.
73
Actavis Laboratories UT, Inc.
74
Actavis Laboratories FL, Inc.
75
Actavis Laboratories FL, Inc.
76
Actavis Laboratories FL, Inc.
77
Actavis Laboratories FL Inc
78
Actavis Elizabeth LLC
79
Abon Pharmaceuticals, LLC
80
Apotex Inc.




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药士
 楼主| 发表于 2018-3-1 23:49:47 | 显示全部楼层
本帖最后由 beiwei5du 于 2018-3-1 23:57 编辑

可参考:
美国首仿药,很多印度造!

2018-01-11 转载 培优创新药品研发与一致性评价

印度公司在 2017 年美国 FDA 批准的首仿药中占了四分之一以上。这些首仿批准包括一些有限竞争的药品和复杂产品,部分反映了小型和大型印度公司正在将其投资组合向着这些有着很大渗透空间和更多利润的投资组合调整

“首仿药”代表 FDA 首次批准允许制造商在美国市场上销售一款仿制药 — 实质上是参照产品的首个仿制药。FDA 认为首仿药对公共卫生至关重要,并优先审评这些提交。FDA 2017 年的数据(截至 2017 年 12 月 19 日更新)显示有 74 个首仿药批准,其中印度公司及其子公司占 29% 以上。这些产品中包括复杂产品,例如,Aurobindo 制药公司的仿制 Renvela(司维拉姆),而另一印度公司 Natco 制药公司的伙伴 Mylan 公司则获得了 Teva 制药治疗多发性硬化的 Copaxone(醋酸格拉替雷)。

一线印度公司一直渴望逐步发展为涵盖复杂仿制药、生物类似药和特殊药品的模式,以确保能够在美国市场定价和其它压力下持续进步。

Lupin 公司总经理 Nilesh Gupta 在去年的一次演讲中指出,印度公司在复杂仿制药上的渗透仅有 19%,而在简单仿制药上的渗透有 34%。Gupta 在去年九月份的 Motilal Oswal投资者会议上表示,“复杂产品大类通常是没有被仿制的,或仍处于半专营期,IV 段专利声明的机会总是有利可图的。”但是在复杂仿制药领域面临的挑战通常包括昂贵的生物研究或临床研究,更长的研发时间表和更长的 FDA 审评周期,但审评周期这一点可能正在发生改变。

一些分析师认为,印度公司在 FDA 首仿药批准清单上的持续存在虽然并不令人感到意外,但是是令人鼓舞的,这意味着印度公司在围绕生产合规偏差方面的所有噪音中显示了其普遍的研发实力。

Research Delta Advisors 的创始人 Nimish Mehta 表示,印度公司在 2017 年 FDA 首仿药批准清单中的强势表现,表明了印度公司如何从研发角度从普通仿制药过渡到复杂仿制药和有限竞争的产品。Mehta 表示,“印度公司正处于最前沿,而像 Natco 公司(Mylan 公司仿制药 Copaxone 的合作伙伴)这样的小公司正与 Sandoz 这样的大公司肩并肩站在一起。”并且,一些印度公司,不论规模大小,现在都在寻求进入复杂仿制药和有限竞争产品的游戏中来。但是,他警告指出,生产复杂仿制药也意味着具有潜在更高的 GMP 风险。

但 Mehta 指出,印度公司在首仿药中的贡献百分比在过去几年中基本保持不变。“尽管许多印度大公司出现 GMP 合规问题,但其他印度小公司却能够在一定程度上填补这一空白。”2017 年 FDA 首仿药批准清单包括像 Inventia Healthcare 公司这样的不太起眼的印度公司。

编译:识林-椒
转自:识林(Shilin_X)
原文题目:印度继续在 2017 美国首仿药批准清单中占据显著地位
【转自:识林】
【编辑:笑笑】

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药士
发表于 2018-3-1 23:57:12 | 显示全部楼层
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药生
发表于 2018-3-2 06:42:25 | 显示全部楼层
支持制剂进军国际市场。
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药生
发表于 2018-3-2 07:19:41 | 显示全部楼层
原料药就不要凑这个热闹。
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药士
发表于 2018-3-2 08:32:03 | 显示全部楼层
04/05咋一样的
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药士
发表于 2018-3-2 08:34:54 | 显示全部楼层
那么印度在2017年共获得多少个ANDA呢??(共计300多个),参见下面文章:
Indian pharma cos get record 300 USFDA generic drug nods,其中 Zydus一家企业在2017年就批准了66个ANDA——小看了阿三了,中国有点比不了啊:@

点评

这个是按产品列的!zydus(US)也是印度zydus子公司,总的来说首仿药有20多个吧!  发表于 2018-3-2 09:09
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药徒
发表于 2018-3-2 08:51:09 | 显示全部楼层
印度的原料药就是坑啊,我们公司买的印度的原料药,周期好长,他自己原料的分析方法变更了居然不通知我们,等我分析方法验证时发现不合适时,他才提供给我们最新的分析方法,简直就是坑啊。

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咖喱佬们做事一向如此  详情 回复 发表于 2018-3-5 11:03
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药徒
发表于 2018-3-2 09:02:37 | 显示全部楼层
榜上有名啊
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药士
发表于 2018-3-2 09:50:24 | 显示全部楼层
zj3801033 发表于 2018-3-2 08:51
印度的原料药就是坑啊,我们公司买的印度的原料药,周期好长,他自己原料的分析方法变更了居然不通知我们, ...

呵呵,我们国内很多厂不也是这样吗,一年都在变,啥也不体现。
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药徒
发表于 2018-3-2 10:00:16 | 显示全部楼层
zysx01234 发表于 2018-3-2 09:50
呵呵,我们国内很多厂不也是这样吗,一年都在变,啥也不体现。

原料药厂不分国内国外都一个样,唯一的好处国内的沟通起来比较快,和印度沟通就慢了,我们那个原料药的分析方法验证前前后后搞了近2个月。
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药士
 楼主| 发表于 2018-3-3 12:33:15 | 显示全部楼层
本帖最后由 beiwei5du 于 2018-3-3 12:35 编辑

2015年的一篇文章,仅做参考!
https://www.linkedin.com/pulse/pharmaceutical-sourcing-india-china-abhishek-singh?trk=pulse-det-nav_art
Pharmaceutical Sourcing: INDIA or CHINA?
  • 发布日期: 2015 年 6 月 13 日
JZMed, Inc., a market research company: Amazing findings

The pharmaceutical markets of China and India have been experiencing such rapid growth in the past decade that they are widely recognized as two of the world’s most dynamic emerging markets. Consequently, they have attracted many drug companies around the world.
Similarly, the pharmaceutical industry in these two countries has also experienced rapid advancements in recent years. The technical capabilities, production skills, and regulatory knowledge of the local companies have accordingly been greatly improved and reached acceptable levels for global companies. These features, coupled with the still-low costs of their services and/or products compared with those of the developed countries, have made these two countries the primary choices of global drug companies for sourcing raw materials and finished products or outsourcing of manufacturing work.
However, despite a number of similarities between China and India, there are still a larger number of differences between these two countries in the areas related to pharmaceutical manufacturing. The strengths and weaknesses of each country and their advantages and disadvantages to certain sourcing/outsourcing projects have become the key differentiators. Many sourcing/outsourcing companies are, however, still not clearly aware of these differences.
We recently conducted an in depth study and analysis on the pharmaceutical manufacturing industries in both China and India. Our study focused on the growth and development history of 200 major pharma companies in each country. The study revealed some interesting results, such as similarities and differences regarding their capabilities, capacities, market sizes, cost structures, strengths, and shortcomings. The research also indicated future development potentials, as well as the strategies of multinational companies in these two countries. This article summarizes our results.

General Comparison Of Pharmaceutical Industry Between China And India
In many aspects, China and India are very similar. Both countries are located in Asia with similar sized populations, and both belong to the group of emerging markets with fast-growing economies. Both countries also have low wages for most workers in many industries.
There are, however, also significant differences between these two countries. For example, generally speaking, China has a better general industrial infrastructure than India because the Chinese government has put enormous efforts and investments in this during the past two decades. The logistic service in China also is better developed and less expensive than in India. These advantages have made China attractive to foreign companies looking for a country where doing business is relatively easy.
However, India has its advantages, too. It has a better infrastructure in information technology (IT) than China, which is significant since IT skills play an important role in data management, bioinformatics, and clinical trials. The business philosophy and operating culture in most Indian companies are closer to Western traditions than their Chinese counterparts. This makes Indian companies easier to negotiate and reach business deals with their Western partners.
Analysing further, to some extent, China has a better education system in biology, molecular biology, and other life science–related fields, resulting in, generally speaking, a better biotech industry in China than in India. However, India has paid attention to promoting its pharmaceutical industry a lot earlier than China. This has directly resulted in a stronger pharmaceutical industry in India than in China. For example, India currently has a substantial number of key players whose capabilities are strong enough to compete full-scale in the international market; whereas so far none of the Chinese drug companies has reached the same level or even come anywhere close.
At present, to global pharma companies, China and India possess the best ratio of cost to product/service quality among all emerging countries. However, the current labor and raw material costs in the Indian pharmaceutical industry are generally about 25% to 30% higher than in China. That fact makes China more attractive than India to pharma companies when they source bulk materials or outsource long-term, large-scale manufacturing projects.

Comparing China’s And India’s API Manufacturing
Unlike their Chinese counterparts, the majority of Indian pharma companies began with simple dosage forms and then gradually moved to novel and/or complex drug delivery systems, and later decided to expand their business scope to include APIs. This development model is commonly called reverse-engineering. To a large extent, this development pattern has resulted in the shortage of APIs in India. At present, only about 70% of the APIs the Indian pharma industry needs are made domestically. The rest are imported from other countries, mostly from China. Many Indian drug companies have thus been sourcing APIs from China for many years.
Compared with its Indian counterpart, in the global pharmaceutical manufacturing industry, China has been well recognized as the world largest API producer. For example, among the total of 2,000 or so APIs in the global market, China can make close to 1,600 of them. As a comparison, the Indian pharma industry is currently able to make about 400 APIs. However, at present, most Chinese API makers still do not have sufficiently good technical or R&D capabilities. They are mostly engaged in only low-tech manufacturing.
Currently, the most popular Chinese-made APIs are still those for the medications of bacterial infections. As a comparison, the APIs in the therapeutic areas of oncology, cardiology, diabetes, and tropical diseases are the main products of most Indian pharma companies.
APIs are also the largest class of products among all Chinese made pharma-related products marketed overseas. China currently has about 1,000 API makers that market their products in the international market. The export value of the Chinese-made APIs reached $22 B in 2011, accounting for about 49% of the total export value of all Chinese-made pharma-related products. From 2005 to 2011 this Chinese pharma sector successfully maintained a CAGR of around 13%. As a comparison, the current export value of the Indian-made APIs marketed overseas is only about $6.7 B. From 2007 to 2011, this Indian pharma sector has successfully maintained a CAGR of about 15%.
Currently, there are about 150 Chinese API manufacturers that have various numbers of APIs registered with the international regulatory agencies; and about 30 of them have API production facilities that are cGMP-certified by the regulated countries. As a comparison, there are a total of more than 120 Indian pharma plants that have passed FDA’s cGMP inspection. More than 800 manufacturing units in India are also in compliance with WHO’s standard.

Comparing Drug Formulation And Manufacture Of Dosage Forms
For a number of years, China has been well-known for marketing APIs in the global market, but less recognized for any of its dosage form drugs. Although a large number of Chinese companies also produce dosage forms, only a handful of them are currently able to market a limited number of their finished products in the regulated markets. To a large extent, this has determined the low-end position of the Chinese-made pharma products in the international market and the long value chain of global pharmaceutical supply.
Collectively, the Chinese pharma industry is able to produce more than 60 dosage forms with a total of about 5,000 medicines. Among all dosage forms, the powder for injection is the largest group, followed by oral solids. As a comparison, India is currently able to make almost all types of dosage forms with a total of more than 60,000 medicines. A large number of Indian companies has even gained the formulation and manufacturing capabilities for difficult-to-make forms, including injectables and soft gels. Attracted by their capabilities in formulation, a number of major pharma companies have collaborated with Indian companies on codevelopment of generic drugs or licensed the sales rights to them.
Currently, an increasing number of Chinese pharma companies are aggressively improving their production facilities and aim to get them certified by the regulated countries. Compared with their Chinese counterparts, a larger number of Indian pharma companies possess large manufacturing facilities that have already been certified by the regulated countries.
Currently, China markets finished drugs in more than 170 countries and regions. But the largest markets are still the developing countries. The current total export value of dosage forms is only a little more than $2 B. Sales of the Chinese-made finished drugs in the developed countries account for about 40% and are mostly marketed by the Chinese divisions of major multinational pharma companies. In comparison, the current total export value of India’s finished drugs is about $11 B. About half of the Indian made finished drugs are marketed in the well-regulated markets, mostly by the Indian companies themselves.

Where To Source Or What To Outsource
India has been playing increasingly important roles in the global pharmaceutical manufacturing industry. Its recognized capabilities in formulation development, finished drug manufacturing, and product marketing in the regulated markets have made it a trusted source for global pharma companies when seeking partners for co development and/or co marketing of generics.
China’s current strengths reside in its better industrial infrastructure, large-scale manufacturing capabilities of raw materials, and relatively low labor and material costs. India’s current strengths include its stronger capability in process development, drug formulation, dosage form manufacturing, and marketing in well regulated markets.
Thus, it can be concluded that, at present, the Indian companies are the better choice for formulation development, manufacturing, and marketing of dosage form drugs. In contrast, Chinese companies are a better fit for upstream work, such as contract manufacturing (and sourcing) of advanced pharma intermediates and APIs. Also, Chinese companies charge less than Indian counterparts for the same type of services/products, thereby offering better cost-reduction benefits.
On the other hand, as our research results have revealed, even though China and India are presently the hotbeds for global pharmaceutical manufacturing, they still play much less significant roles than developed countries, in particular in the high-end areas such as the special formulation techniques and the manufacture of APIs and finished drugs that are still under patent protection. The situation is largely determined by the intrinsic weaknesses of these two countries in low R&D investment in pharmaceutical industry.

Originally written by: Jim Zhang, Ph.D., is president and managing director of JZMed, Inc., a market research company specializing in research on the Chinese pharmaceutical outsourcing industry.





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大师
发表于 2018-3-4 14:12:51 | 显示全部楼层
改名为中印仿制药对比
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药徒
发表于 2018-3-5 11:03:41 | 显示全部楼层
zj3801033 发表于 2018-3-2 08:51
印度的原料药就是坑啊,我们公司买的印度的原料药,周期好长,他自己原料的分析方法变更了居然不通知我们, ...

咖喱佬们做事一向如此
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药徒
发表于 2018-3-6 10:00:18 | 显示全部楼层
roadman 发表于 2018-3-4 14:12
改名为中印仿制药对比

直接秒杀中国在制药方面。。。。
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药生
发表于 2018-3-6 16:42:25 | 显示全部楼层
2018年2月13日, WHO发布立场文件关于秦皇岛紫竹制药有限公司。




WHO_QZP.jpg

WHO Position Paper_QZP.pdf

39.15 KB, 下载次数: 4

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药生
发表于 2018-3-6 16:47:59 | 显示全部楼层
榜上有名,仍需要努力
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药徒
发表于 2018-3-7 08:46:01 | 显示全部楼层
这些企业确实NB啊!作为制药人深感骄傲。
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