根據(jù)《關(guān)于貫徹實(shí)施〈藥品生產(chǎn)質(zhì)量管理規(guī)范(2010年修訂)〉的通知》(國食藥監(jiān)安〔2011〕101號(hào))、《關(guān)于藥品GMP證書延續(xù)有關(guān)事宜的通知》(食藥監(jiān)辦安函〔2011〕269號(hào))規(guī)定,經(jīng)我局組織現(xiàn)場檢查,以下藥品生產(chǎn)企業(yè)符合《藥品生產(chǎn)質(zhì)量管理規(guī)范(1998年修訂)》要求,現(xiàn)同意延續(xù)其藥品GMP證書有效期,并予以公布。
廣東省食品藥品監(jiān)督管理局
2014年6月30日
序號(hào) |
原證書編號(hào) |
企業(yè)名稱 |
生產(chǎn)地址 |
批準(zhǔn)延續(xù)的認(rèn)證范圍 |
批準(zhǔn)延續(xù) 日期 |
有效期 延續(xù)至 |
備注 |
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英文 |
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1 |
粵K0725 |
廣州同康藥業(yè)有限公司 |
Guangzhou Tung Hong Medicine Co., Limited |
廣州經(jīng)濟(jì)技術(shù)開發(fā)區(qū)永和經(jīng)濟(jì)區(qū)華峰路8號(hào) |
No.8 Huafeng Road Yonghe District Guangzhou Economic-Technological Development Area Guangdong China |
中藥飲片(凈制、切制) |
Prepared Slices of Chinese Crude Drugs |
2014-05-07 |
2015-12-31 |
—— |
2 |
粵K0751 |
廣東德鑫制藥有限公司 |
Guangdong Dexin Pharmaceutical Co.,Ltd. |
廣東省江門市新會(huì)區(qū)圭峰山(紅旗山) |
Guifengshan Xinhui District Jiangmen City of Guangdong Province |
片劑 |
Tablets |
2014-05-07 |
2015-12-31 |
—— |
3 |
粵K0773 |
廣東臺(tái)城制藥股份有限公司 |
Grunagdong Taicheng Pharmaceutical Co.,Ltd. |
臺(tái)山市北坑工業(yè)園 |
Taishan Beikeng Industrial Park |
片劑,顆粒劑,茶劑,硬膠囊劑(含頭孢菌素類),散劑,軟膏劑,乳膏劑(含激素類),口服溶液劑,合劑,糖漿劑,中藥前處理和提取車間(口服制劑),中藥飲片(含直接口服飲片,凈制、切制、炒制、炙制、蒸制) |
Tablets, Granules, Medicinal Teas, Capsules(Including Cephalosporins), Powders, Ointment, Cream(Including Hormones), Oral Solutions, Mixture, Syrup, Prepared Slices of Chinese Crude Drugs. |
2014-05-07 |
2015-12-31 |
—— |
4 |
粵K0797 |
廣東紅珊瑚藥業(yè)有限公司 |
Guangdong Hongshanhu Pharmaceutical Co.,Ltd. |
湛江經(jīng)濟(jì)技術(shù)開發(fā)區(qū)龍平南路5號(hào) |
No.5 Long Pin Nan Lu Road, Zhangjiang Economic &Technological Developgical Development Zone,P.R.China |
顆粒劑,片劑,硬膠囊劑,中藥前處理及提取車間(口服制劑) |
Granules, Tablets, Capsules. Workshop of Traditional Chinese medicine extraction. |
2014-05-17 |
2015-12-31 |
—— |
5 |
粵K0777 |
廣東恒誠制藥有限公司 |
Guangdong Hengcheng Pharmaceutical Co., Ltd. |
湛江市經(jīng)濟(jì)技術(shù)開發(fā)區(qū)平樂工業(yè)區(qū) |
Pingle Industrial Park,Economic &Technological Development Zone,Zhanjiang. |
片劑,顆粒劑,丸劑(水蜜丸、水丸),露劑,溶液劑(外用,激素類),散劑(外用),酒劑,酊劑,茶劑,中藥前處理及提取車間(口服制劑) |
Tablets, Granules, Pills, Aromatic Solution, Solution(External Use, Hormones), Powders(External Use), Medicinal Wine, Tincture, Medicinal Teas, Chinese traditional medicine pretreatment and extraction(Oral preparation) |
2014-05-16 |
2015-12-31 |
—— |
6 |
粵J0556 |
化州市光華中藥飲片有限公司 |
Huazhou Chinese Medicine Sliced Herbs CO.,Ltd |
廣東鑒江經(jīng)濟(jì)開發(fā)試驗(yàn)區(qū) |
Test Region of Economic Devoloping Zone Jianjiang Guangdong |
中藥飲片(凈制、切制、炒制、炙制、煮制、蒸制、燀制、煅制、制炭) |
Prepared Slices of Chinese Crude Drugs |
2014-05-26 |
2015-12-31 |
—— |
7 |
粵K0813 |
深圳致君制藥有限公司 |
SHENZHEN ZHIJUN PHARMACEUTICAL CO., LTD |
深圳市寶安區(qū)觀瀾高新技術(shù)產(chǎn)業(yè)園區(qū) |
HI-TECH ZONE,Guanlan, Baoan Area,Shenzhen |
片劑,硬膠囊劑 |
Tablets, Capsules |
2014-05-27 |
2015-12-31 |
—— |