【公函轉知】印度與中國原料藥廠違反GMP及Warning Letter相關資訊(持續更新)

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轉知食藥署公函關於國際原料藥廠違反GMP之相關資訊(依照公函轉知日期排序):

  1. 印度「Alchymars ICM SM Private Limited」
    (廠址:A-14 & 20 Sidco Pharmaceutical Complex, Alathur, Tamil Nadu, India)
  2. 中國「Hangzhou Yiqi Biotechnology Co., Ltd」
    (廠址:Room 204, Building 3, No. 66 Xixiang Road, Puyan Street, Hangzhou, Zhejiang 310018, China)
  3. 中國「Harbin Jixianglong Biotech Co., Ltd.」
    (廠址:North of Baoan Road, East of Changqing Street, Liminzhen Hulan District, Harbin, Heilongjiang, China)
  4. 印度「Cadchem Laboratories Limited」
    (廠址:Village Jaula Khurd, Tehsil Derabassi, Lalru, Sahibzada Ajit Singh Nagar, Punjab, 140501, India)
  5. 印度「Eugia Pharma Specialities Limited」
    (廠址:Unit 2 A 1128 B 1127, RIICO Industrial Area Phase III, District Khairthal Tijara, Bhiwadi, 301019, India)
  6. 中國「Henan Lvyuan Pharmaceutical Company Limited」
    (廠址:Industrial Park, Qiliying Town, Xinxiang County, Henan, China)
  7. 印度「Flowchem Pharma Private Limited」
    (廠址:Plot No. 2B-2 & 2C, Survey No. 7(p) & 8(p), Gollapuram Industrial Park, Hindupur Taluk, Andhra Pradesh, India)
  8. 印度「EUGIA PHARMA SPECIALITIES LIMITED」
    (廠址:Unit-2, A-1128 and B-1127, RIICO Industrial Area, Phase III, District Khairthal-Tijara, 301 019 Bhiwadi, Rajasthan, India.)
  9. 中國「HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD.」
    (廠址:No.57 Zhangju Road, Luancheng County, China-051 430 Shijiazhuang City, Hebei Province)
  10. 印度「Chemspec Chemicals Private Limited」
    (廠址:Plot 3-C, Taluka Panvel, Navi Mumbai, Maharashtra, India)
  11. 美國「Darmerica, LLC」
    (廠址:4380 Oakes Road, Suite 800, Davie, United States)
  12. 馬來西亞「Sm Biomed Sdn. Bhd.」
    (廠址:Lot 90, Sungai Petani Industrial Estate, Sungai Petani, 08000, Malaysia)
    輸台品項:ERYTHROMYCIN
  13. 印度「Cdymax India Pharma Private Limited」
    (廠址:77d & 116/117, KIADB Industrial Area, Jigani, Bangalore, Karnataka, India)
    輸台品項:ENZALUTAMIDE、OLAPARIB、OLAPARIB MONOHYDRATE、OLAPARIB REFERENCE STANDARD。
  14. 美國「Scientific Protein Laboratories, LLC」
    (廠址:700 East Main Street, Waunakee, United States)
    輸台品項:PANCRELIPASE、LIPASE、PROTEASE、AMYLASE。
  15. 中國「NINGXIA TAIYICIN BIOTECH CO., LTD.」
    (廠址:Pacific Road No. 1, Nuanquan Economic Zone Helan County, Yinchuan City, Ningxia Province, China-750 205)
  16. 中國「Chengdu Brilliant Biopharmaceutical Co., Ltd.」
    (廠址:#33, Tengfei 12th Road, Southwest Airport Economic Dev Zn, Shuangliu District Chengdu, Sichuan, China)
  17. 印度「Hikal Limited」
    (廠址:72 – 82 /A Kiadb Industrial Area, Jigani, Karnataka, 560105, India)
  18. 印度「Macsen Drugs」
    (廠址:F-261, 262, 263 Riico Industrial Area, Gudli Tehsil Mavli, Udaipur 313024 Rajasthan India)
  19. 印度「NECTAR LIFESCIENCES LIMITED」
    (廠址:UnitII, Village Saidpura District Sahibzada Ajit Singh Nagar India-140 507 Tehsil Dera Bassi, Punjab)
  20. 印度「Mentha & Allied Products Private Ltd.」
    (廠址:16th Km Rampur-Swar Road, Rampur, Uttar Pradesh, India)
  21. 印度「NECTAR LIFESCIENCES LIMITED」
    (廠址:Unit II, Village Saidpura District Sahibzada Ajit Singh Nagar India-140 507 Tehsil Dera Bassi, Punjab)
  22. 印度「Aspen Biopharma Labs Private Limited」
    (廠址:Plot 10, Phase – II; Lalgadi Malakpet Village, Rangareddy, Hyderabad, Telangana, 500078, India)
  23. 印度「Shree Jaya Laboratories PVT. LTD.」
    (廠址:Sy. No. 299, Malkapur Village and Post, Choutuppal Mandal, Yadadri Bhuvanagiri District, Telangana, India)
  24. 印度「Tyche Industries Ltd」
    (廠址:6-223, Sarpavaram (V), Kakinada, India)
  25. 中國「Chengdu Innovation Pharmaceutical Co., Ltd.」
    (廠址:No.123, 1st Floor, No 91 Zhongheng Street, Jinniu District, Chengdu, Sichuan, China)
  26. 中國「Wuhu Nuowei Chemistry Co., Ltd.」
    (廠址:Xuancheng 323 Provincial Road, Pang, Jingde, Xuancheng, China)
  27. 印度「Maithili Life Sciences Private Limited」
    (廠址:Plot No 2, Apiic Industrial Estate, Gajulamandyam, Tirupati, Renigunta, Andhra Pradesh, 517520, India)

詳情請參閱附件說明,並請確認廠內是否使用上述廠商生產之產品。


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