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市场: DIGEMID (Peru), ANVISA (Brazil), ISP (Chile), 俄罗斯卫生当局, EMA (EU), SFDA (Saudi Arabia), TGA (Australia), INVIMA (Colombia), MHRA (UK)
批量大小: 中等的, 大的
类别/产品: FDF / 药品
遵守: ISP (Chile BPM), Roszdravnadzor (Russia GMP), EMA (EU GMP), DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), SFDA (Saudi Food & Drug Authority), ECOVADIS, INVIMA, Health Canada (Canada GMP)
受控物质: 滥用可能性最低
地区: 欧洲, 亚太地区, 拉丁美洲, 北美, MENA
使用: 人类, 兽医
服务: 分析/质量控制服务, 制造服务, 监管服务, 开发服务, 包装, 质量保证服务
OEB（职业暴露带）: 2（PDE = 1,000 - 10,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）
BSL（生物安全等级）: 1
专业治疗领域 (ATC): (J) 全身使用的抗感染药
市场: ANMAT (Argentina), ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)
批量大小: 小的, 中等的, 大的
类别/产品: FDF / 药品
遵守: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
受控物质: 滥用可能性最低, 降低滥用的可能性, 滥用可能性低
地区: 欧洲
使用: 人类, 兽医
服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 开发服务, 包装, 质量保证服务
OEB（职业暴露带）: 2（PDE = 1,000 - 10,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）, 3（PDE = 100 - 1,000 微克/天）
专业治疗领域 (ATC): (M) 肌肉骨骼系统, (三) 心血管系统, (A) 消化道和新陈代谢, (N) 神经系统
批量大小: 中等的, 大的
专业治疗领域 (ATC): (R) 呼吸系统, (J) 全身使用的抗感染药, (三) 心血管系统, (A) 消化道和新陈代谢, (D) 皮肤科, (N) 神经系统
类别/产品: FDF / 药品
遵守: ISP (Chile BPM), EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), ECOVADIS, INVIMA, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
受控物质: 滥用可能性最低, 降低滥用的可能性, 滥用可能性低
地区: 欧洲
BSL（生物安全等级）: 3, 1, 2
市场: ANVISA (Brazil), ISP (Chile), PMDA (Japan), EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
使用: 人类, 兽医
服务: 分析/质量控制服务, 制造服务, 监管服务, 开发服务, 包装, 质量保证服务
OEB（职业暴露带）: 2（PDE = 1,000 - 10,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）, 3（PDE = 100 - 1,000 微克/天）
批量大小: 小的, 中等的, 大的
遵守: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO, ICH
地区: 欧洲
使用: 人类, 兽医
服务: 分析/质量控制服务, 制造服务, 监管服务, 开发服务, 质量保证服务
类别/产品: 寡核苷酸
OEB（职业暴露带）: 2（PDE = 1,000 - 10,000 微克/天）, 4 / HPAPI（PDE = 10 - 100 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）, 3（PDE = 100 - 1,000 微克/天）
市场: FDA (USA), EMA (EU)
批量大小: 小的, 中等的, 大的
遵守: EMA (EU GMP), MHRA (UK GMP), French Service-Public (CIR), FDA (cGMP)
地区: 欧洲
使用: 人类
服务: 分析/质量控制服务, 制造服务, 监管服务, 开发服务, 包装, 质量保证服务
市场: FDA (USA), EMA (EU), MHRA (UK)
类别/产品: 生物制剂
BSL（生物安全等级）: 1, 2
市场: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
批量大小: 小的, 中等的, 大的
类别/产品: FDF / 药品, 生物制剂
遵守: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS
地区: 欧洲
使用: 人类, 兽医
服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 开发服务, 包装, 质量保证服务
OEB（职业暴露带）: 2（PDE = 1,000 - 10,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）, 3（PDE = 100 - 1,000 微克/天）
BSL（生物安全等级）: 1, 2
市场: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
批量大小: 小的, 中等的, 大的
遵守: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
地区: 欧洲
使用: 人类, 兽医
服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 开发服务, 质量保证服务
类别/产品: 生物制剂
BSL（生物安全等级）: 1, 2
市场: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
批量大小: 小的, 中等的
地区: 欧洲
服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 开发服务
类别/产品: 生物制剂
BSL（生物安全等级）: 1
遵守: ISO
市场: ANMAT (Argentina), ANVISA (Brazil), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia)
批量大小: 小的, 中等的, 大的
类别/产品: FDF / 药品
遵守: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
受控物质: 滥用可能性最低, 降低滥用的可能性, 滥用可能性低
地区: 欧洲
使用: 人类, 兽医
服务: 分析/质量控制服务, 后勤, 制造服务, 包装, 质量保证服务
OEB（职业暴露带）: 2（PDE = 1,000 - 10,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）, 3（PDE = 100 - 1,000 微克/天）
专业治疗领域 (ATC): (M) 肌肉骨骼系统, (J) 全身使用的抗感染药, (三) 心血管系统, (A) 消化道和新陈代谢, (N) 神经系统
市场: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), 俄罗斯卫生当局, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
批量大小: 小的, 中等的
受控物质: 滥用可能性最低
地区: 欧洲
服务: 制造服务, 开发服务
类别/产品: 生物制剂
BSL（生物安全等级）: 1, 2
OEB（职业暴露带）: 1 / 低危害（PDE > 10,000 µg/天）
遵守: ISO
批量大小: 中等的
市场: EDE (UAE), FDA (USA), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), NMPA (China), Health Canada (Canada), MHRA (UK)
遵守: EMA (EU GMP), IFS, UAE Ministry of Health & Prevention, World Health Organization (GMP / HACCP), FDA (cGMP), NSF, SFDA (Saudi Food & Drug Authority), Halal Research Council
地区: 欧洲
使用: 人类, 兽医
服务: 制造服务
类别/产品: 营养保健品
HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes
HISTOCELL
Histocell 是一家西班牙 CDMO，致力于开发和制造细胞疗法、分泌组和外泌体以及医疗设备。
市场: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), 俄罗斯卫生当局, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
批量大小: 小的, 中等的
专业治疗领域 (ATC): (R) 呼吸系统, (M) 肌肉骨骼系统, (三) 心血管系统, (A) 消化道和新陈代谢, (D) 皮肤科, (N) 神经系统, (B) 血液和造血器官
类别/产品: FDF / 药品, 化妆品, 服务, 生物制剂
遵守: EMA (EU GMP), ISO
地区: 欧洲
使用: 人类, 兽医
服务: 分析/质量控制服务, 制造服务, 开发服务, 质量保证服务
BSL（生物安全等级）: 1, 2
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