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为您的药物开发和制造项目寻找高技能合作伙伴。
PHARMALOOP S.L. - a Salvat Company
Laboratorios Salvat
适用于吹-灌-封 (BFS)、无菌多剂量、非无菌多剂量、小袋、胶囊和片剂的完全集成 CDMO 解决方案。
批量大小: 小的, 中等的, 大的
类别/产品: FDF / 药品, 粒子工程
遵守: EMA (EU GMP), FDA (cGMP), ISO
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)
专业治疗领域 (ATC): (V01) 过敏原, (S) 感觉器官
BSL（生物安全等级）: 1
OEB（职业暴露带）: 1 / 低危害（PDE > 10,000 µg/天）
FDF / 药品 manufacturing site
MAI network supplier
非病毒传递计划的解决方案
注册后可用位置
FDF / 药品 manufacturing site
MAI network supplier
以色列 CDMO 专门从事复杂合成药物产品和化学医疗器械的开发和 GMP 制造。
注册后可用位置
FDF / 药品 manufacturing site
MAI network supplier
我们在药物开发过程的各个阶段通过小批量生产服务支持药物开发。
注册后可用位置
这些设施符合您的主要标准，但不符合所有可选过滤器。
市场: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), 俄罗斯卫生当局, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)
遵守: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)
使用: 人类
批量大小: 大的, 小的, 中等的
服务: 分析/质量控制服务, 包装, 质量保证服务, 制造服务
OEB（职业暴露带）: 3（PDE = 100 - 1,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）, 2（PDE = 1,000 - 10,000 微克/天）
受控物质: 滥用和医疗用途的可能性很高
类别/产品: FDF / 药品, 服务
地区: 欧洲
市场: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)
服务: 后勤, 开发服务, 制造服务, 分析/质量控制服务, 质量保证服务, 监管服务, 包装
地区: 欧洲
遵守: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
批量大小: 大的, 小的, 中等的
使用: 人类, 兽医
BSL（生物安全等级）: 1, 2
OEB（职业暴露带）: 2（PDE = 1,000 - 10,000 微克/天）, 3（PDE = 100 - 1,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）
类别/产品: 生物制剂, FDF / 药品
市场: EMA (EU), MHRA (UK), TGA (Australia)
地区: 欧洲
使用: 人类, 兽医
BSL（生物安全等级）: 1
服务: 开发服务, 制造服务, 分析/质量控制服务, 质量保证服务, 监管服务, 包装
OEB（职业暴露带）: 4 / HPAPI（PDE = 10 - 100 微克/天）, 2（PDE = 1,000 - 10,000 微克/天）, 3（PDE = 100 - 1,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）
批量大小: 小的, 中等的
遵守: EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
类别/产品: FDF / 药品
BSL（生物安全等级）: 3, 1, 2
市场: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), 俄罗斯卫生当局, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), 世界其他地区
服务: 后勤, 开发服务, 制造服务, 分析/质量控制服务, 质量保证服务, 监管服务, 包装
遵守: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
批量大小: 大的, 小的, 中等的
使用: 人类, 兽医
受控物质: 滥用可能性最低
OEB（职业暴露带）: 4 / HPAPI（PDE = 10 - 100 微克/天）, 2（PDE = 1,000 - 10,000 微克/天）, 3（PDE = 100 - 1,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）
地区: 北美
类别/产品: FDF / 药品
市场: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), 俄罗斯卫生当局, MHRA (UK), INVIMA (Colombia), SFDA (Saudi Arabia), TGA (Australia)
地区: 亚太地区, MENA, 拉丁美洲, 欧洲, 北美
遵守: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
批量大小: 大的, 中等的
使用: 人类, 兽医
BSL（生物安全等级）: 1
服务: 开发服务, 制造服务, 分析/质量控制服务, 质量保证服务, 监管服务, 包装
专业治疗领域 (ATC): (J) 全身使用的抗感染药
受控物质: 滥用可能性最低
OEB（职业暴露带）: 2（PDE = 1,000 - 10,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）
类别/产品: FDF / 药品
市场: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
服务: 后勤, 开发服务, 制造服务, 分析/质量控制服务, 质量保证服务, 监管服务, 包装
地区: 欧洲
遵守: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
批量大小: 大的, 小的, 中等的
使用: 人类, 兽医
专业治疗领域 (ATC): (三) 心血管系统, (M) 肌肉骨骼系统, (N) 神经系统, (A) 消化道和新陈代谢
受控物质: 滥用可能性最低, 滥用可能性低, 降低滥用的可能性
OEB（职业暴露带）: 2（PDE = 1,000 - 10,000 微克/天）, 3（PDE = 100 - 1,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）
类别/产品: FDF / 药品
OEB（职业暴露带）: 5 / HPAPI（PDE < 10 微克/天）, 4 / HPAPI（PDE = 10 - 100 微克/天）, 2（PDE = 1,000 - 10,000 微克/天）, 3（PDE = 100 - 1,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）
市场: EMA (EU)
地区: 欧洲
使用: 人类
BSL（生物安全等级）: 1, 2
服务: 制造服务, 包装
批量大小: 小的, 中等的
遵守: EMA (EU GMP)
类别/产品: 生物制剂, FDF / 药品
BSL（生物安全等级）: 3, 1, 2
市场: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)
地区: 欧洲
批量大小: 大的, 中等的
使用: 人类, 兽医
服务: 开发服务, 制造服务, 分析/质量控制服务, 质量保证服务, 监管服务, 包装
专业治疗领域 (ATC): (三) 心血管系统, (D) 皮肤科, (J) 全身使用的抗感染药, (N) 神经系统, (R) 呼吸系统, (A) 消化道和新陈代谢
受控物质: 滥用可能性最低, 滥用可能性低, 降低滥用的可能性
遵守: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
OEB（职业暴露带）: 2（PDE = 1,000 - 10,000 微克/天）, 3（PDE = 100 - 1,000 微克/天）, 1 / 低危害（PDE > 10,000 µg/天）
类别/产品: FDF / 药品
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