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Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Seacross Pharmaceutical Co Ltd
研发中心在支持原料药和成品剂型的开发方面发挥着基础性作用。
遵守: MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF, DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
类别/产品: FDF / 药品, 化学合成
OEB（职业暴露带）: 1 / 低危害（PDE > 10,000 µg/天）, 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）
专业治疗领域 (ATC): (V04)诊断剂, (三) 心血管系统, (D) 皮肤科, (H) 全身性激素制剂，不包括。性激素和胰岛素, (J) 全身使用的抗感染药, (L) 抗肿瘤药和免疫调节剂, (M) 肌肉骨骼系统, (N) 神经系统, (P) 抗寄生虫产品、杀虫剂和驱虫剂, (R) 呼吸系统, (S) 感觉器官, (V01) 过敏原, (V06) 营养素, (V09-10)放射性药物, (B) 血液和造血器官, (A) 消化道和新陈代谢, (G) Genito泌尿系统和性激素
BSL（生物安全等级）: 3, 4, 1, 2
受控物质: 滥用和医疗用途的可能性很高, 滥用可能性最低, 滥用可能性低, 滥用可能性高且无医疗用途, 降低滥用的可能性
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
地区: 亚太地区
批量大小: 大的, 小的, 中等的
使用: 人类
Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
Seacross Pharmaceutical Co Ltd
制剂生产基地致力于复杂、高价值剂型的开发和生产。
专业治疗领域 (ATC): (V04)诊断剂, (三) 心血管系统, (D) 皮肤科, (H) 全身性激素制剂，不包括。性激素和胰岛素, (J) 全身使用的抗感染药, (L) 抗肿瘤药和免疫调节剂, (M) 肌肉骨骼系统, (N) 神经系统, (P) 抗寄生虫产品、杀虫剂和驱虫剂, (R) 呼吸系统, (S) 感觉器官, (V01) 过敏原, (V06) 营养素, (B) 血液和造血器官, (A) 消化道和新陈代谢, (G) Genito泌尿系统和性激素
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）
BSL（生物安全等级）: 3, 4, 1, 2
受控物质: 滥用和医疗用途的可能性很高, 滥用可能性最低, 滥用可能性低, 滥用可能性高且无医疗用途, 降低滥用的可能性
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
地区: 亚太地区
遵守: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), 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), SQF (Safe Quality Food), NSF
批量大小: 大的, 小的, 中等的
使用: 人类
类别/产品: 服务, FDF / 药品
受控物质: 滥用和医疗用途的可能性很高, 滥用可能性最低, 滥用可能性低, 滥用可能性高且无医疗用途, 降低滥用的可能性
市场: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), EDE (UAE), 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), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU 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, (D) 皮肤科, (J) 全身使用的抗感染药, (L) 抗肿瘤药和免疫调节剂, (M) 肌肉骨骼系统, (N) 神经系统, (P) 抗寄生虫产品、杀虫剂和驱虫剂, (A) 消化道和新陈代谢
类别/产品: FDF / 药品
OEB（职业暴露带）: 1 / 低危害（PDE > 10,000 µg/天）
受控物质: 滥用和医疗用途的可能性很高, 滥用可能性最低, 滥用可能性低, 滥用可能性高且无医疗用途, 降低滥用的可能性
市场: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), 俄罗斯卫生当局, MHRA (UK), MFDS (South Korea), TGA (Australia)
地区: 欧洲
遵守: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
使用: 人类
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, (H) 全身性激素制剂，不包括。性激素和胰岛素, (J) 全身使用的抗感染药, (N) 神经系统, (A) 消化道和新陈代谢
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
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）
BSL（生物安全等级）: 3, 4, 1, 2
受控物质: 滥用和医疗用途的可能性很高, 滥用可能性最低, 滥用可能性低, 降低滥用的可能性
市场: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)
地区: 欧洲
遵守: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), NMPA (China 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
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): (H) 全身性激素制剂，不包括。性激素和胰岛素, (L) 抗肿瘤药和免疫调节剂, (G) Genito泌尿系统和性激素
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）
BSL（生物安全等级）: 3, 4
受控物质: 滥用和医疗用途的可能性很高
遵守: ICH, ISO, ANVISA (Brazil B-GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP)
市场: EMA (EU), NMPA (China), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities
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
批量大小: 大的, 小的, 中等的
使用: 人类
专业治疗领域 (ATC): (L) 抗肿瘤药和免疫调节剂
类别/产品: FDF / 药品
化学合成 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
端到端制药 CDMO
注册后可用位置
服务 manufacturing site
MAI network supplier
液体和冻干瓶 - 两个符合附录 I 的 BSL-2 洁净室套件。
注册后可用位置
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