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Aenova Group - Location Tittmoning, Germany
德国

Aenova Group - Location Tittmoning, Germany

Aenova

能力中心常规固体大容量工厂。

市场: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)

地区: 欧洲

遵守: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP)

批量大小: Large, Medium

类别/产品: 营养保健品, FDF / 药品

使用: Human, Veterinary

服务: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

OEB(职业暴露带): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

Aenova Group - Location Sisseln, Switzerland
瑞士

Aenova Group - Location Sisseln, Switzerland

Aenova

复杂传统固体能力中心。

地区: 欧洲

市场: FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities

遵守: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), World Health Organization (GMP / HACCP), MFDS/KFDA (Republic of Korea GMP)

批量大小: Large, Small, Medium

类别/产品: 营养保健品, FDF / 药品

使用: Human

服务: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

OEB(职业暴露带): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

Aenova Group - Location Regensburg, Germany
德国

Aenova Group - Location Regensburg, Germany

Aenova

能力中心高效固体(肿瘤学)常规固体 - 特种半固体和液体。

OEB(职业暴露带): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

市场: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities

地区: 欧洲

遵守: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

批量大小: Large, Small, Medium

类别/产品: 化妆品, 营养保健品, FDF / 药品, 粒子工程

使用: Human, Veterinary

服务: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

Aenova Group - Location Münster, Germany
德国

Aenova Group - Location Münster, Germany

Aenova

能力中心低剂量高效固体(激素、类激素)、低剂量胶囊。

OEB(职业暴露带): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

市场: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities

地区: 欧洲

遵守: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

批量大小: Large, Small, Medium

使用: Human, Veterinary

服务: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

专业治疗领域 (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins

类别/产品: FDF / 药品

Aenova Group - Location Marburg, Germany
德国

Aenova Group - Location Marburg, Germany

Aenova

复杂的常规固体和麻醉品能力中心。

受控物质: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse

市场: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities

地区: 欧洲

遵守: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP)

批量大小: Large, Small, Medium

类别/产品: 营养保健品, FDF / 药品

使用: Human

服务: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

OEB(职业暴露带): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

Aenova Group - Location Latina, Italy
意大利

Aenova Group - Location Latina, Italy

Aenova

动物保健产品和无菌技术能力中心。

市场: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

服务: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

地区: 欧洲

遵守: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP)

批量大小: Large, Small, Medium

使用: Human, Veterinary

BSL(生物安全等级): 1, 2

OEB(职业暴露带): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

类别/产品: FDF / 药品

OEB(职业暴露带): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

市场: EMA (EU), FDA (USA), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)

服务: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

地区: 欧洲

遵守: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), World Health Organization (GMP / HACCP), MFDS/KFDA (Republic of Korea GMP)

批量大小: Large, Small, Medium

类别/产品: 化妆品, 营养保健品, FDF / 药品

使用: Human, Veterinary

专业治疗领域 (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V06) Nutrients, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

Aenova Group - Location Killorglin, Ireland
爱尔兰

Aenova Group - Location Killorglin, Ireland

Aenova

喷雾干燥和缓释微丸技术中心。

市场: EMA (EU), PMDA (Japan), SFDA (Saudi Arabia), MFDS (South Korea)

地区: 欧洲

遵守: ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

批量大小: Large, Small, Medium

类别/产品: 营养保健品, FDF / 药品, 粒子工程

使用: Human, Veterinary

服务: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

OEB(职业暴露带): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

Aenova Group - Location Gronau, Germany
德国

Aenova Group - Location Gronau, Germany

Aenova

传统固体和临床服务能力中心。

市场: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, EDE (UAE)

服务: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

地区: 欧洲

遵守: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), UAE Ministry of Health & Prevention, EMA (EU GMP)

批量大小: Large, Small, Medium

使用: Human, Veterinary

OEB(职业暴露带): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

类别/产品: FDF / 药品

服务: Logistics, Manufacturing services, Packaging

市场: FDA (USA), Health Canada (Canada)

遵守: FDA (cGMP), Halal Research Council, Health Canada (Canada GMP), NSF

批量大小: Large, Small, Medium

类别/产品: 营养保健品

使用: Human

地区: 北美

Aenova Group - Location Feldkirchen, Germany
德国

Aenova Group - Location Feldkirchen, Germany

Aenova

半固体和液体能力中心。

市场: EMA (EU), FDA (USA), Russian Health Authorities

地区: 欧洲

遵守: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), EMA (EU GMP)

批量大小: Large, Small, Medium

类别/产品: 化妆品, FDF / 药品

使用: Human, Veterinary

服务: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

专业治疗领域 (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system

OEB(职业暴露带): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

Aenova Group - Location Cornu, Romania
罗马尼亚

Aenova Group - Location Cornu, Romania

Aenova

软明胶胶囊和 VegaGels® 的能力中心和一站式商店。

地区: 欧洲

市场: FDA (USA), Health Canada (Canada), TGA (Australia)

遵守: FDA (cGMP), ISO, Halal Research Council, TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP)

批量大小: Large, Small, Medium

类别/产品: 营养保健品, FDF / 药品

使用: Human

服务: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

OEB(职业暴露带): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

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