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Cenexi
法国

Cenexi

Cenexi

GMP 工厂位于巴黎以东 9 公里处,占地四公顷。它是注射安瓿的卓越中心。

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), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), EDE (UAE), 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), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

批量大小: Large, Small, Medium

使用: Human, Veterinary

专业治疗领域 (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism

类别/产品: FDF / 药品

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

Cenexi Hérouville Saint Clair
法国

Cenexi Hérouville Saint Clair

Cenexi

Hérouville-Saint-Clair 工厂位于诺曼底卡昂附近,专门从事注射和非注射无菌液体的制造和灌装。

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), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), Russian Health Authorities, 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: Human

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

专业治疗领域 (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (N) Nervous system, (A) Digestive tract and metabolism

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)

批量大小: Small, Medium

类别/产品: FDF / 药品

Cenexi Laboratoires Thissen
比利时

Cenexi Laboratoires Thissen

Cenexi

这家工厂占地 8,000 平方米,占地近 7 公顷,建筑物星罗棋布,位于布鲁塞尔以南 20 公里处,拥有 340 名员工*。

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)

BSL(生物安全等级): 3, 4, 1, 2

受控物质: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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: 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, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones

类别/产品: FDF / 药品

Korott - EVP Iberia
西班牙

Korott - EVP Iberia

Korott - EVP Iberia

我们是食品补充剂开发和制造的专家:胶囊、棒状、自装袋、粉末和小瓶。

市场: EMA (EU), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), ANMAT (Argentina), INVIMA (Colombia)

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

地区: 欧洲

遵守: BRCGS, ISO, IFS, World Health Organization (GMP / HACCP)

批量大小: Large, Small, Medium

类别/产品: 化妆品, 营养保健品

使用: Human

专业治疗领域 (ATC): (V06) Nutrients

STE PRASFARMA
西班牙

STE PRASFARMA

STE PRASFARMA

CMO/CDMO 细胞抑制剂和高效产品。

OEB(职业暴露带): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

BSL(生物安全等级): 3, 4

受控物质: High potential for abuse & medical use

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

地区: 欧洲

批量大小: Large, Small, Medium

使用: Human

专业治疗领域 (ATC): (L) Antineoplastic and immunomodulating agents

类别/产品: FDF / 药品

视野有限

化学合成 manufacturing site

MAI network supplier

制药 CRO/CMO

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化学合成 manufacturing site

MAI network supplier

拥有全球认证的原料药及中间体制造商。

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视野有限

生物制剂 manufacturing site

MAI network supplier

符合 GMP 要求的生物制剂生产设施,专门生产重组酶和蛋白质。

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