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SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland
瑞士

SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland

Senn Chemicals

瑞士肽和肽中间体研发基地,拥有 SPPS、LPPS、混合合成、公斤级实验室放大、纯化和分析。

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

地区: 欧洲

类别/产品: 化妆品, 化学合成, 服务, 粒子工程

批量大小: Small

SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland
瑞士

SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland

Senn Chemicals

小型 GMP 肽和有机合成实验室,适用于需要灵活 cGMP 生产的临床、利基和高价值项目。

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

地区: 欧洲

类别/产品: 化学合成, 粒子工程

批量大小: Small

SENN Chemicals | GMP Production | Dielsdorf, Switzerland
瑞士

SENN Chemicals | GMP Production | Dielsdorf, Switzerland

Senn Chemicals

瑞士 cGMP 生产基地,用于从试点到早期商业规模的 LPPS、SPPS 和混合肽生产。

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, Medium

类别/产品: 化学合成, 粒子工程

SENN India | Non-GMP Plant | Hyderabad, India
印度

SENN India | Non-GMP Plant | Hyderabad, India

Senn Chemicals

用于肽中间体、有机合成、LPPS 操作和扩大生产的大型非 GMP 生产基地。

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

地区: 亚太地区

批量大小: Large, Small, Medium

类别/产品: 化妆品, 化学合成, 服务, 粒子工程

SENN India | R&D Lab | Hyderabad, India
印度

SENN India | R&D Lab | Hyderabad, India

Senn Chemicals

肽和有机化学研发中心,提供 SPPS、纯化、冻干、分析和颗粒工程支持。

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

地区: 亚太地区

类别/产品: 化学合成, 粒子工程

批量大小: Small

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
西班牙

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

倍内酰胺抗生素 (FDF) 开发和制造拥有最先进的设施。

市场: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Russian Health Authorities, 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: Large, Medium

使用: Human, Veterinary

BSL(生物安全等级): 1

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

专业治疗领域 (ATC): (J) Antiinfectives for systemic use

受控物质: Lowest potential for abuse

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

类别/产品: FDF / 药品

Laboratorios Grifols | Barcelona Plant
西班牙

Laboratorios Grifols | Barcelona Plant

Grifols International

软袋和小瓶中的无菌生产解决方案(小分子)。

市场: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), 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, 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: Large, Small, Medium

使用: Human, Veterinary

专业治疗领域 (ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism

受控物质: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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

White Raven - Legiapark
比利时

White Raven - Legiapark

White Raven

专门用于 GMP 配方和无菌液体注射剂无菌灌装的灌装和加工场地。

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)

地区: 欧洲

使用: Human

BSL(生物安全等级): 1, 2

服务: Manufacturing services, Packaging

批量大小: Small, Medium

遵守: EMA (EU GMP)

类别/产品: 生物制剂, FDF / 药品

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
西班牙

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

注射剂(液和液体)和液体生产设施。

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: Large, 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): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism

受控物质: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

类别/产品: FDF / 药品

Sylentis
西班牙

Sylentis

Sylentis

寡核苷酸生产商。

遵守: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)

市场: EMA (EU), FDA (USA)

地区: 欧洲

批量大小: Large, Small, Medium

使用: Human, Veterinary

类别/产品: 寡核苷酸

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

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)

VIVEbiotech
西班牙

VIVEbiotech

VIVEbiotech

您领先的 GMP 认证 CDMO 专门致力于慢病毒载体的生产。

市场: EMA (EU), FDA (USA), MHRA (UK)

地区: 欧洲

遵守: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)

批量大小: Large, Small, Medium

使用: Human

BSL(生物安全等级): 1, 2

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

类别/产品: 生物制剂

Viswa Laboratories Pvt Ltd
印度

Viswa Laboratories Pvt Ltd

Viswa Laboratories Private Limited

CRAMS/CDMO、API、中间体和特种化学品。

市场: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)

地区: 亚太地区

批量大小: Large, Small, Medium

使用: Human, Veterinary

BSL(生物安全等级): 1, 2

类别/产品: 化学合成

服务: Development services, Manufacturing services

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

受控物质: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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)

遵守: World Health Organization (GMP / HACCP)

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