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Seda Pharma Development Services
英国

Seda Pharma Development Services

Seda Pharma Development Services Ltd

Seda 药物开发服务专门从事综合药物开发和临床药理学。

专业治疗领域 (ATC): (A) 消化道和新陈代谢, (G) Genito泌尿系统和性激素, (三) 心血管系统, (D) 皮肤科, (M) 肌肉骨骼系统, (N) 神经系统, (B) 血液和造血器官

市场: TGA (Australia), 世界其他地区, 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)

批量大小: 小的, 中等的

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), 5 / HPAPI(PDE < 10 微克/天), 4 / HPAPI(PDE = 10 - 100 微克/天)

遵守: MHRA (UK GMP), ECOVADIS

类别/产品: FDF / 药品

地区: 欧洲

使用: 人类

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

PHARMALOOP S.L. - a Salvat Company
西班牙

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。

市场: EMA (EU), FDA (USA)

地区: 欧洲

遵守: FDA (cGMP), ISO, EMA (EU GMP)

批量大小: 大的, 小的, 中等的

使用: 人类

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): (S) 感觉器官, (V01) 过敏原

类别/产品: FDF / 药品, 粒子工程

OEB(职业暴露带): 1 / 低危害(PDE > 10,000 µg/天)

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 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

视野有限

FDF / 药品 manufacturing site

MAI network supplier

Lannetts 的主要生产基地位于印第安纳州西摩,拥有口服固体剂 (OSD) 和液体剂的生产能力。

注册后可用位置

视野有限

化妆品 manufacturing site

MAI network supplier

API 和关键中间体的一站式 CDMO 解决方案。

注册后可用位置

视野有限

化妆品 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。

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